(368 days)
The Proton Therapy System - Proteus 235 (brand names: Proteus ONE) 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 PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.
The Proton Therapy System - Proteus 235 (Proteus One, Proteus Plus, Proteus TK2) 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 system includes a proton accelerator (either an isochronous cyclotron (C230) or a Superconducting Synchro-Cyclotron (S2C2)) for beam production, which can be shared between several treatment rooms or directed to a single room. The system can be equipped with different types of treatment rooms, such as fixed beam or gantry rooms, connected to the beam line. The change introduced in this filing is the option of a new IBA Compact Beam Production System (CBPS) based on a Superconducting Synchro-Cyclotron (S2C2).
The provided text contains information about a 510(k) premarket notification for a Proton Therapy System, specifically focusing on the introduction of a new Compact Beam Production System (CBPS) feature. However, it does not include the type of study typically associated with device performance against acceptance criteria for diagnostic or AI-based devices (e.g., studies involving human readers, ground truth establishment through expert consensus, or performance metrics like sensitivity/specificity).
Instead, the document details the technical specifications and comparative performance of a radiation therapy system, which is evaluated based on physical beam characteristics and operational parameters rather than diagnostic accuracy.
Therefore, many of the requested items (e.g., sample size for test set, expert qualifications, MRMC study, standalone performance for diagnostic tasks, training set details) are not applicable or not present in the provided text for this type of medical device.
Here's an attempt to answer the applicable questions based on the provided text, while noting the limitations:
1. A table of acceptance criteria and the reported device performance
The document provides a table comparing key clinical beam performance characteristics. While not explicitly termed "acceptance criteria" in the context of diagnostic performance, these are the parameters against which the new CBPS feature is evaluated for equivalency to the predicate device.
| Characteristic | Acceptance Criteria (Predicate Device K132919) | Reported Device Performance (IBA Proteus Compact Gantry Beam Line with Superconducting synchrocyclotron (CBPS) - K152224) |
|---|---|---|
| Maximum Beam Range in Patient (Tissue depth) | >= 32 cm | >= 32 cm |
| Field Size | 24 cm x 20 cm | 24 cm x 20 cm |
| Beam Distal Fall Off | = 2m | >= 2m |
2. Sample sized 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 text. The evaluation is based on "testing performed at the system and sub-system level" rather than patient or diagnostic data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the device is a radiation therapy system, not a diagnostic device requiring expert interpretation of images or patient data for ground truth. The 'ground truth' for this type of device would involve physical measurements and technical specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for the reasons stated above.
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
A multi-reader multi-case (MRMC) comparative effectiveness study is not applicable as this is a radiation therapy system, not an AI-assisted diagnostic device. The study is comparing the technical performance of a new component (CBPS) to an existing one.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable in the context of an AI algorithm, as this device is a physical system. The "standalone performance" is implicitly the performance of the system as described in the table, without human interaction in its beam delivery characteristics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance would be established through physical measurements and engineering specifications (e.g., beam range, field size, spot size, irradiation time) using phantoms or measurement equipment, rather than expert consensus on diagnostic images or pathology. The text states "Testing has been performed at the system and sub-system level."
8. The sample size for the training set
This is not applicable as this is not an AI/machine learning device that would require a "training set" in the conventional sense.
9. How the ground truth for the training set was established
This 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.