(85 days)
ProBeam Proton Therapy System provides protons for precision radiotherapy of lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
ProBeam Proton therapy system, has been designed by Varian Medical Systems to deliver radiation treatment in accordance with a prescribed treatment plan. The system takes advantage of the characteristics of proton charged particle beam delivery. The major characteristic of proton radiation therapy utilizes the Bragg peak to prevent radiation of normal tissue outside the target volume. The system consists of 4 major components: 1) Cyclotron required to generate the proton beam (output 250MeV) 2) Beam line to transport beam from the cyclotron to the required treatment room 3) Treatment room where the patient is irradiated as per the prescribed treatment plan 4) Control room to select patient and activate treatment delivery
The provided text describes the "ProBeam Proton Therapy System" and its substantial equivalence to a predicate device, but it does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria in the way typically expected for an AI/ML medical device.
Instead, the document is a 510(k) summary for a medical device that delivers radiation therapy. The submission focuses on demonstrating substantial equivalence to a previously cleared device (K101294 ProBeam Proton Therapy System and K042720 Varian On-board Imager Device) by comparing technological characteristics.
Therefore, many of the requested sections about acceptance criteria, study details, ground truth, and expert involvement are not explicitly present in the provided text.
Based on the information available:
1. A table of acceptance criteria and the reported device performance:
The document doesn't provide a table of acceptance criteria for specific performance metrics that would be applicable to an AI/ML device (e.g., sensitivity, specificity, accuracy). Instead, it compares the technological characteristics of the modified device to the predicate device. The "performance" in this context refers to the technological specifications and capabilities, not a clinical or analytical performance study.
Here's an adaptation of the table comparing the modified ProBeam to the predicate, highlighting the changes:
| Feature | Predicate Device (ProBeam K101294) | Modified Device (ProBeam) |
|---|---|---|
| Proton Energy Selection (usable) | 90-230 MeV | 70 - 240 MeV |
| Number of beam delivery rooms | 1 to 4 treatment rooms with isocentric gantries. No fixed beam treatment stations. | Customer can choose up to 6 beam delivery room modules. The facility would be comprised of a combination of modules including Treatment rooms (either Isocentric gantries or fixed beam) and/or research rooms. |
| Beam angle adjustment | Adjustable via Rotating Isocentric Gantry | Adjustable only in Rotating Isocentric Gantry rooms. For fixed beam rooms the beam is provided at a fixed angle. |
| Beam characteristics: spot shape | 4 mm (Sigma) in the specified range (tolerance range: for energies ≤100 MeV, beam spot size +30% / -20%, for energies> 100 MeV beam spot sizes ± 20%) | 4.0 mm +/- 15% (Sigma) for beam energies equal or greater than 140 MeV to 240 MeV. (-0.02 * E / MeV + 6.8) +/- 15 % mm for beam energies E from 70 MeV to less than 140 MeV. |
| Beam characteristics: field size | Maximum field size is 25cm (x) x 25cm (y) | Maximum field size is 30cm (x) x 40cm (y) |
| Maximum deviation of undeflected beam from isocenter | 3.0 mm | 1.0 mm |
| Value of energy dose rate at the Nominal Treatment Distance | >1 Gy/l/min | 2 Gy/l/min |
| Patient Positioning | Varian 6-Axis Treatment Table | Forte 6-Axis Robotic Treatment Table (K122413) |
| Maximum Load | 150Kg (330lbs) | 273 Kg (550lbs) |
| Patient Position Verification System | Not included (Predicate was Varian On-board Imager Device K042720) | Included (ProBeam Device Component: kV Imaging) |
| Target localization technology | Single kV X-ray System | Dual kV X-ray System |
| 2D/3D Match | Not included | Included |
| X-ray source | Varian G-242 | Varian GS-20712 |
| Voltage | 40-150kV | 40-140kV |
| Exposure | 0.5-630 mAs | 0.1-370.1 mAs |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. The document states "Testing has been performed at the system and sub-system level" but does not detail specific test sets, sample sizes, or data provenance in the context of analytical or clinical performance of an AI/ML algorithm. This is a proton therapy system, not an AI/ML software.
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):
Not applicable. Ground truth for an AI/ML algorithm is not relevant for this device submission as described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable.
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:
Not applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable.
8. The sample size for the training set:
Not applicable.
9. How the ground truth for the training set was established:
Not applicable.
Summary of Performance Testing mentioned in the document:
The document (Page 3) explicitly states: "Testing has been performed at the system and sub-system level and demonstrated ProBeam is substantially equivalent to the predicate device." This indicates engineering and functional testing to ensure the modified device meets its specifications and functions similarly to the predicate, rather than a clinical performance study using patient data and ground truth as would be relevant for an AI/ML device.
§ 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.