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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

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

The beam production system is composed of the following components

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

The system incorporates several optional features and accessories, namely:

• The Mini Ridge Filter ("mRF") is an optional accessory to modify the beam of the o PROBEAT-V system. The mRF is installed manually and may be used in conjunction with the range shifters inside the nozzle or extended range shifter. The mRF can be added to the cleared PROBEAT-V nozzle to spread out the Bragg peak along the axis of the beam in order to reduce the amount of beam energy in the delivery of proton radiation to defined target volumes.
• Beam gating function allowing for interface with cleared external gating systems to o control the beam delivery for treatment such as to synchronize irradiation with respiration. Although the overall treatment time tends to be longer than the treatment time without gating, the extension of the treatment time will not affect irradiation performance to the target treatment site. Instead, the gating functionality may limit radiation exposure to regions outside of the target treatment volume.
• Allows for use of fluoroscopy during proton irradiation at the physician's discretion. o Fluoroscopy may be used for observation of treatment site during treatment, which could be used for interruption of the treatment or analysis for treatment planning.

The provided text describes a 510(k) premarket notification for a medical device called PROBEAT-V, a proton beam therapy system. It outlines additional optional features and the performance data for these features.

However, the document does not contain the following information typically found in a comprehensive acceptance criteria and study report:

• A table of acceptance criteria and reported device performance: While it states "All tests were successful and confirmed the performance of these additional optional features," it does not specify quantitative acceptance criteria or the numerical performance metrics.
• Sample size used for the test set and data provenance.
• Number of experts used to establish the ground truth for the test set and their qualifications.
• Adjudication method for the test set.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improve with AI vs without AI assistance. (This is not an AI device, so an MRMC study related to AI assistance would not be applicable here).
• If a standalone performance study (algorithm only without human-in-the-loop performance) was done. (Again, not an AI device).
• The type of ground truth used.
• The sample size for the training set. (Not an AI/machine learning device that typically requires a training set in that context).
• How the ground truth for the training set was established. (Not an AI/machine learning device).

Summary of available information regarding acceptance criteria and study:

The device's additional optional features are the Mini Ridge Filter (mRF), an external beam gating function, and the ability to use fluoroscopy during proton irradiation.

1. Acceptance Criteria and Reported Device Performance:

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

• Not specified. The document mentions "testing" but does not detail the number of tests performed or the data used.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable / not specified. For a physical device like a proton therapy system, "ground truth" relates to physical measurements and engineering specifications, not expert interpretation of outputs in the same way it would for diagnostic imaging devices.

4. Adjudication method for the test set:

• Not applicable / not specified.

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:

• No. This is not an AI-assisted device, so an MRMC study for AI assistance is not relevant.

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

• Yes (for the device's functions). The "Performance Data" section describes testing conducted on the device's features (mRF, gating, fluoroscopy) to confirm their intended function. This is a standalone performance evaluation of the device itself rather than an AI algorithm.

7. The type of ground truth used:

• Physical measurements and engineering specifications. For a proton therapy system, "ground truth" would be established through calibrated instruments measuring beam properties (range, dose falloff, spot size) and system responses to ensure they meet pre-defined engineering tolerances and physical laws.

8. The sample size for the training set:

• Not applicable. This device is not an AI/machine learning system that requires a "training set" in the conventional sense. Its functionality is based on established physics and engineering.

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

• Not applicable. As above, no training set in the context of machine learning.

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The Real Time Image Gating System for Proton Beam Therapy Systems is intended for use with compatible Hitachi proton beam therapy systems and is designed to generate gating signals to deliver a proton beam when the position of a fiducial marker, which is implanted near a tumor and tracked by use of X-ray fluoroscopy, is within a given tolerance from its planned position.

The Real-time Image Gating System for proton beam therapy (RGS) is a gating signal generator accessory to proton beam therapy systems (PBTS) and used to track an implanted fiducial and to control the proton beam. The RGS is installed on the PBTS workstation and receives information from the PBTS imaging systems, processes the images, and sends timing signals to the PBTS irradiation controller. This RGS system recognizes the position of a fiducial marker in the human body at a regular frame rate using the X-ray imaging systems. The marker is implanted near the tumor using image guided implantation. Using two diagnostic X-ray sources and two X-ray FPDs configured around the treatment isocenter, the imaging data are combined to obtain precise 3D trajectories in the RGS. The RGS tracks the implanted marker on the image, and this chosen marker's position viewed in 3 dimensions. Using X-ray fluoroscopy devices in two distinct planes, the location of marker on the fluoroscopic image is automatically extracted using the pattern recognition technology of the RGS and the spatial position of the marker is calculated and monitored throughout the treatment. Synchronized irradiation of the tumor with gating control occurs only when the marker is within a given tolerance from its planned coordinates relative to the beam isocenter. This synchronized irradiation is performed at high speed which enables accurate irradiation of a tumor whose position may move inside the body, e.g., due to respiration.

