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The cosmic™ system is intended for posterior, noncervical pedicle fixation as an adjunct to fusion for the following indications: severe spondylolisthesis (grades 3 and 4) at L5-S1, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).

The cosmic™ System includes rods and pedicle screws in a variety of lengths and diameters and transverse stabilizers. The pedicle screw threads comprise a calcium phosphate coating.

The provided text is a 510(k) summary and FDA clearance letter for the cosmic™ System, a pedicle screw spinal fixation system. It addresses regulatory aspects, substantial equivalence, and intended use, but it does not contain information about acceptance criteria or a study proving the device meets those criteria, specifically regarding artificial intelligence (AI) performance.

Therefore, I cannot fulfill your request for the tables and information related to AI performance, sample sizes, ground truth establishment, or expert involvement, as these details are not present in the provided document.

The document states: "Documentation was provided which demonstrated the cosmic™ System to be substantially equivalent to the previously cleared SSCS System. The substantial equivalence is based upon equivalence in basic design, intended use, indications, materials, anatomic sites and performance." This implies a comparison to a predicate device rather than a study with specific acceptance criteria and performance metrics for the cosmic™ System itself.

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