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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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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 autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and supplemental fixation.

When used as a vertebral body replacement device (VBR) the SeaSpine Spacer System is intended for use in the thoracolumbar spine (T1 to L5) to replace a collapsed, damaged or unstable complete or partial vertebral body due to tumor or trauma/fracture, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The SeaSpine Spacer 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. Additionally, the SeaSpine Spacer System is intended for use with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone.

When used as an intervertebral body fusion device, the Vu ePOD Intervertebral Body Fusion Device 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 autograft bone graft and/or allogeneic bone graft composed of cancellous bone. The Vu e•POD Intervertebral Body Fusion Devices are 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 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 Vu e•POD VBR 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 autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone. The Vu ePOD VBR System is intended for use with supplemental internal spinal fixation.

The SeaSpine Spacer System (Hollywood, Hollywood VI, Ventura, Pacifica), and Vu e-POD, are intervertebral fusion devices intended to promote spinal fusion by acting as a disc spacer and holding autograft bone graft and/or allogeneic bone graft composed of cancellous and /or corticocancellous bone. The implants have teeth on the superior and inferior surfaces and a central canal for receiving the autograft. The devices are available in a variety of shapes, lengths, widths, and heights to accommodate variations in pathology and patient anatomy. All implants are manufactured from PEEK (per ASTM F2026) with radiographic markers manufactured from tantalum (per ASTM F560). The implants are offered either in all PEEK (ASTM F2026) or coated with commercially pure titanium (ASTM F67), NanoMetalene.

The NanoMetalene spacers are provided in gamma sterilized packaging, while the PEEK spacers are provided non-sterile for subsequent sterilization at the healthcare facility.

The instruments included with each system facilitate the placement and adjustment of the interbody spacers, and removal if necessary. The instruments are placed in trays and caddies for storage, protection, and organization prior to and during the steam sterilization process.

This document is a 510(k) premarket notification decision letter from the FDA regarding spinal intervertebral body fusion devices. It outlines the regulatory classification, intended use, and a summary of technological characteristics. Crucially, it explicitly states that "Clinical Testing" is "Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data."

Therefore, I cannot provide a table of acceptance criteria and reported device performance using this document, nor can I describe a study proving the device meets acceptance criteria. The document indicates that no clinical performance data or studies were required or used for this 510(k) clearance. The determination of substantial equivalence was based on non-clinical testing and comparison to predicate devices.

Here's why I cannot answer your specific questions based on the provided text:

1. A table of acceptance criteria and the reported device performance: No performance data from clinical studies are presented in this document. The FDA's determination is based on "substantial equivalence" to existing devices, not on meeting specific, de novo clinical performance criteria. The non-clinical testing mentioned (packaging, shipping, sterilization, bacterial endotoxin) relates to manufacturing and sterility assurance, not device efficacy or clinical performance.
2. Sample sizes used for the test set and the data provenance: No clinical test set data is provided or referenced.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical test set data was used.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no clinical test set data was used.
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 document pertains to a medical device (spinal spacer), not an AI algorithm for image reading.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable, as no clinical test data was used for effectiveness.
8. The sample size for the training set: Not applicable, as this is not an AI algorithm.
9. How the ground truth for the training set was established: Not applicable, as this is not an AI algorithm.

In summary, the provided FDA 510(k) letter explicitly states that clinical testing was "Not applicable" for the determination of substantial equivalence for these spinal spacer devices. Therefore, the information you are requesting regarding acceptance criteria and performance studies is not contained within this document, because such studies were not a prerequisite for this particular 510(k) clearance.

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SeaSpine® Spacer System - Hollywood NanoMetalene®, Hollywood VI NanoMetalene®, and Ventura NanoMetalene®:

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 (autograft) and supplemental fixation.

Cambria is intended to be used as an adjunct to spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain 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, and used with autogenous bone and supplemental fixation, such as an anterior plating system.

The SeaSpine® Spacer System (Hollywood NanoMetalene®, Hollywood VI NanoMetalene®, Ventura NanoMetalene®), and the Cambria NanoMetalene® are intervertebral fusion devices manufactured from polyetheretherketone (PEEK OPTIMA LT1 per ASTM F2026) with markers (tantalum per ASTM F560 or Ti-6AI-4V ELI per ASTM F136) for radiographic visualization. The implants have a one-micron thick surface coat of commercially pure (CP) titanium. The devices have a central canal for receiving autogenous bone graft and are offered in a variety of sizes and geometries to accommodate variations in pathology and patient anatomy. The purpose of this 510(k) is to receive clearance to offer the interbody devices of the noted systems gamma sterilized in individual packaging.

