(59 days)
The DePuy Motech PEAK 3mm Fixation Rod System is intended for use in treating fractures of the pelvis, acetabulum, clavicle, scapula, and distal humerus.
The subject devices consist of a Transverse Connector Hook used to connect the 3mm rods at right angles or transversely across the fracture: an Inner Screw used to hold the rods and hook connectors together; and the Transverse Connector Assembly that consists of the subject Transverse Hook Connector, subject Inner Set Screw, and the predicate 3mm Fixation Rod (K980368).
The provided text is a 510(k) summary for the DePuy Motech PEAK™ Fixation System, which is a medical device for bone fixation. It details the device's intended use, materials, and substantial equivalence to existing devices. However, this document does not describe a study involving device performance metrics, acceptance criteria, or ground truth establishment for an AI/algorithm-based device.
Instead, it's a regulatory document for a physical bone fixation appliance, focusing on its mechanical equivalence and intended use compared to predicate devices. Therefore, I cannot generate the requested information based on the input text.
The information requested, such as acceptance criteria, reported device performance, sample sizes for test/training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types, are typically relevant for the evaluation of AI/Machine Learning-based medical devices, especially those that generate diagnostic or prognostic outputs. The provided document is for a mechanical orthopedic implant.
To provide the requested table and study details, I would need a document describing the testing and validation of an AI-powered 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.