The GE Road Warrior PET CT Imaging System is intended for use in head and whole body attenuation corrected Positron Emission Tomography (PET) imaging, facilitation of emission activity in the patient anatomy by means of integrated CT and PET images, and stand alone head and whole body multislice X-ray computed tomography diagnostic imaging.

Device Description

The GE Road Warrior PET CT Imaging System integrates a GE Positron Emission Tomography system and a GE LightSpeed Ultra CT System. In addition to providing CT and PET standalone capabilities, it uses the CT images to correct for non-uniform attenuation of the PET images and to facilitate localization of the emission activity in the patient anatomy.

AI/ML Overview

The provided documentation for the GE Road Warrior PET CT System (K022812) does not contain information regarding detailed acceptance criteria or a study proving the device meets specific performance criteria through a clinical evaluation involving human readers or ground truth analysis.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (GE Discovery LS CT-PET System) based on:

Similar technological characteristics.
Comparable safety and effectiveness features.
Same basic design, construction, and materials.
Same intended uses.
Conformance with electrical and radiation safety standards.
Compliance with quality systems (21 CFR 820, ISO 9001, EN 46001).

Here's a breakdown of why the requested information cannot be fully provided based on the input:

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

Cannot be provided. The document states, "Clinical Tests: None required." and relies on substantial equivalence to the predicate device and compliance with safety standards rather than specific performance metrics against acceptance criteria.

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 / Cannot be provided. No clinical test set data is mentioned.

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 / Cannot be provided. No clinical test set and thus no ground truth establishment by experts is described.

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

Not applicable / Cannot be provided. No clinical test set is mentioned.

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 / Cannot be provided. This device is an imaging system, not an AI-powered diagnostic tool. No MRMC studies or AI involvement are mentioned.

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

Not applicable / Cannot be provided. This is an imaging system, not an AI algorithm.

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

Not applicable / Cannot be provided. No clinical test set and thus no ground truth is described.

8. The sample size for the training set

Not applicable / Cannot be provided. No training set for an algorithm is mentioned as this is a hardware imaging system, not an AI model.

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

Not applicable / Cannot be provided. No training set is mentioned.

Summary of what is present in the document regarding "acceptance criteria" and "proof":

Acceptance Criteria (Implied):
- Substantial equivalence to the GE Discovery LS CT-PET System in technological characteristics, safety, effectiveness, design, construction, materials, and intended uses.
- Conformance with applicable medical device safety standards (electrical, radiation).
- Compliance with 21 CFR 820, ISO 9001, and EN 46001 quality systems.
Study Proving Acceptance Criteria (Implied):
- A "Summary of Studies" section generally states: "The device has been evaluated for electrical, and radiation safety, and conforms with applicable medical device safety standards."
- The "Conclusion" states: "The design and development process of the manufacturer conforms with 21 CFR 820, ISO 9001 and EN 46001 quality systems. The device conforms to applicable medical device safety standards and compliance is verified through independent evaluation with factory surveillance."
- The primary "proof" is the argument for substantial equivalence to the predicate device, which inherently suggests the device meets the established safety and effectiveness profile of that predicate without requiring new clinical performance studies. The FDA's 510(k) clearance letter (K022872) validates this substantial equivalence determination.

Summary

{0}------------------------------------------------

Special 510(k) Premarket Notification GE Medical Systems - GE Road Warrior PET CT System August 23, 2002

FP 1 2 2002

KO22812

Attachment B:

Summary of Safety and Effectiveness Prepared in accordance with 21 CFR Part 807.92(c).

Image /page/0/Picture/5 description: This document contains information about GE Medical Systems. It lists the submitter as GE Medical Systems, located in Milwaukee, WI. The contact person is D. Duersteler, with contact information including a telephone number of 262-312-7029 and a fax number of 262-312-7144. The document also mentions the device name as GE Road Warrior PET CT Imaging System and the marketed device as GE Medical Systems GE Discovery LS Positron Emission Tomography System, with the number K010641.

Device Description: The GE Road Warrior PET CT Imaging System integrates a GE Positron Emission Tomography system and a GE LightSpeed Ultra CT System. In addition to providing CT and PET standalone capabilities, it uses the CT images to correct for non-uniform attenuation of the PET images and to facilitate localization of the emission activity in the patient anatomy.

Indications for Use: The GE Road Warrior PET CT Imaging System is intended for use in head and whole body attenuation corrected Positron Emission Tomography (PET) imaging, facilitation of emission activity in the patient anatomy by means of integrated CT and PET images, and stand alone head and whole body multislice X-ray computed tomography diagnostic imaging.

Comparison with Predicate Device: The GE Road Warrior PET CT Imaging System is of a comparable type and substantially equivalent to the currently marketed GE Discovery LS CT-PET System. It has the same technological characteristics, is comparable in key safety and effectiveness features, uses the same basic design, construction, and materials, and has the same intended uses as the predicate device.

Summary of Studies: The device has been evaluated for electrical, and radiation safety, and conforms with applicable medical device safety standards.

Clinical Tests: None required.

Conclusion: Intended uses and other key features are consistent with traditional clinical practice, FDA guidelines, and established methods of patient examination. Intended uses and fundamental scientific technology are the same as the legally marketed GE Discovery LS CT-PET System. The design and development process of the manufacturer conforms with 21 CFR 820, ISO 9001 and EN 46001 quality systems. The device conforms to applicable medical device safety standards and compliance is verified through independent evaluation with factory surveillance. Therefore, it is the opinion of GE Medical Systems that the GE Road Warrior PET CT Imaging System is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the edge. In the center of the circle is a stylized image of an eagle or other bird with three curved lines representing its wings or feathers. The logo is black and white and appears to be a seal or emblem.

Food and Drug Administration 0 Corporate Boulevard ockville MD 20850

SEP 1 2 2002

Mr. David Duersteler Safety and Regulatory Engineering GE Medical Systems P.O. Box 414 MILWAUKEE WI 53201

Re: K022872

Trade/Device Name: GE Road Warrior PET CT Imaging System Regulation Number: 21 CFR 892.1200 Regulation Name: Emission conputed tomography system

Regulatory Class: II Product Code: 90 KPS Dated: August 23, 2002 Received: August 29, 2002

Dear Mr. Duersteler:

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.

If your device is classified (sec 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); 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,

{2}------------------------------------------------

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 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 (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Snigdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Special 510(k) Premarket Notification GE Medical Systems - GE Road Warrior PET CT System August 23, 2002

STATEMENT OF INTENDED USE

510(k) Number (if known): K022872

Device Name: GE Road Warrior PET CT Imaging System

Indications for Use

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801-109)

OR Over-The-Counter Use

David A. Ingram

and Rad 510(k) Number

Regulation Number and Section

§ 892.1200 Emission computed tomography system.

(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.