(26 days)
The PTS 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 device has been modified to introduce two additional treatment modes: the Single scattering and the Uniform scanning. The Single scattering technique is a technique dedicated to the irradiation of fields smaller than seven centimeters in diameter. Single scattering decreases the amount of scattering in the nozzle compared to double scattering and lead to better lateral penumbra. Uniform scanning is an active technique for spreading beam in a transversal direction. The incoming narrow beam, whose size is a significant fraction of the field to be treated, is moved by magnetic scanning so as to yield a flat field. The beam is deviated in x and y directions by two magnets, making the beam travel along a saw-tooth pattern with rounded corners. A patient specific aperture and bolus need therefore to be used just as in double scattering mode. A Uniform Scanning session is composed of several mini-irradiations that are used to build a Spread Out Bragg Peak within the treatment volume that is divided in a stack of layers, each of them corresponding to one penetration depth.
This document is a 510(k) summary for a device modification to the IBA PROTON THERAPY SYSTEM - PROTEUS 235. The modifications introduce two new treatment modes: Single scattering and Uniform scanning. The summary primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study report as typically found in clinical trials for new medical devices.
Therefore, the requested information elements cannot be fully extracted directly from the provided text, as this type of regulatory submission has a different focus.
However, based on the information provided, here's what can be gathered and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative performance metric format for the newly introduced treatment modes. Instead, it relies on a comparison of technological characteristics to a predicate device to demonstrate substantial equivalence.
The table presented in the document (pages 2-4) focuses on comparing the new device modifications with the predicate device across various technical aspects. It primarily notes "No Change" for most characteristics, indicating that the core functionality and safety parameters are consistent with the legally marketed device. For the new features, it describes their characteristics rather than setting and meeting performance criteria against numerical targets.
For example, under "Beam Range Patient (Tissue Depth)", the document reports the following for the modified devices:
- Uniform Scanning: 3.5 cm to 32 cm in for 40x30cm field
- Single Scattering: 3.5 cm to 20 cm for Maximum field size 6 cm diameter field
- Predicate Device: 5 cm to 28 cm for Φ 10 cm field; 5 cm to 24 cm for Φ 20 cm field
However, these are descriptive specifications, not acceptance criteria with pass/fail thresholds. The "performance" is inherently implied to meet the design specifications of the new modalities.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document does not describe a "test set" in the context of clinical or performance data for the device modifications. The submission is for a device modification based on engineering and physics principles, not a clinical study requiring patient data. Therefore, information on sample size or data provenance is not applicable or provided.
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. As this is not a study involving human interpretation or clinical data requiring ground truth establishment by experts, this information is not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no test set requiring adjudication of findings is described.
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 device is a proton therapy system, not an AI diagnostic or assistance tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This refers to an automated system's performance, which is not the primary focus of this device modification (a physically controlled beam delivery system). The performance of the beam characteristics would be assessed through physical measurements and simulations, but the document does not detail these specific tests or their results beyond the reported specifications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The "ground truth" for a proton therapy system's physical parameters (like range, field size, scattering properties) would be based on established physics principles, validated simulation models, and direct physical measurements with dosimetry equipment. The document doesn't detail the experimental setup for proving the device characteristics, but it would not involve expert consensus, pathology, or outcomes data in the traditional sense for these technical specifications.
8. The sample size for the training set
Not applicable. This device is not a machine learning or AI-based system that requires a "training set" of data.
9. How the ground truth for the training set was established
Not applicable for the same reasons as point 8.
§ 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.