The GENESIS IMRT Linear Accelerator is intended to deliver megavoltage x-ray treatment for therapeutic application in the treatment of cancer. The GENESIS delivers these treatments conformally, shaping the field of radiation to the tumor volume. The depth of penetration emulating from the GENESIS ideally suits itself for treating deep-seated tumors while providing a skin sparing effect.

Device Description

The GENESISTM Linear Accelerator is a single energy, high dose medical linear accelerator. The GENESISTM includes a Multileaf Collimator (MLC), Dual Asymmetric Capability, Virtual Wedge™, and PRIMEVIEW.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Siemens GENESIS™ IMRT Medical Linear Accelerator. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than detailed performance studies against specific acceptance criteria like those often seen for novel diagnostic AI devices.

Therefore, many of the requested points, such as detailed acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, or MRMC studies, are not applicable or available in this document. The submission's core is a comparison to a predicate device.

Here's an analysis based on the provided text:

Analysis of Acceptance Criteria and Study for Siemens GENESIS™ IMRT Medical Linear Accelerator (K982502)

This 510(k) submission for the Siemens GENESIS™ IMRT Medical Linear Accelerator primarily focuses on demonstrating substantial equivalence to a predicate device (MEVATRON M Class, K882729), rather than presenting a performance study against specific acceptance criteria for a novel AI device. As such, many of the requested details regarding independent performance testing are not explicitly stated.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria (from predicate comparison)	Reported Device Performance (as claimed by manufacturer for substantial equivalence)
Intended Use	Same as predicate (MEVATRON M Class): "to deliver x-ray radiation for therapeutic treatment of cancer."	"The intended use of the GENESIS™ is the same as the 6 MV MEVATRON M Class and has not changed as a result of this modification."
Technological Characteristics	No significant changes in materials, energy source, or performance characteristics compared to predicate.	"The GENESIS™ 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."
Safety and Effectiveness	Equivalent to predicate device. Implied that the change in electron path does not adversely affect safety or effectiveness, as "design and functionality...are essentially the same" after the target.	Siemens considers "the MEVATRON M Class system and the GENESIS™ to be equivalent." The FDA's 510(k) clearance confirms substantial equivalence, implying deemed safety and effectiveness.

2. Sample size used for the test set and the data provenance:

Not Applicable. This submission is not a performance study evaluating a new algorithm or diagnostic output against a test set. It's a technical comparison to a predicate device. The "test" is essentially the manufacturer's internal engineering analysis showing the new design meets the same performance characteristics as the predicate.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. No explicit "ground truth" for a test set is discussed in the context of this 510(k) submission.

4. Adjudication method for the test set:

Not Applicable. No test set or associated adjudication is described.

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 device is a linear accelerator for radiation therapy, not an AI-assisted diagnostic tool for human readers.

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

Not Applicable. This is a hardware device for radiation delivery. There is no "algorithm only" performance reported in this context.

7. The type of ground truth used:

Not Applicable. The "ground truth" in this context is the established safety and effectiveness of the existing predicate device, to which the new device is compared for substantial equivalence.

8. The sample size for the training set:

Not Applicable. This is not an AI/machine learning device requiring a training set.

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

Not Applicable. No training set is described.

Summary Explanation:

The K982502 submission for the GENESIS™ IMRT Linear Accelerator is a Pre-Market Notification (510(k)). The primary purpose of a 510(k) is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device. This typically involves showing that the device has the same intended use and similar technological characteristics, or if there are differences, that those differences do not raise new questions of safety or effectiveness.

In this case, Siemens argues that the GENESIS™ is equivalent to the MEVATRON M Class system (K882729). The main difference identified is the "path of the electrons prior to striking the target." However, Siemens asserts that "From this point on, the design and functionality for the GENESIS™ and 6 MV MEVATRON M Class are essentially the same," and that it "does not have significant changes in materials, energy source or performance characteristics."

Therefore, the "study" proving the device meets "acceptance criteria" here is the manufacturer's internal engineering analysis and comparison to the predicate device. The "acceptance criteria" are effectively that the device's technical specifications and performance match or are demonstrably equivalent to those of the predicate device, especially considering its intended use. No separate clinical trials or AI performance evaluations with test sets and expert ground truth are described or required for this type of submission.

Summary

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JUL 3 | 1998

K982502

SUMMARY OF SAFETY AND EFFECTIVENESS

1.	Submitter's Information:	Dated: July 17, 1998Siemens Medical SystemsOncology Care Systems Group4040 Nelson AvenueConcord, CA 94520
	Contact Person:	Kathryn B. DoddVice President Regulatory Affairs and Quality Assurance
2.	Common or Usual Name:Proprietary Name:Classification Name:	Linear AcceleratorGENESISTM IMRT Medical Linear AcceleratorMedical Charged Particle Radiation Therapy System21 CFR § 892.5710Class II, Product Code: RA 90 IYE

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

Description of Device: The GENESISTM Linear Accelerator is a single energy, high dose 4. medical linear accelerator. The GENESISTM includes a Multileaf Collimator (MLC), Dual Asymmetric Capability, Virtual Wedge™, and PRIMEVIEW.
Statement of intended use: The intended use of the GENESIS™ is to deliver x-ray radiation for પં therapeutic treatment of cancer. The intended use of the GENESIS™ is the same as the 6 MV MEVATRON M Class and has not changed as a result of this modification
Statement of technological characteristics: The GENESIS™ linear accelerator does not ર્. 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 6 MV MEVATRON M Class system and the GENESIS™ Linear Accelerator 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 GENESIS™ is perpendicular to the isocentric plane and is aligned with the radiation axis. Electrons in both types of accelerators produce photons by striking a target made from high-Z (i.e., high atomic number) material. From this point on, the design and functionality for the GENESISTM 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 GENESISTM 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 consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 31 ಿರಿದರೆ

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

Re:

K982502 Genesis IMRT 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 Approval), 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 Onality System Regulation (OS) 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 S10%) premarket notification. The FDA finding of substantial equivalence of your device 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/cdrh/dsmaldsmamain.html".

Sincerely yours,

Kilian Yin
Lillian Yin, Ph.D.

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

Enclosure

್ಕೆ ನಿವ

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SIEMENS

510(k) Number: Product:

K982502 GENESIS, IMRT LINEAR ACCELERATOR

INDICATIONS FOR USE

h. Mian Yn..

(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Device 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.