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The NuVasive Cohere Thoracolumbar Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. When used with or without the Cohere XLIF internal fixation, the system is indicated for use with supplemental spinal fixation systems cleared by the FDA for use in the thoracolumbar spine. The devices are to be used in patients who have had at least six months of non-operative treatment.

The NuVasive Cohere Thoracolumbar Interbody System is interbody fusions in the thoracic spine from T1 to T12, at the thoracolumbar junction (T12-L1), and in the lumbar spine from L1 to S1 for the treatment of symptomatic disc degeneration (DDD) or degenerative spondylolisthesis at one or two adjacent levels, including thoracic disc herniation (with myelopathy with or without axial pain). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The NuVasive Cohere Thoracolumbar Interbody System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.

The NuVasive Cohere Thoracolumbar Interbody System comprises of sterile, single use implant grade polyetheretherketone (PEEK) devices, available in varied footprints and heights, designed for supplemental stabilization of the thoracolumbar spinal column in thoracolumbar intervertebral body fusion procedures.

Each device within the Cohere Thoracolumbar Interbody System is comprised of a continuous body of PEEK formed into the final product shape with a porous architecture on select faces of the implant. The porous architecture is derived directly from the implant body and is not a sintered or otherwise additive coating. In addition to PEEK, the device assembly may contain two or more radiolucent markers, depending on footprint, to enable visibility under x-ray in vivo.

The implants are available in a variety sizes and lordostic angles to suit the individual pathology and anatomical conditions of the patient. The device is intended to be used with supplemental spinal fixation systems that are cleared by the FDA for use in the lumbar spine.

An optional single-sided or dual-sided internal fixation plate with bone screw(s) is offered; this is referred to as the AMS XLIF Plate Single-Sided and AMS XLIF Plate Dual-Sided, respectively. The AMS XLIF Plate is placed in the adjacent vertebral body or bodies for additional migration resistance. The AMS XLIF Plates are available in a variety of sizes to suit the individual pathology and anatomical conditions of the patient. The AMS XLIF Plate Single/Dual Sided and bone screws are substantially equivalent to the plate and screws cleared in predicate Modulus XLIF Interbody System (K192760).

This document describes NuVasive® Cohere® Thoracolumbar Interbody System, an intervertebral body fusion device. No information on acceptance criteria or results from studies proving the device meets those criteria is provided for AI/imaging device performance since this is a physical medical device, not an AI or imaging device. The document is an FDA 510(k) clearance letter and summary for a physical medical implant, specifically an intervertebral body fusion device made of PEEK.

Therefore, the requested information regarding acceptance criteria, study design for AI/imaging device performance (e.g., sample size for test sets, number of experts, MRMC studies, standalone performance), and ground truth establishment does not apply to this device.

The "Performance Data" section (Section G) explicitly states: "Non-clinical testing was performed to demonstrate that the subject Cohere Thoracolumbar Interbody System is substantially equivalent to other predicate devices. Engineering rationale and the following testing was performed: Static Axial Compression (per ASTM F2077), Dynamic Axial Compression (per ASTM F2077), Dynamic Torsion (per ASTM F2077), Compressive and Torsional Wear Particulate Analysis (per ASTM F1877), Implant subsidence and expulsion analysis, Screw push-out analysis. The results demonstrate that the subject Cohere Thoracolumbar Interbody System meets the same criteria as the predicate devices, and the subject device was therefore found to be substantially equivalent to the predicate. No clinical studies were conducted."

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