The GE BrightSpeed Delight Series Computed Tomography X-ray system is intended to produce crosssectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, patient for all ages, including Axial, Cine, Helical, Cardiac, and Gated acquisitions. These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

This device may include data and image processing to produce images in a variety of trans-axial and reformatted planes. Further the images can be post processed to produce additional imaging planes or analysis results.

The GE BrightSpeed Delight Series CT Scanner System is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications.

The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy.

Device Description

The GE BrightSpeed Delight Series CT Scanner System (aka GE BrightSpeed Elite, BrightSpeed Elite Select, BrightSpeed Edge Select, and BrightSpeed Excel Select) is composed of a gantry, patient table, operator console, computer, and PDU and includes image acquisition hardware, image acquisition and reconstruction software, associated accessories and connections/interfaces to accessories. The GE BrightSpeed Delight Series CT Scanner System is an evolutionary modification to StarSpeed Series CT system (K052855). It is developed from the hardware platform of StarSpeed system by adding new application features that involve changes in hardware, software, firmware, recon, and scan mode.

The GE BrightSpeed Delight Series CT Scanner System is designed to be a head and whole body CT scanner incorporating the same basic fundamental operating principles and similar Indications for Use. Materials and construction are equivalent to our existing marketed products, which are compliant with UL 60601-1, IEC 60601-1 and associated collateral and particular standards, and 21CFR Subchapter J.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study information for the GE BrightSpeed Series CT Scanner System:

The provided document is a 510(k) summary for a GE BrightSpeed Series CT Scanner System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness or specific performance metrics with clinical studies of the type described in the prompt. Therefore, much of the requested information regarding acceptance criteria, specific device performance, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not present in this document.

The document focuses on demonstrating that the new device, the GE BrightSpeed Delight Series CT Scanner System, is an "evolutionary modification" of a previously cleared device (GE StarSpeed Series CT Scanner System K052855) and performs "as well as or better than devices currently on the market," without introducing new safety risks.

Here's a breakdown of what can be extracted and what is explicitly not available from the provided text, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Safety: No new potential safety risks compared to predicate.	Device designed and manufactured under 21CFR820. Potential hazards identified and controlled via system verification/validation, adherence to industry standards (UL/CSA, IEC), and compliance with 21CFR Subchapter J.
Effectiveness/Functionality: Performs as well as or better than predicate.	Evolutionary modification with new application features (hardware, software, firmware, recon, scan mode). Uses same basic fundamental operating principles and similar Indications for Use as predicate.
Compliance: Certified to applicable X-ray, safety, and quality standards.	Certified to 21CFR1020.30, 21CFR1020.33 (X-ray requirements); UL 60601-1, IEC 60601-1 (safety requirements); and associated collateral and particular standards.
Substantial Equivalence: Comparable type, similar intended uses, and compliant with same or equivalent standards as predicate.	Directly compared to GE StarSpeed Series CT Scanner System (K052855). Stated to be "of comparable type and substantially equivalent."

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

This information is not provided in the 510(k) summary. A 510(k) for an evolutionary modification typically relies on technical comparisons, design verification, and adherence to standards rather than new clinical testing on a "test set" of patient data for performance claims.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided as a formal "test set" with expert-established ground truth as you describe for AI performance evaluation is not detailed in this type of submission. The evaluation is primarily against engineering specifications and predicate equivalency.

4. Adjudication Method for the Test Set

This information is not provided for the same reasons as above.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study is not mentioned or described in this 510(k) summary. This type of study (comparing human readers with and without AI assistance to quantify improvement) is typically associated with AI/CADe (Computer-Aided Detection) or CADx (Computer-Aided Diagnosis) devices, which aim to aid in interpretation. This document describes a CT scanner system, an image acquisition device, not a diagnostic aid algorithm in that sense.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable and not provided. The device in question is a Computed Tomography X-ray system, which is inherently a hardware and software system used by humans to acquire images. It does not perform a standalone diagnostic algorithm in the way an AI CADe/CADx device might.

7. The Type of Ground Truth Used

The concept of "ground truth" as it pertains to clinical outcomes or definitive diagnoses for evaluating an algorithm's performance is not directly applicable or detailed in this 510(k). The "truth" in this context is adherence to engineering specifications, safety standards, and functional equivalence to the predicate device.

8. The Sample Size for the Training Set

This information is not provided and is not relevant for this type of device submission. CT scanners do not typically have a "training set" in the machine learning sense to learn to perform their primary function of image acquisition and reconstruction. While there are internal development and testing processes, they are not described as a formal "training set" for an algorithm in this document.

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

This information is not provided and is not relevant for this type of device submission for the reasons outlined in point 8.

Summary

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OCT 0 8 2008

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GE Healthcare

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 807.07(h).

