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The Synthes Antegra-T System is indicated for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels as an adjunct to fusion. This system is indicated in the treatment of lumbar and lumbosacral (LI - Sl) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), pseudoarthrosis, spondylolysis, spondylolisthesis, scoliosis, lordotic deformities of the spine, spinal stenosis, or a failed previous spine surgery.

Warning: This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

The Synthes Antegra-T System consists of one-level titanium lumbar and sacral plates and cancellous screws with locking heads. The plates attach to the anterior portion of the lumbar and lumbosacral spine (L1-S1). These one-level plates are available in lengths ranging from 37 mm to 53 mm in 2mm increments. The sacral plates have a step on the underside that allows for precise sacral placement. The Antegra-T System uses the bone-screws from the Synthes Antegra System (K063158).

The provided text describes a medical device, the Synthes Antegra-T System, and its 510(k) summary, but it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The document is a 510(k) summary for a spinal intervertebral body fixation orthosis. The key takeaway from the provided text regarding performance is:

• Non-Clinical Performance and Conclusions: "Bench testing results demonstrate that the Synthes Antegra-T System is substantially equivalent to the predicate devices."
• Clinical Performance and Conclusions: "Clinical data and conclusions were not needed for this device."

This means the device's substantial equivalence was established through bench testing only, comparing it to existing predicate devices. Since clinical data was not required, and no study is mentioned in the provided text, the specific information requested in the prompt (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, etc.) cannot be extracted.

Therefore, for each of the requested points, the answer is that the information is not available in the provided document.

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