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The TranS1® Facet Screws are to supplement legally marketed anterior fusion products in order to create an anterior/posterior fixation construct as an aid to fusion.

The facet screws may be implanted using one of two techniques: transfacetpedicular or translaminar. The screws are inserted bilaterally through the superior side of the facet, across the facet joint (usually) at a single level and into the pedicle. Alternatively, the facet screws may be cross inserted from the base of the spinous process into the opposite lamina and across the facet joint into the base of the lower vertebral transverse process. Bone graft must be used for both fixation methods.

For both techniques, the system is indicated for the posterior surgical treatment at C2-S1 (inclusive) spinal levels for the following: Spondylolisthesis; Spondylolysis; Pseudarthrosis or failed previous fusions which are symptomatic; Degenerative Disc Disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies and/or degenerative disease of the facets with instability.

The TranS1® Facet Screws are made of medical grade titanium alloy conforming to such standards as ASTM F-136 and/or ISO 5832-3 or ASTM F-138 Stainless Steel.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that the device meets specific criteria. The document is a 510(k) Premarket Notification for TranS1® Facet Screws, which primarily focuses on establishing substantial equivalence to predicate devices and defining the device's intended use and technological characteristics.

Therefore, I cannot provide the requested table, sample sizes, expert details, adjudication methods, MRMC study information, standalone performance, ground truth types, or training set details as this information is not present in the provided text.

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