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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.

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