The Veo reconstruction option is intended to produce cross-sectional images of the head and body by computer reconstruction of X-ray transmission data taken at different angles and planes, including Axial and Helical (Volumetric) acquisitions for all ages.

When used, it allows for an alternate reconstruction method designed to reduce image noise, increase resolution and improve low contrast detectability in images produced using raw Computed Tomography data from GE CT scanners. The Veo reconstruction option can be used to reduce noise in diagnostic images and also to reduce the dose required for routine imaging, including CT scans of the head, chest, abdomen and pelvis. The Veo reconstruction option may also improve the image quality of low dose non-diagnostic Filtered Backprojection images such that they become diagnostic.

Currently, Veo is for use with the Discovery CT750 HD CT Scanner.

Device Description

The Veo Reconstruction Option is composed of Server hardware and reconstruction software. The Veo reconstruction Server is connected to the CT system's operator console via a dedicated Ethemet connection to receive raw scan data for processing and send back the reconstructed image data when completed. Additionally, some minor changes to the CT system software are made to include functionality for installation and operation of the Veo Reconstruction Option. The option when used with the Discovery CT750 HD system (K081105) is an evolutionary modification and performs as well as or better than the computed tomography devices currently on the market. The product changes are primarily associated with the new reconstruction software and hardware. The Veo Reconstruction Option provides another method for reconstruction to that already provided by the CT system.

The Veo Reconstruction Option is intended for head and whole body CT scans when higher image quality and/or lower dose acquisitions are desired for challenging cases. The GE Veo Reconstruction Option when used with the CT System uses virtually the same materials and identical CT imaging principles as our existing marketed product. Discovery CT750 HD.

AI/ML Overview

The provided document is a 510(k) summary for the GE Veo Reconstruction Option, which is an add-on to existing CT systems. It does not contain a detailed study report with specific acceptance criteria and performance metrics in the format requested. The document primarily focuses on establishing substantial equivalence to a predicate device and outlining the intended use and device description.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I elaborate on sample sizes, ground truth establishment, expert qualifications, or multi-reader multi-case studies, as this information is not present in the provided text.

The document states: "The Veo Reconstruction Option when used with a GE CT system is an evolutionary modification and performs as well as or better than the computed tomography devices currently on the market." This suggests that the "acceptance criteria" were likely based on demonstrating that the Veo option did not degrade the performance of the CT system and potentially improved certain aspects like noise reduction, resolution, and low contrast detectability, compared to conventional reconstruction methods. However, specific quantitative acceptance criteria or detailed study results are not provided.

Here's what can be extracted and inferred from the text regarding the study and evaluation, acknowledging the significant gaps in detail:

1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly provided in the document. The submission focuses on demonstrating substantial equivalence rather than reporting specific performance metrics against pre-defined acceptance criteria.

Inferred Performance Claims (Qualitative):
- Reduce image noise
- Increase resolution
- Improve low contrast detectability
- May improve the image quality of low dose non-diagnostic Filtered Backprojection images such that they become diagnostic.
- Allows for an alternate reconstruction method.
- Performs as well as or better than the computed tomography devices currently on the market.

2. Sample size used for the test set and the data provenance
The document does not specify any sample size for a test set or data provenance (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not mentioned in the provided text.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not mentioned in the provided text.

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
The document does not describe an MRMC comparative effectiveness study or any effect size related to human reader improvement with or without AI assistance. The Veo Reconstruction Option is described as a reconstruction method, not specifically an AI algorithm with human-in-the-loop performance evaluation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document describes the device as a "reconstruction option" that processes raw CT data. It is implied that the performance of this reconstruction is evaluated in terms of image quality metrics (noise, resolution, low-contrast detectability) rather than a diagnostic algorithm's standalone performance on a specific task.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not mentioned in the provided text. Given the focus on image quality parameters (noise, resolution, contrast), the evaluation likely involved quantitative phantom studies and potentially qualitative assessment by experts on clinical images, but the method of establishing ground truth is not detailed.

