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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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