The MEVATRON MX Linear Accelerator is intended to deliver megavoltage x-ray treatment for therapeutic application in the treatment of cancer. The depth of penetration emulating from the MEVATRON MX ideally suits itself for treating deep-seated tumors while providing a skin sparing effect.

Device Description

The MEVATRON MX is a single energy, high dose medical linear accelerator. The MEVATRON MX includes dual dose rate, asymmetric jaws, and either Virtual Wedge™ or standard cross-plane wedges.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the MEVATRON MX Linear Accelerator (K982513). This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics for a novel AI or diagnostic device.

Therefore, many of the requested categories for AI/diagnostic device studies are not applicable to this submission.

Here's a breakdown based on the information available:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Substantial Equivalence to Predicate Device: The MEVATRON MX should demonstrate substantial equivalence to the MEVATRON M Class (K882729) in terms of intended use, technological characteristics, and performance characteristics.	The submission explicitly states: "The intended use of the MEVATRON MX is the same as the 6 MV MEVATRON M Class and has not changed as a result of this modification." and "The MEVATRON MX linear accelerator does not have significant changes in materials, energy source or performance characteristics compared to the predicate devices. The intended use and the performance characteristics are the same as the predicate device and therefore we believe it is substantially equivalent to it."
Intended Use: To deliver x-ray radiation for therapeutic treatment of cancer.	The intended use is clearly stated as: "to deliver x-ray radiation for therapeutic treatment of cancer." and "The MEVATRON MX Linear Accelerator is intended to deliver megavoltage x-ray treatment for therapeutic application in the treatment of cancer."
Performance Standards: No applicable FDA performance standards.	No applicable performance standards have been established by FDA under section 514 of the Food, Drug and Cosmetic ACT.

It's important to note that for a 510(k) submission like this, the "acceptance criteria" are primarily centered around demonstrating substantial equivalence to a legally marketed predicate device. There aren't explicit quantitative performance metrics in the same way one would find for a diagnostic or AI device.

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. This is a submission for a linear accelerator, not a diagnostic or AI device that relies on a test set of data for performance evaluation in the traditional sense. The equivalence is based on engineering design, performance characteristics (such as radiation output and beam properties), and intended use, not on analyzing patient data.

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. Ground truth for a test set is not relevant for this device's substantial equivalence determination.

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

Not applicable. No test set requiring adjudication in this context.

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 not an AI device, and no MRMC study was performed or needed.

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

Not applicable. This is a medical device for radiation therapy, not an algorithm.

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

Not applicable. The "ground truth" in this context is the performance and safety established for the predicate device, against which the new device is compared in terms of its technical specifications and intended functionality.

8. The sample size for the training set

Not applicable. This device does not involve a training set as it is not an AI or machine learning product.

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

Not applicable. No training set is involved.

Summary

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K982513

SUMMARY OF SAFETY AND EFFECTIVENESS

1.	Submitter's Information:	Dated: July 17, 1998




	Contact Person:	Kathryn B. Dodd
		Vice President Regulatory Affairs and Quality Assurance
2.	Common or Usual Name:	Linear Accelerator
		Proprietary Name:
		Classification Name:


3.	Predicate Device:	MEVATRON M Class, 510(k) No. K882729

Description of Device: The MEVATRON MX is a single energy, high dose medical linear 4. accelerator. The MEVATRON MX includes dual dose rate, asymmetric jaws, and either Virtual Wedge™ or standard cross-plane wedges.
ર્જ Statement of intended use: The intended use of the MEVATRON MX is to deliver x-ray radiation for therapeutic treatment of cancer. The intended use of the MEVATRON MX is the same as the 6 MV MEVATRON M Class and has not changed as a result of this modification
ર્. Statement of technological characteristics: The MEVATRON MX linear accelerator does not have significant changes in materials, energy source or performance characteristics compared to the predicate devices. The intended use and the performance characteristics are the same as the predicate device and therefore we believe it is substantially equivalent to it.
1. Differences: The main difference between the existing 6 MV MEVATRON M Class system and the MEVATRON MX is the path of the electrons prior to striking the target. In the MEVATRON M machine, the axis of the accelerator is parallel in the isocentric plane; thus electrons must exit the structure through a 270° bend. In contrast, the axis of the MEVATRON MX is perpendicular to the isocentric plane and is aligned with the radiation axis. Electrons in both types of accelerators product photons by striking a target made from high-A (i.e., high atomic number) material. From this point on, the design and functionality for the MEVATRON MX and 6 MV MEVATRON M Class are essentially the same.
1. Performance Standards: No applicable performance standards have been established by FDA under section 514 of the Food, Drug and Cosmetic ACT.

Siemens considers the MEVATRON M Class system and the MEVATRON MX to be equivalent.

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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 3 | 1998

Kathryn Berry Dodd Vice-President, RA & QA Siemens Medical Systems, Inc. Oncology Care Systems 4040 Nelson Avenue Concord. CA 94520

Re:

K982513 MX Mevatron Linear Accelerator Dated: July 17, 1998 Received: July 20, 1998 Regulatory class: II 21 CFR 892.5050/Procode: 90 IYE

Dear Ms. Dodd:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.

If your device is classified (see above) into either class II (Premarket Apporal), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (2) CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your derice to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (2) CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdr/dsmaldsmamain.html".

Sincerely yours,

Kilian Yin

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number: K982513 Product: MEVATRON MX LINEAR ACCELERATOR

INDICATIONS FOR USE

William Ch

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

✓

Siemens Medical Systems, Inc.

Oncology Care Systems

4040 Nelson Avenue Concord, CA 94520

Tel: (510) 246-8200 FAX (510) 246-8284

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.