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The Activ Ortho Continuous Compression Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation of small bones and small bone fragments.

The ActivOrtho Continuous Compression Screw System is a cannulated Nitinol bone screw having various sizes to accommodate a variety of applications. The screws are headed, cannulated, and partially threaded. The continuous compression screw incorporates a helical expansion section in the smooth shaft of the screw which elongates as the distal thread engages bone to produce a continuous compression force across the fracture site.

This document does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. The provided text is an FDA 510(k) clearance letter for the ActivOrtho Continuous Compression Screw System, which establishes substantial equivalence to previously marketed devices. This type of submission relies on comparisons to existing devices rather than new clinical outcome studies with predefined acceptance criteria.

Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment based on the provided text.

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