Submitter:
Name:	GE Medical Systems, LLC (GE Healthcare)
Address:	3000 N. Grandview Blvd., W-1140Waukesha, WI 53188
Contact:	Steve KachelmeyerPremarket Regulatory Affairs Program ManagerTel: 262-548-2432, Fax: 262-997-1080e-mail: Steven.Kachelmeyer@med.ge.com
Date Prepared:	August 11, 2008
PRODUCT IDENTIFICATION
Name:	GE BrightSpeed Series CT(Also known as BrightSpeed Delight Series CTScanner System)
Classification Name:	Computed Tomography X-ray System21CFR892.1750, 90-JAK
Manufacturer:	GE Yokogawa Medical Systems7-127 asahigaoka 4-chomeHino-shi, Tokyo, Japan 191-8503GE Hangwei Medical Systems Co. Ltd.No 1 Young Change North RdBeijing Economic and Tech Development ZoneBeijing, China 100176Future Production may also be accomplished at one of ourother registered CT Manufacturing facilities.
Distributor:	GE Medical Systems LLC. (GE Healthcare)3000 N. Grandview Blvd.Waukesha, WI 53188

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Marketed Devices: The GE BrightSpeed Delight series CT Scanner System (aka GE BrightSpeed Elite, BrightSpeed Elite Select, BrightSpeed Edge Select, and BrightSpeed Excel Select) is of comparable type and substantially equivalent to GE's currently marketed Computed Tomography X-ray Systems that comply with the same or equivalent standards and have similar intended uses, such as the previous StarSpeed CT Scanners.

Predicate Device(s):

GE StarSpeed Series CT Scanner System (K052855)

DEVICE DESCRIPTION

Indications for Use:

The GE BrightSpeed Delight Series Computed Tomography X-ray system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, patient for all ages, including Axial, Cine, Helical, Cardiac, and Gated acquisitions. These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

The GE BrightSpeed Delight Series CT Scanner System is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications.

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The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy.

Comparison with Predicate:

The GE BrightSpeed Delight Series CT Scanner System is developed from the hardware platform of our StarSpeed system (K052855). The GE BrightSpeed Delight Series CT involves changes from the StarSpeed CT system to add new application features that involve changes in hardware, application software, firmware, recon, and scan mode. The GE BrightSpeed Delight Series CT Scanner System uses virtually the same materials and identical operating principle as our existing marketed product, StarSpeed CT system as well as having similar indications for use. We believe the GE BrightSpeed Delight Series CT Scanner System is of comparable type and substantially equivalent to our currently marketed system listed above and complies with the same or equivalent standards and have the same intended uses.

The GE BrightSpeed Delight Series CT Scanner System will be certified to comply with the X-ray requirements of 21CFR1020.30 and1020.33, as well as the safety requirements of UL 60601-1, 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 including hazard analysis and controlled by:

System verification and validation to ensure performance to specifications, . Federal Regulations, and user requirements.
. Adherence and certification to industry and international standards. (UL/CSA and IEC).
. Compliance to applicable CDRH 21CFR subchapter J requirements.

The device is designed and manufactured under the Quality System Regulations of 21CFR820.

Conclusions:

The GE BrightSpeed Delight Series CT Scanner System is an evolutionary modification to the StarSpeed Series CT system (K052855). It does not result in any new potential safety risks and performs as well as or better than devices currently on the market. The GE BrightSpeed Delight Series CT system will be certified to comply with the X-ray requirements of 21CFR 1020.30 and 1020.33, as well as the safety requirements of UL 60601-1, and IEC 60601-1 and associated collateral and particular standards. GE considers the GE BrightSpeed Delight Series CT Scanner System to be equivalent to other marketed devices with similar indications for use and meeting similar standards.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 0 8 2008

GE Medical Systems, LLC % Mr. James W. Monroe Official Correspondent Intertek Testing Services 2307 E. Aurora Rd., Unit B7 TWINSBURG OH 44087

Re: K082816

Trade/Device Name: GE BrightSpeed Delight Series CT Scanner Systems (aka GE BrightSpeed Elite, BrightSpeed Elite Select, BrightSpeed Edge Select, and BrightSpeed Excel Select)

Regulation Number: 21 CFR 892.1750

Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: September 24, 2008 Received: September 25, 2008

Dear Mr. Monroe:

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.

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Page 2

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.

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 this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Jorque M. Whang

Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: GE BrightSpeed Delight Series CT Scanner Systems (aka GE BrightSpeed Elite, BrightSpeed Elite Select, BrightSpeed Edge Select, and BrightSpeed Excel Select)

Indications for Use:

The GE BrightSpeed Delight Series CT Scanner System is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications.

The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy.

X Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Helmut Leman

Page 1 of 1

(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devic 510(k) Number

4-2

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.