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The Pillar Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients undergoing fusion by autogenous bone grafting having implants attached to the lumbar and sacral spine with removal of implants after the attainment of a solid fusion.

The Pillar Pedicle Screw System also is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spinc: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture. spinal stenosis, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis, and failed previous fusion.

The Pillar Pedicle Screw System is an internal fixation device for spinal surgery consisting of pedicle screws and rods that are interconnected using crosslinks and set screws. To chable close conformance to patient anatomy, pedicle screws and rods are available in various lengths, diameters, and/or contours. A series of manual surgical instruments (not a subject of this submission) intended to assist the insertion and placement of the implants are provided in an instrument tray.

The provided document is a 510(k) summary for the "Pillar Pedicle Screw System." It describes the intended use and equivalence to marketed products but does not contain any information about acceptance criteria or specific studies to prove device performance in terms of clinical outcomes or diagnostic accuracy.

The 510(k) process is primarily a premarket notification to demonstrate that a device is substantially equivalent to a legally marketed predicate device, not necessarily to prove its clinical efficacy or diagnostic performance through specific acceptance criteria and studies in the way you've outlined for an AI-powered diagnostic device.

Therefore, I cannot populate your requested table and information points based on the provided text. The document focuses on regulatory approval based on substantial equivalence, not on performance metrics against predefined acceptance criteria from a study.

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