Materials: Materials and construction are equivalent to the LightSpeed 3.0 CT Scanner System (K002978) are compliant with UL 2601-1, IEC 60061-1, and 21CFR Subchapter J.

Design: The system is designed to be a head and whole body CT scanner utilizing a new solid state detector, an intuitive Operator Console, and the same tube and similar features to the LightSpeed 3.0 CT Scanner System (K002978), but now capable of imaging 16 slices per rotation. The system will use a new multi-slice detector having thinner detector elements.

AI/ML Overview

The provided text describes a 510(k) summary for the LightSpeed 4.0 CT Scanner System. However, it does not include specific acceptance criteria or a detailed study proving the device meets particular performance metrics.

Instead, the document focuses on demonstrating substantial equivalence to existing legally marketed devices. This means that the manufacturer is asserting their new device is as safe and effective as a predicate device, rather than providing new performance data against specific, novel acceptance criteria.

Therefore, many of the requested items in your prompt cannot be answered directly from the provided text.

Here's what can be extracted and what cannot:

1. Table of acceptance criteria and reported device performance:

Acceptance Criteria: Not explicitly stated as quantifiable metrics. The "criteria" are implied to be "as good as or better than" currently marketed devices and compliance with relevant standards.
Reported Device Performance: No specific performance metrics (e.g., spatial resolution, contrast-to-noise ratio, dose efficiency) are provided in the summary. The "performance" is generally described as being "as well as or better than devices currently on the market."

Criterion (Implied)	Reported Device Performance
Safety and Effectiveness comparable to predicate devices	"Performs as well as or better than devices currently on the market."
Compliance with X-ray requirements (21CFR1020.30 & .33)	"It will comply with the X-ray requirements..."
Compliance with safety standards (UL2601-1, IEC 60601-1)	"It will comply with... safety requirements..."

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

Not Applicable. The document does not describe a clinical study with a test set of human subjects or data. It relies on a comparison to predicate devices and adherence to engineering/safety standards.

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

Not Applicable. No ground truth establishment is described, as there's no clinical test set for performance comparison.

4. Adjudication method for the test set:

Not Applicable. No test set or adjudication process 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 document is for a CT scanner system, not an AI or CAD (Computer-Aided Detection/Diagnosis) device. Therefore, an MRMC study with AI assistance is not relevant or mentioned.

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

No. This is a hardware device (CT scanner), not a standalone algorithm.

7. The type of ground truth used:

Not Applicable. No clinical ground truth is described. The basis for safety and effectiveness is substantial equivalence to a predicate device and compliance with standards.

8. The sample size for the training set:

Not Applicable. This is a hardware device; there is no mention of a "training set" in the context of an algorithm.

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

Not Applicable. As there's no training set, there's no ground truth establishment for one.

Summary of the "Study" (or rather, the basis for clearance):

The "study" or basis for clearance is not a traditional clinical trial with acceptance criteria for device performance. Instead, it is a demonstration of substantial equivalence through:

Design comparison: Stating the LightSpeed 4.0 CT Scanner System is "of comparable type and substantially equivalent" to currently marketed systems, sharing features like an intuitive Operator Console and the same tube as its predecessor (LightSpeed 3.0 CT Scanner System K002978).
Material comparison: Stating materials and construction are equivalent to the LightSpeed 3.0 CT Scanner System (K002978).
Compliance with standards: Adherence to UL 2601-1, IEC 60061-1, IEC 60601-1, 21CFR Subchapter J, and the X-ray requirements of 21CFR1020.30 and 1020.33. These standards, rather than direct performance metrics against a clinical dataset, form the "acceptance criteria" and the "proof" of meeting them is the attestation of compliance.
Risk Management: Identification and control of potential electrical, mechanical, and radiation hazards through system verification and validation, and adherence to industry/international standards.

In essence, the "study" is a compliance and comparison exercise with a predicate device and established standards, rather than an independent performance study against specific clinical criteria.

Summary

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NOV 0 82001

Image /page/0/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a circular border. The letters and the border are solid black, contrasting with the white background. The logo is simple and iconic, representing the well-known multinational conglomerate.

K013561

GE Medical Systems

General Electric Compa

Page 1 of 2

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).

Larry A. Kroger, Ph.D. Submitter: Senior Regulatory Programs Manager TEL: 262-544-3894, FAX: 262-544-3863 Summary prepared: October 15, 2001

PRODUCT IDENTIFICATION

Name:	LightSpeed 4.0 CT Scanner System
Classification Name:	Computed Tomography X-ray System
Manufacturer:	General Electric Medical Systems16800 W. Ryerson RoadNew Berlin, WI 53151
Distributor:	Same as Manufacturer
Marketed Devices:	The LightSpeed 4.0 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.

DEVICE DESCRIPTION

The LightSpeed 4.0 CT Scanner System is composed of a gantry, patient table, console, computer, and associated accessories.

Materials: Materials and construction are equivalent to the LightSpeed 3.0 CT Scanner System (K002978) are compliant with UL 2601-1, IEC 60061-1, and 21CFR Subchapter J.

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Indications for Use:

The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Cor Tomography applications.

Comparison with Predicate:

It is the opinion of GE Medical Systems that the LightSpeed 4.0 CT Scanner System is of a type and substantially equivalent to currently marketed head and whole body X-ray computed tomography systems with respect to design, material composition, energy source, and radiation characteristics. It will comply with the X-ray requirements of 21CFR1020.30 and1020.33, as well as the safety requirements of UL2601-1, IEC 60601-1 and collateral 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 . Requlations, and user requirements.
Adherence to industry and international standards. (UL/CSA and IEC). .

CONCLUSIONS

The LightSpeed 4.0 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 4.0 CT System to be equivalent 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 Department of Health & Human Services - USA. The logo is a circular seal with the department's name around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with healthcare. The caduceus is depicted with three lines representing the snakes entwined around a staff.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 0 82001

General Electric Medical Systems % Mr. Reiner Krumme Division Manager, Medical Division TUV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470

Re: K013561

Trade/Device Name: LightSpeed 4.0 CT Scanner System Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: 90 JAK Dated: October 22, 2001 Received: October 26, 2001

Dear Mr. Krumme:

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 for do bear of 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 I ou may , ators, and second 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 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 11 you 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. 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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NOV 0 8 2001

STATEMENT OF INTENDED USE

K013561

510(k) Number (if known): __ Kor 356 /

Device Name: LightSpeed 4.0 CT Scanner System

Indications For Use:

The LightSpeed 4 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

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K013561

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.