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Reef TO/TA System: When used as an intervertebral body fusion device, the Reef TO/TA System with NanoMetalene® surface technology is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had six months of non-operative treatment. The device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fission and supplemental fixation.

Regatta Lateral System: Interbody Device (IBD) Implants (i.e., interbody implants used alone): The Regatta Lateral System with NanoMetalene® surface technology is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD, defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies). It is intended for use at ether one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of DDD with up to Grade 1 spondylolisthesis at the involved level(s). The interior of the interbody spacer component may be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, corticocancellous bone or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The Regatta Lateral System is intended for use with supplemental fixation. TruProfile Interbody Implants: The Regatta Lateral System assembled with the TruProfile Lateral Plate, when used with Screws, is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the spacer component may be packed with autogenous bone graff and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The Regatta Lateral System assembled with the 1 - hole TruProfile Lateral Plate, when used with Screws, is intended for use with supplemental fixation.

Explorer TO System: When used as an intervertebral body fusion device, the system is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in sketally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had six months of non-operative treatment. The device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion and supplemental fixation.

WaveForm C Interbody System: The WaveForm C Interbody System are interbody fusion devices intended for use in skeletally mature patient with degenerative disc disease (DDD) of the cervical spine (C2-T1) for multiple contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. When used as a standalone system, the WaveForm C Interbody System, which includes the 2,3,4-hole TruProfile plates and 2-hole No-profile interfixated spacer, is intended to be used as an adjunct to spinal fusion procedures at multiple contiguous levels of the cervical spine (C2-T1) and must be used with bone screw fixation and locking covers. When the WaveForm C Interbody (excluding 2-hole No-profile interfixated spacer) is used with supplemental fixation, such as anterior cervical plates, the WaveForm C Interbody System is intended to be used as an adjunct to spinal fusion procedures at multiple contiguous levels of the cervical spine (C2-T1).

WaveForm TO Interbody System: When used as an intervertebral body fusion device, the system is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had six months of non-operative treatment. The device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cortical, cancellous, and/or corticocancellous bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion and supplemental fixation.

WaveForm TA Interbody System: When used as an intervertebral body fusion device, the system is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had six months of non-operative treatment. The device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cortical, cancellous, and/or corticocancellous bone or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion and supplemental fixation.

FORZA XP Expandable Spacer: FORZA XP Expandable Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved levels. These patients may have had a previous non-fusion surgery at the involved level(s). FORZA XP Expandable Spacer System is intended for use with autograft comprised of cancellous, cortical, and/or corticocancellous bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion and supplemental fixation. Patients must have undergone a regimen of at least six months of non-operative treated with FORZA XP Expandable Spacer System.

Shoreline ACS and RT Interbody System: Shoreline ACS Interbody System: The Shoreline ACS Interbody System with NanoMetalene® surface technology are interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) for multiple contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature had at least six (6) weeks of non-operative treatment. These devicesare to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone or a bone void filler as cleared by FDA for use in intervertebral body fusion. When used as a standalone system, the Shoreline ACS Interbody System, which includes the TruProfile plates and Noprofile spacer, is intended to be used as an adjunct to spinal fusion procedures at multiple contiguous levels of the cervical spine (C2-T1) and must be used with bone screw fixation and locking covers. The Shoreline ACS interbody spacers with > 20° lordosis are intended to be used with supplemental fixation. When the Shoreline ACS Interbody (excluding the No-profile spacer) is used with supplemental fixation, such as anterior cervical plates, the Shoreline ACS Interbody System is intended to be used as an adjunct to spinal fusion procedures at multiple contiguous levels of the cervical spine (C2-T1). Shoreline RT Interbody System: The Shoreline RT Interbody System with NanoMetalene® surface technology are interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) for multiple contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. When used as a standalone system, the Shoreline RT Interbody System, which includes the TruProfile plates, is intended to be used as an adjunct to spinal fusion procedures at multiple contiguous levels of the (C2-T1) and must be used with bone screw fixation and locking covers. The Shoreline RT interbody spacers with ≥ 20° lordosis are intended to be used with supplemental fixation. When the Shoreline RT Interbody System is used with supplemental fixation, such as anterior cervical plates, the Shoreline RT Interbody System is intended to be used as an adjunct to spinal fusion procedures at multiple contiguous levels of the cervical spine (C2-T1).

Meridian Interbody System: Interbody Device (IBD) Implants (i.e., interbody implants used alone): The Meridian System with NanoMetale@ surface technology when used with or without a Spin Plate, is indicated for use as an adjunct to fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients should be skeletally mature and have had at least six (6) months of non-operative treatment. The interded to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. The Meridian Interbody is intended for use with supplemental fixation. No-Profile Interbody Implants with Screws: The Meridian System 2-Hole No-profile Interbody, when used with Screws and with or without a No-profile Locking Cover, is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The interbody is intended to be used with autogenous bone graft and/or allogeneic bone graft composed cancellous, cortical, and/or corticocancellous bone or a bone void filler as cleared by FDA for use in intervertebral body fusion. The Meridian System 2-Hole and 3-Hole No-profile Interbody must be used with the maximum number of screws allowed. Hyperlordotic sizes (greater than 20°) are intended for use with supplemental fixation. The Meridian System 4-Hole No-profile Interbody, when used with or without a No-profile Locking Cover, is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The interbody is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. The Meridian System 4-Hole No-profile Interbody may be used as a standalone device only when at least two Screws are inserted with one inferior and one superior screw traiectory. If the surgeon chooses to use the 4-Hole No-profile Interbody with fewer than two Screws inserted with one inferior and one superior screw trajectory, then additional supplemental fixation system must be used. Hyperlordotic sizes (greater than 20°) are intended for use with supplemental fixation. No-Profile Interbody Implants with Inline Fixation Anchors: The Meridian System No-profile Interbody, when used with Inline Fixation Anchors and a No-profile Locking Cover, is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The interbody is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, corticocancellous bone or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. The Meridian System No-profile Interbody with Inline Fixation Anchors is intended for use with supplemental fixation. TruProfile Interbody Implants: The Meridian System TruProfile Interbody assembled with the Anterior Plate, when used with Screws, an Anterior Plate Locking Cover, and with or without a Spin Plate, is a standalone indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The interbody is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. Hyperlordotic sizes (greater than 20°) are intended for use with supplemental fixation.

WaveForm A Interbody System: Interbody Device (IBD) Implants (i.e., interbody implants used alone): The WaveForm A System Interbody, when used with or without a Spin Plate, is indicated for use as an adjunct to fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients should be skeletally mature and have had at least six (6) months of non-operative treatment. The interbody is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. The WaveForm A System Interbody is intended for use with supplemental fixation. No-profile Interbody Implants with Screws: The WaveForm A System 2-Hole and 3-Hole No-profile Interbody, when used with Screws and with or without a No-profile Locking Cover, is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The interbody is intended to be used with autogenous bone graft and/or allogeneic bone graft composed cancellous, cortical, and/or corticocancellous bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. The WaveForm A System 2-Hole and 3-Hole No-profile Interbody must be used with the maximum number of screws allowed. Hyperloriosis sizes (greater than 20°) are intended for use with supplemental fixation. The WaveForm A System 4-Hole No-profile Interbody, when used with Screws and with or without a No-profile Locking Cover, is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients must have undergone a regimen of at least six (6) months of non-overative treatment prior to being treated with the device. The interbody is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. The WaveForm A System 4-Hole No-profile Interbody may be used as a standalone device only when at least two Screws are inserted with one inferior and one superior screw traiectory. If the surgeon chooses to use the 4-Hole No-profile Interbody with fewer than two Screws inserted with one inferior and one superior screw trajectory, then additional supplemental fixation system must be used. Hyperlordotic sizes (greater than 20°) are intended for use with supplemental fixation. No-profile Interbody Implants with Inline Fixation Anchors: The WaveForm A System No-profile Interbody, when used with Inline Fixation Anchors and with a No-profile Locking Cover, is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radios. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. The WaveForm A System No-profile Interbody with Inline Fixation Anchors is intended for use with supplemental fixation. TruProfile Interbody Implants: The WaveForm A System TruProfile Interbody assembled with the Anterior Plate, when used with Screws, an Anterior Plate Locking Cover, and with or without a Spin Plate, is a standalone indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The interbody is intended to be used with autogenous bone graft composed of cancellous, cortical. and/ or corticocancellous bone or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. Hyperlordotic sizes (greater than 20°) are intended for use with supplemental fixation.

Reef TO/TA System: The Reef TO/TA Interbody System featuring NanoMetalene® surface technology consists of straight, rectangular-shaped (Reef TO) and curved, banana-shaped (Reef TA), posterior lumbar intervertebral body fusion devices manufactured from polyetheretherketone (PEEK) (per ASTM F2026) with tantalum (per ASTM F560) markers for radiographic visualization and NanoMetalene, which is a one-micron thick surface laver of commercially pure titanium (per ASTM F67) that provides a microscopic roughened surface with nano-scale features. The interbody spacers are available in a variety of footprints, and lordotic options to accommodate variations in pathology and patient anatomy and include a central graft window for receiving autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical. and/or corticocancellous bone or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. The spacers are individually packaged and gamma sterilized. The system includes the associated non-sterile instruments that facilitate the placement, adjustment, and removal, if necessary, of the system implants as well as trays and caddies that may be used for storage, protection, and organization prior to and during the steam sterilization process for the non-sterile components.

Regatta Lateral System: The Regatta Lateral System featuring NanoMetalene surface technology consists of lateral lumbar intervertebral body fusion devices manufactured from polyetheretherketone (PEEK) (ASTM F2026) with from tantalum (per ASTM F560) radiographic markers and a one-micron thick surface layer of commercially pure titanium (per ASTM F67). The interbody spacers are available in a variety of footprints, heights, and lordotic options to accommodate variations in pathology and patient anatomy and include central graft windows for receiving autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion and supplemental fixation. The spacers are individually packaged and gamma sterilized. The Regatta Lateral interbody spacers can be used alone with supplemental fixation or in combination with fixation implants (i.e., plates, screws, and locking covers) to create the TruProfile Interbody configuration. The fixation implants are manufactured from titanium alloy (Ti-6A1-4V ELI per ASTM F136) and provided non-sterile. The system includes the associated non-sterile instruments that facilitate the placement, adjustment, and removal, if necessary, of the system implants as well as trays and caddies that may be used for storage, protection, and organization prior to and during the steam sterilization process for the non-sterile components.

Explorer TO System: The Explorer TO System is a lumbar intervertebral body fusion device used to act as a disc spacer and hold bone graft to promote fusion in the lumbar spine. The system consists of non-sterile implants manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136). The system is comprised of height expandable and lordotic expandable interbody spacers, and both configurations are available in a range of lengths, widths, heights, and lordotic angles. The system includes the associated non-sterile instruments that facilitate the placement, adjustment, and removal, if necessary, of the system implants as well as travs and caddies that mav be used for storage, protection, and organization prior to and during the steam sterilization process for the non-sterile components.

