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The STERLING® Interference Screw ST is used to provide interference fixation of f moral and/or tibial tunnels in anterior cruciate ligament reconstruction using a soft tissue graft, and fixation during posterior cruciate ligament reconstruction utilizing a soft tissue graft.

The STERLING® Interference Screw HT is used to provide interference fixation in anterior cruciate ligament reconstruction using a bone-tendon-bone graft, and fixation during posterior cruciate ligament reconstruction utilizing a bone-tendonbone graft.

The STERLING® Interference Screw HT is machined from processed bovine cortical bone, with lengths ranging from 20 to 35mm and diameters ranging from 7 to 12 mm. The STERLING® Interference Screw HT is threaded and has an external squared-drive.

The STERLING® Interference Screw ST is machined from processed bovine cortical bone, with lengths ranging from 20 to 35mm and diameters ranging from 7 to 12 mm. The STERLING® Interference Screw ST is threaded and has an internal hexdrive.

The provided text is a 510(k) summary for the STERLING® Interference Screw HT and ST devices. This document focuses on demonstrating substantial equivalence to predicate devices and does not contain information on acceptance criteria or a study proving device performance against such criteria. The studies mentioned are related to material characteristics and remodeling in an animal model, not clinical performance metrics typically associated with acceptance criteria for AI/ML-based devices.

Therefore, I cannot provide the requested information about acceptance criteria and a study that proves the device meets them, as the provided input does not contain this kind of data. The document describes a traditional medical device (bone fixation screw) and its regulatory submission, not a software or AI/ML device that would typically have acceptance criteria presented in the manner requested.

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