(69 days)
The ARIX Ankle System(Fibula) is intended for use in internal fixation of the distal fibula.
The ARIX Ankle System is rigid fixation consisting of plates and screws in various configurations, shapes and sizes. The ARIX Ankle System is made of Unalloyed Titanium Alloy (Ti-6Al-4V), which meet ASTM F67, Standard Specification for Unalloyed Titanium for Surgical Implant Applications, and ASTM F136, Standard Specification for Wrought Titanium-6 Aluminum-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 self-tapping, which are applied with the reconstruction locking screws together. The Locking Screws are provided with diameter 3.5mm and Cortical Screws are provided with diameter 3.5mm. And both are provided with lengths from 10 mm to 70 mm.
The provided text describes the 510(k) premarket notification for the ARIX Ankle System, a bone fixation device. It details the device's characteristics, intended use, and comparison to a predicate device. However, this document does not contain information about acceptance criteria or a study proving that an AI/device meets acceptance criteria related to diagnostic performance or efficacy.
The FDA letter and the 510(k) summary are for a mechanical orthopedic implant (plates and screws for ankle fixation), not an AI-powered diagnostic device. Therefore, the questions about AI performance, ground truth, expert readers, MRMC studies, and training/test set sizes are not applicable to this submission.
The "Non-Clinical Test Summary" section mentions engineering analyses and ASTM standards (F382 for bending performance, F543 for screw testing), which are mechanical performance tests for the implant, not diagnostic accuracy. The "Clinical Test Summary" explicitly states: "No clinical studies were considered necessary and performed." This further confirms the absence of performance data relevant to AI acceptance criteria.
§ 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.