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The OsteoCentric ACL Fixation Fasteners are used to provide bone fixation in orthopedic procedures, including bonetendon-bone graft fixation in anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL) reconstruction of the knee.

The OsteoCentric ACL Fastener System consists of ACL Fixation Fasteners and select singleuse and reusable instrumentation to facilitate implantation.

The ACL Fixation Fasteners are threaded titanium interference screws with a tapered tip for easy insertion into bone. The fasteners are cannulated to allow the use of a guidewire to assist with placement of the fastener into the bone tunnel. The fastener is used to maintain the fixation of bone-tendon-bone grafts in orthopedic procedures. The ACL Fixation Fasteners are provided sterile.

ACL Fixation single-use instruments are: a 2.4mm OD stainless steel drill-tipped passing pin, a 1.6mm OD nitinol guidewire, and a stainless-steel graft retractor. The ACL single-use instruments are provided sterile.

ACL Fixation reusable instruments are: a 2.5mm hex driver, and a 3.5mm Hex Driver. The ACL Fixation reusable instruments are provided non-sterile and must be sterilized prior to use.

The provided text is a 510(k) summary for the OsteoCentric ACL Fixation System. It describes the device, its intended use, and its equivalence to predicate devices, supported by performance testing. However, the document does not contain any information about a study involving AI, human readers, or the establishment of ground truth for an AI system.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of an AI/human reader study, as the provided input does not discuss such a study. The performance data mentioned (Torsional Properties, Driving Torque, Removal Torque, Engineering analysis comparison of theoretical axial pullout, Axial Pushout) are all mechanical tests for the physical medical device itself, not for an AI algorithm's performance in image analysis or similar tasks.

In summary, none of the requested information regarding AI acceptance criteria, study design (sample size, data provenance, expert consensus, adjudication, MRMC, standalone performance), or training set details is present in the provided document.

The document is a standard medical device 510(k) submission focusing on demonstrating substantial equivalence of a physical implantable device (an ACL fixation fastener) to existing devices based on material properties and mechanical performance.

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