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The PROBEAT-FR 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-FR 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-FR 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 performance data presented in the 510(k) summary focuses on demonstrating that the PROBEAT-FR functions as intended and meets its specifications for various aspects, thus establishing substantial equivalence to its predicate device, the PROBEAT-CR.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The provided text does not specify a sample size for a test set in the context of patients or cases. The performance data described refers to engineering and system-level testing rather than clinical trials with patient data.

• Sample Size: Not applicable in the context of clinical patient data for this submission. The tests performed are on the device itself and its components.
• Data Provenance: Not applicable in the context of clinical patient data. The tests are system-level and engineering evaluations.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The provided text does not mention the use of expert radiologists or other medical professionals to establish ground truth for a test set in the context of a diagnostic or therapeutic performance evaluation involving medical images or patient outcomes. The testing described is focused on the technical performance and safety of the proton beam therapy system.

4. Adjudication Method for the Test Set

Since there is no mention of a test set involving human interpretation or decision-making on patient data, an adjudication method (like 2+1 or 3+1) is not applicable to the described performance tests.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned in the provided text. The submission focuses on demonstrating substantial equivalence based on the technical performance and safety of the device's features, not on improved human reader performance with AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The provided text does not describe a standalone algorithm-only performance study. The device is a proton beam therapy system, not an AI-driven diagnostic or image analysis algorithm that would typically undergo such a study. While it contains "Real Time Image Gating System software" and a "Positioning Image Analysis System (PIAS)," the performance testing described is at the total system level, not specifically isolating the performance of these software components as standalone algorithms.

7. Type of Ground Truth Used

The "ground truth" for the tests described is based on the engineering specifications and design requirements of the PROBEBEAT-FR system, as well as compliance with relevant international standards (e.g., IEC 60601-1, IEC 60601-1-2). For instance:

• For mechanical performance, "ground truth" would be the specified movement ranges, precision, and stability.
• For beam performance, "ground truth" would be the specified dose accuracy, beam shape, and energy.
• For safety interlocks, "ground truth" would be the successful triggering of safety mechanisms under defined conditions.

8. Sample Size for the Training Set

The provided text does not mention a training set size. This type of information would typically be relevant for machine learning or AI-driven devices that learn from data. The PROBEAT-FR is a hardware-intensive proton beam therapy system with integrated control software, not an AI model that undergoes a "training set" in the conventional sense.

9. How the Ground Truth for the Training Set Was Established

Since there is no mention of a "training set" for an AI or machine learning model, the method for establishing its ground truth is not applicable.

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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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The PROBEAT-V with X-ray Limiting Accessory 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 with X-ray Limiting Accessory 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.

The X-ray Beam Limiting accessory for use in conjunction with the cleared PROBEAT-V system is designed to limit the patient's X-ray exposure during for patient positioning with the Cone Beam CT (CBCT). The device has 4 motorized leaves which are controlled by the PROBEAT-V imaging software to position the leaves in order to limit the patient's radiation exposure during patient positioning.

The provided text describes a 510(k) premarket notification for the PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory. The document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and detailed performance data on the X-ray Limiting Accessory itself.

Based on the provided information, I can extract the following:

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

The document does not provide a specific table of acceptance criteria with numerical targets. Instead, it states that "In all cases, the device performed as intended and met all pre-specified success criteria." The performance evaluation focused on the integration of the X-ray Beam Limiting Device with the PROBEAT-V system.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not provide details on sample sizes for the test set or data provenance (country of origin, retrospective/prospective). The testing appears to be a validation of the integrated system in an engineering and performance testing context rather than a clinical study with patient data.

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)

Not applicable. The testing described appears to be technical performance testing of the device itself (e.g., accuracy, resolution, safety) and not a diagnostic or therapeutic output requiring interpretation by medical experts to establish ground truth.

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

Not applicable. The testing described appears to be technical performance testing of the device itself and not a diagnostic or therapeutic output requiring adjudication.

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

Not applicable. This document describes a proton beam therapy system with an X-ray limiting accessory, not an AI-based diagnostic or therapeutic assistance system.

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

This refers to the performance of the device's X-ray limiting accessory and its integration with the PROBEAT-V system. The "Performance Data" section describes this standalone performance testing for the integrated system, including slice pitch accuracy, spatial accuracy, spatial resolution, isocenter accuracy, and performance with the proton beam therapy positioning system, as well as electrical safety and electromagnetic compatibility. The device performed as intended and met all pre-specified success criteria in these tests.

