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Synthes 2.4mm VA-LCP Two-Column Narrow Volar 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 VA-LCP Two-Column Narrow Volar Distal Radius Plates are metallic plates intended for treatment of various fracture modes of the distal radius. The plates incorporate variable-angle locking hole technology and are available in versions composed of stainless steel and titanium.

This document is a 510(k) premarket notification for a medical device and does not contain information about acceptance criteria or a study proving the device meets those criteria, nor does it describe AI performance.

The provided text only includes a 510(k) summary and the FDA's letter of clearance for the Synthes (USA) 2.4mm VA-LCP Two-Column Narrow Volar Distal Radius Plates. This device is a metallic bone fixation appliance, not an AI or software-as-a-medical-device (SaMD) product.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth, experts, or AI performance because this information is not present in the provided document. The document describes a traditional medical device, not an AI-powered one.

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