(63 days)
Synthes Articulating Distal Radius Fixator System is intended for stabilizing fractures of the distal radius.
The Articulating Distal Radius Fixator is a preassembled mechanically adjustable external wrist fixator. It is a one-piece construct, which consists of plastic and metal components. The device is applied to the bone with four self-drilling Schanz Screws that lock into two fixator clamps. The device is operated by turning screws, which operates gears to achieve incremental movement.
Based on the provided text, there is no information about acceptance criteria for device performance, a study proving the device meets acceptance criteria, sample sizes, data provenance, number of experts, adjudication methods, multi-reader multi-case studies, standalone performance, training set details, or how ground truth was established.
The document is a 510(k) summary for a medical device (Synthes Articulating Distal Radius Fixator) and an FDA clearance letter. It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with acceptance criteria.
Therefore, I cannot provide the requested table and information.
§ 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.