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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 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's 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 the modification of the SL Rapid Clamps and the addition of a 'MRI Safe' labeling claim to the existing System when the newly modified SL Rapid Clamps are utilized. The intended use and fundamental scientific technology have not changed from the previously cleared submission.

The provided text describes a Special 510(k) Device Modification for the EBI® XFIX® Vision® Fixation System. This submission is for modifications to the SL Rapid Clamps and the addition of an 'MRI Safe' labeling claim. However, the document does not contain any information regarding specific acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or details about ground truth establishment.

The submission focuses on demonstrating substantial equivalence to previously cleared predicate devices (K993886, K011711, K014194) based on unchanged intended use, materials, and fundamental scientific technology. The approval letter from the FDA confirms this substantial equivalence.

Therefore, I cannot provide the requested table and detailed study information as it is not present in the provided text. The document is a 510(k) summary for a device modification, which primarily focuses on demonstrating equivalence rather than presenting new clinical study data with performance metrics.

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