WaveForm C Interbody System: The WaveForm C Interbody System consists of anterior cervical intervertebral body fusion devices additively manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F3001). The interbody spacers are offered in a variety of footprints, heights, and lordotic options to accommodate variations in pathology and patient anatomy. The spacers, which include a central graft window for receiving autogenous bone graft and/or allogenic bone graft material, are individually packaged and gamma sterilized. The WaveForm C Interbody System can be used with supplemental fixation, such as an anterior plate, or as a standalone construct in combination with the Shoreline ACS Interbody System non-sterile fixation implants (i.e., plates, bone screws, and locking covers) to create the TruProfile and No-profile configurations. The fixation implants are manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136). The system includes the associated non-sterile instruments that facilitate the placement, adjustment, and removal, if necessary, of the system implants as well as trays and caddies that may be used for storage, protection, and organization prior to and during the steam sterilization process for the non-sterile components.

WaveForm TO Interbody System: The WaveForm TO Interbody System consists of posterior lumbar intervertebral body fusion devices additively manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F3001). The straight, rectangular-shaped interbody spacers are available in a variety of footprints, heights, and lordotic options to accommodate variations in pathology and patient anatomy and include a central graft window for receiving autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. The spacers are individually packaged and gamma sterilized. The system includes the associated non-sterile instruments that facilitate the placement, adjustment, and removal, if necessary, of the system implants as well as trays and caddies that may be used for storage, protection, and organization prior to and during the steam sterilization process for the non-sterile components.

WaveForm TA Interbody System: The WaveForm TA Interbody System consists of posterior lumbar intervertebral body fusion devices additively manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F3001). The curved, banana-shaped interbody spacers are available in a variety of footprints, heights, and lordotic options to accommodate variations in pathology and patient anatomy and include a central graft window for receiving autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. The spacers are individually packaged and gamma sterilized. The system includes the associated non-sterile instruments that facilitate the placement, adjustment, and removal, if necessary, of the system implants as well as trays and caddies that may be used for storage, protection, and organization prior to and during the steam sterilization process for the non-sterile components.

FORZA XP Expandable Spacer System: The FORZA XP Expandable Spacer System is comprised of an assortment of single-use spacers made from titanium alloy and PEEK polymer with height expansion capability. The implants feature a bulleted nose for ease of insertion and anti-migration ripples on both the inferior and superior surfaces to provide increased stability and help prevent anterior/posterior movement of the device. FORZA XP spacers are provided in both sterile and non-sterile configurations. The implants are offered in non-lordotic, lordotic, and hyperlordotic configurations to help restore the natural curvature of the spine. The implants can be used in single placement or pairs with typical approaches being transforaminal lumbar interbody fusion (TLIF) and posterior lumbar interbody fusion (PLIF). The FORZA XP Expandable Spacer System is not intended to be used as a stand-alone device and must be used with a supplemental fixation system.

Shoreline ACS Interbody System: The Shoreline ACS Interbody System featuring NanoMetalene® surface technology consists of anterior cervical intervertebral body fusion devices manufactured from polyetheretherketone (PEEK) (per ASTM F2026) with tantalum (per ASTM F560) and/or titanium alloy (Ti-6Al-4V ELI per ASTM F136) markers for radiographic visualization and NanoMetalene, which is a onemicron thick surface layer of commercially pure titanium (per ASTM F67) that provides a microscopic roughened surface with nano-scale features. The interbody spacers are offered in a variety of footprints, heights, and lordotic options to accommodate variations in pathology and patient anatomy. The spacers, which include a central graft window for receiving autogenous bone graft and/or allogenic bone graft material or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion and supplemental fixation, are individually packaged and gamma sterilized. The Shoreline ACS Interbody System can be used with supplemental fixation, such as an anterior plate, or as a standalone construct in combination with non-sterile fixation implants (i.e., plates, bone screws, and locking covers) to create the TruProfile configurations. The fixation implants are manufactured from titanium allov (Ti-6Al-4V ELI per ASTM F136). The system includes the associated non-sterile instruments that facilitate the placement, adjustment, and removal, if necessary, of the system implants as well as travs and caddies that mav be used for storage, protection, and organization prior to and during the steam sterilization process for the non-sterile components.

Shoreline RT Interbody System: The Shoreline RT Interbody System featuring NanoMetalene® surface technology consists of anterior cervical intervertebral body fusion devices manufactured from polyetheretherketone (PEEK) (per ASTM F2026) with tantalum (per ASTM F560) and/or titanium alloy (Ti-6A1-4V ELI per ASTM F136) markers for radiographic visualization and NanoMetalene, which is a onemicron thick surface layer of commercially pure titanium (per ASTM F67) that provides a microscopic roughened surface with nano-scale features. The interbody spacers are offered in a variety of footprints, heights, and lordotic options to accommodate variations in pathology and patient anatomy. The spacers, which include a central graft window for receiving autogenous bone graft and/or allogenic bone graft material or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion and supplemental fixation, are individually packaged and gamma sterilized. The Shoreline RT Interbody System can be used with supplemental fixation, such as an anterior plate, or as a standalone construct in combination with the Shoreline ACS Interbody System nonsterile fixation implants (i.e., plates, bone screws, and locking covers) to create the TruProfile configuration. The fixation implants are manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136). The system includes the associated non-sterile instruments that facilitate the placement, adjustment, and removal, if necessary, of the system implants as well as trays and caddies that may be used for storage, protection, and organization prior to and during the steam sterilization process for the non-sterile components.

Meridian Interbody System: The Meridian Interbody System featuring NanoMetalene® surface technology consists of anterior lumbar intervertebral body fusion devices manufactured from polyetheretherketone (PEEK) (per ASTM F2026) with tantalum (per ASTM F560) and titanium alloy (Ti-6Al-4V ELI per ASTM F136) markers for radiographic visualization and NanoMetalene, which is a one-micron thick surface layer of commercially pure titanium (per ASTM F67). NanoMetalene surface technology provides a microscopic roughened surface with nano-scale features. The interbody spacers are available in a variety of footprints, heights, and lordotic options to accommodate variations in pathology and patient anatomy and include a central graft window for receiving autogenous and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion and supplemental fixation. The spacers are individually packaged and gamma sterilized. The Meridian Interbody System spacers can be used alone with supplemental fixation or in combination with fixation implants to create the TruProfile and No-profile Interbody configurations. Fixation implants include Anterior Plates, Screws, Inline Fixation Anchors, Anterior Plate Locking Covers, and No-profile Locking Covers, all of which are manufactured from titanium alloy (Ti-6A1-4V ELI per ASTM F136) and provided non-sterile. The system includes the associated non-sterile instruments that facilitate the placement, adjustment, and removal, if necessary, of the system implants as well as travs and caddies that mav be used for storage, protection, and organization prior to and during the steam sterilization process for the non-sterile components.

WaveForm A Interbody System: The WaveForm A Interbody System consists of anterior lumbar intervertebral body fusion devices additively manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F3001). The interbody spacers are offered in a variety of footprints. heights, and lordotic options to accommodate variations in pathology and patient anatomy as well as with and without a sodium hydroxide (NaOH) surface treatment that provides a microscopic, roughened surface with nanoscale features. The interbody spacers, which include a central graft window for receiving autogenous and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion and supplemental fixation, are individually packaged and gamma sterilized. The WaveForm A Interbody System spacers can be used alone with supplemental fixation or in combination with fixation implants to create the TruProfile and No-profile Interbody configurations. Fixation implants include Anterior Plates, Screws, Inline Fixation Anchors, Anterior Plate Locking Covers, and No-profile Locking Covers, all of which are manufactured from titanium alloy (Ti-6A1-4V ELI per ASTM F136) and provided non-sterile. The system includes the associated non-sterile instruments that facilitate the placement, adjustment, and removal, if necessary, of the system implants as well as trays and caddies that may be used for storage, protection, and organization prior to and during the steam sterilization process for the non-sterile components.

Here's an analysis of the provided text regarding acceptance criteria and study information:

Based on the provided text, the submission is not about a medical device with an artificial intelligence/machine learning (AI/ML) component or software. The text describes various intervertebral body fusion devices, their indications for use, and their technological characteristics. The "performance testing summary" explicitly states:

"The purpose of this submission is to expand the indications for use of the Orthofix Medical Inc. Interbody System devices to include use in the use of a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. Because the subject device is identical to the previously cleared primary predicate devices (K231076. K221751. K203714. K231735), it was determined that existing testing data is adequate to support the expanded indications proposed in the current submission."

This indicates that the submission relies on comparison to predicate devices and existing testing data for mechanical and material properties, rather than new studies demonstrating software performance, AI efficacy, or human-in-the-loop improvements. Therefore, most of the requested information regarding acceptance criteria for AI models, sample sizes for test/training sets, expert ground truth, adjudication methods, and MRMC studies are not applicable.

However, I can extract the relevant information about the "acceptance criteria" and the "study" that proves the device meets them in the context of this 510(k) submission, even without an AI component.

Acceptance Criteria and Device Performance (in the context of a 510(k) "Substantial Equivalence" claim):

Study Information (Based on the provided Text):

1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

   • Not Applicable in the traditional sense for testing an AI model. This submission relies on a claim of "substantial equivalence" to predicate devices. There is no new test set of patient data being evaluated for the device's performance because the device itself (hardware) hasn't changed, only the allowable bone graft material. The "testing data" referenced is existing data from the predicate devices. The document does not specify the provenance of this existing data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

   • Not applicable. There is no "test set" in the context of an AI model requiring expert-established ground truth. The acceptance is based on engineering principles, material science, and comparison to legally marketed predicate devices.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable. See point 2.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No. This is not an AI/ML device, so an MRMC study is not relevant to this submission.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • No. This is not an AI/ML device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not applicable for an AI ground truth. The "ground truth" for this type of submission is the established safety and effectiveness of the predicate devices for their stated indications, combined with engineering and material testing data demonstrating their mechanical properties and biocompatibility.

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML device.

8. How the ground truth for the training set was established:

   • Not applicable. This is not an AI/ML device.

Summary regarding AI/ML:

The provided document describes a 510(k) submission for intervertebral body fusion devices. The core of the submission is to expand the indications for use of these existing devices to include the use of bone void fillers. The approval is based on demonstrating substantial equivalence to previously cleared predicate devices, asserting that the subject devices are "identical in all respects except for the indications for use" and that "existing testing data is adequate." Therefore, this document does not contain information related to AI/ML acceptance criteria, performance studies, or ground truth establishment.

Ask a specific question about this device

Shoreline ACS Interbody System: The Shoreline ACS Interbody System with NanoMetalene® surface technology are interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) for multiple contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone. When used as a standalone system, the Shoreline ACS Interbody System, which includes the TruProfile plates and Noprofile spacer, is intended to be used as an adjunct to spinal fusion procedures at multiple contiguous levels of the cervical spine (C2-T1) and must be used with bone screw fixation and locking covers. The Shoreline ACS interbody spacers with > 20° lordosis are intended to be used with supplemental fixation. When the Shoreline ACS Interbody (excluding the No-profile spacer) is used with supplemental fixation, such as anterior cervical plates, the Shoreline ACS Interdody System is intended to be used as an adjunct to spinal fusion procedures at multiple contiguous levels of the cervical spine (C2-T1).

