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The Synthes Low Profile Reconstruction Plates are intended for pelvic and acetabular reconstruction and fixation of fractures of the distal humerus, clavicle, and scapula.

The Synthes 3.5 mm Low Profile Reconstruction Plates consist of straight, curved, and J-shaped plates. The shape and profile of these plates are designed to minimize soft tissue irritation and minimize the need for intraoperative contouring. However, when intraoperative contouring is required for a precise fit with the bone, the plate design allows for simple and uniform bending.

The provided text is a 510(k) summary for the Synthes Low Profile Reconstruction Plates and an FDA clearance letter. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the provided input. This type of information would typically be found in detailed clinical or non-clinical performance studies, which are not included in this 510(k) summary.

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