(59 days)
The Synthes Locking Hand Plates are intended for fixation of fractures, osteotomies, non-unions, replantations and fusions of small bones and small bone fragments, particularly in osteopenic bone.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA to Synthes (USA) regarding their Locking Hand Plates. This document confirms the device's substantial equivalence to predicate devices and outlines general regulatory compliance.
However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies. The letter is an administrative approval, not a technical report detailing performance evaluations.
Therefore, I cannot provide the requested information based on the input text.
§ 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.