(58 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, metatarsals, phalanges), wrist, pelvis, fibula, ankle, and foot. The clavice 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 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.
In addition, small fragment, mini fragment, proximal tibia, clavicle, metaphyseal, and distal fibula plates are indicated for use in infant, child, and adolescent pediatric subgroups and small stature adults. Distal tibia, metaphyseal, and mini fragment plates are indicated for use in adolescents (12-21 years of age). Plating can 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 titanium, titanium allov, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F67, F136, F1295, F1472, F1537, F2229, F138 and F139.
I am sorry, but the provided text from the FDA 510(k) clearance letter for the ANTHEM® Fracture System (K212433) does not contain any information regarding acceptance criteria or the study that proves the device meets those criteria for an artificial intelligence (AI) or machine learning (ML) enabled device.
The document describes a medical device for bone fixation (plates and screws) and primarily focuses on its physical characteristics, materials, and mechanical performance testing (in accordance with ASTM F382 and ASTM F543) to demonstrate substantial equivalence to predicate devices. It discusses the "Performance Data" in terms of engineering analysis and biocompatibility, not AI performance criteria.
Therefore, I cannot provide the requested information, as the input document does not pertain to an AI/ML device study.
§ 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.