Shoreline RT Interbody System: The Shoreline RT Interbody System with NanoMetalene® surface technology are interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) for multiple contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone. When used as a standalone system, the Shoreline RT Interbody System, which includes the TruProfile plates, is intended to be used as an adjunct to spinal fusion procedures at multiple contiguous levels of the cervical spine (C2-T1) and must be used with bone screw fixation and locking covers. The Shoreline RT interbody spacers with ≥ 20° lordosis are intended to be used with supplemental fixation. When the Shoreline RT Interbody System is used with supplemental fixation, such as anterior cervical plates, the Shoreline RT Interbody System is intended to be used as an adjunct to spinal fusion procedures at multiple contiguous levels of the cervical spine (C2-T1).

Regatta Lateral System: Interbody Device (IBD) Implants (i.e., interbody implants used alone): The Regatta Lateral System with NanoMetalene® surface technology is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD, defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies). It is intended for use at ether one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of DDD with up to Grade 1 spondylolisthesis at the involved level(s). The interior of the interbody spacer component may be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The Regatta Lateral System is intended for use with supplemental fixation. TruProfile Interbody Implants: The Regatta Lateral System assembled with the TruProfile Lateral Plate, when used with Screws, is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the spacer component may be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The Regatta Lateral System assembled with the 1- hole TruProfile Lateral Plate, when used with Screws, is intended for use with supplemental fixation.

Reef L Interbody System: Interbody Device (IBD) Implants (i.e., interbody implants used alone): The Reef L Interbody System with NanoMetalene® surface technology is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD, defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies). It is intended for use at evel or two contiguous levels in the lumbar spine, from L1 to S1, for the treatment of DDD with up to Grade 1 spondylolisthesis at the involved level(s). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The interbody is intended to be used with autogenous bone graft and/or allogence bone graft composed of cancellous, cortical, and/or corticocancellous bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. The Reef L Interbody System is intended for use as an adjunct to fusion in the thoracolumbar spine from T1 to T12 and at the thoracolumbar junction (T12-L1) for the treatment of symptomatic disc degeneration (DDD) or degenerative spondylolisthesis at one or two contiguous levels, including thoracic disc herniation (with myelopathy and/or radiculopathy with or without axial pain). DDD is defined as back pain of discogenc origin with degeneration of the disc confirmed by history and radiographic studies. The Reef L Interbody System can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. The Reef L Interbody System is intended for use with supplemental fixation. Hyperlordotic sizes (greater than 200) must be used with legally marketed anterior supplemental fixation. TruProfile Interbody Implants (i.e., interbody implants used with TruProfile Plates): The Reef L Interbody System assembled with the TruProfile Lateral Plate, when used with Screws, is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L1 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients must have undergone a regimen of at least six (6) months of nonoperative treatment prior to being treated with the device. The interded to be used with autogenous bone graft, allogeneic bone graft composed of cancellous, corticocancellous bone or a bone void filler as cleared by FDA for use in intervertebral body fusion. The Reef L Interoody System assembled with the TruProfile Lateral Plate, when used with Screws, can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. The Reef L Interbody System assembled with the 1-Hole TruProfile Lateral Plate, when used with a single Screw, is intended for use with additional legally marketed anterior or posterior supplemental fixation.

Reef TO/TA System: When used as an intervertebral body fusion device, the Reef TO/TA System with NanoMetalene® surface technology is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenc origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had six months of non-operative treatment. The device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone and supplemental fixation.

Meridian Interbody System: Interbody Device (IBD) Implants (i.e., interbody implants used alone): The Meridian System with NanoMetalene® surface technology when used with or without a Spin Plate, is indicated for use as an adjunct to fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients should be skeletally mature and have had at least six (6) months of non-operative treatment. The interded to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. The Meridian Interbody is intended for use with supplemental fixation. No-Profile Interbody Implants with Screws: The Meridian System 2-Hole No-profile Interbody, when used with Screws and with or without a No-profile Locking Cover, is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenc origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The interbody is intended to be used with autogenous bone graft and/or allogeneic bone graft composed cancellous, cortical, and/or corticocancellous bone. The Meridian System 2-Hole No-profile Interbody must be used with the maximum number of screws allowed. Hyperlordotic sizes (greater than 20°) are intended for use with supplemental fixation. The Meridian System 4-Hole No-profile Interbody, when used with or without a No-profile Locking Cover, is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenc origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The interbody is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. The Meridian System 4-Hole No-profile Interbody may be used as a standalone device only when at least two Screws are inserted with one inferior and one superior screw trajectory. If the surgeon chooses to use the 4-Hole No-profile Interbody with fewer than two Screws inserted with one inferior and one superior screw trajectory, then additional supplemental fixation system must be used. Hyperlordotic sizes (greater than 20°) are intended for use with supplemental fixation. No-profile Interbody Implants with Inline Fixation Anchors: The Meridian System No-profile Interbody, when used with Inline Fixation Anchors and a No-profile Locking Cover, is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The interded to be used with autogenous bone graft and/or allogence bone graft composed of cancellous, corticocancellous bone. The Meridian System No-profile Interbody with Inline Fixation Anchors is intended for use with supplemental fixation. TruProfile Interbody Implants: The Meridian System TruProfile Interbody assembled with the Anterior Plate, when used with Screws, an Anterior Plate Locking Cover, and with or without a Spin Plate, is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1.

WaveForm C Interbody System: The WaveForm C Interbody System are interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) for multiple contiguous levels. DDD is defined as discogenc pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone. When used as a standalone system, the WaveForm C Interbody System, which includes the 2,3,4-hole TruProfile plates and 2-hole No-profile interfixated spacer, is intended to be used as an adjunct to spinal fusion procedures at multiple contiguous levels of the cervical spine (C2-T1) and must be used with bone screw fixation and locking covers. When the WaveForm C Interbody System (excluding 2-hole No-profile interfixated spacer) is used with supplemental fixation, such as anterior cervical plates, the WaveForm C Interbody System is intended to be used as an adjunct to spinal fusion procedures at multiple contiguous levels of the cervical spine (C2-T1).

WaveForm L Interbody System: Interbody Device (IBD) Implants (i.e., interbody implants used alone): The WaveForm L Interbody System is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD, defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies). It is intended for use at either one level or two contiguous levels in the lumbar spine, from L1 to S1, for the treatment of DDD with up to Grade 1 spondylolisthesis at the involved level(s). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The interbody is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and or corticocancellous bone or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. The WaveForm L Interbody System is intended for use as an adjunct to fusion in the thoracolumbar spine from T1 to T12 and at the thoracolumbar junction (T12-L1) for the treatment of symptomatic disc degenerative spondylolisthesis at one or two contiguous levels, including thoracic disc herniation (with myelopathy and/or radiculopathy with or without axial pain). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The WaveForm L Interbody System can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. The WaveForm L Interbody System is intended for use with supplemental fixation. Hyperlordotic sizes (greater than 20°) must be used with legally marketed anterior supplemental fixation. TruProfile Interbody Implants (i.e., interbody implants used with TruProfile Plates): The WaveForm L Interbody System assembled with the TruProfile Lateral Plate, when used with Screws, is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L1 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients must have undergone a regimen of at least six (6) months of nonoperative treatment prior to being treated with the device. The interbody is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. The WaveForm L Interbody System assembled with the TruProfile Lateral Plate, when used with Screws, can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. The WaveForm L Interbody System assembled with the 1-Hole TruProfile Lateral Plate, when used with a single Screw, is intended for use with additional legally marketed anterior or posterior supplemental fixation.

WaveForm TO Interbody System: When used as an intervertebral body fusion device, the system is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had six months of non-operative treatment. The device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone and supplemental fixation.

WaveForm TA Interbody System: When used as an intervertebral body fusion device, the system is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had six months of non-operative treatment. The device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone and supplemental fixation.

WaveForm A Interbody System: Interbody Device (IBD) Implants (i.e., interbody implants used alone): The WaveForm A System Interbody, when used with or without a Spin Plate, is indicated for use as an adjunct to fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients should be skeletally mature and have had at least six (6) months of non-operative treatment. The interbody is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. The WaveForm A System Interbody is intended for use with supplemental fixation. No-profile Interbody Implants with Screws: The WaveForm A System 2-Hole No-profile Interbody, when used with Screws and with or without a No-profile Locking Cover, is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The interbody is intended to be used with autogenous bone graft and/or allogeneic bone graft composed cancellous, cortical, and/or corticocancellous bone. The WaveForm A System 2-Hole and 3-Hole No-profile Interbody must be used with the maximum number of screws allowed. Hyperlordotic sizes (greater than 20°) are intended for use with supplemental fixation. The WaveForm A System 4-Hole No-profile Interbody, when used with or without a No-profile Locking Cover, is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The interbody is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. The WaveForm A System 4-Hole No-profile Interbody may be used as a standalone device only when at least two Screws are inserted with one inferior and one superior screw trajectory. If the surgeon chooses to use the 4-Hole No-profile Interbody with fewer than two Screws inserted with one inferior and one superior screw trajectory, then additional supplemental fixation system must be used. Hyperlordotic sizes (greater than 20°) are intended for use with supplemental fixation. No-profile Interbody Implants with Inline Fixation Anchors: The WaveForm A System No-profile Interbody, when used with Inline Fixation Anchors and with a No-profile Locking Cover, is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The interded to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. The WaveForm A System No-profile Interbody with Inline Fixation Anchors is intended for use with supplemental fixation. TruProfile Interbody Implants: The WaveForm A System TruProfile Interbody assembled with the Anterior Plate, when used with Screws, an Anterior Plate Locking Cover, and with or without a Spin Plate, is a standalone indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients must have undergone a regimen of at least six (6) months of nonoperative treatment prior to being treated with the device. The interbody is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/ or corticocancellous bone. Hyperlordotic sizes (greater than 20°) are intended for use with supplemental fixation.

Shoreline ACS Interbody System: The Shoreline ACS Interbody System featuring NanoMetalene surface technology consists of anterior cervical intervertebral body fusion devices manufactured from polyetheretherketone (PEEK) (per ASTM F2026) with tantalum (per ASTM F560) and/or titanium alloy (Ti-6Al-4V EU per ASTM F136) markers for radiographic visualization and NanoMetalene, which is a one-micron thick surface layer of commercially pure titanium (per ASTM F67) that provides a microscopic roughened surface with nano-scale features. The interbody spacers are offered in a variety of footprints, heights, and lordotic options to accommodate variations in pathology and patient anatomy. The spacers, which include a central graft window for receiving autogenous bone graft and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone, are individually packaged and gamma sterilized. The Shoreline ACS Interbody System can be used with supplemental fixation, such as an anterior plate, or as a standalone construct in combination with non-sterile fixation implants (i.e., plates, bone screws, and locking covers) to create the TruProfile configurations. The fixation implants are manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136). The system includes the associated non-sterile instruments that facilitate the placement, adjustment, and removal, if necessary, of the system implants as well as trays and caddies that may be used for storage, protection, and organization prior to and during the steam sterilization process for the non-sterile components.

