(126 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 includes optional accessories to assist the radiation oncologist in the delivery of proton radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess 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 treatment site. The equipment to perform the above work is composed of two main components: (1) a beam delivery system whose primary responsibility is to ensure that the desired prescription parameters are properly delivered and (2) equipment necessary to generate the proton beam and direct it to the beam delivery system for patient treatment.
This document describes the PROBEAT-V and its accessories, focusing on modifications to the minimum MU and the introduction of a high-accuracy camera system for patient positioning. The document states that testing was conducted to confirm the device meets pre-defined acceptance criteria. However, it does not provide specific details about the acceptance criteria or the study that proves the device meets them.
Therefore, I cannot answer your request based on the provided text. The document states that "All the tests were successfully conducted and confirmed that the device meets the pre-defined acceptance criteria," but it does not elaborate on:
- A table of acceptance criteria and the reported device performance: No table or specific performance metrics are provided.
- Sample size used for the test set and the data provenance: No information on sample size or data origin is given.
- Number of experts and their qualifications: No details about experts are mentioned.
- Adjudication method: Not described.
- MRMC comparative effectiveness study: No indication of such a study.
- Standalone performance: Not explicitly addressed in terms of a separate study.
- Type of ground truth: Not specified.
- Sample size for the training set: Not applicable as this is not a description of an AI/ML algorithm development.
- How ground truth for the training set was established: Not applicable.
§ 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.