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MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.

The MHI-TM2000 Linear Accelerator System (hereinafter called "MHI-TM2000 (Ver. 3.5)") is an Image-Guided Radiation Therapy device generating 6MV high energy X-ray for precision radiation therapy of tumors and conditions, where radiation treatment is indicated.

It includes a linear accelerator, multi-leaf collimator, electric portal imaging device and couch. It also includes O-ring-type gantry platform, X-ray-head-mounted gimbals, Built-in Imaging System, and function to continuously align treatment beam with moving target for precise radiotherapy of moving targets, as notable characteristics.

The MHI-TM2000 (Ver. 3.5) has been developed based on MHI-TM2000 Linear Accelerator System previously cleared by FDA under K122450 (hereinafter called "MHI-TM2000 (K122450)'').

Modification was made for introducing a method of radiation therapy called "Dynamic WaveArc" ("DWA") that delivers radiation while rotating both O-ring-shaped gantry (Gantry rotation) and rotational floor of the gantry that moves entire gantry (Ring rotation), or rotating the Ring rotation only.

Radiation type, energy, and the method of generating radiation are identical between MHI-TM2000 (Ver. 3.5) and MHI-TM2000 (K122450)

This document describes a 510(k) premarket notification for the MHI-TM2000 Linear Accelerator System, focusing on a modification (Ver. 3.5) that introduces a "Dynamic WaveArc" (DWA) radiation therapy method.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies:

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

   The document does not explicitly provide a table of acceptance criteria and reported device performance in the typical sense of quantitative metrics for a diagnostic or AI device. Instead, it states that the device's substantial equivalence is based on its conformance to:

   • Applicable requirements specifications.
   • Hazard safeguards functioning properly.
   • Customer needs and intended use.

   The modification (addition of "Dynamic WaveArc" radiation therapy method) is evaluated against the predicate device (MHI-TM2000 (K122450)). The device performance is implicitly stated as meeting the standards and ensuring safety and effectiveness, as indicated in the "Summary of Performance Testing" and "Conclusion" sections.

   The key performance characteristic discussed is the addition of the Dynamic WaveArc (DWA) radiation therapy method, which is present in MHI-TM2000 (Ver. 3.5) and not in the predicate device. All other technological characteristics, indications for use, operation principles, and methods of operation are stated to be identical.

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

   The document describes "verification testing" and "validation testing" but does not provide specific details on sample sizes for test sets (e.g., number of patients, treatment plans, or cases). It also does not specify the data provenance (country of origin, retrospective/prospective). The testing appears to be primarily focused on engineering verification and validation rather than clinical trial data involving patient outcomes.

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):

   The document does not mention the involvement of experts to establish ground truth for a test set. This is consistent with the nature of the device being a radiation therapy delivery system, where the focus is on the accurate and safe delivery of radiation as programmed, rather than diagnostic interpretation.

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

   No adjudication method is described, as the testing does not involve subjective interpretation or a need for consensus among experts for ground truth establishment.

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 MRMC comparative effectiveness study was conducted or described. This document pertains to a linear accelerator system, which is a treatment delivery device, not a diagnostic imaging or AI-assisted diagnostic device that would typically involve human readers interpreting AI outputs.

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

   The term "standalone" performance for an algorithm is not applicable here as the device is a physical radiation therapy system, not a standalone AI algorithm. The performance testing focuses on the system's ability to deliver radiation according to its design and specifications.

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

   The concept of "ground truth" as typically applied to AI/diagnostic devices (e.g., pathology for cancer detection) is not explicitly mentioned or used in this document. The "ground truth" for a linear accelerator would relate to its physical performance metrics, such as radiation dose accuracy, beam shaping precision, gantry rotation accuracy, and the ability to deliver the planned treatment. These are evaluated through engineering tests, calibration, and quality assurance procedures against established physical and safety standards.

8. The sample size for the training set:

   The document does not mention a training set sample size. This device is a hardware system with a new operational method, not a machine learning model that requires a training set.

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

   As there is no mention of a training set, the establishment of ground truth for such a set is not applicable.

Summary of Study Described:

The study proving the device meets its acceptance criteria is primarily an engineering verification and validation study based on design control procedures.