Shoreline RT Interbody System: The Shoreline RT Interbody System featuring NanoMetalene surface technology consists of anterior cervical intervertebral body fusion devices manufactured from polyetheretherketone (PEEK) (per ASTM F2026) with tantalum (per ASTM F560) and/or titanium alloy (Ti-6Al-4V ELI per ASTM F136) markers for radiographic visualization and NanoMetalene, which is a one-micron thick surface layer of commercially pure titanium (per ASTM F67) that provides a microscopic roughened surface with nano-scale features. The interbody spacers are offered in a variety of footprints, heights, and lordotic options to accommodate variations in pathology and patient anatomy. The spacers, which include a central graft window for receiving autogenous bone graft and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone, are individually packaged and gamma sterilized. The Shoreline RT Interbody System can be used with supplemental fixation, such as an anterior plate, or as a standalone construct in combination with the Shoreline ACS Interbody System nonsterile fixation implants (i.e., plates, bone screws, and locking covers) to create the TruProfile configuration. The fixation implants are manufactured from titanium alloy (Ti-6AI-4V ELI per ASTM F136). The system includes the associated non-sterile instruments that facilitate the placement, adjustment, and removal, if necessary, of the system implants as well as trays and caddies that may be used for storage, protection, and organization prior to and during the steam sterilization process for the non-sterile components.

Regatta Lateral System: The Regatta Lateral System featuring NanoMetalene surface technology consists of lateral lumbar intervertebral body fusion devices manufactured from polyetheretherketone (PEEK) (ASTM F2026) with from tantalum (per ASTM F560) radiographic markers and a one-micron thick surface layer of commercially pure titanium (per ASTM F67). The interbody spacers are available in a variety of footprints, heights, and lordotic options to accommodate variations in pathology and patient anatomy and include central graft windows for receiving autogenous bone graft and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone. The spacers are individually packaged and gamma sterilized. The Regatta Lateral interbody spacers can be used alone with supplemental fixation or in combination with fixation implants (i.e., plates, screws, and locking covers) to create the TruProfile Interbody configuration. The fixation implants are manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136) and provided non-sterile. The system includes the associated non-sterile instruments that facilitate the placement, adjustment, and removal, if necessary, of the system implants as well as trays and caddies that may be used for storage, protection, and organization prior to and during the steam sterilization process for the non-sterile components.

Reef L Interbody System: The Reef L Interbody System featuring NanoMetalene surface technology consists of lateral lumbar intervertebral body fusion devices manufactured from polyetheretherketone (PEEK) (per ASTM F2026) with tantalum (per ASTM F560) markers for radiographic visualization and NanoMetalene, which is a one-micron thick surface layer of commercially pure titanium (per ASTM F67) that provides a microscopic roughened surface with nano-scale features. The interbody spacers are available in a variety of footprints, heights, and lordotic options to accommodate variations in pathology and patient anatomy and include central graft windows for receiving autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. The spacers are individually packaged and gamma sterilized. The Reef L interbody spacers can be used alone with supplemental fixation or in combination with fixation implants (i.e., plates, screws, and locking covers) to create the TruProfile Interbody configuration. The fixation implants are manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136) and provided non-sterile. The system includes the associated non-sterile instruments that facilitate the placement, adjustment, and removal, if necessary, of the system implants as well as trays and caddies that may be used for storage, protection, and organization prior to and during the steam sterilization process for the non-sterile components.

Reef TO/TA System: The Reef TO/TA Interbody System featuring NanoMetalene surface technology consists of straight, rectangular-shaped (Reef TO) and curved, banana-shaped (Reef TA), posterior lumbar intervertebral body fusion devices manufactured from polyetheretherketone (PEEK) (per ASTM F2026) with tantalum (per ASTM F560) markers for radiographic visualization and NanoMetalene, which is a one-micron thick surface layer of commercially pure titanium (per ASTM F67) that provides a microscopic roughened surface with nano-scale features. The interbody spacers are available in a variety of footprints, heights, and lordotic options to accommodate variations in pathology and patient anatomy and include a central graft window for receiving autogenous bone graft and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone. The spacers are individually packaged and gamma sterilized. The system includes the associated non-sterile instruments that facilitate the placement, adjustment, and removal, if necessary, of the system implants as well as trays and caddies that may be used for storage, protection, and organization prior to and during the steam sterilization process for the non-sterile components.

Meridian Interbody System: The Meridian Interbody System featuring NanoMetalene surface technology consists of anterior lumbar intervertebral body fusion devices manufactured from polyetheretherketone (PEEK) (per ASTM F2026) with tantalum (per ASTM F560) and titanium alloy (Ti-6Al-4V ELI per ASTM F136) markers for radiographic visualization and NanoMetalene, which is a one-micron thick surface layer of commercially pure titanium (per ASTM F67). NanoMetalene surface technology provides a microscopic roughened surface with nano-scale features. The interbody spacers are available in a variety of footprints, heights, and lordotic options to accommodate variations in pathology and patient anatomy and include a central graft window for receiving autogenous and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone. The spacers are individually packaged and gamma sterilized. The Meridian Interbody System spacers can be used alone with supplemental fixation or in combination with fixation implants to create the TruProfile and No-profile Interbody configurations. Fixation implants include Anterior Plates, Screws, Inline Fixation Anchors, Anterior Plate Locking Covers, and No-profile Locking Covers, all of which are manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136) and provided non-sterile. The system includes the associated non-sterile instruments that facilitate the placement, adjustment, and removal, if necessary, of the system implants as well as trays and caddies that may be used for storage, protection, and organization prior to and during the steam sterilization process for the non-sterile components.

WaveForm C Interbody System: The WaveForm C Interbody System consists of anterior cervical intervertebral body fusion devices additively manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F3001). The interbody spacers are offered in a variety of footprints, heights, and lordotic options to accommodate variations in pathology and patient anatomy. The spacers, which include a central graft window for receiving autogenous bone graft and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone, are individually packaged and gamma sterilized. The WaveForm C Interbody System can be used with supplemental fixation, such as an anterior plate, or as a standalone construct in combination with the Shoreline ACS Interbody System nonsterile fixation implants (i.e., plates, bone screws, and locking covers) to create the TruProfile and No-profile configurations. The fixation implants are manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136). The system includes the associated non-sterile instruments that facilitate the placement, adjustment, and removal, if necessary, of the system implants as well as trays and caddies that may be used for storage, protection, and organization prior to and during the steam sterilization process for the non-sterile components.

WaveForm L Interbody System: The WaveForm L Interbody System consists of lateral lumbar intervertebral body fusion devices additively manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F3001). The interbody spacers are available in a variety of footprints, heights, and lordotic options to accommodate variations in pathology and patient anatomy and include a central graft window for receiving autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion. The spacers are individually packaged and gamma sterilized. The WaveForm L interbody spacers can be used alone with supplemental fixation or in combination with fixation implants (i.e., plates, screws, and locking covers) to create the TruProfile Interbody configuration. The fixation implants are manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136) and provided non-sterile. The system includes the associated non-sterile instruments that facilitate the placement, adjustment, and removal, if necessary, of the system implants as well as trays and caddies that may be used for storage, protection, and organization prior to and during the steam sterilization process for the non-sterile components.

WaveForm TO Interbody System: The WaveForm TO Interbody System consists of posterior lumbar intervertebral body fusion devices additively manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F3001). The straight, rectangular-shaped interbody spacers are available in a variety of footprints, and lordotic options to accommodate variations in pathology and patient anatomy and include a central graft window for receiving autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. The spacers are individually packaged and gamma sterilized. The system includes the associated non-sterile instruments that facilitate the placement, adjustment, and removal, if necessary, of the system implants as well as trays and caddies that may be used for storage, protection, and organization prior to and during the steam sterilization process for the non-sterile components.

WaveForm TA Interbody System: The WaveForm TA Interbody System consists of posterior lumbar intervertebral body fusion devices additively manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F3001). The curved, banana-shaped interbody spacers are available in a variety of footprints, heights, and lordotic options to accommodate variations in pathology and patient anatomy and include a central graft window for receiving autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. The spacers are individually packaged and gamma sterilized. The system includes the associated non-sterile instruments that facilitate the placement, adjustment, and removal, if necessary, of the system implants as well as trays and caddies that may be used for storage, protection, and organization prior to and during the steam sterilization process for the non-sterile components.

WaveForm A Interbody System: The WaveForm A Interbody System consists of anterior lumbar intervertebral body fusion devices additively manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F3001). The interbody spacers are offered in a variety of footprints, heights, and lordotic options to accommodate variations in pathology and patient anatomy as well as with and without a sodium hydroxide (NaOH) surface treatment that provides a microscopic, roughened surface with nanoscale features. The interbody spacers, which include a central graft window for receiving autogenous and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone, are individually packaged and gamma sterilized. The WaveForm A Interbody System spacers can be used alone with supplemental fixation or in combination with fixation implants to create the TruProfile and No-profile Interbody configurations. Fixation implants include Anterior Plates, Screws, Inline Fixation Anchors, Anterior Plate Locking Covers, and No-profile Locking Covers, all of which are manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136) and provided non-sterile. The system includes the associated non-sterile instruments that facilitate the placement, adjustment, and removal, if necessary, of the system implants as well as trays and caddies that may be used for storage, protection, and organization prior to and during the steam sterilization process for the non-sterile components.

This is a 510(k) premarket notification for a medical device, specifically a family of intervertebral body fusion devices. This type of submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than presenting novel clinical efficacy data that would typically involve acceptance criteria for device performance as an AI/ML algorithm.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth, expert adjudication, and MRMC studies is not applicable in the context of this FDA clearance document. This document primarily addresses the mechanical and material characteristics of the devices and their equivalence to existing technologies.

However, I can extract information related to the demonstration of substantial equivalence:

1. A table of acceptance criteria and the reported device performance

Since this is a 510(k) for an interbody fusion device, the acceptance criteria relate to manufacturing, materials, and mechanical performance, rather than algorithm performance. The document states:

• "The subject and predicate systems are identical in regard to intended use/indications for use and technological characteristics, including operating principle, design and components, manufacturing, biocompatibility, labeling, sterility, and non-clinical testing (i.e., mechanical performance)."
• "The subject systems differ from the predicate systems in regard to an additional sterile packaging configuration, which does not raise questions of safety and effectiveness as demonstrated through non-clinical testing."

Non-Clinical Testing Acceptance Criteria (Implied by equivalence to predicate devices and additional testing):

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable. The document describes a medical device, not an AI/ML algorithm. The "testing" refers to mechanical, material, and packaging assessments, not evaluation against a "test set" of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable. There is no mention of a test set with ground truth established by experts. The determination is based on substantial equivalence to predicate devices, which involves regulatory review of engineering and manufacturing data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. There is no test set or adjudication method described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. This is not an AI-assisted device, nor does the submission involve a MRMC comparative effectiveness study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This information is not applicable. No ground truth in the context of an AI/ML algorithm is relevant here. The "ground truth" for these devices would be established engineering and material standards, and the successful performance of predicate devices.

