(59 days)
The ANTHEM® Fracture System is indicated for fixation of fractures, arthrodesis and reconstruction of bones for the appropriate size of the device to be used in adult patients, including the clavicle, scapula, humerus, radius, ulna, small bones (metacarpals, phalanges), wrist, pelvis, femur, tibia, fibula, ankle, and foot. The clavicle hook plate may be used for dislocations of the acromioclavicular joint. Mini fragment plates are also indicated for fixation of fractures of the acetabulum, patella, and bone fragments, replantation, malunions and nonunion, and for non-load bearing stabilization and reduction of long bone fragments. Metaphyseal plates are indicated for non-load bearing stabilization and reduction of long bone fragments, and for fixation of bones including the radius and ulna.
Small fragment, mini fragment, proximal tibia, clavicle, metaphyseal, and distal fibula plates may be used in all pediatric subgroups (except neonates) and small stature adults. Distal tibia, metaphysed, and mini fragment plates may be used in adolescents (12-21 years of age). Plating may be used in patients with osteopenic bone.
The ANTHEM® Fracture System is a family of plates and screws designed to be used for internal bone fixation. The implants are available in various sizes and shapes to accommodate patient anatomy, and may be contoured or straight, with various lengths and types of screws. ANTHEM® implants are manufactured from commercially pure titanium alloy, cobalt chromium molybdenum alloy, or stainless steel.
This document pertains to the 510(k) premarket notification for the ANTHEM® Fracture System (K202496), a metallic bone fixation device. The information provided describes the device, its intended use, and the basis for its substantial equivalence to predicate devices. However, this document does not describe a study involving an AI/algorithmic device, nor does it provide acceptance criteria and performance data for such a device in the context of human-in-the-loop or standalone performance.
The performance data mentioned in the document relates to mechanical testing (ASTM F382) and biocompatibility/sterility testing (Bacterial Endotoxin Testing and material standards) of the physical medical device (bone plates and screws). It does not involve evaluation of an algorithm's diagnostic or assistive performance.
Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving an AI device meets these criteria, as the provided text describes a traditional hardware medical device submission.
If you provide a document that details the regulatory submission for an AI/algorithmic device, I would be able to answer your questions.
§ 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.