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When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the DANEK® Plate and Screw System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the DANEK® Plate and Screw System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint: (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.

The DANEK® Plate and Screw System consists of plates, screws, hooks. CROSSLINK® Plates and other components used to build a spinal construct. Instrumentation is also available to facilitate implantation of the device components. The purpose of the DANEK® Plate and Screw System is to provide stabilization during the development of a solid spinal fusion.

DANEK® Plate and Screw implant components are fabricated from medical grade stainless steel described by such standards as ASTM F138 or ISO 5832-1 or ISO 5832-9. The DANEK® Plate and Screw System implant components may be sold either sterile or non-sterile

The provided 510(k) summary (K991036) for the DANEK® Plate and Screw System does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria.

This document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a previously legally marketed device, not on presenting novel performance data from clinical trials or specific test criteria.

Therefore, I cannot populate the requested table or answer the specific questions related to acceptance criteria, device performance studies, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, ground truth, or training set details from the provided text.

The core of the submission is described in Section V: "The DANEK® Plate and Screw System is substantially equivalent to itself. The new pedicle screw classification indications described in the classification Final Rule published in the July 27,1998 Federal Register were used to expand the previously cleared indications for the DANEK® Plate and Screw System. This system is also substantially equivalent to the DYNA-LOK® Spinal System."

The FDA's response letter also confirms this: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..."

In summary, the document states that the device is substantially equivalent to existing devices and references updated indications for use, but it does not include data from a study designed to prove acceptance criteria or demonstrate device performance as per your request.

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