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The BioScrew® XtraLok™ interference screw provides tibial interference fixation of a soft tissue graft for ACL and PCL reconstruction.

The BioScrew Xtralok™ is a cannulated, sterile, single-use bone screw made of an absorbable homopolymer derived from Poly (L-Lactic Acid).

The BioScrew XtraLok will be available in 6 sizes: 9, 10, and 11mm diameters by 35 or 40mm lengths. The proximal face is angled from the axis of the BioScrew, and the proximal region of the threaded body tapers to a larger diameter.

This document is a 510(k) summary for the BioScrew XtraLok Bioabsorbable Interference Screw. It describes the device and its intended use, but it does not contain acceptance criteria or the study that proves the device meets specific acceptance criteria. This type of regulatory submission (510(k)) primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed performance data against specific acceptance criteria.

Therefore, I cannot fulfill your request for the detailed table and information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth, as this information is not present in the provided text. The document states that "The BioScrew XtraLok interference screw does not raise any new issues of safety or effectiveness when compared to this predicate device," which is the basis of its
510(k) clearance, not a study proving its performance against acceptance criteria.

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