The provided text does not describe acceptance criteria for a medical device's performance, nor does it detail a study proving specific performance metrics. Instead, it is an FDA 510(k) clearance letter for the SeaSpine® Spacer System, which focuses on demonstrating substantial equivalence to previously marketed predicate devices rather than proving new performance criteria.

Here's an analysis based on the information provided, specifically addressing the points in your request:

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

This information is not provided in the document. The document focuses on demonstrating substantial equivalence to predicate devices, not on setting or meeting specific performance acceptance criteria for a new device's functionality. The "Performance Testing" section under "Summary of Technological Characteristics" states "No new testing required," indicating that performance was largely inferred from the predicate devices.

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 provided. The document explicitly states "Clinical Testing: Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data." This means there was no clinical test set in the traditional sense for assessing device performance.

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 provided. As no clinical testing was performed for the device's efficacy or safety to establish a ground truth, there were no experts used for this purpose in the context of a performance study.

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

This information is not provided. There was no test set or clinical study requiring an adjudication method.

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 provided. The device is an intervertebral body fusion device, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human readers and AI assistance is not applicable.

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

This information is not provided. The device is a physical implant, not an algorithm. The concept of "standalone performance" for an algorithm is not relevant here.

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

This information is not explicitly stated as no clinical performance data was assessed for the subject device to establish a "ground truth." The determination of safety and effectiveness for substantial equivalence relies on the established performance characteristics and indications for use of the predicate devices, not on new ground truth established for the subject device itself.

8. The sample size for the training set

This information is not provided. As no AI/algorithm is involved, the concept of a "training set" is not applicable.

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

This information is not provided. As no AI/algorithm is involved, the concept of a "training set" and its ground truth is not applicable.

Summary of Device and Approval Process (based on the document):

The document is an FDA 510(k) clearance for the SeaSpine® Spacer System - Hollywood NanoMetalene®, Hollywood VI NanoMetalene®, Ventura NanoMetalene®, and SeaSpine® Cambria NanoMetalene®.

• Type of Device: Intervertebral Body Fusion Device
• Purpose of 510(k): To receive clearance to offer the interbody devices gamma sterilized in individual packaging, rather than being sterilized by the end-user as with the predicate devices.
• Key Argument for Clearance: Substantial equivalence to legally marketed predicate devices (K102026 and K142488).
• Evidence for Substantial Equivalence:
  • Intended Use/Indications for Use: The subject devices have substantially equivalent indications and intended use as the cited predicates.
  • Technological Characteristics: Similar operating principle, design, materials (PEEK-OPTIMA with titanium alloy/tantalum markers and CP titanium surface), manufacturing.
  • Performance (Mechanical Safety): No new mechanical testing was required because the design and materials are essentially the same as the predicate devices, which underwent analysis and static & dynamic testing (ASTM F2027), wear evaluation (ASTM F1877), and subsidence (ASTM F2267).
  • New Element Justified: The change to pre-sterilized packaging required non-clinical testing, including packaging, shipping, sterility validation (SAL 10⁻⁶), and bacterial endotoxin testing (BET) in accordance with ANSI/AAMI ST-72:2011.
• Clinical Testing: Not applicable; the determination of substantial equivalence was not based on an assessment of clinical performance data.

In essence, the "study that proves the device meets the acceptance criteria" in this context is the 510(k) submission itself, which demonstrated substantial equivalence to predicate devices, thereby implying that existing acceptance criteria for similar devices are met without requiring new primary performance studies. The "acceptance criteria" here are aligned with the FDA's requirements for substantial equivalence to a predicate device, as opposed to specific clinical performance metrics for a novel technology.

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SeaSpine Spacer System – Hollywood NanoMetalene, Pacifica NanoMetalene, Redondo NanoMetalene, Ventura NanoMetalene:
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 (autograft) and supplemental fixation.

Cambria NanoMetalene:
Cambria is intended to be used as an adjunct to spinal fusion procedures at one level (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 and supplemental fixation, such as an anterior plating system.

Vu aPOD-L NanoMetalene:
The Integra Vu aPOD-L Intervertebral Body Fusion Device 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 (i.e. autograft). The Integra Vu aPOD-L 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 desc confirmed by history and radiographic studies. These patients should be skeletally mature and at least six (6) months of non-operative treatment.

