(94 days)
The Activ Ankle Locking Plating System is intended for the fixation of fractures and pseudarthrosis of the distal and the diaphyseal fibula and for syndesmotic repair in adults.
The Activ Ankle Locking Plating System consists of a plate with many screws as holes (slots) designed for fixation of fractures, osteotomies and pseudarthrosis of the distal and diaphyseal fibula and for the syndesmotic repair in adults. The plates and screws are manufactured from titanium alloy and color anodized. Washers are also available for use with syndesmosis screws. The Activ Ankle Locking Plating System will be provided non sterile for sterilization by health care professionals prior to use or provided sterile by gamma sterilization.
This document describes the 510(k) premarket notification for the "Activ Ankle Locking Plating System," a medical device, and therefore does not contain information about software or AI-enabled insights, acceptance criteria, or study results in the context of AI/ML performance.
The document discusses the device's intended use, materials, and mechanical testing results to demonstrate substantial equivalence to predicate devices, as required for FDA 510(k) clearance.
Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, data provenance, ground truth establishment, or multi-reader multi-case studies because this document is about a bone fixation device and does not involve AI or clinical performance studies of an AI algorithm.
§ 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.