The GE LightSpeed 5.0 CT Scanner System is composed of a gantry, patient table, image acquisition hardware and software, an operator console, and associated accessories. Materials and construction are equivalent to the LightSpeed 4.0 CT Scanner System and are compliant with UL2601-1. IEC 60601-1 and associated collateral and particular standards, and applicable sections of 21 CFR Subchapter J.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the GE LightSpeed 5.0 CT System. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria for a novel device. Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, and expert adjudication is not present in this document.

This submission states: "The GE LightSpeed 5.0 Computed Tomography System is a modification of, and of comparable type and substantially equivalent to the currently marketed GE LightSpeed 4.0 (aka LightSpeed®) CT 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 use as the predicate device."

The study summarized is focused on safety and compliance, not performance.

Here's a breakdown of what can be extracted and what is not available based on your request:

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

Acceptance Criteria: Not explicitly stated as performance metrics. The implicit acceptance criteria are related to being "substantially equivalent" in safety and effectiveness to the predicate device (LightSpeed 4.0 CT System) and conforming to applicable standards. The document mentions compliance with UL2601-1, IEC 60601-1, associated collateral and particular standards, and applicable sections of 21 CFR Subchapter J.
Reported Device Performance: No specific performance metrics (e.g., spatial resolution, contrast-to-noise ratio, dose reduction) are reported for comparison against quantitative acceptance criteria. The document only states that the device "has been evaluated for electrical, mechanical, and radiation safety, and conforms to applicable medical device safety and performance standards."

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

Not Applicable. This submission does not describe a clinical performance study with a test set of patient data to assess diagnostic accuracy or similar performance metrics. The evaluation was for electrical, mechanical, and radiation safety, and standards conformance.

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

Not Applicable. As no clinical performance study on a test set (e.g., imaging data) is described, there is no mention of experts or ground truth establishment in this context.

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

Not Applicable. No clinical performance study on a test set requiring 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

No. This is a CT scanner system, not an AI-powered diagnostic tool, and no MRMC study or AI assistance is mentioned.

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

No. This is a CT scanner, not an algorithm.

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

Not Applicable. For the safety and standards conformance evaluation, the "ground truth" would be the specifications and requirements of the relevant safety and performance standards.

8. The sample size for the training set

Not Applicable. This is a hardware system, not a software algorithm that requires a training set.

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

Not Applicable. (See point 8)

Summary

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KO30420

Special 510(k) Premarket Notification GE Medical Systems - LightSpeed 5.0 CT System February 7, 2003

Image /page/0/Picture/2 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The logo is black and white.

MAR 1 0 2003

GE Medical Systems

3000 N. Grandvew W-1140 Waukesha, WI 53188

This 510(k) summary of Safety and Effectiveness information is submitted in accordance with the requirements of 21 CFR 807.87(h)

Submitter:	GE Medical Systems3000 N. Grandview Blvd.Waukesha, WI 53188
Contact Person:	John W. JaeckleLead CT Safety and Regulatory EngineerTelephone: 262-312-7358; Fax: 262-312-7369
Date Prepared:	February 7, 2003
Device Name:	LightSpeed 5.0 Computed Tomography System.Computed Tomography X-ray System, 21 CFR 892.1750, 90-JAK
Marketed Device:	GE Medical System's LightSpeed 4.0 Computed Tomography System (aka LightSpeed16); 510(k) Number K013561, currently in commercial distribution.

Device Description:

Indications for Use:

The LightSpeed 5.0 CT Scanner System is indicated for head and whole body X-ray computed tomography applications.

Comparison with Predicate Device:

The GE LightSpeed 5.0 Computed Tomography System is a modification of, and of comparable type and substantially equivalent to the currently marketed GE LightSpeed 4.0 (aka LightSpeed®) CT 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 use as the predicate device.

Summary of Studies:

The device has been evaluated for electrical, mechanical, and radiation safety, and conforms to applicable medical device safety and performance standards.

Conclusion:

Intended use and fundamental scientific technology are the legally marketed GE LightSpeed 4.0 CT System. The design and development process of the manufacturer conforms with 21 CFR 820, and ISO 9001/ EN 46001 quality systems. The device conforms to applicable medical device safety and performance standards. Results of the testing and standards conformance described above demonstrate, in the opinion of GE Medical Systems, that the LightSpeed 5.0 CT System is substantially equivalent to the currently cleared LightSpeed 4.0 CT System.

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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three lines forming its body and wings. The eagle faces right and is positioned within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 0 2003

Mr. John W. Jaeckle Lead CT Safety and Regulatory Engineer GE Medical Systems 3000 N. Grandview Blvd., W-1140 WAUKESHA WI 53188

Re: K030420 Trade/Device Name: LightSpeed 5.0 CT Scanner System Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: 90 JAK Dated: February 7, 2003 Received: February 10, 2003

Dear Mr. Jaeckle:

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 (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); 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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This letter will allow you to begin marketing your device as described in your Section 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 the 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" (21CFR Part 807.97) you may obtain. 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. Brogdon

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

Enclosure

Page 2

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Special 510(k) Premarket Notification GE Medical Systems - LightSpeed 5.0 CT System February 7, 2003

STATEMENT OF INTENDED USE

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: LightSpeed 5.0 CT System

Indications for Use

The LightSpeed 5.0 CT Scanner System is indicated for head and whole body X-ray computed tomography applications.

(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)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

Nancy Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal

and Radiological Devices 510(k) Number

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.