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The UniVy™ OsteoVy™-Ti Cervical IBF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The system devices are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level.

The UniVy™ OsteoVy™-Ti Cervical IBF System is intended for use at one level in the cervical spine, from C3 to T1, for treatment of cervical degenerative disease (DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The UniVy™ OsteoVy™ Ti Cervical IBF System is to be used in patients who have six weeks of non-operative treatment.

The UniVy™ OsteoVy™-Ti Cervical IBF System is comprised of implant components. The implant component is a spacer which inserts between vertebral bodies in the anterior column of the cervical spine. The subject UniVy™ OsteoVy™-Ti Cervical IBF System spacer is comprised of additively manufactured Titanium 6Al-4V ELI conforming to ASTM F3001-14. The UniVy™ Osteo Vy™-Ti NanoVy™-HA Cervical IBF components' surfaces have been treated with a 20-40 nanometer thin hydroxyapatite (HA) surface treatment. The surface treatment presents nano-scale topography on the entirety of the implant surface, in addition to macro-/micro-scale topography existing from prior to treatment.

The provided text describes a 510(k) premarket notification for a medical device called the UniVy™ OsteoVy™-Ti Cervical IBF System. It establishes substantial equivalence to predicate devices based on non-clinical testing. However, the document does not contain information related to acceptance criteria, device performance metrics, sample sizes for test sets or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC comparative effectiveness studies. These types of studies are typically associated with performance claims for AI/ML-driven devices or diagnostics, which this device is not.

Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence for a physical medical implant through mechanical and material testing, not through clinical performance metrics involving AI or expert review.

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