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The Spinal Elements Buttress Plate System is intended for anterior intravertebral body screw fixation/attachment to one vertebral body of the L1-S1 spine, extending over the adjacent intervertebral space to stabilize and buttress bone grafts/intervertebral body fusion devices following reconstruction for degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The system is intended to be used in skeletally mature patients in conjunction with traditional fixation and is not intended for load bearing applications.

The Spinal Elements Buttress Plate System is comprised of plates and screws that are used for attachment to the anterior lumbar spine. Both plates and screws are available in a variety of sizes to suit the individual pathology and anatomic condition of the patient. Plates and screws are manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F 136 or ISO 5832-3.

The provided text is a 510(k) summary for the Spinal Elements Buttress Plate System. This type of regulatory document focuses on establishing "substantial equivalence" to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through extensive clinical studies with reported performance metrics.

For this reason, the document does not contain the detailed information requested regarding acceptance criteria, device performance, study design (sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance), or training set information.

Instead, the submission primarily states that the device is "substantially equivalent" to two predicate devices (K2M Cayman Buttress Plate System (K080302) and the Synthes TiLPS (K970048)) in terms of "indications for use, material, general design features, and function." This implies that the device's acceptable performance is inferred from the established safety and effectiveness of the predicate devices.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details based on the provided text. The document acts as a regulatory submission for substantial equivalence rather than a report on a clinical trial with performance metrics.

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