The intended use of the proposed GE Imatron e-Speed EBT Scanner System remains unchanged from the intended uses of prior predicate Imatron devices and other scanners. The e-Speed is designed -- as are all predicate devices -- to produce cross sectional images of the entire human anatomy.

Specifically, the e-Speed is intended:

to permit radiologic visualization of the heart, blood vessels, or lymphatic system, during or after injection of a contrast medium;
to function as a diagnostic x-ray system to produce two and three dimensional images of the heart, blood vessels, or lymphatic system from a volume of computer reconstructed cross-sectional images from x-ray transmission data from the same axial plane taken at different angles;
to permit the data from certain three dimensional images to also be presented in time-sequenced or cine fashion;
to permit the data from three dimensional images to be viewed from a point of view moving inside the tissue, called "fly-through" mode for colons, blood vessels, or airways;
to be used for clinical situations requiring determination of specific quantitative information, such as the determination of calcium or other materials in bone, tumors, or organs;
to be used by the physician as an aid in the diagnosis of lung pathology;
for real-time motion studies, vascular and tissue blood flow analysis, and full three-dimensional volume imaging.

The e-Speed will make use of previously cleared workstation software products and software applications.

Finally, such system is intended to be used in a manner consistent with those devices already classified and set forth in 21 CFR Sections 892.1600 and 892.1750.

Device Description

The e-Speed EBT Scanner System ("e-Speed") is composed of a Gantry/Front End Assembly, Rear Electrical/Mechanical Assembly with Electron Source, Patient Table, Operator Console, Computer, HV Power Supply and Power Conditioning and Distribution System, water chiller, and associated accessories.

Materials: Materials and construction are equivalent to the C150XP EBT Scanner System (K001550) and are compliant with UL2601-1, IEC 60601-1, and 21CFR Subchapter J.

Design: The system is designed to be an angiographic X-ray system, and a whole body CT scanner utilizing electron beam technology, a modernized beam control system and redesigned x-ray data acquisition system, a higher power HV supply, an operator console, and the capability to scan at 0.050 sec as the primary mode of operation.

AI/ML Overview

The provided document is a 510(k) summary for the GE Imatron e-Speed Electron Beam Tomography (EBT) Scanner System, not a study report detailing acceptance criteria and performance metrics in the way a clinical trial or algorithm validation study would.

This document focuses on establishing substantial equivalence to predicate devices. Therefore, it does not contain the specific information requested regarding acceptance criteria, study methodologies, and performance metrics typically associated with establishing a device's efficacy against defined criteria.

Here's a breakdown of why the requested information cannot be fully provided from this document:

No specific acceptance criteria: The document asserts that the e-Speed EBT Scanner System performs "as well as or better than devices currently on the market" and is "substantially equivalent" to predicate devices. It discusses design, material composition, energy source, and radiation characteristics, and compliance with safety standards (UL2601-1, IEC 60601-1, 21CFR 1020.30, 1020.31, 1020.33, 21CFR Subchapter J), but it does not list quantitative acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, accuracy for specific medical conditions).
No detailed study: The document refers to "System verification and validation to ensure performance to specifications" and "Adherence to industry and international standards." However, it does not present a detailed study with methods, sample sizes, ground truth establishment, or performance results in the manner requested for an AI/device performance study.

Given the nature of this 510(k) submission, the requested table and information about specific study parameters are not present. The document focuses on regulatory compliance and substantial equivalence, not detailed performance validation against specific diagnostic criteria.

Response based on the provided document:

Table of acceptance criteria and the reported device performance:

Acceptance Criteria	Reported Device Performance
Safety Standards Compliance
UL2601-1	Compliant
IEC 60601-1	Compliant
21CFR 1020.30	Compliant
21CFR 1020.31	Compliant
21CFR 1020.33	Compliant
21CFR Subchapter J	Compliant
Performance Equivalence
Performance relative to currently marketed devices	Performs "as well as or better than" devices currently on the market. Considered "substantially equivalent" to other marketed devices with the same indications for use and meeting similar standards.
Risk Management	Identified and controlled by system verification/validation and adherence to standards.
Adverse effects on health controlled	Identified and controlled by system verification/validation and adherence to standards.
Design/Material/Energy/Radiation Characteristics
Substantially equivalent to predicate angiographic and whole body X-ray computed tomography systems	Substantially equivalent to currently marketed angiographic and whole body X-ray computed tomography systems.

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- This information is not provided in the 510(k) summary. The document does not describe a specific clinical test set or its provenance for diagnostic performance evaluation, as it's a submission for substantial equivalence based on engineering and safety standards.
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):
- This information is not provided. No specific test set requiring expert ground truth establishment for diagnostic performance is described.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not provided. No specific test set or adjudication method is described.
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 MRMC or AI assistance study is mentioned. This device is a CT scanner, not an AI-powered diagnostic algorithm designed to assist human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This device is a medical imaging scanner (CT system), not an algorithm. Therefore, "standalone algorithm performance" is not applicable in the context requested. The document asserts the overall system's performance is "as good as or better than" predicate devices.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- This information is not provided. The document focuses on engineering specifications, safety compliance, and functional equivalence, not on diagnostic accuracy validated against specific ground truth types.
The sample size for the training set:
- This information is not provided. This document does not pertain to the training of a machine learning algorithm.
How the ground truth for the training set was established:
- This information is not provided. This document does not pertain to the training of a machine learning algorithm.

