(171 days)
The Piccolo Composite Distal Femur Plate System is indicated for buttressing multifragmentary distal femur fractures including supra-condylar, intra-articular and extra-articular condylar fractures, periprosthetic fractures in normal or osteopenic bone, nonunions and malunions.
The Piccolo Composite Distal Femur Plate System comprises implants (plates and screws), and a set of instruments.
The plates are made of carbon fiber reinforced polyetheretherketone (CFR-PEEK), and are marked with a tantalum thread, to provide for their visualization under fluoroscopy. The screws are made of titanium alloy. Both non-locking screws and locking screws are available, in various dimensions.
This document describes the Piccolo Composite® Plate System, a medical device for bone fixation. Since this is a 510(k) summary for a medical device and not an AI/software product, the provided text does not contain information about acceptance criteria, study details, or ground truth relevant to AI performance. Therefore, I cannot extract the requested information.
The document discusses the substantial equivalence of the device to predicate devices based on intended use, design, materials, technological characteristics, principles of operation, and performance characteristics as evaluated per ASTM F 382. It does not involve a study of an AI algorithm.
§ 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.