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

For the technical performance tests mentioned (slice pitch accuracy, spatial accuracy, etc.), the "ground truth" would be established by validated measurement standards and reference devices used in engineering and quality control, rather than clinical ground truth like pathology or expert consensus. For electrical safety and electromagnetic compatibility, the ground truth would be compliance with relevant international and national standards.

8. The sample size for the training set

Not applicable for this type of device and submission. This is not an AI/machine learning device requiring a training set.

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

Not applicable for this type of device and submission. This is not an AI/machine learning device requiring a training set.

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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 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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Hitachi's PROBEAT with DSSS 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 with DSSS 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 PBTS is designed to be safe and reliable. The equipment to perform the above work is comprised of two main components. One is a beam delivery system whose primary responsibility is to ensure that the desired prescription parameters are properly delivered. The other is the equipment necessary to generate the proton beam and direct it to the beam delivery system.

The provided text describes a Special 510(k) submission for the PROBEAT with DSSS, a modification to an existing proton beam therapy system. This type of submission is used for devices that are substantially equivalent to a predicate device and have only minor modifications that do not raise new questions of safety or effectiveness. As such, the submission primarily focuses on demonstrating substantial equivalence rather than presenting extensive new performance data or clinical studies like those for novel devices.

Therefore, many of the typical acceptance criteria and study details you requested for AI/software-based medical devices are not explicitly mentioned in this document. The document states that performance testing was conducted, but it does not detail specific acceptance criteria in terms of quantitative metrics, sample sizes, or expert involvement as one would expect for an AI algorithm.

Here's an attempt to answer your questions based on the provided text, indicating where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

Not applicable in the context of this 510(k) summary for a hardware modification to an existing proton therapy system. The "test set" would likely refer to engineering and system validation tests rather than a clinical dataset in the AI sense. The document does not specify details of these tests, their 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

Not applicable. This information is not provided. Ground truth in this context would likely be based on physical measurements and engineering specifications, not expert interpretation of data.

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

Not applicable. This information is not provided.

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

Not applicable. This is a hardware modification for a proton beam therapy system, not an AI-based diagnostic or assistive device that would involve human readers.

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

Not applicable. This refers to the performance of the overall Proton Beam Therapy System with the added DSSS component, which is a physical beam delivery system, not an algorithm.

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

Not explicitly stated. For a proton beam therapy system, ground truth for performance testing would typically involve:

• Physical measurements: Verifying beam parameters (dose, energy, shape, position) using phantoms, dosimeters, and other radiation detectors.
• Engineering specifications: Comparing actual performance against designed specifications.
• Pre-clinical verification: Potentially using biological samples or animal models to assess beam effects (though not explicitly mentioned here for this modification).

8. The sample size for the training set

Not applicable. This is a hardware modification to an existing proton therapy system. The concept of a "training set" is relevant for machine learning algorithms, which is not the primary subject of this 510(k) summary.

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

Not applicable for the same reasons as above.

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Hitachi's PROBEAT with MGCS 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 with MGCS 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 PBTS is designed to be safe and reliable. The equipment to perform the above work is comprised of two main components. One is a beam delivery system whose primary responsibility is to ensure that the above listed prescription parameters are properly delivered. The other is the equipment necessary to generate the proton beam and direct it to the beam delivery system. The only difference between the PROBEAT with MGCS and the cleared PROBEAT is the addition of the MGCS that converts the scale and format of the dimensional data of the patient specific aperture and/or compensator generated by commercially available patient treatment planning/management software into the scale and format used by an industrial, computer controlled milling machine to enable the milling machine to fashion the required aperture or compensator for patient treatment.

The acceptance criteria and study proving device performance are not explicitly detailed in the provided text in the structured format requested. However, based on the information given for the Hitachi PROBEAT with MGCS, we can infer some aspects of the performance and the nature of the study.

Key takeaway: This document is a 510(k) summary for a modification to an already cleared proton beam therapy system. The primary goal is to demonstrate "substantial equivalence" to a predicate device, rather than present a de novo clinical study with detailed acceptance criteria and performance metrics typically seen for novel devices. The modification (MGCS) is described as an addition that "converts the scale and format of the dimensional data... into the scale and format used by an industrial, computer controlled milling machine." The document asserts that this modification "does not raise any new questions of safety or effectiveness."

Here's an attempt to structure the available information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not specified. The document states "The submission includes performance testing," but does not detail the number of cases or patients involved in this testing. Given the nature of the modification (data conversion for milling), the "test set" likely refers to engineering tests validating the MGCS's output and the resulting milled components, rather than a patient-based test set.
• Data Provenance: Not specified. Based on the context of a 510(k) submission for a medical device manufacturer, this would typically involve internal company testing and validation. It's not explicitly stated as retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

• This information is not provided. Given the nature of the device modification and the type of performance testing indicated (validation of data conversion and mechanical output for aperture/compensator milling), "ground truth" would likely be established through engineering specifications, reference measurements, and quality control checks on the milled components, rather than expert evaluation of clinical images or outcomes.

