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The Osteonics® FX-Cablelok™ Grip Components are indicated for trochanteric reattachment and are intended for use with the commercially available Osteonics® FX-Cablelok™ System cable and sleeve components to provide fixation of the greater trochanter secondary to osteotomy in total hip replacement arthroplasty, surface replacement arthroplasty or any hip procedure requiring a trochanteric osteotomy.

The subject devices are characterized by the following design features: Staple like grip design with proximal and distal hooks used in conjunction with trochanteric cable and crimp sleeves.

The provided text is a 510(k) Premarket Notification for the Osteonics® FX-Cablelok™ Grip Components. This document establishes substantial equivalence to previously marketed devices and does not contain information about acceptance criteria, a standalone study proving performance, sample sizes for test/training sets, or specific details on ground truth establishment or expert involvement in a study.

Therefore, I cannot provide the requested information as the provided text does not describe a study that proves the device meets acceptance criteria. The document focuses on regulatory approval based on demonstrating equivalence to predicate devices, rather than presenting a performance study with acceptance criteria.

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