The LightSpeed 6.0 CT Scanner System is composed of a gantry, patient table, console, and PDU, and includes image acquisition hardware, image acquisition and reconstruction software, and associated accessories. LightSpeed 6.0 is evolutionary modification to LightSpeed 5.0 (K030420) and is designed to be a head and whole body CT scanner incorporating the same basic operating principles.

AI/ML Overview

This document describes a 510(k) summary for the GE Medical Systems LightSpeed 6.0 CT Scanner System. The submission focuses on demonstrating substantial equivalence to a predicate device (LightSpeed 5.0 CT Scanner System) rather than outlining specific performance metrics with acceptance criteria for a novel AI/CAD device.

Therefore, many of the requested elements for a study proving device meeting acceptance criteria (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are not applicable to this type of regulatory submission. The focus here is on hardware and system modifications, safety, and compliance with existing standards.

However, I can extract information related to the device description and the general safety and effectiveness statement:

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

Since this is a CT scanner system and not a diagnostic AI/CAD device, the "acceptance criteria" are related to system specifications, safety features, and compliance with regulatory standards, rather than diagnostic accuracy metrics.

Acceptance Criteria (Implied)	Reported Device Performance
Intended Use: Head and whole body X-ray Computed Tomography applications.	LightSpeed 6.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications, identical to the predicate device.
Technological Characteristics & Operating Principles: Comparable to predicate.	LightSpeed 6.0 has the "same technological characteristics and operating principles." It is an "evolutionary modification to LightSpeed 5.0."
Key Safety & Effectiveness Features: Comparable to predicate.	LightSpeed 6.0 is "comparable in key safety and effectiveness features."
Design, Construction, Materials: Same basic as predicate.	LightSpeed 6.0 uses the "same basic design, construction, and materials." Materials and construction are "equivalent to the LightSpeed 5.0 CT Scanner System."
Compliance with Standards: UL 2601-1, IEC 60601-1, 21CFR Subchapter J, 21CFR1020.30, 21CFR1020.33.	LightSpeed 6.0 is designed to comply with UL 2601-1, IEC 60061-1 (and associated collateral/particular standards), 21CFR Subchapter J. It "will be certified to comply with the X-ray requirements of 21CFR1020.30 and 1020.33, as well as the safety requirements of UL2601-1, and IEC 60601-1 and associated collateral and particular standards." Adherence to industry and international standards (UL/CSA and IEC) is part of risk control.
Safety Risks: No new potential safety risks compared to predicate.	The LightSpeed 6.0 CT Scanner System "does not result in any new potential safety risks." Potential electrical, mechanical, and radiation hazards are identified and controlled.
Performance: Performs as well as or better than devices currently on the market.	"Performs as well as or better than devices currently on the market." (General statement of equivalence). System verification and validation are used to "ensure performance to specifications, Federal Regulations, and user requirements."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable for this 510(k) submission. The document does not describe a clinical performance study with a test set of patient data as one would for an AI/CAD system. Instead, it focuses on engineering and regulatory compliance documentation.

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. See point 2.

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

Not applicable. See point 2.

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/CAD device for radiological interpretation.

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

Not applicable. This is a CT scanner system, not a standalone algorithm.

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

Not applicable. The "ground truth" in this context revolves around engineering specifications, safety standards, and performance characteristics validated through system testing and compliance checks, rather than diagnostic "ground truth" for disease detection.

8. The sample size for the training set

Not applicable. This is a CT scanner system, not an AI/CAD device that requires a training set of patient data.

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

Not applicable. See point 8.

Summary

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

Image /page/0/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circular frame. The frame has decorative elements resembling stylized droplets or flourishes around its perimeter. The logo is presented in black against a white background, giving it a clear and recognizable appearance.

NOV 2 0 2003

GE Medical Systems

3000 N. Grandview Blvd. W-1140 Waukesha, WI 53188

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

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

John W. Jaeckle Submitter: Lead CT Safety and Regulatory Engineer Tel: 262-312-7358, Fax: 262-312-7369 e-mail: John.Jaeckle@med.ge.com Date Prepared: October 8, 2003

PRODUCT IDENTIFICATION

Name:	LightSpeed 6.0 CT Scanner System
Classification Name:	Computed Tomography X-ray System21CFR892.1750, 90-JAK
Manufacturer:	General Electric Medical Systems3000 N. Grandview Blvd.Waukesha, WI 53188
Distributor:	Same as Manufacturer
Marketed Devices:	The LightSpeed 6.0 CT Scanner System is of comparable type andsubstantially equivalent to currently marketed ComputedTomography X-ray Systems that comply with the same or equivalentstandards and have the same intended uses, such as the previousLightSpeed CT Scanners (LightSpeed 5.0, 4.0, etc.).

DEVICE DESCRIPTION

Materials and construction are equivalent to the LightSpeed 5.0 CT Scanner System, which are compliant with UL 2601-1, IEC 60061-1 and associated collateral and particular standards, and 21CFR Subchapter J.

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

Indications for Use:

The LightSpeed 6.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications.

Comparison with Predicate:

LightSpeed 6.0 is a modification of the LightSpeed 5.0 CT Scanner System and has identical indications for use. It has the same technological characteristics and operating principles, is comparable in key safety and effectiveness features, and uses the same basic design, construction, and materials.

In the opinion of GE Medical Systems, the LightSpeed 6.0 CT Scanner System is of comparable type and substantially equivalent to currently marketed head and whole body X-ray computed tomography systems that comply with the same or equivalent standards and have the same intended uses. LightSpeed 6.0 will be certified to comply with the X-ray requirements of 21CFR1020.30 and1020.33, as well as the safety requirements of UL2601-1, and IEC 60601-1 and associated collateral and particular standards.

Adverse Effects on Health:

Potential electrical, mechanical and radiation hazards are identified in a risk management summary (hazard analvsis) and controlled by:

System verification and validation to ensure performance to specifications. Federal ● Requlations, and user requirements.
. Adherence to industry and international standards. (UL/CSA and IEC).

CONCLUSIONS

The LightSpeed 6.0 CT Scanner Systems does not result in any new potential safety risks and performs as well as or better than devices currently on the market. GE considers the LightSpeed 6.0 CT System to be equivalent to other marketed devices with the same indications for use and meeting similar standards.

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 0 2003

GE Medical Systems % Mr. Juergen Welte Acting Program Manager 510(k) TUV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470

Re: K033502

Trade/Device Name: LightSpeed 6.0 CT Scanner System Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system

Regulatory Class: II Product Code: 90 JAK Dated: November 4, 2003 Received: November 5, 2003

Dear Mr. Welte:

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 such 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.

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

Page 2

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

{4}------------------------------------------------

STATEMENT OF INTENDED USE

510(k) Number (if known):

Device Name: LightSpeed 6.0 CT Scanner System

Indications For Use:

The LightSpeed 6.0 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)

-OR-

Over-The-Counter Use

Nancy C. Beagdon

(Division Division of Reproductive, 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.