(36 days)
The Synthes Low Profile Reconstruction Plates are intended for pelvic and acetabular reconstruction and fixation of fractures of the distal humerus, clavicle, and scapula.
The Synthes 3.5 mm Low Profile Reconstruction Plates consist of straight, curved, and J-shaped plates. The shape and profile of these plates are designed to minimize soft tissue irritation and minimize the need for intraoperative contouring. However, when intraoperative contouring is required for a precise fit with the bone, the plate design allows for simple and uniform bending.
The provided text is a 510(k) summary for the Synthes Low Profile Reconstruction Plates and an FDA clearance letter. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the provided input. This type of information would typically be found in detailed clinical or non-clinical performance studies, which are not included in this 510(k) summary.
§ 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.