4. Adjudication Method for the Test Set

• This information is not provided. As above, the nature of the testing suggests engineering validation rather than human reader adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence through technical characteristics and internal performance testing, not a clinical study comparing human readers with and without AI assistance. The device modification (MGCS) is a technical component for manufacturing patient-specific treatment accessories, not directly an AI for image interpretation or diagnosis that would typically involve human reader studies.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• The information available indicates that "performance testing that Hitachi conducted to demonstrate that the device meets its performance specifications" was performed. This implies testing of the system, including the MGCS component, in a standalone capacity to ensure it performs its function of converting data for milling correctly and ensures the overall system maintains its designed delivery parameters. However, the details of this "standalone" testing are not elaborated upon. The MGCS's function itself is an "algorithm only" task of data conversion.

7. The Type of Ground Truth Used

• The type of ground truth used would be based on engineering specifications, physical measurements, and quality control standards for the proton beam delivery system and the milled patient-specific apertures/compensators. Specifically for the MGCS, the ground truth would be the accurate conversion of dimensional data from treatment planning software to the milling machine's format, ensuring the resulting milled components precisely match the design.

8. The Sample Size for the Training Set

• This information is not applicable/not provided. The MGCS is described as a data conversion system for manufacturing. It does not appear to be a machine learning or AI algorithm that requires a "training set" in the conventional sense of learning from data. Its function is deterministic: converting specified data formats, not learning patterns from a large dataset.

9. How the Ground Truth for the Training Set Was Established

• This question is not applicable, as there is no indication of a "training set" for the MGCS. The ground truth for its function would be derived from the pre-defined standards and specifications for dimensional data conversion and the physical requirements for the apertures/compensators.

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Hitachi's PROBEAT 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 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 and dose distribution to the prescribed patient treatment site. The equipment is comprised of two main components. One is a beam delivery system whose primary responsibility is to ensure that the above listed prescription parameters are properly delivered. The other is the equipment necessary to generate the proton beam and direct it to the beam delivery system.

The provided text describes Hitachi's PROBEAT, a proton beam therapy system, and its 510(k) submission for FDA clearance. However, it does not contain detailed information about specific acceptance criteria or a study designed to prove the device meets those criteria in the way typically required for AI/ML-based medical devices (e.g., performance metrics like sensitivity, specificity, or AUC against a ground truth).

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed performance study with quantitative results against established acceptance criteria.

Here's an attempt to answer your questions based only on the provided text, highlighting where information is absent:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

Information regarding a specific "test set" with a defined sample size for evaluating the PROBEAT's performance as a medical device is not provided. The document mentions general "performance testing" but does not detail the nature of this testing (e.g., patient data, phantom studies) or its provenance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Information about experts establishing ground truth for a test set is not provided. This type of detail is usually relevant for diagnostic devices or those involving human interpretation, which is not the primary focus of this submission for a radiation therapy delivery system.

4. Adjudication Method for the Test Set

Information on an adjudication method for a test set is not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study, which typically evaluates human reader performance with and without AI assistance, was not mentioned and is not relevant for this type of device (a proton beam therapy delivery system). This device delivers the therapy, it does not assist human readers in making diagnoses or interpretations of images in the same way an AI diagnostic tool would.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The document refers to "performance testing" conducted by Hitachi but does not explicitly describe it as a "standalone" algorithm-only performance study in the context of AI. The PROBEAT is a physical system, not primarily a software algorithm for interpretation. The performance testing would be focused on the hardware's ability to create and deliver the proton beam accurately and safely.

7. The Type of Ground Truth Used

The document does not specify the type of ground truth used for the "performance testing." For a proton beam therapy system, ground truth would likely involve:

• Physical measurements using dosimeters in phantoms to verify dose distribution and accuracy against planned treatment.
• Engineering specifications and calibration standards.
• Possibly pre-clinical studies or simulations.

8. The Sample Size for the Training Set

Information about a "training set" is not provided. As this is a proton beam therapy delivery system, and not an AI/ML-based diagnostic or predictive algorithm, the concept of a "training set" for the device's core function (beam generation and delivery) is not applicable in the same way it would be for an AI algorithm. Its design and engineering would be based on physics principles and engineering validation, not statistical learning from a large dataset.

9. How the Ground Truth for the Training Set Was Established

Information about how ground truth for a "training set" was established is not provided, as the concept of a training set is not applicable to the description of the device's validation in this document.

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