(125 days)
The ANTHEM® Fracture System is indicated for fixation of fractures, osteotomies, 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, femur, tibia, fibula, ankle, and foot. The clavicle hook plate may be used for dislocations of the acromioclavicular joint. Distal femur, distal humerus, proximal ulna, and proximal radius plates are indicated for diaphyseal, metaphyseal, epiphyseal, supracondylar, intra-articular, extra-articular, condylar, periprosthetic, and comminuted fractures, and for non-unions and malunions. 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.
In addition to adult patients, small fragment, mini fragment, proximal tibia, clavicle, metaphyseal, distal humerus, proximal ulna, proximal radius, and distal fibula plates are indicated for use in infant, child, and adolescent pediatric subgroups and small stature adults. Distal femur plates are indicated for use in the diaphyseal and metaphyseal areas of long bones in adolescent pediatric patients. Distal radius, 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, screws, and washers designed to be used for internal bone fixation. The implants are available in various sizes and shapes, and may be contoured or straight, with various lengths to accommodate patient anatomy. The subject ANTHEM® plates are manufactured from titanium alloy per ASTM F136 or stainless steel as specified in ASTM F138 and F139. Plates are also available additively manufactured from titanium alloy powder per ASTM F3001.
I am sorry, but based on the provided FDA clearance letter for the ANTHEM® Fracture System, I cannot extract the information you requested regarding acceptance criteria and the study that proves the device meets those criteria, specifically concerning human-in-the-loop performance, ground truth establishment, or training set details.
This document is a 510(k) clearance letter for a physical medical device (bone fixation system) and focuses on demonstrating substantial equivalence to predicate devices, primarily through engineering analysis and mechanical testing of the physical components. It does not appear to involve any AI/software component that would require the kind of performance study details you are asking for (e.g., sample size for test/training sets, expert adjudication, MRMC studies, standalone algorithm performance, or different types of ground truth like pathology or outcomes data).
Therefore, I cannot populate the table or answer the specific questions about AI/software performance studies. The "Performance Data" section solely refers to mechanical testing according to ASTM F382 and biocompatibility, which are standard for physical implants.
§ 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.