(42 days)
To be used by trained medical professionals for the stable support and positioning of patients undergoing external beam radiation therapy treatment in a clinic or hospital setting.
In particular, these items provide the stable positioning of patients in various positions, chosen to facilitate accurate treatment of tumors.
Patients are those that have been diagnosed and are undergoing treatment for cancerous tumors. Treatment is supervised and administered by licensed doctors and therapists trained in the application of radiation therapy treatments.
Not Found
The provided document is a 510(k) clearance letter from the FDA for several medical devices, primarily baseplates and support systems used in radiation therapy. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document is a regulatory approval notice, not a scientific study report.
§ 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.