(30 days)
The UBP System III is intended to bring together bone fragments in order to augment fracture healing of the small bones of the foot, wrist, and hand.
The UBP III System consists of single and multi-segmented titanium bone plates of various sizes and lengths, titanium bone screws in 3.5 and 4.0mm diameters and various lengths, and associated instrumentation. Fixation is provided by the insertion of bone screws through the openings in the plate.
The provided document is a 510(k) summary for the Universal Bone Plate III System. It describes a medical device, and the information requested pertains to the evaluation of AI/ML-based medical devices. This document does not contain any information related to AI/ML or a study proving that an AI/ML device meets acceptance criteria.
Therefore, I cannot fulfill the request using the provided text. The document focuses on the mechanical testing of a bone plate system to demonstrate substantial equivalence to a predicate device, which is a different type of evaluation from the one described in the 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.