(34 days)
The PROBEAT-V is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
The PROBEAT-V is a proton beam irradiation system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam with the prescribed dose, dose distribution and directed to the prescribed patient site. The equipment to perform the above work is composed of two main components: (1) a beam delivery system properly delivered and (2) equipment necessary to generate the proton beam and direct it to the beam delivery system for patient treatment.
The beam delivery system is composed of the following components"
- o Gantry Room
- · Rotating Gantry
- . Scanning Nozzle
- . Patient Couch (or Patient Positioning System)
- . X-ray Imaging System
- o Fixed Beam Room
- Scanning Nozzle .
- . Patient Couch (or Patient Positioning System)
- . X-ray Imaging System
The beam production system is composed of the following components"
- Accelerator system (LINAC, Synchrotron) O
- Beam transport system (Low/High Energy Beam Transport systems) O
The provided text describes the 510(k) premarket notification for the Hitachi PROBEAT-V, a medical charged-particle radiation therapy system. It outlines performance data but does not contain information about specific acceptance criteria, study methodologies, or AI performance metrics as requested.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details as these are not present in the provided document.
The document indicates that Hitachi performed validation testing to evaluate:
- Mechanical performance: Specifically for the rotating gantry and patient couch.
- Beam performance: To assess beam dose shape and beam dose.
- Safety interface testing: To evaluate beam stop control, dose monitor, area safety, and mechanical interlocks.
- Electrical safety and electromagnetic compatibility: In accordance with IEC 60601-1 and IEC 60601-1-2.
The conclusion of these tests was that "In all instances, the PROBEAT-V functioned as intended and met its specifications." This statement broadly implies that the device met its internal acceptance criteria for these functional and safety aspects, but the specific numerical or qualitative criteria for "met its specifications" are not detailed.
§ 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.