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The Edge upper cervical system is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1 to C7) and the thoracic spine (T1 to T3):

· Traumatic spinal fractures and/or traumatic dislocations;

• · instability or deformity:
• · failed previous fusions (e.g., pseudarthrosis);
• · tumors involving the cervical/thoracic spine;

· degenerative disease, including intractable radiculopathy and/or arm pain of discogenic origin as confirmed by radiographic studies, and

· degenerative disease of the facets with instability.

The Edge UCS 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. The Edge UCS is intended for use only with the Innosys Anax™ OCT Spinal System.

The Edge UCS consists of a main body that clamps on to the posterior arch of C1 to provide fixation and stability. The Edge UCS is then connected to the Innosys Anax OCT instrumentation using polyaxial rods to form a posterior cervical construct, similar to that of the predicate devices. The Edge device is an additively manufactured clamp composed of two fixation jaws superior to the C1 posterior arch, an inferior jaw base, and two receiving joints for polyaxial rods. The Edge UCS accommodates varying patient anatomy by providing three implant sizes. The Edge UCS is additively manufactured from titanium alloy Ti6Al4V ELI and is designed with areas for bone graft to be placed on the medial and lateral bone contacting regions of the device.

The provided text describes a medical device, the "Edge Upper Cervical System," and its clearance by the FDA based on a determination of substantial equivalence to predicate devices. However, the document does not contain the information requested regarding the acceptance criteria, specific study details, sample sizes, expert qualifications, or ground truth establishment for AI/algorithm performance.

The "Performance Data" section solely outlines mechanical performance tests conducted on the physical device (e.g., ASTM F1717 Static Axial Compression, ASTM F1717 Dynamic Torsion, Custom Sawbones Pull Off Test) to demonstrate its structural integrity and suitability for its intended use. These tests are not related to an AI/algorithm's performance.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance for an AI/algorithm.
2. Sample sizes for a test set or data provenance related to AI.
3. Number of experts and their qualifications for AI ground truth.
4. Adjudication method for an AI test set.
5. MRMC comparative effectiveness study results for AI.
6. Standalone performance of an AI algorithm.
7. Type of ground truth used for AI.
8. Sample size for an AI training set.
9. How ground truth for an AI training set was established.

This document is for a physical spinal implant system, not a software or AI-driven medical device.

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