(89 days)
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.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.