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The DePuy Advantage Fixation Screw System is intended to be used to provide interference fixation of patellar bone-tendon-bone grafts in anterior cruciate ligament (ACL) reconstruction.

The DePuy Advantage Fixation screw is a fully threaded titanium alloy cancellous bone screw available in 7mm and 9mm diameters. Each diameter is available in six (6) lengths (15, 20, 25, 30, 35, and 40mm) in a cannulated version, and in five (5) lengths (20, 25, and 40mm) in a non-cannulated version. The Advantage screw has a polished satin finish, a 29 degree included angle tapered tip, a round body thread, and a radius on the socket end of the screw. Each screw has an internal hex fitting for instrument insertion during surgery.

The provided document is a summary effectiveness statement for a medical device, the DePuy Advantage™ Fixation Screw System. It describes the device, its intended use, and provides a basis for its substantial equivalence to another device (DePuy M. Kurosaka™ Interference Screws).

However, the document does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria, especially in the context of typical clinical performance metrics like accuracy, sensitivity, or specificity. It is for a bone screw, not an AI/imaging device, so the requested information (like multi-reader, multi-case studies, ground truth establishment by experts, etc.) is not applicable to this type of device.

Therefore, I cannot fulfill the request as the necessary data is not present in the provided text.

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