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The nv is intended for spinal fusion procedures at one level, from C2-T1, in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. One device is to be used per intervertebral space. Patients should receive six weeks of non-operative treatment prior to treatment with an intervertebral body fusion device. The nv- devices must be used with supplemental fixation and are designed for use with autograft bone to facilitate fusion. The devices are to be implanted via an anterior approach.

The nv& is an intervertebral body fusion device used in the cervical spine following discectomy. All devices are manufactured from PEEK Optima LT1 per ASTM F2026 and include tantalum markers per ASTM F560 for radiographic visualization.

The devices have multiple footprints to adapt to the general shape of the vertebral endplates and have a hollow center to accommodate bone graft. The devices are implanted via an anterior approach. Each footprint is available in multiple heights to accommodate patient variability and there are anti-migration features on the superior and inferior surfaces designed to improve fixation, stability, and prevent back out and migration.

This document is a 510(k) premarket notification from the FDA, classifying the medical device "nv°" an "Intervertebral Body Fusion Device." The document reviews the device's indications for use, device description, and comparison to predicate devices, but it does not contain information about software or AI/ML-driven components. Therefore, the requested information about acceptance criteria and a study proving the device meets those criteria, particularly regarding AI/ML performance metrics, cannot be extracted from this document.

The document discusses the substantial equivalence of the "nv°" device to previously cleared devices based on non-clinical testing such as engineering analysis of mechanical performance (compression, shear, torsion, subsidence, expulsion). The conclusion states that the device is substantially equivalent based on design control activities, identical indications for use, and similar technological characteristics, implying that no new clinical studies were required or conducted to demonstrate safety and efficacy compared to the predicate devices.

Therefore, I cannot provide the detailed information requested in your prompt regarding acceptance criteria, study design, sample sizes, expert involvement, or AI/ML specific performance metrics, as these are not relevant to the content of this 510(k) premarket notification for this specific medical device.

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