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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:

1. Incorporation of a previously cleared Real Time Image Gating System (RGS or RGPT) for tracking implanted fiducials.
2. 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.

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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 is a modification to the cleared PROBEAT-V system, for installation at a different clinical 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 provided text is a 510(k) summary for the PROBEAT-CR Proton Beam Therapy System. It describes the device, its intended use, and a comparison to predicate devices, but it does not contain information regarding software performance, acceptance criteria for an AI/algorithm, or a study that specifically proves the device meets such criteria.

The document primarily focuses on demonstrating the substantial equivalence of the PROBEAT-CR to its predicate devices (PROBEAT-V systems K151132 and K152592) in terms of hardware components, technological characteristics, and overall function as a proton beam therapy system.

The "Performance Data" section discusses:

• Mechanical performance of the rotating gantry and patient couch.
• Beam performance testing (dose shape and dose).
• Safety interface testing (beam stop control, dose monitor, area safety, mechanical interlocks).
• Electrical safety and electromagnetic compatibility (IEC 60601-1 and IEC 60601-1-2).

It states: "In all instances, the PROBEAT-CR functioned as intended and met its specifications. Testing demonstrated substantial equivalence to the predicates." However, it does not specify what those "specifications" or "acceptance criteria" were, nor does it detail the study design, sample sizes, or ground truth for any algorithmic performance evaluation.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving an AI/algorithm meets those criteria based solely on the provided text. The document describes a physical medical device (proton beam therapy system), not an AI or algorithm with associated performance metrics.

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