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The NuVasive® VuePoint® II OCT System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudoarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The VuePoint II OCT System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the VuePoint II OCT System may be connected to the NuVasive® SpheRx® Spinal System, Precept® Spinal System, Armada® Spinal System and Reline® 4.5-5.0 System via the rod to rod connectors or transition rods.

The NuVasive VuePoint II OCT System consists of screws, hooks, rods, offset connectors, rod to rod connectors, set screws, cross connectors, occipital plates and associated general instruments. Implant components are available in a variety sizes and can be rigidly locked into a variety of configurations to suit the individual pathology and anatomical conditions of the patient. The scope of this submission includes the introduction of 5.0 and 5.5 mm diameter multi axial bone screws, sterile implants, as well as minor modifications to the implant design since clearance of reference device NuVasive VuePoint II OCT System (K150474).

This document is a 510(k) Pre-market Notification for the NuVasive® VuePoint® II OCT System, a spinal fusion device. It does not describe a study involving an algorithm or AI. Therefore, it is not possible to extract information related to acceptance criteria and device performance based on AI/algorithm evaluation, sample sizes for test/training sets, data provenance, expert adjudication, MRMC studies, standalone performance, or ground truth establishment for such a device.

The "Performance Data" section (G) in the document refers to nonclinical testing performed to demonstrate substantial equivalence to a predicate device. This testing involved static and dynamic mechanical tests on the physical device components, rather than an AI or algorithm.

Therefore, the requested information in the form of a table for acceptance criteria and reported device performance (for an AI/algorithm) cannot be provided from this document.

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