(49 days)
Synthes LCP Distal Femur Plates are intended for buttressing multifragmentary distal femur fractures including: supracondylar, intraarticular and extra-articular condylar, periprosthetic fractures and fractures in normal or osteopenic bone, nonunions and malunions, and osteotomies of the femur.
Synthes LCP Distal Femur Plates are part of the Synthes Locking Compression Plate (LCP) System. The plates have a low profile design, are available in left and right versions with Dynamic Compression Plate (DCP) holes combined with locking screw holes in the shaft of the plate and threaded screw holes in the head of the plate. The plates will be offered in stainless steel and titanium and will be available in sterile and non-sterile versions.
This 510(k) summary for the Synthes LCP Distal Femur Plates does not contain information about acceptance criteria or a study proving the device meets those criteria.
The document describes the device, its intended use, and states that information presented supports substantial equivalence to a predicate device. This is typical for a 510(k) submission, where the primary goal is to demonstrate that a new device is as safe and effective as a legally marketed predicate device, rather than providing new clinical study data with specific performance metrics and acceptance criteria.
Therefore, I cannot provide the requested information, including the table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details, as they are not present in the provided 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.