(163 days)
The ProBeam 360° Proton Therapy System provides protons for precision radiotherapy of lesions, turnors, and conditions anywhere in the body where radiation treatment is indicated.
The ProBeam 360° Proton Therapy System is a device that generates ionizing radiation (protons) in order to deliver radiation therapy in accordance with a predetermined treatment plan. The ProBeam 360° System version 1.0 is available in single-room, compact configuration and includes the following primary components: Cyclotron, Beam Transport System, Treatment Room with a rotating Gantry, Treatment Control Room.
The provided text is a 510(k) Premarket Notification summary for the Varian ProBeam 360° Proton Therapy System. It details the device, its intended use, comparison to a predicate device, and a summary of performance testing.
However, it does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of an AI/ML-driven medical device validation. The document explicitly states:
"No animal studies or clinical tests have been included in this pre-market submission."
This indicates that the submission relies on design verification and validation testing, conformance to standards, and comparison to a predicate device, rather than performance studies that would involve a test set, ground truth experts, MRMC studies, or standalone algorithm performance as typically found in AI/ML medical device submissions.
Therefore, I cannot extract the information required to answer your prompt points 1-9 from the provided text. The document describes a traditional medical device (a radiation therapy system), not an AI/ML device that requires validation of its diagnostic or predictive performance on a data set.
§ 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.