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Synthes LCP Dia-Meta Volar Distal Radius Plates are indicated for fractures, osteotomies, and non-unions of the radius and other small bones.

The Synthes LCP Dia-Meta Volar Distal Radius Plates provide stable fixation for radius fractures. The plates have threaded locking holes in the head of the plate that accept 2.4 mm locking screws, and dynamic compression holes combined with locking holes in the shaft of the plate which accept 3.5 mm cortex, 3.5 mm locking, or 4.0 mm cancellous screws. The plates are available in various lengths and are available in right and left versions to accommodate varying patient anatomy. The plates are manufactured in either titanium or stainless steel.

This document is a 510(k) summary for the Synthes LCP Dia-Meta Volar Distal Radius Plate. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML device.

The document describes a medical device, which is a metallic bone fixation appliance, and its intended use. It is a traditional medical device (implantable plate and screws) and not an AI/ML powered device.

Therefore, I cannot extract the requested information (acceptance criteria, device performance, study details, sample sizes, ground truth, expert qualifications, etc.) as it pertains to AI/ML performance because this document is not about such a device.

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