(60 days)
The ARIX Ankle System 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 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well-known biocompatibility.
This document describes a 510(k) premarket notification for the "ARIX Ankle System," which is a device for internal fixation of the distal fibula. The submission claims substantial equivalence to existing predicate devices.
Crucially, the provided text explicitly states there was no clinical study performed for this device, and therefore no data regarding AI performance, acceptance criteria for AI, or human reader studies.
Therefore, I cannot provide the requested information about acceptance criteria for AI, study details (sample size, ground truth, experts, adjudication, MRMC, standalone performance), or training set information.
The relevant section from the document states:
"Clinical Test Summary
No clinical studies were considered necessary and performed."
This indicates that the FDA clearance for the ARIX Ankle System was based on non-clinical bench testing and a comparison of its technological characteristics and intended use to predicate devices, not on a study involving AI performance or human reader analysis.
§ 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.