(53 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 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.
The beam delivery system is composed of the following components:
- Gantry Room
- Rotating Gantry
- Scanning Nozzle
- Patient Positioning System
- Cone Beam CT / X-ray Imaging System
- Fixed Beam Room
- Scanning Nozzle
- Patient Positioning System
- Cone Beam CT
The beam production system is composed of the following components:
- Accelerator system (LINAC, Synchrotron)
- Beam transport system (Low/High Energy Beam Transport systems)
The provided text is a 510(k) summary for the PROBEAT-V proton beam therapy system. It describes the device, its intended use, and performance data. However, it does not contain the detailed information required to answer all the questions about specific acceptance criteria and a study proving the device meets those criteria, particularly regarding AI performance, expert ground truth, sample sizes for training/test sets, and adjudication methods, as this is neither an AI device nor does it have relevant information about AI device testing.
Here's a breakdown of what can be extracted from the document:
1. A table of acceptance criteria and the reported device performance
The document provides a general statement about performance testing without specific quantitative acceptance criteria. It broadly states that the device "functioned as intended and met its specifications."
| Acceptance Criteria (Stated broadly) | Reported Device Performance |
|---|---|
| Mechanical performance of rotating gantry and patient couch | Functioned as intended and met specifications |
| Beam dose shape and beam dose | Functioned as intended and met specifications |
| Beam stop control, dose monitor, area safety, and mechanical interlocks | Functioned as intended and met specifications |
| Electrical safety (IEC 60601-1) | Met specifications |
| Electromagnetic compatibility (IEC 60601-1-2) | Met specifications |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document describes general performance testing but does not specify sample sizes or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not applicable/provided. The PROBEAT-V is a therapeutic device (proton beam therapy system), not a diagnostic or AI-driven decision support system that typically requires expert-established ground truth for image interpretation or diagnosis. The performance testing focuses on the physical and functional aspects of the hardware and beam delivery.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable/provided for the same reasons as the previous point. Adjudication methods are typically used in studies involving subjective assessments or classifications by human readers, which is not the nature of the described performance testing for a proton beam therapy system.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There is no indication that an MRMC comparative effectiveness study was done, nor is AI assistance mentioned. The device is a proton beam therapy system, not an AI-driven image analysis or decision support tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided. The PROBEAT-V is a physical medical device for radiation therapy, not an algorithm. Its performance testing relates to its mechanical, electrical, and beam delivery functionalities.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically applied to diagnostic studies (e.g., pathology for a tumor diagnosis) is not directly applicable here. The performance testing described (mechanical, beam, safety interfaces, electrical safety, EMC) likely uses objective, measurable physical parameters and engineering standards as its "ground truth" or reference for meeting specifications. For example, a "beam dose shape" would be compared against a pre-defined expected profile, or electrical safety against a standard like IEC 60601-1.
8. The sample size for the training set
This information is not applicable/provided. The PROBEAT-V is a hardware medical device; it does not involve a "training set" in the context of machine learning. Its design and manufacturing are based on engineering principles and established medical device standards.
9. How the ground truth for the training set was established
This information is not applicable/provided for the same reasons as the previous point.
§ 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.