(109 days)
The nomosSTAT device is intended to provide 3-dimensional conformal treatments in radiation therapy when used with an external beam photon therapy syment.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a device called "nomoSTAT". It confirms that the device is substantially equivalent to a predicate device for its indicated use, which is to provide 3-dimensional conformal treatments in radiation therapy when used with an external beam photon therapy system.
However, the letter does not contain any information about acceptance criteria, specific studies proving the device meets those criteria, sample sizes, data provenance, expert involvement, adjudication methods, multi-reader multi-case studies, standalone performance, or details about the training set.
Therefore, I cannot provide the requested information based on the given text. The provided document is a regulatory clearance letter, not a scientific study report or clinical trial summary.
§ 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.