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The I.T.S. FR.O.H. Calcaneus Repair System is a titanium implant fracture fixation system for repairing fractures located in the calcaneus heel bone of the foot.

Indications for Use include: Intra and extra-articular fracture(s) of the calcaneus, corrective osteotomy, joint depression, non-displaced and tonque type, severely comminuted fractures, multifragmentary fractures, revision procedures, joint fusion, stabilization and fixation of fresh fractures, reconstruction of the calcaneus bones, and open and closed fractures of the calcaneus. The system can be used in both adult and pediatric patients.

This system is not intended for spinal use.

The I.T.S. FR.O.H. Calcaneus Repair System is a combination of fracture reduction and alignment instrumentation with either calcaneus plate and/or cannulated cancellous screw fixation across calcaneal heel bone fracture site(s). The 15-hole Calcaneus Plate (universal left and right in 2 sizes) is made from CP titanium according to ASTM F 67-00 and corresponding plate locking and self-tapping 3.5 & 4.2mm Cancellous Screws from 6-4 alloyed titanium according to ASTM F 136-02. The fully threaded 7.3mm Cannulated Cancelous Screw is in various lengths from 50 to 90mm in 5mm increment sizes and is also made from 6-4 alloyed titanium according to ASTM F 136-02. All titanium plates and screws are surface conditioned with a TIODIZE, Type II preparation

The provided document is a 510(k) summary for the "FR.O.H. Calcaneus Repair System," a bone plate and cannulated cancellous bone screw system. However, this type of regulatory submission (from 2005) does not contain the detailed study information regarding acceptance criteria and performance metrics typically found for AI/ML-based devices.

This document describes a traditional medical device (implants for bone fracture fixation) and not an AI/ML-based device that would require such performance studies.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document focuses on demonstrating substantial equivalence to pre-existing devices through material composition, design, and intended use, rather than through performance metrics of a device's "performance" in diagnosing or treating conditions based on data analysis.

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