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Synthes Trochanter Stabilization Plate (TSP) for DHS® is intended to treat stable and unstable intertrochanteric, subtrochanteric, pertrochanteric and basilar neck fractures when used in conjunction with the Synthes Dynamic Hip Screw System (DHS®).

The Synthes Trochanter Stabilization Plate for DHS is a component of the Synthes DHS System, which fits over the sideplate of the DHS. The spoon-shaped area of the TSP, which is proximal to the shaft, resides along the greater trochanter. Screw holes of the TSP shaft line up with the screw holes of the DHS plate to accept the 4.5 mm cortex screws used for fixation to the femoral shaft. Two screw slots accommodate the DHS lag screw and the anti-rotational screw located proximal to it. Synthes Trochanter Stabilization Plates are provided both pre-sterilized by gamma radiation and nonsterile.

The provided text is a 510(k) Summary for the Synthes (USA) Trochanter Stabilization Plate for DHS®. This document describes a medical device seeking market clearance in the United States and asserts its substantial equivalence to a predicate device.

Critically, this document is a regulatory submission for a physical medical device (an orthopedic plate), not an AI/ML-driven device or an imaging study. Therefore, the questions related to AI/ML device performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, or MRMC studies are not applicable to the provided input.

The document describes the device, its intended use, and its predicate device, and the FDA's clearance letter. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML system.

Therefore, I cannot fulfill the request to describe acceptance criteria and associated study details because the provided input does not pertain to an AI/ML device or a study of its performance.

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