The GE LightSpeed Ultra CT Scanner System with Wide - View is composed of a gantry, patient table, image acquisition hardware and software, an operator console, and associated accessories. Materials and construction are equivalent to the LightSpeed Ultra CT Scanner System and are compliant with UL2601-1, IEC 60601-1 and associated collateral standards, and applicable sections of 21 CFR Subchapter J.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the GE LightSpeed Ultra CT System with Wide-View. However, it does not contain information about acceptance criteria, specific performance metrics, or a study designed to prove the device meets such criteria in the way typically expected for an AI/CADe device.

This document is a regulatory submission for a modification to an existing CT scanner (adding a "Wide-View" option). The submission focuses on demonstrating substantial equivalence to the predicate device, not on proving new performance characteristics through a clinical study with detailed acceptance criteria.

Therefore, for many of your points, the answer will be that the information is not provided or not applicable based on the type of submission.

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

1. Table of Acceptance Criteria and Reported Device Performance

Not Applicable. This 510(k) submission for the LightSpeed Ultra CT System with Wide-View does not define specific performance acceptance criteria (e.g., sensitivity, specificity, accuracy) for a new clinical performance study. Instead, it relies on demonstrating substantial equivalence to a legally marketed predicate device (the GE LightSpeed Ultra CT System, K000300). The "Summary of Studies" section only states: "The device has been evaluated for electrical, mechanical, and radiation safety, and conforms to applicable medical device safety and performance standards." It does not provide quantitative performance metrics against specific acceptance thresholds in a clinical context.

2. Sample Size Used for the Test Set and Data Provenance

Not Provided. No information regarding a specific test set, its sample size, or data provenance (country of origin, retrospective/prospective) is included in this 510(k) submission. The submission focuses on safety and performance standard conformity and substantial equivalence, not a new clinical performance study.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not Provided. Since no specific clinical test set or ground truth establishment process is described for device performance, information about experts or their qualifications is not present.

4. Adjudication Method for the Test Set

Not Provided. No test set or related adjudication method is mentioned in this submission.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not Done. The document does not describe an MRMC comparative effectiveness study, nor does it mention AI or human-in-the-loop performance. This device is a CT scanner, not an AI/CADe system.

6. Standalone (Algorithm Only) Performance Study

Not Applicable. This is a hardware modification to a CT scanner, not a standalone algorithm. Therefore, no such study was performed or described.

7. Type of Ground Truth Used

Not Applicable. For the purpose of this 510(k) submission, the "ground truth" focused on ensuring the modified device met safety standards and maintained performance comparable to its predicate. This is assessed through engineering testing, compliance with standards (e.g., UL2601-1, IEC 60601-1, 21 CFR Subchapter J), and a review of the design and manufacturing process (21 CFR 820, ISO 9001/ EN 46001). There isn't a clinical ground truth (like pathology or outcomes data) established for a new clinical performance claim in this document.

8. Sample Size for the Training Set

Not Applicable. This document describes a CT scanner modification, not an AI/ML algorithm that would require a training set.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. As no training set is relevant to this device submission, this information is not provided.

Summary

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Ko2 3332

Special 510(k) Premarket Notification GE Medical Systems - LightSpeed Ultra CT System with Wide - View option October 3, 2002

Image /page/0/Picture/2 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circular frame. The letters and the frame are solid black, creating a strong contrast against the white background.

OCT 2 3 2002 GE Medical Systems

P.O. Box 414. W-1140 Milwaukee, WI 53201

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

Submitter:	GE Medical SystemsPO Box 414Milwaukee, WI 53201
Contact Person:	Larry A. Kroger Ph.D.Senior Regulatory Programs ManagerTelephone: 262-544-3894; Fax: 262-548-4768
Date Prepared:	October 2, 2002
Device Name:	LightSpeed Ultra Computed Tomography System with Wide - View.Computed Tomography X-ray System, 21 CFR 892.1750, 90-JAK
Marketed Device:	GE Medical System's LightSpeed Ultra Computed Tomography System510(k) Number K000300, currently in commercial distribution.

Device Description:

Indications for Use:

The LightSpeed Ultra CT Scanner System with Wide - View is indicated for head and whole body X-ray computed tomography applications.

Comparison with Predicate Device:

The GE LightSpeed Ultra Computed Tomography System with Wide - View is a modification of, and of comparable type and substantially equivalent to the currently marketed GE LightSpeed Ultra CT System. It has the same technological characteristics, is comparable in key safety and effectiveness features, uses the same basic design, construction, and materials, and has the same intended use as the predicate device.

Summary of Studies:

The device has been evaluated for electrical, mechanical, and radiation safety, and conforms to applicable medical device safety and performance standards.

Conclusion:

Intended use and fundamental scientific technology are the same as the legally marketed GE LightSpeed Ultra CT System. The design and development process of the manufacturer conforms to 21 CFR 820, and ISO 9001/ EN 46001 quality systems. The device conforms to applicable medical device safety and performance standards. Results of the testing and standards conformance described above demonstrate, in the opinion of GE Medical Systems, that the LightSpeed Ultra CT System with Wide - View is substantially equivalent to the currently cleared LightSpeed Ultra CT System.

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Food and Drug Administration 200 Corporate Boulevard Rockville MD. 20850

Larry A. Kroger, Ph.D. Senior Regulatory Programs Manager GE Medical Systems P.O. Box 414, W-1140 MILWAUKEE WI 53201

Re: K023332

Trade/Device Name: LightSpeed Ultra CT Scanner with Wide-View Option Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system

Regulatory Class: II Product Code: 90 JAK Dated: October 3, 2002 Received: October 7, 2002

Dear Dr. Kroger:

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.

Image /page/1/Picture/12 description: The image shows a partial view of a seal or emblem. The visible portion includes stylized lettering arranged vertically, spelling out "DEPARTMUT OF HEALTH". The text curves along the edge of the emblem, and a portion of a graphic element is visible to the right of the text.

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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 vours,

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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al 510(k) Premarket Notification GE Medical Systems - LightSpeed Ultra CT System with Wide - View option October 3. 2002

STATEMENT OF INTENDED USE

510(k) Number (if known): ______________________________________________________________________________________________

Device Name: LightSpeed Ultra CT System with Wide - View

Indications for Use

The LightSpeed Ultra CT Scanner System with Wide - View 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)

Over-The-Counter Use_

Nancy C hogdon

510k) N E-2

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.