The provided text describes a 510(k) premarket notification for a Medical Device, the "Real Time Image Gating System for Proton Beam Therapy Systems." While the document outlines performance tests conducted, it does not provide detailed acceptance criteria or the specific results of these tests in a quantitative manner that would allow for a complete table of acceptance criteria and reported performance.

The document primarily focuses on establishing substantial equivalence to predicate devices based on intended use, technological characteristics, and general safety/effectiveness. It lists the types of performance tests performed but lacks the specific metrics (e.g., "accuracy > 95%") and the outcome of those metrics.

Therefore, for aspects requested in the prompt that are not explicitly present in the provided text (e.g., exact acceptance criteria values, specific performance metrics, sample sizes for test/training sets, detailed ground truth establishment for training, number of experts, adjudication methods, MRMC study details), the answer will state that the information is not provided in the source document.

Here is a summary of the information available and what is missing based on your request:

Overview of Device Performance and Equivalence Study

The Real Time Image Gating System for Proton Beam Therapy Systems is designed to generate gating signals to deliver a proton beam when the position of an implanted fiducial marker (tracked by X-ray fluoroscopy) is within a given tolerance from its planned position. The system uses pattern recognition technology to automatically extract the marker's location and calculates its spatial position in 3D throughout treatment.

The performance data presented in the 510(k) summary aims to establish substantial equivalence to predicate devices (MedCom GmbH's Verisuite and Elekta Ltd.'s XVI R5.0). The study was conducted by Hitachi, Ltd. Healthcare.

1. Table of Acceptance Criteria and Reported Device Performance

As stated above, the document does not explicitly list quantitative acceptance criteria or specific reported device performance values for the tests conducted. It only lists the types of tests performed.

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

• Sample Size for Test Set: The document does not specify the sample size used for any of the performance tests (e.g., number of images, number of instances of fiducial tracking, or number of patients/phantoms).
• Data Provenance (e.g., country of origin, retrospective/prospective): The document does not explicitly state the country of origin for the data used in the performance tests. The submitter is Hitachi Ltd. Healthcare in Japan. It also does not specify if the data was retrospective or prospective.

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

The document does not specify if human experts were involved in establishing ground truth for the performance tests, nor does it mention the number or qualifications of any such experts. The system uses "pattern recognition technology" to automatically extract marker positions.

4. Adjudication Method for the Test Set

As there is no mention of human expert involvement in ground truth establishment for the test set, an adjudication method (e.g., 2+1, 3+1) is not applicable or not described in the provided text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

An MRMC study was not conducted or described in this 510(k) submission. The performance tests appear to be focused on the device's technical specifications and functionality, not a comparison of human reader performance with and without AI assistance. Therefore, an effect size of human reader improvement with AI assistance cannot be determined from this document.

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

The performance tests described (Recognition accuracy of a static fiducial marker, System latency, Tracking of moving marker, etc.) appear to be standalone assessments of the device's technical capabilities, without human intervention as part of the primary performance evaluation. The device is described as an "accessory" that processes images and sends timing signals automatically.

7. The Type of Ground Truth Used

The document implies that the ground truth for "recognition accuracy of a static fiducial marker" and "tracking of moving marker" would be based on the known, controlled, or planned positions of the fiducial markers (e.g., in a phantom or controlled experimental setup). It does not mention expert consensus, pathology, or outcomes data as sources for ground truth in these specific performance tests. The system itself "recognizes the position" and "tracks the implanted marker," suggesting a comparison against a known physical position.

8. The Sample Size for the Training Set

The document does not provide any information regarding a training set or its sample size. This type of detail is typically not required for a 510(k) submission focused on substantial equivalence where the device's core technology (pattern recognition) is presumed to be developed prior to the specific product's submission.

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

Since no information about a training set is provided, how its ground truth was established is also not described in the document.

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