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The GPS™ Cervical Spacers are indicated for use at multiple contiguous levels, from C2-T1, in skeletally mature patients who have had six weeks of non-operative treatment. The device is intended to treat cervical disc degeneration and/or cervical spinal instability as confirmed by imaging studies (radiographs, CT, MRI) that results in radiculopathy, myelopathy and/or pain. The device is to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and in combination with supplemental fixation cleared for use in the cervical spine.

The basic shape of the GPS™ Cervical Spacers is a structural column having upper and lower implant openings and a central cavity for autograft bone. The devices have a have a "B" shaped cross-section. Surface teeth assist in the seating the implant between the vertebral bodies. Devices are available in a variety of size and angulation combinations to accommodate the diversity in patient anatomy.

The provided text is a 510(k) Premarket Notification from the FDA for a medical device called "GPS™ Cervical Spacers". This document does not describe or include a study proving that the device meets specific performance acceptance criteria.

Instead, the document details:

• The FDA's determination of substantial equivalence (K210890) to a legally marketed predicate device (K142456).
• The device's indications for use: treating cervical disc degeneration and/or cervical spinal instability at multiple contiguous levels (C2-T1) in skeletally mature patients who have had non-operative treatment, to be used with autogenous and/or allogeneic bone graft and supplemental fixation.
• The device's description, materials (PEEK and tantalum), and technological characteristics (hollow structural frame, material, basic design, sizes).
• The fact that no new mechanical testing was performed for the current submission (K210890) because the change to a non-sterile condition does not create a mechanical worst-case scenario. It states: "Performance data remains unchanged for the subject devices as compared to the predicate versions of the device."

Therefore, based solely on the provided text, I cannot answer the questions about acceptance criteria and a study proving the device meets those criteria, a sample size, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details. The document explicitly states that performance data remains unchanged from "the predicate versions of the device," implying that any such performance studies would have been associated with the original predicate device (K142456), not the current submission (K210890).

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