Vu ePOD NanoMetalene:
When used as an intervertebral body fusion device the Vu ePOD Intervertebral Body Fusion Devices are 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 autograft only. The Vu ePOD Intervertebral Body Fusion Devices are intended for use with supplemental fixation such as the Coral Spinal System or the BodyForm Thoracolumbar Fixation System. 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.

The SeaSpine Spacer System (Hollywood NanoMetalene, Pacifica NanoMetalene, Redondo NanoMetalene, Ventura NanoMetalene), Cambria NanoMetalene, Vu aPOD-L NanoMetalene, Vu ePOD NanoMetalene devices are intervertebral fusion devices made from polyetheretherketone (PEEK OPTIMA LT1 per ASTM F2026) with markers (tantalum per ASTM F560 or Ti-6Al-4V ELI per ASTM F136) for radiographic visualization. The devices have a central canal for receiving autogenous bone graft and are offered in a variety of sizes and geometries to accommodate variations in pathology and patient anatomy. The purpose of this 510(k) is to add a 1 micrometer surface of titanium (per ASTM F67) to the exterior surface of each of these devices.

This document is a 510(k) Premarket Notification from the FDA regarding the "SeaSpine Spacer System" with various models incorporating "NanoMetalene®". This document is a regulatory approval, not a scientific study that measures device performance against acceptance criteria in the way a clinical trial or AI algorithm validation would.

Therefore, most of the information requested in your prompt (e.g., acceptance criteria, test set sample size, expert qualifications, adjudication methods, MRMC study, standalone performance, training set size, etc.) is not applicable or available within this type of document.

Here's an explanation of what can be extracted and what cannot:

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

• Acceptance Criteria: Not explicitly stated as pass/fail thresholds for clinical performance in this document. The "acceptance criteria" here is that the device must be "substantially equivalent" to legally marketed predicate devices, meaning it has the same intended use and technological characteristics and any differences do not raise new questions of safety or effectiveness.
• Reported Device Performance: The document states that "analysis demonstrated that the titanium surface does not negatively impact mechanical performance of the NanoMetalene subject devices when compared to the predicate devices." This is a qualitative statement of engineering analysis and non-clinical testing results, not a quantifiable performance metric against specific clinical acceptance criteria.

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

• Not Applicable. This document focuses on non-clinical testing (engineering analysis, mechanical tests). There is no "test set" in the context of clinical data or AI algorithms. The "data provenance" mentioned in the document refers to the origin of the predicate devices and the regulatory process in the USA.

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 Applicable. There is no "ground truth" establishment by experts for a test set in this regulatory submission. The "ground truth" concept is typically applied to clinical or diagnostic AI evaluations.

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

• Not Applicable. No explicit "adjudication method" is described as there is no test set of clinical cases being reviewed.

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

• No. An MRMC study was not done. This device is an intervertebral body fusion device, not a diagnostic AI system or an imaging modality requiring human reader interpretation in the context of an MRMC study.

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

• No. This is a hardware medical device (an implant), not a software algorithm. Therefore, "standalone algorithm" performance is not applicable.

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

• Not Applicable / Implied by Regulatory Framework. For this type of device submission, the "ground truth" or standard for comparison is compliance with recognized engineering standards (e.g., ASTM standards for mechanical testing) and demonstrating substantial equivalence to predicate devices that have already been deemed safe and effective by the FDA. The performance is assessed against these established non-clinical benchmarks rather than clinical "ground truth" data (like pathology or outcomes) in this specific submission.

8. The sample size for the training set

• Not Applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Not Applicable. As there is no training set, this question is not relevant.

In summary: This FDA 510(k) letter and summary describe a regulatory approval process for a medical device (intervertebral body fusion device) based on proving "substantial equivalence" to existing predicate devices through engineering analysis and non-clinical testing. It is not a clinical study or AI algorithm validation with specific clinical acceptance criteria, test sets, or expert ground truth adjudication.

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When used as an intervertebral body fusion device, the Seaser 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 nonfusion 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 (autograft) and supplemental fixation.

When used as a vertebral body replacement device (VBR), the SeaSpine Spacer System is intended for use in the thoracolumbar spine (T1 to L5) to replace a collapsed, diseased, damaged or unstable complete or partial vertebral body due to tumor or trauma/fracture, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The SeaSpine Spacer 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. Additionally, the device is intended for use with bone graft.

Not Found

This document is a 510(k) premarket notification decision letter from the FDA for the SeaSpine Spacer System - Hollywood NM (Nanometalene). It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document primarily focuses on the FDA's determination of substantial equivalence to predicate devices and outlines general regulatory requirements for the manufacturer.

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

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