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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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