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The In-Line Orthopedic Cable Cerclage System is intended for use in general orthopedic trauma surgery involving olecranon, patella, femur (including periprosthetic fractures), pelvic, acetabular, humeral, and ankle fractures, acromioclavicular dislocations, prophylactic banding during total joint procedures, and temporary reduction during open reduction internal fixation (ORIF) procedures.

The In-Line Orthopedic Cable Cerclage System consists of a cable and crimp assembly to allow cerclage fixation of various long bone, pelvic and acetabular fractures as well as tension band fixation of the patella, olecranon, ankle and shoulder. The implants are manufactured from medical grade titanium alloy per ASTM F 136, unalloyed titanium per ASTM F 67, and cobalt chromium alloy per ASTM F 90. The implants are provided sterile. Instrumentation has been designed for use with this implant system.

I apologize, but the provided text from the FDA 510(k) K151888 for the "Frontier Medical Devices In-line Orthopedic Cable Cerclage System" does not contain any information about a study involving AI/ML device performance, human expert evaluation, or ground truth establishment.

The document describes a traditional medical device (a cable cerclage system for orthopedic fixation) and its 510(k) clearance process. The performance data mentioned refers to "Static and dynamic testing," which are mechanical bench tests, not clinical studies involving human readers or AI algorithms.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI-based device from this document. The information you are asking for (e.g., sample size, expert qualifications, MRMC studies, ground truth) is relevant to the evaluation of AI/ML-driven medical devices, which this product is not.

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