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For use as permanently-filled and -sealed artificial fiduciary markers with the head rings and localizer I brass as permanently and systems in order to facilitate localizing and documenting the precise superimposition of CT and MRI imaging data.

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I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a device called "MRI Line Marker Non-invasive Radiographic Skin Marker." This document approves the device for market based on substantial equivalence to a predicate device, but it does not contain any information about acceptance criteria or a study that proves the device meets those criteria.

The 510(k) clearance process in the U.S. generally focuses on demonstrating substantial equivalence to pre-existing legally marketed devices, rather than requiring new clinical trials to establish independent safety and effectiveness metrics through specific acceptance criteria and detailed study designs as might be required for a Premarket Approval (PMA).

Therefore, I cannot fulfill your request for the specific details regarding acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment based on the provided text.

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