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Synthes 2.4mm LCP Volar Column Distal Radius Plates are intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones.

The Synthes 2.4mm LCP Volar Column Distal Radius Plates are part of the Synthes Locking Distal Radius System which is a system consisting of metallic bone fixation plates designed to treat fractures and osteotomies of the distal radius.

This document is a 510(k) summary and an FDA clearance letter for a medical device: Synthes (USA) 2.4mm LCP Volar Column Distal Radius Plates. It confirms that the device is substantially equivalent to a predicate device and is approved for market.

However, the provided text does not contain any information about 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 them based on the provided input. The document focuses on regulatory approval, not on the technical details of performance testing that would typically include such information.

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