(21 days)
The EBI XFIX DFS Wristfix System is intended for use in upper extremity applications for the reduction, alignment and stabilization of intra-articular and extra-articular fractures, corrective osteotomies, and soft tissue deformities.
The EBI XFIX DFS Wristfix System has not changed the Indications for Use or fundamental scientific technology of the previous cleared system. The system consists of external fixation components and implantable bone screws. The EBI XFIX DFS Wristfix System is utilized in the following manner: bone screws are inserted through the patient skin and soft tissue and into the bone. The fixator frame of the EBI XFIX DFS Wristfix System is attached to the shanks of the bone screws.
The provided text is a 510(k) Summary of Safety & Effectiveness for the EBI XFIX DFS Wristfix™ System, specifically focusing on its substantial equivalence to previously marketed devices. It does not contain any information about acceptance criteria, device performance metrics, or any studies involving AI, human readers, or ground truth establishment.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. The document explicitly states:
- "The EBI XFIX DFS Wristfix System has not changed the 4. Indications for Use or fundamental scientific technology of the previous cleared system."
- "There are no significant differences between the EBI XFIX DFS Wristfix System and other currently marketed external fixation systems. It is substantially equivalent* to the predicate devices in regards to intended use, materials and function."
This indicates that the submission is based on substantial equivalence to predicate devices, rather than a performance study against specific acceptance criteria for a novel device or 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.