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The Synthes VentroFix MIS System is indicated for use, via the lateral or anterolateral surgical approach, in the treatment of thoracic and thoracolumbar (T1-L5) spine instability as a result of degenerative disc disease (defined as pain of discogenic origin with degeneration of the disc confirmed by patient history or radiographic studies), spondylolisthesis, spondylolysis, fracture (including dislocation and subluxation), spinal stenosis, deformities (i.e., scoliosis, kyphosis, lordosis whether neuromuscular or related to deficient posterior elements), tumors (neoplastic disease), pseudoarthrosis, or a failed previous fusion.

The Synthes VentroFix MIS System consists of a range of plate sizes and screws which attach to the anterolateral aspect of the vertebral body of the thoracolumbar spine (levels T1-L5) and provide stabilization to allow for spinal fusion to occur. All components are manufactured from Titanium alloy.

The provided text is a 510(k) summary and FDA clearance letter for the Synthes VentroFix MIS System. This document describes a medical device, specifically a spinal fixation system, and its indicated uses. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the manner requested (e.g., using performance metrics like sensitivity, specificity, or F1-score as would be found for an AI/CADe device).

Therefore, I cannot extract the requested information to populate the table or answer the subsequent questions. The document pertains to a traditional medical device (implantable hardware) where performance is typically assessed through mechanical testing (e.g., strength, durability, biocompatibility) and clinical outcomes, rather than the AI/software-specific metrics implied by the prompt's structure.

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