(72 days)
This Alta® Plating System line extension includes plates that are intended to provided temporary stabilization of intra- and extra-articular fractures of the distal femur. Types of fractures include simple and comminuted fractures of the femoral condyles, and selected femoral supracondylar fractures. The plates are used in conjunction with cortical and cancellous bone screws. During healing, the plate provides a buttress for the protection of the fracture fragments. Once healing is complete, the plate will generally be removed.
The Alta® Modular Trauma System includes various types of plates for internal fixation of fractures. This Alta plate line extension is a modification of the currently marketed Alta Distal Fracture Plates and Channel Plates cleared for under various 510(k) notifications.
The provided text is a 510(k) summary for the Alta® Plating System Line Extension. It describes the device, its intended use, and its substantial equivalence to previously marketed devices. However, it does not contain any information regarding specific acceptance criteria, device performance metrics, study designs (such as sample sizes, data provenance, expert ground truth, MRMC studies, or standalone performance), or training set details.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or details about a study that proves the device meets acceptance criteria, as this information is not present in the provided document.
The document focuses on the regulatory submission process and the determination of substantial equivalence, which is a different type of evaluation than a performance study with acceptance criteria.
§ 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.