(21 days)
The Synthes 3.5 mm Broad LCP & 4.5 mm LCP Distal Humerus Plates are indicated for fractures of the Distal Humerus.
The Synthes 3.5 mm Broad LCP & 4.5 mm Broad LCP Distal Humerus Plates are contoured to match the anatomy of the distal humerus with a limited contact low profile design. The plate has dynamic compression holes combined with locking holes which accept 3.5 & 4.5 mm cortex, 3.5 & 4.5 mm self-tapping cortex, 3.5 mm shaft, 3.5, 4.0, & 5.0 mm locking, and 4.0 mm cancellous screws. The plates are available in various lenghts.
The provided document is a 510(k) summary for a medical device (Synthes 3.5 mm Broad LCP & 4.5 mm LCP Distal Humerus Plate) seeking substantial equivalence to a predicate device. This type of document focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than proving performance against specific acceptance criteria for a novel AI/software device through a standalone study.
Therefore, the information requested regarding acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert involvement, and MRMC studies is not applicable (N/A) to this specific document.
The document primarily relies on the concept of substantial equivalence to a predicate device (Synthes 3.5 mm LCP Reconstruction Plate) rather than a performance study with defined acceptance criteria and statistical analysis.
§ 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.