The provided text is a 510(k) Summary of Safety and Effectiveness for the GE CT/e Computed Tomography scanner system. This document is focused on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving performance against specific acceptance criteria for a new, novel AI-enabled device.

Therefore, many of the requested details about acceptance criteria, specific studies, sample sizes, expert involvement, and ground truth establishment are not present in this type of submission. This document predates the widespread use of AI in medical imaging devices and the specific regulatory guidance around its validation.

Here's an analysis based on the information available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the context of an ordinary 510(k) submission for a conventional CT scanner. The submission's goal is to demonstrate substantial equivalence, not to meet pre-defined performance metrics for a novel algorithm.

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

Not applicable. This is not a study validating an AI algorithm with a test set of images. The "test" here refers to system verification and validation against specifications and regulatory requirements, not performance on a clinical image dataset.

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

Not applicable. Ground truth establishment with experts is typical for AI/ML device validation. This document describes a conventional CT scanner submission.

4. Adjudication method for the test set

Not applicable.

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

Not applicable. This is not an AI-enabled device and therefore no MRMC study was performed in relation to AI assistance.

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

Not applicable.

7. The type of ground truth used

Not applicable in the context of validating performance on a clinical dataset. The "ground truth" for this conventional device would be its adherence to established engineering specifications, regulatory standards (e.g., 21 CFR Subchapter J, IEC 60601-1), and the performance of the predicate devices.

8. The sample size for the training set

Not applicable. This device is not an AI/ML device that requires a training set.

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

Not applicable.

Summary of what is present and relevant in the document:

Device Type: Conventional CT scanner (CT/e Computed Tomography scanner system)
Regulatory Pathway: 510(k) clearance, demonstrating "substantial equivalence."
Predicate Device: HiSpeed LX/i, FX/i and DX/i (K980169)
Performance (as stated for substantial equivalence):
- "The CT/e Computed Tomography system is of comparable type and substantially equivalent to currently marketed computed tomography systems that comply with the same or equivalent standards and have the same intended uses."
- "It is the opinion of GE Medical Systems that the CT/e Computed Tomography system is of comparable 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 performance standards of 21 CFR as well as the safety requirements of the IEC 60601-1 series of standards."
- "System verification and validation to insure performance to specifications, regulatory requirements and user requirements."
- "Adherence to Industry and International Standards (UL/IEC/CSA)"
- "Use of the CT/e Computed Tomography system does not result in any new potential safety risks and performs as well as, or better than devices currently on the market."

In essence, this document demonstrates that the CT/e system meets its "acceptance criteria" by being substantially equivalent to existing, legally marketed CT systems and by complying with relevant safety and performance standards for such devices. The "study" for this type of submission is the comprehensive engineering design, manufacturing adherence, and verification/validation activities typical for conventional medical devices.

Summary

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DEC 2 | 1999

Image /page/0/Picture/1 description: The image shows a handwritten string of alphanumeric characters. The string appears to be "K993645". The characters are written in a dark ink on a white background. The handwriting is somewhat stylized, with some characters having distinct features.

Image /page/0/Picture/2 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a circle. There are four decorative teardrop shapes placed symmetrically around the circle's perimeter. The logo is presented in black and white.

GE Medical Systems

P.O. Box 414 Milwaukee, WI 53201

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

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

Submitter: Larry A. Kroger Senior Regulatory Programs Manager who may be contacted at 414-544-3894 or FAX 414-544-3863 Summary prepared May 11, 1999 CT/e Computed Tomography scanner system Device Name:

Device Name:	CT/e Computed Tomography scanner system.
Classification Name:	Computed Tomography X-ray System
Manufacturer	GE-YMS7-127 Asahigaoka 4-ChomeHino-Shi, Tokyo, Japan 191
Distributor	General Electric Medical Systems3000 North Grandview Blvd.Waukesha, WI 53188

Marketed Devices:

The CT/e Computed Tomography system is of comparable type and substantially equivalent to currently marketed computed tomography systems that comply with the same or equivalent standards and have the same intended uses.

Device Description:

The CT/e Computed Tomography system consist of a gantry, patient support, operator console, computer and associated accessories.

Materials: All construction and materials are compliant with 21 CFR Subchapter J and IEC 60601-1 and are equivalent to HiSpeed LX/i, FX/i and DX/i (K980169)

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Design: The system is designed to be a head and whole body CT scanner utilizing a solid state detector and an intuitive Operator Console with similar features to the HiSpeed LX/i, FX/i and DX/i (K980169).

Indications for Use:

CT/e Computed Tomography system is indicated for head and whole body x-ray computed tomography applications.

Comparison with Predicate Device:

It is the opinion of GE Medical Systems that the CT/e Computed Tomography system is of comparable 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 performance standards of 21 CFR as well as the safety requirements of the IEC 60601-1 series of standards.

Adverse Effects on Health:

Potential electrical, mechanical, fire and radiation hazards are identified in the attached Risk Analysis and controlled by:

System verification and validation to insure performance to . specifications, regulatory requirements and user requirements.
Adherence to Industry and International Standards (UL/IEC/CSA) ●

Conclusions:

Use of the CT/e Computed Tomography system does not result in any new potential safety risks and performs as well as, or better than devices currently on the market.

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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 consists of a stylized eagle with three stripes extending from its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DFC 21 1999

Larry A. Kroger, Ph.D. Senior Regulatory Programs Manager GE Medical Systems. Inc. P.O. Box 414, W-709 Milwaukee, WI 53201

Re:

K993645 CT/e Computed Tomography System Dated: October 25, 1999 Received: October 28, 1999 Regulatory class: II 21 CFR 892.1750/Procode: 90 JAK

Dear Dr. Kroger:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 notfication"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

CAPT Daniel S. Schultz, M.D.

APT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: CT/e Computed Tomography system

Indications For Use:

The CT/e Computed Tomography system is intended 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)

Daniel G. Ingram

(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Device 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

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.