(88 days)
The Acumed Congruent Bone Plate System provides fixation for fractures, fusions, or osteotomies for the clavicle, humerus, radius, ulna, metacarpal, metatarsal, malleolus, tibia, and fibula.
The predicate Congruent Bone Plate System (K012655) consists of bone plates and screws which provide fixation for fractures, fusions, and osteotomies of the clavicle, humerus, radius, ulna, metacarpal, metatarsal, malleolus, tibia, and fibula. The purpose of this 510(k) is to modify two components of the Congruent Bone Plate System and to add one component to this predicate system. These modifications are intended to allow the operating surgeon to better accommodate various patient anatomies when treating distal and midshaft fractures of the radius. All components are made of titanium alloy conforming to ASTM F136.
The provided text describes a 510(k) summary for the Acumed Congruent Bone Plate System. This is a medical device for bone fixation, and the summary details its indications for use, device description, and preclinical testing.
However, the information required to answer the specific questions about "acceptance criteria and the study that proves the device meets the acceptance criteria" is not present in the provided text. The document refers to preclinical testing (static and dynamic 4-point bend testing in accordance with ASTM F382) to demonstrate substantial equivalence to a predicate device. This type of testing evaluates the mechanical properties of the device, not its "performance" in the context of diagnostic accuracy, human reader improvement, or ground truth establishment, which are typical metrics for AI/ML-based medical devices or diagnostic tools.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer the specific questions related to sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment, as these concepts are not applicable to the type of device and testing described in this 510(k) summary.
In summary, the provided document does not contain the requested information regarding acceptance criteria and studies related to diagnostic/AI performance.
§ 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.