8. The sample size for the training set

This information is not applicable. This is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable. This is not an AI/ML algorithm that requires a training set or its associated ground truth establishment.

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Meridian Interbody System
Interbody Device (IBD) Implants (i.e., interbody implants used alone):
The Meridian System with NanoMetalene® surface technology when used with or without a Spin Plate, is indicated for use as an adjunct to fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenc origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients should be skeletally mature and have had at least six (6) months of non-operative treatment. The interbody is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. The Meridian Interbody is intended for use with supplemental fixation.
No-Profile Interbody Implants with Screws:
The Meridian System 2-Hole No-profile Interbody, when used with Screws and with or without a No-profile Locking Cover, is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenc origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The interbody is intended to be used with autogenous bone graft and/or allogeneic bone graft composed cancellous, cortical, and/or corticocancellous bone. The Meridian System 2-Hole No-profile Interbody must be used with the maximum number of screws allowed. Hyperlordotic sizes (greater than 20°) are intended for use with supplemental fixation.
The Meridian System 4-Hole No-profile Interbody, when used with or without a No-profile Locking Cover, is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenc origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The interbody is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. The Meridian System 4-Hole No-profile Interbody may be used as a standalone device only when at least two Screws are inserted with one inferior and one superior screw trajectory. If the surgeon chooses to use the 4-Hole No-profile Interbody with fewer than two Screws inserted with one inferior and one superior screw trajectory, then additional supplemental fixation system must be used. Hyperlordotic sizes (greater than 20°) are intended for use with supplemental fixation.
No-Profile Interbody Implants with Inline Fixation Anchors:
The Meridian System No-profile Interbody, when used with Inline Fixation Anchors and a No-profile Locking Cover, is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The interbody is intended to be used with autogenous bone graft and/or allogenee bone graft composed of cancellous, cortical, and/or corticocancellous bone. The Meridian System No-profile Interbody with Inline Fixation Anchors is intended for use with supplemental fixation.
TruProfile Interbody Implants:
The Meridian System TruProfile Interbody assembled with the Anterior Plate, when used with Screws, an Anterior Plate Locking Cover, and with or without a Spin Plate, is a standalone indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The interbody is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. Hyperlordotic sizes (greater than 20°) are intended for use with supplemental fixation.
WaveForm A Interbody System
Interbody Device (IBD) Implants (i.e., interbody implants used alone):
The WaveForm A System Interbody, when used with or without a Spin Plate, is indicated for use as an adjunct to fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients should be skeletally mature and have had at least six (6) months of non-operative treatment. The interded to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. The WaveForm A System Interbody is intended for use with supplemental fixation.
No-profile Interbody Implants with Screws:
The WaveForm A System 2-Hole No-profile Interbody, when used with Screws and with or without a Noprofile Locking Cover, is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiosraphic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The interbody is intended to be used with autogenous bone graft and/or allogeneic bone graft composed cancellous, cortical, and/or corticocancellous bone. The WaveForm A System 2-Hole No-profile Interbody must be used with the maximum number of screws allowed. Hyperlordotic sizes (greater than 20°) are intended for use with supplemental fixation.
The WaveForm A System 4-Hole No-profile Interbody, when used with or without a No-profile Locking Cover, is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenc origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The interbody is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. The WaveForm A System 4-Hole No-profile Interbody may be used as a standalone device only when at least two Screws are inserted with one inferior and one superior screw trajectory. If the surgeon chooses to use the 4-Hole No-profile Interbody with fewer than two Screws inserted with one inferior and one superior screw trajectory, then additional supplemental fixation system must be used. Hyperlordotic sizes (greater than 20°) are intended for use with supplemental fixation.
No-profile Interbody Implants with Inline Fixation Anchors:
The WaveForm A System No-profile Interbody, when used with Inline Fixation Anchors and with a No Profile Locking Cover, is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The interbody is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. The WaveForm A System No-profile Interbody with Inline Fixation Anchors is intended for use with supplemental fixation.
TruProfile Interbody Implants:
The WaveForm A System TruProfile Interbody assembled with the Anterior Plate, when used with Screws, an Anterior Plate Locking Cover, and with or without a Spin Plate, is a standalone indicated for use as adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The interbody is intended to be used autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/ or corticocancellous bone. Hyperlordotic sizes (greater than 20°) are intended for use with supplemental fixation.

Meridian Interbody System
The Meridian Interbody System featuring NanoMetalene® surface technology consists of anterior intervertebral body fusion devices manufactured from polyetheretherketone (PEEK) (per ASTM F2026) with tantalum (per ASTM F560) and titanium alloy (Ti-6Al-4V ELI per ASTM F136) markers for radiographic visualization and NanoMetalene, which is a one-micron thick surface layer of commercially pure titanium (per ASTM F67). NanoMetalene surface technology provides a microscopic roughened surface with nano-scale features. The interbody spacers are available in a variety of footprints, heights, and lordotic options to accommodate variations in pathology and patient anatomy and include a central graft window for receiving autogenous and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone. The spacers are individually packaged and gamma sterilized.
The Meridian Interbody System spacers can be used alone with supplemental fixation or in combination with fixation implants to create the TruProfile and No-profile Interbody configurations. Fixation implants include Anterior Plates, Screws, Inline Fixation Anchors, Anterior Plate Locking Covers, and No-profile Locking Covers, all of which are manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136) and provided non-sterile.
The system includes the associated non-sterile instruments that facilitate the placement, adjustment, and removal, if necessary, of the system implants as well as trays and caddies that may be used for storage, protection, and organization prior to and during the steam sterilization process for the non-sterile components.
WaveForm A Interbody System
The WaveForm A Interbody System consists of anterior intervertebral body fusion devices additively manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F3001). The interbody spacers are offered in a variety of footprints, heights, and lordotic options to accommodate variations in pathology and patient anatomy as well as with and without a sodium hydroxide (NaOH) surface treatment that provides a microscopic, roughened surface with nanoscale features. The interbody spacers, which include a central graft window for receiving autogenous and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone, are individually packaged and gamma sterilized.
The WaveForm A Interbody System spacers can be used alone with supplemental fixation or in combination with fixation implants to create the TruProfile and No-profile Interbody configurations. Fixation implants include Anterior Plates, Screws, Inline Fixation Anchors, Anterior Plate Locking Covers, and No-profile Locking Covers, all of which are manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136) and provided non-sterile.
The system includes the associated non-sterile instruments that facilitate the placement, adjustment, and removal, if necessary, of the system implants as well as trays and caddies that may be used for storage, protection, and organization prior to and during the steam sterilization process for the non-sterile components.

The provided text is a 510(k) summary for the SeaSpine Orthopedics Corporation's Meridian Interbody System and WaveForm A Interbody System. This document assesses the substantial equivalence of these spinal implants to existing predicate devices based on non-clinical testing (mechanical performance). It is not an AI/ML medical device submission. Therefore, it does not contain the information required to answer the specific questions about acceptance criteria for an AI/ML device, such as:

• A table of acceptance criteria and reported device performance (for AI/ML metrics like sensitivity, specificity, AUC)
• Sample size for the test set and data provenance (images, clinical data for AI/ML evaluation)
• Number of experts and their qualifications for establishing ground truth for an AI/ML test set
• Adjudication method for an AI/ML test set
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study results
• Standalone performance (algorithm only) for an AI/ML device
• Type of ground truth used (for AI/ML context)
• Sample size for the training set (for AI/ML)
• How ground truth for the training set was established (for AI/ML)

The document explicitly states: "Clinical Testing: Not applicable. The determination of substantial equivalence is not based on an assessment of clinical performance data." and focuses on "Non-Clinical Testing" demonstrating "substantially equivalent mechanical performance".

Therefore, I cannot provide an answer that addresses the requested aspects of acceptance criteria and study design for an AI/ML medical device based on the given text.

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Interbody Device (IBD) Implants (i.e., interbody implants used alone):

The SeaSpine Meridian System with NanoMetalene® surface technology when used with or without a Spin Plate, is indicated for use as an adjunct to fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the device is to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. The SeaSpine Meridian Interbody is intended for use with supplemental fixation. Degenerative disc disease is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and at least six (6) months of non-operative treatment.

No-Profile Implants w/ Screws:

The SeaSpine Meridian System No-Profile Interbody, when used with or without a No-Profile Locking Cover, is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the spacer component may be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. Hyperlordotic sizes (greater than 20 degrees) are intended for use with supplemental fixation.

No-Profile Implants w/ Inline Fixation Anchors:

The SeaSpine Meridian System No-Profile Interbody, when used with Inline Fixation Anchors and a No Profile Locking Cover, is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the spacer component may be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The SeaSpine Meridian No-Profile Implants w/ Inline Fixation Anchors is intended for use with supplemental fixation.

TruProfile Interbody Implants:

The SeaSpine Meridian System Interbody assembled with the Anterior Plate, when used with Screws, an Anterior Plate Locking Cover, and with or without a Spin Plate, is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the spacer component may be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. Patients must have undergone a regimen of at least six (6) months of nonoperative treatment prior to being treated with the device. Hyperlordotic sizes (greater than 20 degrees) are intended for use with supplemental fixation.

Meridian Anterior Plate System

The Meridian Anterior Plate System is indicated as additional support during fusion via an anterior or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (11-51) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, lordosis, spinal stenosis, or a failed previous spine surgery.

The SeaSpine Meridian System featuring NanoMetalene® surface technology are single-use intervertebral body fusion devices manufactured from polyetheretherketone (PEEK) (per ASTM F2026) with tantalum (per ASTM F560) and/or titanium alloy (Ti-6Al-4V ELI per ASTM F136) markers for radiographic visualization and NanoMetalene, which is a one-micron thick surface layer of commercially pure titanium (per ASTM F67). NanoMetalene surface technology provides a microscopic roughened surface with nano-scale features. The spacers are available in a variety of footprints, heights, and lordotic configurations to accommodate variations in pathology and patient anatomy and include a central graft window for receiving autogenous bone graft and/or allogenic bone graft, composed of cancellous, cortical, and/or corticocancellous bone prior to implantation. The spacers are individually packaged in a double PETG/Tyvek tray configuration and gamma sterilized. The Meridian System spacers can be used in combination with Spin Plates, Anterior Plates, Anterior Plate Locking Covers, Screws, Inline Fixation Anchors, and/or No-Profile Locking Covers; these implants are manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136) and are provided non-sterile.

The Meridian Anterior Plate System is comprised of single-use Anterior Plates, Screws, and Anterior Locking Covers, which are shared with the aforementioned Meridian SeaSpine System. The plates are offered in various heights and configurations, and they have no superior or inferior orientation requirement. The implants are manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136) and are provided non-sterile.

