(90 days)
For use in high energy radiation therapy to correct for anatomical irregularities and deliver the prescribed dose to the skin surface and underlying tissue.
Not Found
I am sorry, but based on the text provided, I cannot answer your request. The document is a 510(k) clearance letter from the FDA for a device called "Super Tissue". It confirms that the device is substantially equivalent to a predicate device and can be marketed. However, it does not contain any information about acceptance criteria, study details, performance data, sample sizes, expert ground truth, or any of the other specific study-related information you requested.
The document is purely a regulatory clearance and does not include the technical study results that would typically accompany such a submission.
§ 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.