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The PROBEAT-V 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-V includes optional accessories to assist the radiation oncologist in the delivery of proton radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation.

The PROBEAT-V 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 equipment to perform the above work is composed of two main components: (1) a beam delivery system whose primary responsibility is to ensure that the desired prescription parameters are properly delivered and (2) equipment necessary to generate the proton beam and direct it to the beam delivery system for patient treatment.

This document describes the PROBEAT-V and its accessories, focusing on modifications to the minimum MU and the introduction of a high-accuracy camera system for patient positioning. The document states that testing was conducted to confirm the device meets pre-defined acceptance criteria. However, it does not provide specific details about the acceptance criteria or the study that proves the device meets them.

Therefore, I cannot answer your request based on the provided text. The document states that "All the tests were successfully conducted and confirmed that the device meets the pre-defined acceptance criteria," but it does not elaborate on:

1. A table of acceptance criteria and the reported device performance: No table or specific performance metrics are provided.
2. Sample size used for the test set and the data provenance: No information on sample size or data origin is given.
3. Number of experts and their qualifications: No details about experts are mentioned.
4. Adjudication method: Not described.
5. MRMC comparative effectiveness study: No indication of such a study.
6. Standalone performance: Not explicitly addressed in terms of a separate study.
7. Type of ground truth: Not specified.
8. Sample size for the training set: Not applicable as this is not a description of an AI/ML algorithm development.
9. How ground truth for the training set was established: Not applicable.

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The PROBEAT-V 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-V 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 site. The equipment to perform the above work is composed of two main components: (1) a beam delivery system whose primary responsibility is to ensure that the desired prescription parameters are properly delivered and (2) equipment necessary to generate the proton beam and direct it to the beam delivery system for patient treatment.

The beam delivery system is composed of the following components:

• Gantry Room
  • Rotating Gantry
  • Scanning Nozzle
  • Patient Positioning System
  • Cone Beam CT / X-ray Imaging System
• Fixed Beam Room
  • Scanning Nozzle
  • Patient Positioning System
  • Cone Beam CT

The beam production system is composed of the following components:

• Accelerator system (LINAC, Synchrotron)
• Beam transport system (Low/High Energy Beam Transport systems)

The provided text is a 510(k) summary for the PROBEAT-V proton beam therapy system. It describes the device, its intended use, and performance data. However, it does not contain the detailed information required to answer all the questions about specific acceptance criteria and a study proving the device meets those criteria, particularly regarding AI performance, expert ground truth, sample sizes for training/test sets, and adjudication methods, as this is neither an AI device nor does it have relevant information about AI device testing.

Here's a breakdown of what can be extracted from the document:

1. A table of acceptance criteria and the reported device performance

The document provides a general statement about performance testing without specific quantitative acceptance criteria. It broadly states that the device "functioned as intended and met its specifications."

2. Sample size 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 document. The document describes general performance testing but does not specify sample sizes or data provenance.

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)

This information is not applicable/provided. The PROBEAT-V is a therapeutic device (proton beam therapy system), not a diagnostic or AI-driven decision support system that typically requires expert-established ground truth for image interpretation or diagnosis. The performance testing focuses on the physical and functional aspects of the hardware and beam delivery.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not applicable/provided for the same reasons as the previous point. Adjudication methods are typically used in studies involving subjective assessments or classifications by human readers, which is not the nature of the described performance testing for a proton beam therapy system.

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

There is no indication that an MRMC comparative effectiveness study was done, nor is AI assistance mentioned. The device is a proton beam therapy system, not an AI-driven image analysis or decision support tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable/provided. The PROBEAT-V is a physical medical device for radiation therapy, not an algorithm. Its performance testing relates to its mechanical, electrical, and beam delivery functionalities.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The concept of "ground truth" as typically applied to diagnostic studies (e.g., pathology for a tumor diagnosis) is not directly applicable here. The performance testing described (mechanical, beam, safety interfaces, electrical safety, EMC) likely uses objective, measurable physical parameters and engineering standards as its "ground truth" or reference for meeting specifications. For example, a "beam dose shape" would be compared against a pre-defined expected profile, or electrical safety against a standard like IEC 60601-1.

8. The sample size for the training set

This information is not applicable/provided. The PROBEAT-V is a hardware medical device; it does not involve a "training set" in the context of machine learning. Its design and manufacturing are based on engineering principles and established medical device standards.

9. How the ground truth for the training set was established

This information is not applicable/provided for the same reasons as the previous point.

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The Extended Range Shifter is an accessory to the PROBEAT-V system that is intended to assist the radiation oncologist in the delivery of proton radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation.

This accessory is added to the nozzle of the cleared PROBEAT-V to suppress the beam spreading further compared to use of the standard range shifter.

The provided text is a 510(k) summary for the "Extended Range Shifter" device. It describes the device, its intended use, and its technological characteristics. However, it does not contain the type of information typically found in a study proving a device meets specific acceptance criteria, especially for AI/ML-based medical devices.

Specifically, the text is about a physical accessory for a proton therapy system, not a software or AI device that would require detailed performance metrics like sensitivity, specificity, or human reader improvement with AI assistance. The "Performance Data" section simply states that "All the tests were successfully conducted and confirmed the performance of the ERS." without providing any quantitative data or details about the sample size, ground truth, or expert evaluation methods.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance: The document only generically states tests were "successfully conducted" but provides no specific criteria or performance numbers.
• Sample size and data provenance: Not mentioned.
• Number of experts and qualifications: Not relevant for this type of physical device's performance testing described here.
• Adjudication method: Not applicable.
• MRMC comparative effectiveness study: Not applicable.
• Standalone performance: Not applicable.
• Type of ground truth: Not specified beyond physical measurements.
• Training set sample size and ground truth establishment: Not applicable, as this is not an AI/ML device.

In summary, the provided document does not contain the information required to answer your questions about acceptance criteria and study details for an AI/ML device demonstrating performance. It is a premarket notification for a physical medical device accessory.

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The PROBEAT-V 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-V 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 site. The equipment to perform the above work is composed of two main components: (1) a beam delivery system properly delivered and (2) equipment necessary to generate the proton beam and direct it to the beam delivery system for patient treatment.

The beam delivery system is composed of the following components"

• o Gantry Room
  • · Rotating Gantry
  • . Scanning Nozzle
  • . Patient Couch (or Patient Positioning System)
  • . X-ray Imaging System
• o Fixed Beam Room
  • Scanning Nozzle .
  • . Patient Couch (or Patient Positioning System)
  • . X-ray Imaging System

The beam production system is composed of the following components"

• Accelerator system (LINAC, Synchrotron) O
• Beam transport system (Low/High Energy Beam Transport systems) O

The provided text describes the 510(k) premarket notification for the Hitachi PROBEAT-V, a medical charged-particle radiation therapy system. It outlines performance data but does not contain information about specific acceptance criteria, study methodologies, or AI performance metrics as requested.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details as these are not present in the provided document.

The document indicates that Hitachi performed validation testing to evaluate:

• Mechanical performance: Specifically for the rotating gantry and patient couch.
• Beam performance: To assess beam dose shape and beam dose.
• Safety interface testing: To evaluate beam stop control, dose monitor, area safety, and mechanical interlocks.
• Electrical safety and electromagnetic compatibility: In accordance with IEC 60601-1 and IEC 60601-1-2.

The conclusion of these tests was that "In all instances, the PROBEAT-V functioned as intended and met its specifications." This statement broadly implies that the device met its internal acceptance criteria for these functional and safety aspects, but the specific numerical or qualitative criteria for "met its specifications" are not detailed.

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