(87 days)
The Fixano Radiofix wrist fixation device is intended for use in the fixation of unstable or comminuted extra-articular epiphyseal fracture of the distal radius, by compression, flexion or extension. The epiphyseal fragment must be in one single piece.
The device is a radiolucent external fixator capable of rotation and angulation.
I am sorry, but the provided text does not contain information about acceptance criteria or a study proving device performance for the "Radiofix" device. The document is primarily a 510(k) summary and an FDA clearance letter, which focus on establishing substantial equivalence to a predicate device rather than detailing performance studies and acceptance criteria.
The information present in the text is:
- Device Name: Radiofix
- Manufacturer: Fixano S.A.
- Intended Use: "The Fixano Radiofix wrist fixation device is intended for use in the fixation of unstable or comminuted extra-articular epiphyseal fracture of the distal radius, by compression, flexion or extension. The epiphyseal fragment must be in one single piece."
- Device Description: "The device is a radiolucent external fixator capable of rotation and angulation."
- Substantial Equivalence: To predicate devices such as Orthopedic Innovations Cobra External Fixator (K983881) and Orthofix Non-bridging Pennig Wrist Fixator.
Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment based on the provided document.
§ 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.