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The SpineNet SSP System is intended for anterior screw fixation of the cervical spine (C2 to T1). The system is to be used as an adjunct to fusion for the treatment of the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumors, pseudarthrosis or failed previous fusion.

The SpineNet SSP System is an anterior cervical plate and screw system which includes fixed and variable self-tapping screws and one- through four level plates. The implants are available in a variety of sizes to accommodate the individual anatomic and clinical circumstances of each patient.

The provided document is a 510(k) Premarket Notification from the FDA regarding the SpineNet SSP System. It confirms the device's clearance and substantial equivalence to predicate devices. However, the document does not contain any information about acceptance criteria, device performance metrics (e.g., sensitivity, specificity, accuracy), sample sizes for test or training sets, ground truth establishment, expert qualifications, or MRMC studies for an AI/ML powered device.

The document primarily focuses on the mechanical testing of the implant device itself (spinal intervertebral body fixation orthosis), confirming its mechanical performance is substantially equivalent to predicate devices.

Therefore, it is not possible to complete the requested table or answer the questions related to AI/ML device performance and validation based on the provided text. The document refers to "Performance Data" which states: "Mechanical testing of the worst case SpineNet SSP System construct was performed according to ASTM F1717 and included static and dynamic compression and static torsion. The mechanical test results demonstrate that the SpineNet SSP System device performance is substantially equivalent to the predicate devices." This clearly indicates a physical device, not a software or AI/ML product that would require the type of performance evaluation outlined in your request.

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