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To provide fixation of soft-tissue grafts within the tibial tunnel during anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) reconstruction.

The TunneLoc Tibial Fixation Devices are an implant and inserter instrument system that offers components for treatment of patients that require fixation of soft tissue to bone.

This document (K193092) is a 510(k) Premarket Notification for the TunneLoc® Tibial Fixation Device. It is not for an AI-powered medical device, but rather a mechanical orthopedic device. Therefore, the information requested (acceptance criteria, test set details, expert qualifications, MRMC studies, standalone performance, training set details) related to the performance of an AI/algorithm is not applicable to this document.

The document describes the device, its intended use, and substantial equivalence to existing predicate devices. The performance data provided is non-clinical (mechanical testing, FEA, bacterial endotoxins) to demonstrate the safety and effectiveness of design modifications to the device (specifically the inserter and its yoke) and updated labeling. No clinical studies were conducted or provided.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, adjudication methods, expert qualifications, or MRMC studies for an AI device, as this information is not present in the provided document.

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