(189 days)
The PROBEAT-FR 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-FR 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 PROBEAT-FR 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 performance data presented in the 510(k) summary focuses on demonstrating that the PROBEAT-FR functions as intended and meets its specifications for various aspects, thus establishing substantial equivalence to its predicate device, the PROBEAT-CR.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance (PROBEAT-FR) |
|---|---|
| Mechanical Performance | Functioned as intended and met specifications. (Evaluated through testing of rotating gantry, patient couch, and moving snout.) |
| Beam Performance | Functioned as intended and met specifications. (Evaluated through testing of beam dose shape and beam dose.) |
| Real Time Image Gated Particle Therapy Software | Functioned as intended and met specifications. |
| Imaging Guidance Function (CBCT & PIAS) | Functioned as intended and met specifications. |
| Safety Interlock Testing | Functioned as intended and met specifications. (Evaluated beam stop control, dose monitor, area safety, mechanical, and RGPT interlocks.) |
| Comprehensive Treatment Workflow | Functioned as intended and met specifications. |
| Electrical Safety (IEC 60601-1) | Compliant with IEC 60601-1. |
| Electromagnetic Compatibility (IEC 60601-1-2) | Compliant with IEC 60601-1-2. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify a sample size for a test set in the context of patients or cases. The performance data described refers to engineering and system-level testing rather than clinical trials with patient data.
- Sample Size: Not applicable in the context of clinical patient data for this submission. The tests performed are on the device itself and its components.
- Data Provenance: Not applicable in the context of clinical patient data. The tests are system-level and engineering evaluations.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The provided text does not mention the use of expert radiologists or other medical professionals to establish ground truth for a test set in the context of a diagnostic or therapeutic performance evaluation involving medical images or patient outcomes. The testing described is focused on the technical performance and safety of the proton beam therapy system.
4. Adjudication Method for the Test Set
Since there is no mention of a test set involving human interpretation or decision-making on patient data, an adjudication method (like 2+1 or 3+1) is not applicable to the described performance tests.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned in the provided text. The submission focuses on demonstrating substantial equivalence based on the technical performance and safety of the device's features, not on improved human reader performance with AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The provided text does not describe a standalone algorithm-only performance study. The device is a proton beam therapy system, not an AI-driven diagnostic or image analysis algorithm that would typically undergo such a study. While it contains "Real Time Image Gating System software" and a "Positioning Image Analysis System (PIAS)," the performance testing described is at the total system level, not specifically isolating the performance of these software components as standalone algorithms.
7. Type of Ground Truth Used
The "ground truth" for the tests described is based on the engineering specifications and design requirements of the PROBEBEAT-FR system, as well as compliance with relevant international standards (e.g., IEC 60601-1, IEC 60601-1-2). For instance:
- For mechanical performance, "ground truth" would be the specified movement ranges, precision, and stability.
- For beam performance, "ground truth" would be the specified dose accuracy, beam shape, and energy.
- For safety interlocks, "ground truth" would be the successful triggering of safety mechanisms under defined conditions.
8. Sample Size for the Training Set
The provided text does not mention a training set size. This type of information would typically be relevant for machine learning or AI-driven devices that learn from data. The PROBEAT-FR is a hardware-intensive proton beam therapy system with integrated control software, not an AI model that undergoes a "training set" in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a "training set" for an AI or machine learning model, the method for establishing its ground truth is 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.