(165 days)
The Femoral Neck System (FNS) is indicated for basilar femoral neck fractures in adults and adolescents (12-21) in which the growth plates have fused or will not be crossed.
The subject Femoral Neck System is comprised of implants designed to treat basilar femoral neck fractures as well as system-specific insertion instruments. The Femoral Neck System is a modular system consisting of four connected implant components forming a fixed-angle gliding fixation device which allows for controlled collapse of the femoral head. The implants are manufactured from Titanium Alloy and are provided in a range of dimensions. The same construct can be used for the left and right femur.
The provided text does not contain information about the acceptance criteria or a study related to an AI/ML medical device. The document is an FDA 510(k) clearance letter for the DePuy Synthes Femoral Neck System, a metallic bone fixation appliance.
Therefore, I cannot provide a response to the prompt's request for acceptance criteria and study details for an AI/ML device.
§ 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.