This document is a 510(k) Premarket Notification from the FDA for the SeaSpine Meridian System and Meridian Anterior Plate System. It describes the devices but does not contain information about acceptance criteria and a study to prove they meet the criteria in the way typically associated with AI/ML medical devices (e.g., performance metrics, ground truth, expert review).

The document states:
"Clinical Testing: Not applicable. The determination of substantial equivalence is not based on an assessment of clinical performance data."

Therefore, I cannot provide the requested information for acceptance criteria and a study proving device performance, as this type of data is explicitly stated as not applicable for this submission. The submission relies on demonstrating substantial equivalence to existing predicate devices through technological characteristics and non-clinical mechanical testing.

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When used as an intervertebral body fusion device, the SeaSpine Spacer System with NanoMetalene® surface technology is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had six months of nonoperative treatment. The device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone and supplemental fixation.

The SeaSpine Cambria NanoMetalene® Surface technology is intended to be used as an adjunct to spinal fusion procedures at one or two contiguous levels (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain with discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Patients should have received at least six weeks of non-operative treatment prior to treatment with the device. Devices are intended to be implanted via an open, anterior approach and used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone and supplemental fixation, such as an anterior plating system.

The SeaSpine Vu aPOD-L NanoMetalene Intervertebral Body Fusion Device with NanoMetalene® surface technology is indicated for use as an adjunct to fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The device is to be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. The SeaSpine Vu a POD-L NanoMetalene Intervertebral Body Fusion Device is intended for use with supplemental fixation that is in addition to the integrated buttress spin plate, such as a pedicle screw system or anterior plate. Degenerative disc disease is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment.

When used as an intervertebral body fusion device, the SeaSpine Vu e•POD System with NanoMetalene® surface technology is indicated for use as an adjunct to fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The device is indicated for use with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. The SeaSpine Vu e · POD System is intended for use with supplemental fixation. Degenerative disc disease (DDD) is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

When used as a vertebral body replacement (VBR), the SeaSpine Vu e-POD System is indicated for use in the thoracolumbar spine (TI-LS) to replace a collapsed, damaged, or otherwise unstable vertebral body due to tumor or trauma (i.e., fracture). The SeaSpine Vu e-POD System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. The device is indicated for use with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. The SeaSpine Vu e•POD System is intended for use with supplemental internal spinal fixation.

Interbody Device (IBD) Implants (i.e., interbody implants used alone): The SeaSpine Regatta Lateral System with NanoMetalene surface technology is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD, defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies). It is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of DDD with up to Grade 1 spondylolisthesis at the involved level(s). The interior of the interbody spacer component may be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The SeaSpine Regatta Lateral System is intended for use with supplemental fixation.

TruProfile Interbody Implants: The SeaSpine Regatta Lateral System assembled with the TruProfile Lateral Plate, when used with Screws, is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the spacer component may be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The SeaSpine Regatta Lateral System assembled with the 1-hole TruProfile Lateral Plate, when used with Screws, is intended for use with supplemental fixation.

When used with the bone screws, the SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device with NanoMetalene® surface technology is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the interbody spacer component may be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone.

When used with the SpinPlate, the SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the interbody spacer component may be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. When used with the SpinPlate, the SeaSpine Vu a•POD Prime NanoMetalene IntervertebralBody Fusion Device is intended for use with supplemental fixation.

The SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, when used with the bone screws or the bone screws and the SpinPlate, is a stand-alone device. If the SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device is used only with the SpinPlate, then additional supplemental fixation, which has been cleared by the FDA for use in the lumbar spine, must be used to augment stability. Additionally, implants with hyperlordotic angles of >20° must also be used with additional supplemental fixation (e.g., posterior pedicle screw and rod systems). This device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device.

The Shoreline ACS (Anterior Cervical System) with NanoMetalene® surface technology are interbody fusion devices intended for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The Shoreline ACS implants are to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone and implanted via an anterior approach. The device is to be used in patients who have had at least six (6) weeks of nonoperative treatment.

When used as a standalone system, Shoreline ACS is intended to be used as an adjunct to spinal fusion procedures at one level (C2-T1) and must be used with the Shoreline ACS bone screw fixation and locking cover.

When used with supplemental fixation, such as anterior cervical plates, the Shoreline Cervical low profile (TruProfile) Interbody Spacer is intended to be used as an adjunct to spinal fusion procedures at one or two levels of the cervical spine (C2-T1).

The Shoreline Cervical Interbody RT System with NanoMetalene® surface technology are interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) for one or two contiguous levels, depending on the system. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. These devices are to be filled with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone.

When used as a standalone system, the Shoreline Cervical Interbody RT System is intended to be used as an adjunct to spinal fusion procedures at a single level (C2-T1) and must be used with the Shoreline ACS bone screw fixation and locking cover.

When used with supplemental fixation, such as anterior cervical plates, the Shoreline Cervical Interbody RT System is intended to be used as an adjunct to spinal fusion procedures at one or two levels of the cervical spine (C3-C7).

When the system is used at two contiguous levels, the Shoreline Cervical Interbody RT System must be used with supplemental fixation.

When used as an intervertebral body fusion device, the SeaSpine Reef TO/TA System with NanoMetalene® surface technology is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had six months of nonoperative treatment. The device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone and supplemental fixation.

The SeaSpine Reef TH System with NanoMetalene® surface technology is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had six months of nonoperative treatment. The device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone and supplemental fixation.

Interbody Device (IBD) Implants (i.e., interbody implants used alone): The SeaSpine Meridian System with NanoMetalene® surface technology interbody is indicated for use as an adjunct to fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the device is to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. The SeaSpine Meridian Interbody is intended for use with supplemental fixation. Degenerative disc disease is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment.

No-Profile Implants w/ Screws: The SeaSpine Meridian System No-Profile Interbody, when used with Screws and a No-Profile Locking Cover, is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the spacer component may be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. Hyperlordotic sizes (25 and 30 degrees) are intended for use with supplemental fixation.

No-Profile Implants w/ Inline Fixation Anchors: The SeaSpine Meridian System No-Profile Interbody, when used with Inline Fixation Anchors and a No Profile LockingCover, is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the spacer component may be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The SeaSpine Meridian No-Profile Implants w/ Inline Fixation Anchors is intended for use with supplemental fixation.

TruProfile Interbody Implants: The SeaSpine Meridian System Interbody assembled with the Anterior Plate, when used with Screws and an Anterior Plate Locking Cover, is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the spacer component may be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. Patients must have undergone a regimen of at least six (6) months of nonoperative treatment prior to being treated with the device. Hyperlordotic sizes (25 and 30 degrees) are intended for use with supplemental fixation.

The SeaSpine NanoMetalene Systems are single-use intervertebral fusion devices made from polyetheretherketone (PEEK per ASTM F2026) with markers (tantalum per ASTM F560 or Ti-6AI-4V ELI per ASTM F136) for radiographic visualization. The devices have a central canal for receiving autogenous bone graft and or allogenic bone graft, composed of cancellous, cortical, and/or corticocancellous bone prior to implantation. The devices are offered in a variety of sizes and geometries to accommodate variations in pathology and patient anatomy and are provided sterile-packed.

The provided text is a 510(k) Premarket Notification from the FDA, declaring "substantial equivalence" for various SeaSpine intervertebral body fusion devices. This document focuses on demonstrating that the new devices are as safe and effective as previously cleared predicate devices, primarily through comparison of design, materials, and existing performance standards.

Crucially, this document does not describe a clinical study (like an MRMC or standalone study) to prove specific device performance against acceptance criteria for an AI/imaging device. It's about a spinal implant system, not an AI-powered diagnostic or therapeutic device. Therefore, the requested information about acceptance criteria, test set characteristics, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details for an AI-based device is not present in this document.

The "Non-Clinical Testing" section mentions demonstrating equivalent mechanical performance to predicate systems in accordance with ASTM standards (F1978, F1147, F1160, F1044), and equivalent biocompatibility and sterility. These are engineering design and material testing standards, not clinical performance metrics for an AI algorithm.

In summary, this document is entirely about a medical device (spinal intervertebral body fusion devices), not an AI/imaging device. As such, the information required to answer your specific questions about AI acceptance criteria and study details is not available within the provided text.

Ask a specific question about this device

When used as an intervertebral body fusion device, the SeaSpine Spacer System with NanoMetalene® surface technology is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had six months of non-operative treatment. The device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone and supplemental fixation.

The SeaSpine Vu aºPOD-L NanoMetalene Intervertebral Body Fusion Device with NanoMetalene® surface technology is indicated for use as an adjunct to fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The device is to be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. The SeaSpine Vu a•POD-L NanoMetalene Intervertebral Body Fusion Device is intended for use with supplemental fixation that is in addition to the integrated buttress spin plate, such as a pedicle screw system or anterior plate. Degenerative disc disease is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment.

When used as an intervertebral body fusion device, the SeaSpine Vu e•POD System with NanoMetalene® surface technology is indicated for use as an adjunct to fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The device is indicated for use with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. The SeaSpine Vu e•POD System is intended for use with supplemental fixation. Degenerative disc disease (DDD) is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

When used as a vertebral body replacement (VBR), the SeaSpine Vu e•POD System is indicated for use in the thoracolumbar spine (TI-L5) to replace a collapsed, damaged, or otherwise unstable vertebral body due to tumor or trauma (i.e., fracture). The SeaSpine Vu e•POD System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. The device is indicated for use with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. The SeaSpine Vu e POD System is intended for use with supplemental internal spinal fixation.

When used with the bone screws, the SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device with NanoMetalene® surface technology is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the interbody spacer component may be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone.

When used with the SpinPlate, the SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the interbody spacer component may be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. When used with the SpinPlate, the SeaSpine Vu a POD Prime NanoMetalene Intervertebral Body Fusion Device is intended for use with supplemental fixation.

The SeaSpine Vu aºPOD Prime NanoMetalene Intervertebral Body Fusion Device, when used with the bone screws or the bone screws and the SpinPlate, is a stand-alone device. If the SeaSpine Vu aºPOD Prime NanoMetalene Intervertebral Body Fusion Device is used only with the SpinPlate, then additional supplemental fixation, which has been cleared by the FDA for use in the lumbar spine, must be used to augment stability. Additionally, implants with hyperlordotc angles of >20 must also be used with additional supplemental fixation (e.g., posterior pedicle screw and rod systems). This device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone.

Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device.

The Shoreline ACS (Anterior Cervical System) with NanoMetalene® surface technology are interbody fusion devices intended for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The Shoreline ACS implants are to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone and implanted via an anterior approach. The device is to be used in patients who have had at least six (6) weeks of non-operative treatment.

When used as a standalone system, Shoreline ACS is intended to be used as an adjunct to spinal fusion procedures at one level (C2-T1) and must be used with the Shoreline ACS bone screw fixation and locking cover.

When used with supplemental fixation, such as anterior cervical plates, the Shoreline Cervical low profile (TruProfile) Interbody Spacer is intended to be used as an adjunct to spinal fusion procedures at one or two levels of the cervical spine (C2-T1).

