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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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