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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 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 and/or allogeneic 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

The SeaSpine Regatta Lateral System is an intervertebral body fusion device (IBD) with large central graft windows, which are packed with autogenous bone graft and/or allogeneic bone graft, composed of cancellous and/or corticocancellous bone prior to implantation. The spacer has a bulleted insertion end for ease of implantation and tantalum markers to allow easier radiological assessment of the spacer position and orientation. The spacers are manufactured from PEEK (ASTM F2026) with radiographic markers manufactured from tantalum (ASTM F560), with a one-micron thick surface of commercially pure (CP) titanium (ASTM F67), and sterile packaged. The instruments included with the system facilitate the placement and adjustment of the interbody spacer, and removal if necessary. The instruments are placed in trays for storage, protection, and organization prior to and during the steam sterilization process.

Based on the provided text, the document describes a 510(k) Premarket Notification for the SeaSpine Regatta Lateral System. This type of submission to the FDA focuses on establishing substantial equivalence to a predicate device, rather than proving efficacy or safety through new clinical studies measuring specific performance criteria against predefined acceptance thresholds.

Therefore, the requested information about acceptance criteria, device performance, sample size for test sets, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth establishment for a clinical study proving the device meets acceptance criteria is not applicable to this specific submission.

The document explicitly states:

• "Non-Clinical Testing" outlines mechanical performance, packaging, shipping, and sterilization tests. These are engineering and material validation tests, not clinical performance studies where the device's diagnostic or therapeutic accuracy is measured against patient outcomes or expert consensus.
• "Clinical Testing: Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data." This directly confirms that no clinical studies were performed to establish performance metrics against acceptance criteria for this 510(k) submission.

Here's a breakdown of why each point is not applicable to this 510(k) submission:

1. A table of acceptance criteria and the reported device performance: Not applicable. Acceptance criteria for clinical performance are not mentioned because no clinical performance was assessed. The mechanical tests (compression, shear, subsidence, expulsion) have their own engineering acceptance criteria, but these are not for clinical "performance" in the sense of an AI algorithm's accuracy or a diagnostic device's sensitivity/specificity.
2. Sample sized used for the test set and the data provenance: Not applicable. No clinical test set data is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical ground truth was established.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No clinical test set was adjudicated.
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 applicable. This is a medical device (intervertebral body fusion device), not an AI-assisted diagnostic tool. No MRMC study was done.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No clinical ground truth was established.
8. The sample size for the training set: Not applicable. This is a physical device, not a machine learning model.
9. How the ground truth for the training set was established: Not applicable. No training set was used.

In summary, the provided document clearly states that substantial equivalence for the SeaSpine Regatta Lateral System was determined based on non-clinical testing and comparison to predicate devices, not on new clinical performance data or studies involving human readers or AI algorithms.

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