(173 days)
The ARIX Clavicle System is indicated for the fixation of single, segmental and comminuted fractures, malunions, and non-unions of the clavicle.
The ARIX Clavicle System is rigid fixation consisting of plates and screws in various configurations, shapes and sizes. The ARIX Clavicle System is made of Titanium Alloy (Ti-6AL-4V), which meet ASTM F136, Standard Specification for Wrought Titanium-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well-known biocompatibility. The plates vary essentially through different lengths and number of plate holes. The screws are selftapping, which are applied with the reconstruction locking screws together. The Locking Screws are provided with diameter 2.5, 3.5mm and Cortical Screws are provided with diameter 3.5mm. And both are provided with lengths from 6 mm to 110 mm.
This document describes the regulatory approval for the ARIX Clavicle System, a medical device used for bone fixation. However, it does not contain information related to an AI/ML powered medical device. Therefore, I cannot extract the requested information regarding acceptance criteria, study details, human reader performance, or ground truth establishment for such a device.
The provided text pertains to a traditional medical device (metallic bone fixation appliances) and details its substantial equivalence to predicate devices based on design, materials, and mechanical testing, rather than AI performance metrics.
§ 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.