The SeaSpine Cambria System is intended to be used as an adjunct to spinal fusion procedures at one or two contiguous levels (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain with discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Patients should have received at least six weeks of non-operative treatment with the device. Devices are intended to be implanted via an open, anterior approach and used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone and supplemental fixation, such as an anterior plating system.

The SeaSpine Cambria NanoMetalene System with NanoMetalene® surface technology is intended to be used as an adjunct to spinal fusion procedures at one or two contiguous levels (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain with discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Patients should have received at least six weeks of non-operative treatment prior to treatment with the device. Devices are intended to be implanted via an open, anterior approach and used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone and supplemental fixation, such as an anterior plating system.

Interbody Device (IBD) Implants (i.e., interbody implants used alone):

The SeaSpine Regatta Lateral System with NanoMetalene® surface technology is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD, defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies). It is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of DDD with up to Grade 1 spondylolisthesis at the involved level(s). The interior of the interbody spacer component may be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device.

The SeaSpine Regatta Lateral System is intended for use with supplemental fixation.

TruProfile Interbody Implants:

The SeaSpine Regatta Lateral System assembled with the TruProfile Lateral Plate, when used with Screws, is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the spacer component may be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone.

Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device.

The SeaSpine Regatta Lateral System assembled with the 1-hole TruProfile Lateral Plate, when used with Screws, is intended for use with supplemental fixation.

The Shoreline Cervical Interbody RT System with NanoMetalene® surface technology are interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) for one or two contiguous levels, depending on the system. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and havehad at least six (6) weeks of non-operative treatment. These devices are to be filled with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone.

When used as a standalone system, the Shoreline Cervical Interbody RT System is intended to be used as an adjunct to spinal fusion procedures at a single level (C2-T1) and must be used with the Shoreline ACS bone screw fixation and locking cover.

When used with supplemental fixation, such as anterior cervical plates, the Shoreline Cervical Interbody RT System is intended to be used as an adjunct to spinal fusion procedures at one or two levels of the cervical spine (C3-C7).

When the system is used at two contiguous levels, the Shoreline Cervical Interbody RT System must be used with supplemental fixation.

When used as an intervertebral body fusion device, the SeaSpine Reef TO/TA System with NanoMetalene® surface technology is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthess or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should havehad six months of non-operative treatment. The device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone and supplemental fixation.

The SeaSpine Reef TH System with NanoMetalene® surface technology is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the in volved spinal level(s). These patients should have had six months of nonoperative treatment. The device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone and supplemental fixation.

Interbody Device (IBD) Implants (i.e., interbody implants used alone):

The SeaSpine Meridian System with NanoMetalene® surface technology interbody is indicated for use as an adjunct to fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the device is to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. The SeaSpine Meridian Interbody is intended for use with supplemental fixation. Degenerative disc disease is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radio graphic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment.

No-Profile Implants w/ Screws:

The SeaSpine Meridian System No-Profile Interbody, when used with Screws and a No-Profile Locking Cover, is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the spacer component may be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. Patients must have undergone a regimen of at least six (6) months of nonoperative treatment prior to being treated with the device. Hyperlordotic sizes (25 and 30 degrees) are intended for use with supplemental fixation.

No-Profile Implants w/ Inline Fixation Anchors:

The SeaSpine Meridian System No-Profile Interbody, whenused with Inline Fixation Anchors and a No Profile Locking Cover, is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the spacer component may be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The SeaSpine Meridian No-Profile Implants w/ Inline Fixation Anchors is intended for use with supplemental fixation.

TruProfile Interbody Implants:

The SeaSpine Meridian System Interbody assembled with the Anterior Plate, when used with Screws and an Anterior Plate Locking Cover, is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the spacer component may be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. Hyperlordotic sizes (25 and 30 degrees) are intended for use with supplemental fixation.

The SeaSpine spacer systems featuring NanoMetalene® surface technology are single-use intervertebral body fusion devices manufactured from polyetheretherketone (PEEK) (per ASTM F2026), tantalum (per ASTM F560) or Ti-6Al-4V ELI (per ASTM F136) markers for radiographic visualization, and NanoMetalene, which is a one-micron thick surface layer of commercially pure titanium (per ASTM F67). NanoMetalene surface technology provides a microscopic roughened surface with nano-scale features. The devices have a central canal for receiving autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone and are offered in a variety of sizes and geometries to accommodate variations in pathology and patient anatomy. The purpose of this submission is to describe NanoMetalene surface technology as providing a microscopic roughened surface with nano-scale features and to revise the indications for use with reference to the surface technology.

The provided document is a 510(k) Premarket Notification from the FDA for a range of SeaSpine intervertebral body fusion devices. It is a regulatory clearance document, not a study report. Therefore, it does not contain information about acceptance criteria, device performance from a study, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or details about training sets. These types of data are typically found in clinical trial reports or validation studies, which are not part of this 510(k) summary.

The document's purpose is to establish "substantial equivalence" of the new device to existing legally marketed predicate devices, not to prove performance through a new clinical or non-clinical study for the current submission.

Specifically, the document states:

• "Non-Clinical Testing: Not applicable. The determination of substantial equivalence is not based on an assessment of nonclinical performance data."
• "Clinical Testing: Not applicable. The determination of substantial equivalence is not based on an assessment of clinical performance data."

Therefore, I cannot provide the requested information based on this document.

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SeaSpine Meridian System
Interbody Device (IBD) Implants (i.e., interbody implants used alone):
The SeaSpine Meridian System interbody is indicated for use as an adjunct to fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the device is to be used with autogenous bone graft and/or allogeneic bone graft, composed of cancellous, and/or corticocancellous bone. The SeaSpine Meridian Interbody is intended for use with supplemental fixation. Degenerative disc disease is defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of nonoperative treatment.
No-Profile Implants w/ Screws:
The SeaSpine Meridian System No-Profile Interbody, when used with Screws and a No-Profile Locking Cover, is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level. The interior of the spacer component may be packed with autogenous bone graft and/or allogeneic bone graft, composed of cancellous bone. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. Hyperlordotic sizes (25 and 30 degrees) are intended for use with supplemental fixation.
No-Profile Implants w/ Inline Fixation Anchors:
The SeaSpine Meridian System No-Profile Interbody, when used with Inline Fixation Anchors and a No-Profile Locking Cover, is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level. The interior of the spacer component may be packed with autogenous bone graft and/or allogeneic bone graft, composed of cancellous, and/or corticocancellous bone. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The SeaSpine Meridian No-Profile Implants w/ Inline Fixation Anchors is intended for use with supplemental fixation.
TruProfile Interbody Implants:
The SeaSpine Meridian System Interbody assembled with the Anterior Plate, when used with Screws and a Anterior Plate Locking Cover, is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the interior of the spacer component may be packed with autogenous bone graft and/or allogeneic bone graft, composed of cancellous, and/or corticocancellous bone. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. Hyperlordotic sizes (25 and 30 degrees) are intended for use with supplemental fixation.
SeaSpine Regatta Lateral System
Interbody Device (IBD) Implants (i.e., interbody implants used alone):
The SeaSpine Regatta Lateral System is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD, defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies). It is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of DDD with up to Grade 1 spondylolisthesis at the involved level(s). The interior of the interbody spacer component may be packed with autogenous bone graft material composed of cancellous and/or corticocancellous bone. Patients must have undergone a regimen of at least six (6) months of nonoperative treatment prior to being treated with the device.
The SeaSpine Regatta Lateral System is intended for use with supplemental fixation.
TruProfile Interbody Implants:
The SeaSpine Regatta Lateral System assembled with the TruProfile Lateral Plate, when used with Screws, is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level. The interior of the spacer component may be packed with autogenous bone graft and/or allogeneic bone graft, composed of cancellous, and/or corticocancellous bone. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device.
The SeaSpine Regatta Lateral System assembled with the 1-hole TruProfile Lateral Plate, when used with Screws, is intended for use with supplemental fixation.

The Seaspine Meridian and SeaSpine Regatta Lateral Systems are intervertebral fusion devices with large central graft windows which are packed with autogenous bone graft and/or allogenic bone graft, composed of cancellous and/or corticocancellous bone prior to implantation. The implants are manufactured from PEEK (ASTM F2026) with tantalum (ASTM F560) or titanium alloy (ASTM F136) radiographic markers. The implants have a one-micron thick surface coat of commercially pure (CP) titanium (ASTM F67) and are sterile-packed. Both the Meridian and Regatta interbodies have the ability to accept an anterior or lateral faceplate and offer various configurations that can be used with bone screws or inline fixation, locking covers and an optional spin plate. The instruments included with the system facilitate the placement and adjustment of the interbody spacers, and removal if necessary. The instruments are placed in system-specific trays for storage, protection, and organization prior to and during the steam sterilization process.

The provided text is a 510(k) summary for the SeaSpine Meridian System and SeaSpine Regatta Lateral System, which are intervertebral body fusion devices. This type of FDA submission focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and performance, primarily through non-clinical (mechanical) testing. It does not involve AI/ML components or clinical studies with human readers or image interpretation.

Therefore, many of the specific questions regarding AI device performance criteria, human reader studies, and ground truth establishment are not applicable to this document.

However, based on the information provided, here's a description of the acceptance criteria and study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance:

The document doesn't present a table with specific quantitative acceptance criteria or detailed numerical performance results from the non-clinical tests. Instead, it broadly states that the device's mechanical performance in various tests "effectively demonstrates substantial equivalence" to the predicate devices. The implicit acceptance criterion for a 510(k) submission is that the new device performs as safely and effectively as legally marketed predicate devices.

The reported device performance is that the testing performed demonstrated the new systems are:

• "as safe, as effective, and performs at least as safely and effectively as the cited legally marketed predicate."

2. Sample size used for the test set and the data provenance:

• Sample Size: The document does not specify the number of individual devices or components tested in each mechanical test. Mechanical testing typically involves a set number of samples per test type (e.g., n=5 or n=6 per group) to ensure statistical validity, but these exact numbers are not provided.
• Data Provenance: The tests are "non-clinical testing" and are performed in a laboratory setting, not on patient data. Thus, there is no country of origin for patient data, nor is it retrospective or prospective in the clinical sense. The provenance is internal laboratory testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This question is not applicable as the document describes mechanical testing of physical devices, not image analysis or diagnostic performance where expert ground truth would be required.

4. Adjudication method for the test set:

• This question is not applicable for the same reason as above. Mechanical tests are typically evaluated against engineering specifications, not expert adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• This question is not applicable. The device is an intervertebral body fusion device, not an AI-powered diagnostic tool. No human reader studies or AI assistance are involved.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• This question is not applicable. The device is a physical implant, not an algorithm.

7. The type of ground truth used:

• For mechanical testing, the "ground truth" would be the engineering specifications and performance characteristics mandated by the relevant ASTM standards (e.g., F2077 for compression, F2267 for subsidence) and the established performance of the predicate devices. The goal is to show comparable or better performance against these established benchmarks.

8. The sample size for the training set:

• This question is not applicable as there is no AI algorithm being trained.

9. How the ground truth for the training set was established:

• This question is not applicable as there is no AI algorithm being trained.

