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The EBI XFIX® Vision™ Fixation System is a unilateral external 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 EBI XFIX Vision Fixation 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 Vision Fixation 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 Vision Fixation System is attached to the shanks of the bone screws. This submission is for additional components.

The provided text is a 510(k) Summary of Safety & Effectiveness for the EBI XFIX® Vision™ Fixation System, a medical device. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a study.

Therefore, the document does not contain the information requested regarding acceptance criteria, reported device performance, sample sizes for test or training sets, expert qualifications, ground truth establishment, or specific study designs (like MRMC or standalone performance).

Instead, the submission states:

• "The EBI XFIX Vision Fixation System has not changed the 4. Indications for Use or fundamental scientific technology of the previous cleared system."
• "The components of the EBI XFIX Vision Fixation System are fabricated from the same types of materials as the components of the currently marketed EBI XFIX DFS System and Howmedica External Fixation System."
• "The bone screw clamps of the EBI XFIX Vision Fixation System, like the bone screw . clamps currently marketed EBI XFIX DFS System, are designed for attachment to the bone screws."
• "The EBI XFIX Vision Fixation System like the currently marketed EBI XFIX DFS System is provided non-sterile."
• "There are no significant differences between the EBI XFIX Vision Fixation 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 type of submission relies on the prior clearance of predicate devices and highlights the similarities in intended use, materials, and function to argue for its safety and effectiveness, rather than presenting a de novo study with explicit acceptance criteria and performance metrics.

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