(90 days)
The Response Ortho Metaphyseal Fixation System is indicated for treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation.
The Response Ortho Metaphyseal Hinge Fixator System is a unilateral fixation device intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality. The system is designed to provide low profile and comprehensive solution invasively. Implants, reusable instruments, accessories, case&tray are included in the system. Products are non-sterile and implants that exist in the set, are single use. Instruments that are in the system, can be used repeatedly after cleaning and sterilization.
The provided text describes the Response Ortho Metaphyseal Hinge Fixator System, a medical device for orthopedic use. This document does not contain information related to AI/ML software, and therefore, the entire prompt requesting details about AI/ML acceptance criteria and a study proving device meets acceptance criteria cannot be fulfilled.
The text focuses on the device's indications for use, technological characteristics compared to predicate devices, and non-clinical tests performed to demonstrate substantial equivalence. These tests include:
- Determination and Comparison of Stiffness for Response Ortho Metaphyseal Hinge Fixator and EBI XFIX DFS Metaphyseal Correction System Constructs using Half Pins
- Evaluation of The Response Ortho Metaphyseal Hinge Fixator System and EBI XFIX DFS Metaphyseal Correction System Bridging Element Fatigue
- Evaluation of Function and Strength for Response Ortho Metaphyseal Hinge Fixator Distraction Mechanism under Constant Loading
- Evaluation of Response Ortho Half Pin Performance
The conclusion states that the device is substantially equivalent to predicate devices based on these non-clinical tests.
Therefore, I cannot provide the requested information regarding acceptance criteria and studies related to an AI/ML device.
§ 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.