• Design Control Procedures: Include requirements reviews, risk analysis, and verification and validation testing.
• Standards Conformance: The device conforms to several international standards including:
  • ISO14971: Risk Management Standard
  • FDA Quality System regulation (21 CFR 820)
  • ISO13485: Quality Management System Standard
  • IEC 60601-1, IEC 60601-1-2, IEC 60601-2-28, IEC 60825-1, IEC 60976, IEC 62304
• Verification Testing: Included regression testing, showing conformance to applicable requirements specifications and assuring hazard safeguards functioned properly.
• Validation Testing: Showed conformance to customer needs and the intended use of the MHI-TM2000 (Ver. 3.5).
• Bench Testing: The results are explicitly stated to be from "bench testing."
• Substantial Equivalence: The conclusion is that the verification and validation (from bench testing) support the substantial equivalence of the MHI-TM2000 (Ver. 3.5) with its predicate device (MHI-TM2000 (K122450)), particularly noting that the modification (Dynamic WaveArc) does not significantly affect safety and effectiveness.

In essence, the study is a technical compliance review and testing process to ensure the modified device (with the DWA feature) continues to meet safety and performance standards equivalent to its predicate, rather than a clinical study evaluating AI performance or diagnostic accuracy.

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MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.

The MHI-TM2000 Linear Accelerator System (hereinafter called "MHI-TM2000 (VER. 3.0)") has been developed based on MHI-TM2000 Linear Accelerator System previously cleared by FDA under K072047 (hereinafter called "MHI-TM2000 (K072047)").

MHI-TM2000 (VER. 3.0) introduces a new interface functionality for remotely controlling gimbaled motion (pan and tilt motion) of X-ray tube and MLC, based on position data received from radiation therapy positioning system "ExacTrac Vero", which is compatible 3rd party device manufactured by Brainlab AG. This functionality enables continuous alignment of treatment beam with moving target resulting in precise radiation treatment of moving targets.

The gimbal mechanism (pan and tilt) is one of the unique characteristics of MHI-TM2000 (K072047), which is called "X-ray-head-mounted gimbals".

The "X-ray-head-mounted gimbals" have been used to compensate for the residual mechanical deformation, mainly caused by gravity, but the MHI-TM2000 (VER. 3.0) utilizes this mechanism further for moving treatment-X-ray beam axis for continuously aligning it with moving target.

A new interface (communication board) for receiving position data is equipped to System Controller Panel of MHI-TM2000 (VER. 3.0).

The method of generating radiation and irradiation are the same as MHI-TM2000 Linear Accelerator System (K072047).

This 510(k) summary for the MHI-TM2000 Linear Accelerator System (K12245D) focuses on demonstrating substantial equivalence to a predicate device and does not describe acceptance criteria or a detailed study proving the device meets specific performance metrics in the way an AI/ML device submission would.

The document states:

• "The verification testing results from bench testing support the substantial equivalence of the MHI-TM2000 (Ver. 3.0) with the predicate devices."
• "The result also ensured conformance to system specifications, functional requirements, use cases, hazard mitigation, as well as compliance with applicable standards."
• "Accuracy of gimbaled (pan and tilt) motion of X-ray tube and MLC (treatment beam axis) to continuously align with moving target, has also been tested because this is the key function for the new functionality. The results also showed that MHI-TM2000 (Ver.3.0) meet the acceptance criteria."

However, it does not provide any specific acceptance criteria (e.g., numerical thresholds for accuracy, precision, or other performance metrics) nor does it provide a detailed study report with results that would allow for a table of acceptance criteria and reported device performance.

Therefore, most of the requested information cannot be extracted from the provided text.

Here's what can be stated based on the given document:

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

   • Acceptance Criteria: Not explicitly stated in numerical terms (e.g., "accuracy within X mm"). The document only broadly states "meet the acceptance criteria" for the accuracy of gimbaled motion.
   • Reported Device Performance: Not quantified. The document only broadly states "The results also showed that MHI-TM2000 (Ver.3.0) meet the acceptance criteria" for accuracy of gimbaled motion.

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

   • Not applicable/Not provided. The testing described is "bench testing" focusing on the physical performance of a linear accelerator system, not a study involving patient data or a "test set" in the context of an AI/ML device.

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. This is not an AI/ML device requiring expert-established ground truth on medical images or diagnoses. The ground truth for bench testing would typically be engineering specifications and measurement standards.

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

   • Not applicable.

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 medical device (linear accelerator) for radiation therapy, not an AI/ML 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 device is a physical linear accelerator system.

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

   • For the "Accuracy of gimbaled (pan and tilt) motion" testing, the ground truth would be based on precise physical measurements against engineered specifications and calibration standards. No clinical ground truth (like pathology or expert consensus) is mentioned or relevant for this type of device's mechanical performance testing.

8. The sample size for the training set:

   • Not applicable. This is not an AI/ML device that requires a training set.

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

   • Not applicable.

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