(119 days)
The MotoBand™ CP Implant System is indication and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes.
The MotoBAND™ CP Implant System is comprised of implant plates, bone screws and instruments, having various features and sizes to accommodate differing patient anatomy. Plate geometries include the double Y plate, Y-plate, straight plate (2 hole, 4 hole and 5 hole) and MTP plate with 10° Valgus, 0° Dorsi-Flexion.
This document describes the MotoBAND™ CP Implant System, a medical device for orthopedic fixation. It does not contain information about an AI/machine learning device or a corresponding study with acceptance criteria for such a device. The content focuses on the substantial equivalence of the implant system to predicate devices based on theoretical performance analysis.
Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance for an AI/machine learning device as the provided document pertains to a traditional medical implant, not an AI system.
§ 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.