(84 days)
The PROBEAT-CR 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-CR 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-CR has two main subsystems: (1) equipment necessary to generate the proton beam and direct it to the beam delivery system for patient treatment, and (2) a beam delivery system whose primary responsibility is to ensure that the desired prescription parameters are properly delivered. The PROBEAT-CR comprises the following components and subsystems: Beam production system (Accelerator system (LINAC. Synchrotron), Beam transport system (Low/High Energy Beam Transport systems)), Beam delivery system in 4 separate treatment rooms. Each of 3 rooms will have a rotating gantry and 1 room will have a fixed beam. (Gantry Room (Scanning Nozzle, Rotating Gantry, Patient Positioning System, Orthogonal X-ray system, Cone Beam CT), Fixed Beam Room (Patient Positioning System, Orthogonal X-ray system, Treatment Control and Safety System)). The subject PROBEAT-CR is a modification to the cleared PROBEAT-CR to include the incorporation of the previously cleared Real Time Image Gating System for Proton Beam Therapy Systems ("RGS" or "RGPT") (K171049) for tracking implanted fiducials to qate the delivery of the proton beam, and the addition of an optional patient couch top extension as an accessory to allow for different patient positioning configurations.
The provided document is a 510(k) summary for a medical device (PROBEAT-CR Proton Beam Therapy System) seeking substantial equivalence to a predicate device. It does not contain the detailed information required to answer the specific questions about acceptance criteria, clinical study design, and ground truth establishment for an AI/ML powered device.
Based on the provided text, the device is a proton beam irradiation system, and the submission is for a modification to an already cleared device. The modifications include:
- Incorporation of a previously cleared Real Time Image Gating System (RGS or RGPT) for tracking implanted fiducials.
- Addition of an optional patient couch top extension.
The document explicitly states: "The following testing was performed to validate the modifications to the device: Design verification and validation testing for the addition of the optional top couch extension. Software verification and validation for the updated RGS (RGPT) software."
This implies that the testing was primarily focused on engineering validation of the new components and software, rather than a clinical effectiveness study of an AI/ML algorithm's diagnostic or prognostic performance. The document doesn't mention any AI/ML components performing tasks like image analysis or disease detection/classification, which would necessitate the detailed study information requested.
Therefore, I cannot provide the requested information about acceptance criteria, study design, sample sizes, expert qualifications, or ground truth for an AI/ML device because:
- The document does not describe an AI/ML powered device with new functionality that would require such studies. The Real Time Image Gating System (RGS) is mentioned as previously cleared (K171049) and the current submission is for an "updated RGS (RGPT) software." It's likely this update pertains to changes in its existing functionality, not the introduction of new AI-driven diagnostic capabilities.
- The document does not specify acceptance criteria in the context of clinical performance metrics (e.g., sensitivity, specificity, AUC) for an AI/ML algorithm. The "performance data" section is very brief and refers to design and software verification and validation, which are typical for any medical device modification, not necessarily for an AI/ML component's effectiveness.
- No clinical study to evaluate AI/ML performance compared to human readers or standalone AI performance is described.
In summary, the provided text does not contain the detailed information necessary to answer the questions about acceptance criteria, study design, and ground truth for an AI/ML powered device. The submission focuses on device modifications and internal verification/validation, not on the clinical performance evaluation of a new AI-driven diagnostic or prognostic capability.
§ 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.