(88 days)
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.
Not Found
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.
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.