(57 days)
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.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.