(109 days)
The Alians Ulna Locking Plating System is intended for ulnar shortening osteotomy.
The Alians Ulna Locking Plating system consists of a plate with many screws as holes (slots) designed for ulnar shortening osteotomy. The plates and screws are manufactured from titanium alloy and color anodized. The Alians Ulna Locking Plating system will be provided non-sterile for sterilization by health care professional's prior use.
This document is a 510(k) premarket notification for the "Alians Ulna Locking Plating System". It does not describe a study involving an AI/ML device that requires acceptance criteria. Instead, it describes a medical device (a plating system for bone fixation) and the non-clinical tests performed to demonstrate its substantial equivalence to previously marketed predicate devices.
Therefore, I cannot provide a response based on your request, as the provided input does not contain information about an AI/ML device study, acceptance criteria, sample sizes, ground truth establishment, or expert involvement as outlined in your prompt.
§ 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.