(81 days)
Synthes Trochanter Stabilization Plate (TSP) for DHS® is intended to treat stable and unstable intertrochanteric, subtrochanteric, pertrochanteric and basilar neck fractures when used in conjunction with the Synthes Dynamic Hip Screw System (DHS®).
The Synthes Trochanter Stabilization Plate for DHS is a component of the Synthes DHS System, which fits over the sideplate of the DHS. The spoon-shaped area of the TSP, which is proximal to the shaft, resides along the greater trochanter. Screw holes of the TSP shaft line up with the screw holes of the DHS plate to accept the 4.5 mm cortex screws used for fixation to the femoral shaft. Two screw slots accommodate the DHS lag screw and the anti-rotational screw located proximal to it. Synthes Trochanter Stabilization Plates are provided both pre-sterilized by gamma radiation and nonsterile.
The provided text is a 510(k) Summary for the Synthes (USA) Trochanter Stabilization Plate for DHS®. This document describes a medical device seeking market clearance in the United States and asserts its substantial equivalence to a predicate device.
Critically, this document is a regulatory submission for a physical medical device (an orthopedic plate), not an AI/ML-driven device or an imaging study. Therefore, the questions related to AI/ML device performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, or MRMC studies are not applicable to the provided input.
The document describes the device, its intended use, and its predicate device, and the FDA's clearance letter. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML system.
Therefore, I cannot fulfill the request to describe acceptance criteria and associated study details because the provided input does not pertain to an AI/ML device or a study of its 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.