Summary

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Image /page/0/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "G" and "E" intertwined within a circle. The letters and the circle are white, and the background is black.

GE Imatron

General Flectric Compan 89 Ovster Point Boulevarr h San Francisco CA 941 367-6545, 650 583-9964 A GE Medical Systems Company

Ko22794

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).

Submitter:

Kerry A. Spear Regulatory and Compliance Manager, GE Imatron TEL: 650-742-8801 FAX: 650-827-7790 Summary prepared: 19 July 2002

PRODUCT IDENTIFICATION

Name:	e-Speed Electron Beam Tomography (EBT) Scanner System
Classification Name:	Angiographic X-ray SystemComputed Tomography X-ray System
Manufacturer:	GE Imatron389 Oyster Point BoulevardSouth San Francisco, CA 94080
Distributor:	Same as Manufacturer
Marketed Devices:	The e-Speed EBT Scanner System is of comparable type andis substantially equivalent to currently marketed EBT andComputed Tomography X-ray Systems that comply with thesame or equivalent standards and have the same intendeduses.

DEVICE DESCRIPTION

Materials: Materials and construction are equivalent to the C150XP EBT Scanner System (K001550) and are compliant with UL2601-1, IEC 60601-1, and 21CFR Subchapter J.

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Indications for Use:

Specifically, the e-Speed is intended:

to permit radiologic visualization of the heart, blood vessels, or lymphatic 1. system, during or after injection of a contrast medium;
1. to function as a diagnostic x-ray system to produce two and three dimensional images of the heart, blood vessels, or lymphatic system from a volume of computer reconstructed cross-sectional images from x-ray transmission data from the same axial plane taken at different angles;
to permit the data from certain three dimensional images to also be presented in 3. time-sequenced or cine fashion;
1. to permit the data from three dimensional images to be viewed from a point of view moving inside the tissue, called "fly-through" mode for colons, blood vessels, or airways;
to be used for clinical situations requiring determination of specific quantitative న్. information, such as the determination of calcium or other materials in bone, tumors, or organs;
1. to be used by the physician as an aid in the diagnosis of lung pathology;
1. for real-time motion studies, vascular and tissue blood flow analysis, and full three-dimensional volume imaging.

The e-Speed will make use of previously cleared workstation software products and software applications.

Finally, such system is intended to be used in a manner consistent with those devices already classified and set forth in 21 CFR Sections 892.1600 and 892.1750.

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Comparison with Predicate:

It is the opinion of GE Imatron that the e-Speed EBT Scanner System is of a type and substantially equivalent to currently marketed angiographic 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 safety requirements of 21CFR 1020.30, 1020.31, and 1020.33, as well as the safety requirements of UL2601-1, IEC 60601-1 and applicable 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 e-Speed EBT Scanner System does not result in any new potential safety risks and performs as well as or better than devices currently on the market. GE Imatron considers the e-Speed EBT Scanner System to be equivalent to other marketed devices with the same indications for use and meeting similar standards.

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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services (HHS). The seal features a stylized eagle with three lines representing its body and wings. The eagle faces left and is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES" in a circular arrangement.

Food and Drug Administration 0 Corporate Boulevard Rockville MD 20850

OCT 1 1 2002

General Electric Imatron % Mr. Nishith Desai Primary Third Party Reviewer TÜV Rheinland of North America, Inc. 12 Commerce Road NEWTOWN CT 06470

Re: K022794

Trade/Device Name: e-speed Electron Beam Tomography (EBT) Scanner System Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: 90 JAK

Dated: September 27, 2002 Received: September 27, 2002

Dear Mr. Desai:

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 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. Snogdon

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): K022794_____________________________________________________________________________________________________________________________________

Device Name: e-Speed EBT Scanner System

Indications for Use:

The intended use of the proposed GE Imatron e-Speed EBT Scanner System remains unchanged from the intended uses of prior predicate Imatron devices and other scanners. The e-Speed is designed - as are all predicate devices - to produce cross sectional images of the entire human anatomy.

Specifically, the e-Speed is intended:

to permit radiologic visualization of the heart, blood vessels, or lymphatic 1. system, during or after injection of a contrast medium;
1. to function as a diagnostic x-ray system to produce two and three dimensional images of the heart, blood vessels, or lymphatic system from a volume of computer reconstructed cross-sectional images from x-ray transmission data from the same axial plane taken at different angles;
1. to permit the data from certain three dimensional images to also be presented in time-sequenced or cine fashion;

(Continued on following page)

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR -

Daniel A. Seymore

(Division Sign-Off) Division of Reproductive. Abdo and Radiological Devices 510(k) Number

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

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to permit the data from three dimensional images to be viewed from a point of 4. view moving inside the tissue, called "fly-through" mode for colons, blood vessels, or airways;
- to be used for clinical situations requiring determination of specific quantitative information, such as the determination of calcium or other materials in bone, tumors, or organs;

న్.

to be used by the physician as an aid in the diagnosis of lung pathology; 6.
for real-time motion studies, vascular and tissue blood flow analysis, and full 7. three-dimensional volume imaging.

The e-Speed will make use of previously cleared workstation software products and software applications.

Finally, such system is intended to be used in a manner consistent with those devices already classified and set forth in 21 CFR Sections 892.1600 and 892.1750.

Daniel A. Heyman

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.