Summary of Study (Non-Clinical Testing):

The study conducted to demonstrate the device meets acceptance criteria (i.e., substantial equivalence) involves a series of non-clinical, benchtop mechanical tests in accordance with established ASTM (American Society for Testing and Materials) standards.

Specifically, these tests include:

• Compression and Compression-Shear Testing: Performed per ASTM F2077.
• Subsidence Testing: Performed per ASTM F2267.
• Wear Testing: Performed per ASTM F1877.
• Expulsion Testing
• Static Screw Pushout Testing
• Packaging, Shipping, and Sterilization Tests: To validate a Sterility Assurance Level (SAL) of 10-6 and ensure maintenance of a sterile barrier.
• Bacterial Endotoxin Testing (BET): Conducted in accordance with ANSI/AAMI ST-72:2011.

The conclusion drawn from these tests is that the new systems are mechanically similar to the predicate devices and perform comparably, thereby demonstrating that they are as safe and effective. The acceptance criteria are implicitly met by demonstrating that the new devices' performance falls within acceptable ranges when compared to predicate devices and relevant industry standards.

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The Meridian Anterior Plate System is indicated as additional support during fusion via an anterior or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, spinal stenosis, or a failed previous spine surgery.

The SeaSpine Regatta Lateral Plate System is indicated as additional support during fusion via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracolumbar (T) -L5) spine instability or via a lateral or anterolateral surgical approach below the bifurcation of the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, lordosis, spinal stenosis, or a failed previous spine surgery.

The Meridian Anterior Plate and Regatta Lateral Plate Systems each consist of varying sizes of plates and fixation options that accommodate either anterior or lateral surgical approaches in the thoracic, lumbar, and sacral spine (T1-S1). Each plate is manufactured from titanium alloy per ASTM F136 and is designed to provide additional support during spinal fusion procedures.

The provided text is an FDA 510(k) clearance letter and summary for a spinal plate system. It details the device's indications for use, its classification, and a comparison to predicate devices, including the non-clinical testing performed.

However, the document does not describe an AI medical device or a study proving an AI device meets acceptance criteria. It lacks any information regarding:

• Acceptance criteria for an AI device.
• Performance metrics (e.g., sensitivity, specificity, AUC) for an AI device.
• Sample sizes for test sets or training sets for an AI model.
• Data provenance for AI model development.
• Expert involvement in establishing ground truth for AI.
• Adjudication methods.
• Multi-reader multi-case (MRMC) studies or human-in-the-loop performance.
• Standalone AI performance.
• Ground truth types (pathology, outcomes data, etc.) for AI.

Therefore, I cannot extract the requested information as it is not present in the provided text.

The document explicitly states the testing performed:

• Static Compression Bending (ASTM F1717)
• Static Torsion (ASTM F1717)
• Dynamic Compression Bending (ASTM F1717)

These are mechanical and physical performance tests for an orthopedic implant, not an AI diagnostic or assistance device. The conclusion states "Minor differences in non-clinical test results do not impact device performance when compared to the legally marketed predicate devices," which further confirms the focus on mechanical equivalence.

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The Meridian VPS is a single-use device intended to assist in the position and manipulation of the vagina during gynecologic surgical procedures such as sacrocolpopexy.

The Meridian® Vaginal Positioning System (VPS) is a single-use vaginal positioning device comprised of multiple polymers with an ergonomic handle and adjustable head for positioning. The head of the device consists of four main parts: a support body, a kick-out door, an adjustable cervical pin and an adjustable rib feature. The handle of the device consists of three main parts: two handle halves and an actuator knob. The Meridian Vaginal Positioning System is placed in the vagina to stabilize and aid in the identification of vaginal structures including anterior, posterior, apex, fornices and sulci during surgical procedures such as sacrocolpopexy.

This document is a 510(k) summary for the Meridian Vaginal Positioning System (VPS), a medical device. It describes the device, its intended use, and the non-clinical performance testing conducted to demonstrate its safety and effectiveness.

Here's an analysis of the acceptance criteria and study information based on the provided text:

No acceptance criteria and device performance table can be generated from the provided text. The document lists the types of non-clinical performance tests performed (e.g., biocompatibility, sterilization validation, mechanical testing) but does not provide specific quantitative acceptance criteria values or the reported performance data for these tests. It only states that "The results of the performance testing described above demonstrate that the Meridian Vaginal Positioning System is as safe and effective as the predicate device and supports a determination of substantial equivalence."

This document is a 510(k) Summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed clinical study results with acceptance criteria as one might find in a clinical trial report for an AI/ML diagnostic device.

Here's what can be extracted regarding the study, with explanations for what is not present:

1. Table of Acceptance Criteria and Reported Device Performance:

As stated above, this information is not present in the provided 510(k) summary. The document lists the types of tests performed (e.g., Cytotoxicity, Sensitization, Irritation, Functional testing, Maximum force for head, etc.) but does not provide numerical acceptance criteria or the specific results obtained for each test. The summary only states that the performance testing results "demonstrate that the Meridian Vaginal Positioning System is as safe and effective."

2. Sample Sizes Used for the Test Set and Data Provenance:

The document describes non-clinical performance testing (e.g., biocompatibility, mechanical testing, sterilization validation). It does not involve a "test set" in the context of patient data or clinical images. Therefore:

• Sample size for the test set: Not applicable, as this was non-clinical testing of the device itself, not a clinical study involving patient data. The document would typically refer to the number of devices or test units used for each test (e.g., n=5 for bend testing), but these specific numbers are not provided.
• Data provenance (country of origin, retrospective/prospective): Not applicable for non-clinical device testing.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not applicable. This was non-clinical performance testing of a physical medical device (Vaginal Positioning System), not a study involving the interpretation of data where expert ground truth would be established (e.g., image annotation for an AI algorithm).

4. Adjudication Method for the Test Set:

• Not applicable. See point 3.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. This document describes the non-clinical performance testing of a physical surgical instrument. An MRMC study is typically performed for diagnostic devices (especially AI/ML-driven ones) to assess the impact of the device on human reader performance.

6. Standalone (Algorithm Only) Performance:

• No. This device is a physical surgical instrument, not an algorithm. Standalone performance is relevant to AI/ML algorithms that provide an output without human intervention.

7. Type of Ground Truth Used:

• Not applicable. For physical device testing, "ground truth" refers to established material properties, mechanical specifications, and biological safety limits, as defined by standards like ISO 10993-1. The "ground truth" for these tests would be the established limits and specifications against which the device's performance is measured. The document states that tests were performed "per the special controls listed in 21 CFR 884.4910" and according to standards like ISO 10993-1.

8. Sample Size for the Training Set:

• Not applicable. This document is not describing an AI/ML device that requires a training set. The "device" is a physical instrument.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable. See point 8.

In summary:

The provided document is a 510(k) summary for a physical medical device, the Meridian Vaginal Positioning System (VPS). It details non-clinical performance testing to establish substantial equivalence. It does not contain information about acceptance criteria values, reported performance data, clinical study sample sizes, expert adjudication, or AI/ML-specific testing methodologies (like MRMC studies or training set details). The "proof" of meeting safety and effectiveness criteria relies on demonstrating compliance with recognized standards and pre-defined specifications through the listed non-clinical tests, which include biocompatibility, sterilization validation, package integrity, dimensional analysis, and various mechanical tests.

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The Meridian PM is intended to reduce nighttime snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

The Meridian PM is a single device consisting of two parts and upper appliance and lower appliance it is collectively known as the Meridian PM : The Meridian PM treats snoring and Obstructive Sleep Apnea (OSA).

The Meridian PM device is used in a patient treatment model for specific diagnosis of simple snoring, and/or Obstructive Sleep Apnea (OSA).

The upper and lower appliances help to reposition the lower jaw such that it is moved to a forward position during sleep.

The Meridian PM system is used for treating snoring and obstructive sleep apnea and consists of two custom fitted trays which fit over the upper and lower teeth and engage by means of adjustable vertical wings, or by the industry standard "Herbst mechanism" which is a rod and tube type assembly that orientates the jaws in a predetermined relationship. These device(s) function as a mandibular repositioning or mandibular advancment device (MAD) as Meridian PM acts to increase the patient's pharyngeal space, improving their ability to exchange air during sleep, decreasing symptoms of OSA. The devices will be custom made for each patient and allow the dentist or physician to control the degree of mandibular advancement at the time of device(s) will be sold by prescription only.

The provided text describes the submission for K170053, a 510(k) premarket notification for the Meridian PM device, an intraoral device intended to reduce nighttime snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

The submission focuses heavily on demonstrating substantial equivalence to predicate devices (SICAT OptiSleep and TheraSom-CAST) rather than presenting a standalone study of the device's clinical performance against specific acceptance criteria for efficacy in reducing snoring or OSA.

Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical efficacy is not present in the provided document. The performance data presented is entirely non-clinical and relates to the device's material properties and biocompatibility.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

• Clinical Performance/Efficacy: The document does not provide specific acceptance criteria or reported performance for clinical outcomes such as reduction in AHI (Apnea-Hypopnea Index) or snoring intensity. The "acceptance criteria" discussed are for non-clinical tests.

• Non-Clinical Performance:

  Test Category	Test Method	Acceptance Criteria	Reported Performance
  Material Properties		"internal requirements, applied national standards, and applied international standards"	Passed
  Flexural Properties	ISO 178:2010/Amd.1:2013(E) Method A	(Not specified directly, but implied by "passed")	Passed
  Plane-Strain Fracture Toughness	ASTM D5045 -14 (modified notch geometry)	(Not specified directly, but implied by "passed")	Passed
  Tensile Properties	ASTM D638-14 - Modified specimen length, test speed and grip separation	(Not specified directly, but implied by "passed")	Passed
  Biocompatibility	ISO 10993-1:2009 and FDA guidance document	(Not specified directly, but implied by "passed")	Passed
  Cytotoxicity	ISO 10993-5	(Not specified directly, but implied by "passed")	Passed
  Irritation and Skin Sensitization	ISO 10993-10	(Not specified directly, but implied by "passed")	Passed
  Chemical Characterization	ISO 10993-18	(Not specified directly, but implied by "passed")	Passed
  Risk Analysis	ISO 14971	"outcomes of these risks are considered acceptable...all potential risks have been mitigated"	Passed

Regarding the clinical study details, the document does not contain the requested information:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Provided. There is no mention of a human test set for clinical efficacy.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Provided. Not applicable as no clinical test set is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Provided. Not applicable as no clinical test set is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Provided. This is not relevant for this type of device (intraoral snore/OSA device) and no MRMC study or AI component is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Provided. This is not relevant for this type of device and no algorithm is mentioned for performance assessment.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• Not Provided. Not applicable as no clinical ground truth is described. The "ground truth" for the non-clinical tests would be the established chemical, physical, and biological properties as per the standards.

8. The sample size for the training set

• Not Provided. Not applicable as no clinical training set or machine learning model is described.

9. How the ground truth for the training set was established

• Not Provided. Not applicable as no clinical training set is described.

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