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The Solitaire™ PEEK-Optima® Anterior Spinal System is designed for use with autograft and is indicated for stand-alone intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to SI in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of nonoperative treatment.

The Solitaire™ Peek-Optima® Anterior Spinal System consists of a spacer with tantalum radiographic markers and bone screws for intervertebral body fusion. The spacer is PEEK with titanium inserts for the bone screw interface. The Solitaire™ Bone screws will be available in different versions of the the the the the the the types.

I am sorry, but the provided text is a 510(k) summary for a spinal system (Solitaire™ PEEK-Optima Anterior Spinal System). It describes the device, its intended use, and its substantial equivalence to predicate devices based on mechanical testing. This document does not contain information about acceptance criteria or a study that evaluates device performance in the way typically expected for an AI/ML medical device submission (e.g., diagnostic accuracy, sensitivity, specificity, or reader studies).

Therefore, I cannot fulfill your request for the specific details regarding acceptance criteria and performance studies because the information is not present in the provided text. The document focuses on regulatory equivalence for a physical medical implant, not on the performance metrics of a diagnostic or AI-powered device.

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