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

Device Description

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)

AI/ML Overview

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:

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.
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.
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.
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.
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.
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.
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.
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.
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.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 21, 2015

Mitsubishi Heavy Industries, Ltd. % Mr. Katsuhisa Toyama Senior Administrator, Business Development Department 4-6-22 Kan-on-shin-machi, Nishi-ku Hiroshima-shi, Hiroshima-ken 733-8553 JAPAN

Re: K152867

Trade/Device Name: MHI-TM2000 Linear Accelerator System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: September 28, 2015 Received: September 30, 2015

Dear Mr. Toyama:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Robert Ochs

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K152867

Device Name

MHI-TM2000 Linear Accelerator System

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary MHI-TM2000 Linear Accelerator System

The following information is provided following the format of 21 CFR 807.92 for the MHI-TM2000 Linear Accelerator System.

Date prepared: September 17, 2015

1. Submitter: Mitsubishi Heavy Industries, Ltd. Machinery, Equipment & Infrastructure 4-6-22 Kan-on-shin-machi, Nishi-ku, Hiroshima 733-8553 Japan Establishment Registration Number: 3006942329 Contact person: Shuji Kaneko Manager, Medical System Engineering Section Phone: +81-82-291-2146 Fax: +81-82-294-9888

2. Name of the Device:

Trade Name:	MHI-TM2000 Linear Accelerator System/ Vero/ Imavis
Common or Usual name:	Clinical Linear Accelerator
Classification Name:	Medical Charged Particle Radiation Therapy System
	21CFR §892.5050, Class II
	Product Code: IYE

3. Predicate devices to claim substantial equivalence:

MHI-TM2000 Linear Accelerator System: K122450

4. Description of the Device:

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Image /page/4/Picture/0 description: The image shows the logo and address of Mitsubishi Heavy Industries, LTD. The logo is a red emblem consisting of three diamond shapes arranged in a triangular formation. Below the logo is the company name in bold, followed by the description "MACHINERY, EQUIPMENT & INFRASTRUCTURE". The address is listed as 6-22, 4-CHOME, KAN-ON-SHIN-MACHI, NISHI-KU HIROSHIMA, 733-8553 JAPAN.

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)'').

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

5. Intended Use Statement:

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

Indications for Use Statement:

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

6. Technological Characteristics:

Comparison to the predicate device is listed below:

Feature	MHI-TM2000 (Ver. 3.5)	MHI-TM2000 (K122450)
"Dynamic WaveArc" radiationtherapy method	Yes	No

This is the only modification and all other technological characteristics are identical between MHI-TM2000 (Ver. 3.5) and MHI-TM2000 (K122450), such as Indications for use, Operation principles and Method of operation.

7. Summary of Performance Testing:

The design control procedures applied to the development of MHI-TM2000 (Ver. 3.5) includes requirements reviews, risk analysis, and verification and validation testing according to:.

-ISO14971: Risk Management Standard

-FDA Quality System regulation (21 CFR 820) and ISO13485: Quality Management System Standard

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Image /page/5/Picture/0 description: The image shows the logo and address of Mitsubishi Heavy Industries, LTD. The logo is a red, three-diamond shape. Below the logo is the company name, followed by the description "MACHINERY, EQUIPMENT & INFRASTRUCTURE". The address is listed as 6-22, 4-CHOME, KAN-ON-SHIN-MACHI, NISHI-KU HIROSHIMA, 733-8553 JAPAN.

-Other international standards listed in "8. Standards conformance" below in 8.

Result of verification testing, including regression testing, showed conformance to applicable requirements specifications, assured hazard safeguards functioned properly.

Result of validation testing showed conformance to customer needs and intended use of the MHI-TM2000 (Ver. 3.5).

8. Standards conformance:

The MHI-TM2000 (Ver. 3.5) conforms with the FDA recognized consensus standards and other international standards listed below.

IEC 60601-1, IEC 60601-1-2, IEC 60601-2-28, IEC 60825-1, IEC 60976, IEC 62304 ISO13845, ISO13845, ISO14971

9. Conclusion:

The verification and validation testing results from bench testing, including regression testing, support the substantial equivalence of the MHI-TM2000 (Ver. 3.5) with MHI-TM2000 (K122450)

A special 510(k) is applicable to this application due to the following reasons:

-Change/ modification does not significantly affect safety and effectiveness of MHI-TM2000 (K122450);

-There is no change in basic design control activities specified in 21CFR 820.30;

-There is no change in the medical device information specified in 21CFR 807.87;

-There is no change in all Labeling including Indications for Use;

-There is no change in fundamental scientific technologies; and

-There is no change in material used.

Regulation Number and Section

§ 892.5050 Medical charged-particle radiation therapy system.

(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.