The LightSpeed 7.0 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 7.0 is evolutionary modification to LightSpeed 5.0 (K030420) and is designed to be a head and whole body CT scanner incorporating the same basic fundamental operating principles and Indications for Use.

AI/ML Overview

Here's a breakdown of the requested information based on the provided document:

1. Table of acceptance criteria and the reported device performance

The provided document is a 510(k) summary for the LightSpeed 7.0 CT Scanner System. This type of submission focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than establishing new performance acceptance criteria and conducting specific studies to prove those criteria.

Therefore, the document does not contain a table of acceptance criteria or reported device performance in the way a clinical performance study for an AI algorithm would.

Instead, the "performance" demonstrated is the equivalence to the predicate device (LightSpeed 5.0).

Acceptance Criteria (Implied)	Reported Device Performance
Substantial Equivalence to LightSpeed 5.0 CT Scanner System	"LightSpeed 7.0 is an evolutionary modification to LightSpeed 5.0 (K030420) and is designed to be a head and whole body CT scanner incorporating the same basic fundamental operating principles and Indications for Use."
Same technological characteristics and operating principles	"It has the same technological characteristics and operating principles..."
Same indications for use	"...has identical indications for use."
Same basic design, construction, and materials	"...uses the same basic design, construction, and materials."
Compliance with relevant standards (UL, IEC, CFR J)	"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."
No new potential safety risks	"The LightSpeed 7.0 CT Scanner System, as an evolutionary modification to the currently [marketed] LightSpeed 5.0, does not result in any new potential safety risks..."
Performs as well as or better than devices currently on the market	"...and performs as well as or better than devices currently on the market."

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

The document does not describe a test set or data provenance in the context of a clinical performance study. The evaluation for this 510(k) is based on a comparison of technical specifications and design features with the predicate device, not on new clinical data from a test set of patients.

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

This information is not applicable to this 510(k) submission. No clinical test set requiring expert ground truth establishment is described.

4. Adjudication method for the test set

This information is not applicable to this 510(k) submission. No clinical test set 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

This information is not applicable to this 510(k) submission. This is a CT scanner system, not an AI software intended to assist human readers, and no MRMC study is described.

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

This information is not applicable to this 510(k) submission. This is a CT scanner system, not an AI algorithm, and no standalone performance study is described.

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

This information is not applicable to this 510(k) submission. No clinical ground truth is established as part of this submission process. The "ground truth" here is the established safety and effectiveness of the predicate device.

8. The sample size for the training set

This information is not applicable to this 510(k) submission. This device is a hardware system, not a machine learning model, and therefore does not have a training set in the AI sense.

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

This information is not applicable to this 510(k) submission for the reasons stated above.

Summary

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Image /page/0/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" inside a stylized circle. The letters are white, and the circle is black. The logo is simple and recognizable.

MAR - 1. 2004

Image /page/0/Picture/3 description: The image shows a sequence of handwritten alphanumeric characters. The sequence reads 'K040372'. The characters are written in a simple, slightly rough style, giving them a casual appearance. The image is in black and white.

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: February 3, 2003

PRODUCT IDENTIFICATION

Name:	LightSpeed 7.0 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 7.0 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

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.

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Indications for Use:

The LightSpeed 7.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications.

Comparison with Predicate:

LightSpeed 7.0 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 indications for active the came to the towns and QA features, and uses the same basic design, construction, and materials.

In the opinion of GE Medical Systems, the LightSpeed 7.0 CT Scanner System is of in the opinion of GE Mouled Systems, includent 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 7.0 will be certified to comply with the X-ray requirements the same intentional accorded 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 analysis) and controlled by:

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

CONCLUSIONS

The LightSpeed 7.0 CT Scanner System, as an evolutionary modification to the currently rno EightSpeed 5.0, 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 7.0 CT System as or botter that to other marketed devices with the same indications for use and meeting similar standards.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three abstract shapes resembling human figures or birds in flight, arranged in a vertical stack.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 1. 2004

GE Medical Systems % Mr. Juergen Welte Program Manager 510(k) TUV Rheinland of North America 1279 Quarry Lane, Suite A PLEASANTON CA 94566

Re: K040372 Trade/Device Name: LightSpeed 7.0 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 10, 2004 Received: February 17, 2004

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 (OS) 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

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STATEMENT OF INTENDED USE

510(k) Number (if known): K040372

Device Name: LightSpeed 7.0 CT Scanner System

Indications For Use:

The LightSpeed 7.0 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. Brogdon

Division Star Division of Renroductive. and Radiological Device 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.