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The Nu Vasive Cohere ALF System Intervertebral Body Fusion Device is indicated for spinal fusion procedures in skeletally mature patients. The Cohere ALIF System Interverebird Body Fusion Device 10-200 lordotic cages may be used as a standalone system. The System Intervetebral Body Fusion Device 25-30° lordotic cages may be used with supplemental internal spinal fixation systems (e.g., posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine. The System is designed for use with autogenous bone graft, allogeneis bone graft, intervertebral hody fraise to corticocancellous bone graft, or a bone void filler as cleared by FDA, for use in intervertebral body fusion to facilitate fusion. The devices are to be used in patients who have had alleast sim onths of non-operative treatment.

The NuVasive Cohere ALLF System Intervertebral Body Fusion Device is intended for use in interbody fusions in the lumbar spine from L2 to S1, following discectory in the trestment of symptomatic degenerative disc disease (DD) or degenerative spondylolisthesis, and/or spinal stenosis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disconfirmed by history and radiographic studies. The Cohere ALFE System Intervertebral Body Fusion Device implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative spondylolisthanis as saind the used in these patients at multiple levels at multiple levels and for patients with degenerative spondylolisthesis or spinal stenosis at one or two adjacent levels, the Cohere ALIF System Intervetebrah Body Fusion Device must be used with a supplemental internal spinal fixation system (e.g., pedicle screw system) cleared by the FDA for use in the lumbar spine in addition to the internal spillal fixal.

The Cohere ALIF System Intervertebral Body Fusion Device is inclusive of sterile, single use interbody implant grade polyetheretherketone (PEEK) devices, available in varied footprints and heights. Each device within the Cohere ALIF System Intervertebral Body Fusion Devce is comprised of a continuous body of PEEK formed into the final product shape with a porous architecture on select faces of the implant. In addition to PEEK, the device assembly contains radiolucent markets to enable visibility under x-ray in vivo. The implants are available in a variety of sizes and lordotic angles to suit the individual pathology and anatomical conditions of the patient. The Cohere ALIF System Intervertebral Body Fusion Device 10°-20° lordotic cages may be used as a standalone system. The Cohere ALIF System Intervertebral Body Fusion Device 25°-30° lordotic cages must be used with supplemental internal spinal fixation systems (e.g. posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine.

This document describes the NuVasive® Cohere® ALIF System Intervertebral Body Fusion Device, which is an implant made of PEEK material for spinal fusion procedures. The FDA has determined the device is substantially equivalent to legally marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify exact sample sizes for each mechanical test. The tests were non-clinical, implying in-vitro or bench testing. The data provenance is implied to be from the manufacturer's internal testing facilities, as no external data sources (e.g., country of origin, retrospective/prospective) are mentioned.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable. This is a non-clinical, mechanical testing study to assess device performance against established standards and predicate devices, not a study involving human expert judgment for ground truth.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are typically relevant for clinical studies or studies involving human interpretation or subjective assessments. This study involved objective mechanical testing against defined ASTM standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states that "No clinical studies were conducted." This study focuses on the physical and mechanical properties of the device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This device is a physical intervertebral body fusion device and does not involve any algorithms or software that would have standalone performance.

7. The Type of Ground Truth Used

The "ground truth" for this non-clinical study is established by:

• ASTM Standards: Specifically ASTM F2077, F1714, and F1877, which provide benchmark performance requirements for intervertebral body fusion devices and material properties.
• Predicate Device Performance: The subject device's performance was compared to that of legally marketed predicate devices to demonstrate substantial equivalence, meaning the predicate devices' established performance serves as a comparative "ground truth."

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML model. Therefore, there is no "training set."

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

Not applicable. As there is no training set, there is no ground truth, and hence no establishment process for it relevant to this context.

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