(42 days)
The Orthofix Volar Distal Radial Plate is intended for the volar fixation of fractures and osteotomies involving the distal radius.
The Volar Distal Radial Plate is an anatomically contoured, Delta-shaped plate intended for volar applications to the distal radius. The Plate features an angled head with two rows of holes for placement of screws and non-threaded pegs that will be placed distally on the radius to secure bone fragments and provide stabilization. If a bone graft is required, framed access to the site is made possible by the triangular opening in the plate that spans from the plate head to the distal portion of the shaft. The shaft of the Plate is placed proximally on the distal radius and it offers a variety of K-wire and screw placement options for secure fixation to the external surface of the bone. The Plate provides the stabilization and fixation necessary in the treatment of distal radius fractures and osteotomies to allow early functional use of the hand.
An acceptance criteria table and details on a study to prove a device meets acceptance criteria are typically found in the "Performance Data" or "Clinical Studies" sections of a 510(k) submission, neither of which are provided in the input text you've supplied.
The provided text ("510(k) Summary of Safety and Effectiveness" for the "Orthofix Volar Distal Radial Plate") focuses on general device information, description, intended use, and substantial equivalence to predicate devices. It does not contain information regarding device performance, acceptance criteria, study details, sample sizes, expert qualifications, 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 text. The requested information is simply not present in this document.
§ 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.