(74 days)
The DePuy Motech PEAK 3mm Fixation Rod System is intended for use in treating fractures of the pelvis, acetabulum, clavicle, scapula, and distal humerus.
The DePuy Motech PEAK 3mm Fixation Rod System is intended for use in treating fractures of the pelvis, acetabulum, clavicle, scapula, and distal humerus. The system consists of 3 mm rods, ranging in length from 60mm to 180mm, and 3 styles of rod connectors, classified as right, left, and neutral. The rods are secured to the connectors using a pin nut. Screws are used to secure the connectors to the bone.
The provided text is a 510(k) summary for the DePuy Motech PEAK 3mm Fixation Rod System. This document describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria, study methodologies, or performance metrics in the context of an AI-powered medical device or software.
Therefore, I cannot fulfill your request for the tables and information about acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies. This document pertains to a physical bone fixation rod system, not a digital diagnostic or AI-driven system.
§ 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.