8. The sample size for the training set
Not mentioned in the provided text. As this is a reconstruction option, the "training set" concept (as typically applied in machine learning) might not be directly applicable in the conventional sense, or if used, it is not disclosed.

9. How the ground truth for the training set was established
Not mentioned in the provided text.

Summary of what the document DOES state regarding the study/evaluation:

Conclusion about Performance: "The Veo Reconstruction Option when used with a GE CT system is an evolutionary modification and performs as well as or better than the computed tomography devices currently on the market." (Page 3)
Evaluation Methodology (Implied): The device was "developed under GE's Quality System" and "Functional requirements are demonstrated via testing." (Page 3). The claims around noise reduction, increased resolution, and improved low contrast detectability suggest that these were areas of focus for the testing.
Relationship to Predicate: "The GE Veo Reconstruction Option when combined with the GE CT system is of comparable type and substantially equivalent to GE Healthcare's currently marketed Computed Tomography X-ray Systems." (Page 3). This "substantial equivalence" is the primary regulatory pathway demonstrated.
Intended Benefits: The option is "designed to reduce image noise, increase resolution and improve low contrast detectability" and "can be used to reduce noise in diagnostic images and also to reduce the dose required for routine imaging." It "may also improve the image quality of low dose non-diagnostic Filtered Backprojection images such that they become diagnostic." (Page 3)

Summary

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K103489

GE Medical Systems, LLC
510(k) Premarket Notification Submission for: GE Veo Reconstruction Option

ﺎﺕ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟ

SECTION 5

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

SEP - 9 2011

510(k) SUMMARY

Summary of Safety and Effectiveness (3 pages) 5.1

5-2

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Image /page/1/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circle. The circle has a decorative border with curved, leaf-like shapes around it.

GE Healthcare GE Medical Systems, LLC

3000 N. Grandview Blvd. 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 807.87(h).

Date Prepared:	June 1, 2011
Submitter:	GE Healthcare (GE Medical Systems, LLC)3000 N. Grandview Blvd., W-1140Waukesha, WI 53188
Primary Contact:	John JaeckleRegulatory Affairs Manager, MI & CTGE Healthcare (GE Medical Systems, LLC)Tel: 262-312-7358e-mail: john.jaeckle@ge.com
Secondary Contact:	Andrew MendenRegulatory Affairs Leader, MI & CTGE Healthcare (GE Medical Systems, LLC)Tel: 262-312-7068, Fax: 414-908-9585e-mail: andrew.menden@med.ge.com

DEVICE IDENTIFICATION

Trade Name:	GE Veo Reconstruction Option
Common/Usual Name:	Veo
Classification Name:	Computed Tomography X-ray System per21CFR892.1750
Product Code:	90-JAK
Predicate Device(s):	GE Discovery CT750 HD (K081105)

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Manufacturer /Design Location:	GE Medical Systems, LLC (GE Healthcare)3000 N. Grandview Blvd.Waukesha, WI 53188
Manufacturing Location:	GE Medical Systems, LLC (GE Healthcare)3000 N. Grandview Blvd.Waukesha, WI 53188
Distributor:	Same as Manufacturer
Marketed Devices:	The GE Veo Reconstruction Option when combined with theGE CT system is of comparable type and substantiallyequivalent to GE Healthcare's currently marketed ComputedTomography X-ray Systems that comply with the same orequivalent standards and having similar intended use. TheGE CT system with the integrated GE Veo ReconstructionOption remains compliant with the same standards as theCT system.

DEVICE DESCRIPTION

INTENDED USE

The Veo Reconstruction Option is intended for head and whole body CT scans when higher image quality and/or lower dose acquisitions are desired for challenging cases.

INDICATIONS FOR USE

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Currently, Veo is for use with the Discovery CT750 HD CT Scanner.

COMPARISON WITH PREDICATE

The GE Veo Reconstruction Option when used with the CT System uses virtually the same materials and identical CT imaging principles as our existing marketed product. Discovery CT750 HD. The Veo Reconstruction Option provides another method for reconstruction to that already provided by the CT system.

The GE Veo Reconstruction Option when combined with the GE CT system is of comparable type and substantially equivalent to GE Healthcare's currently marketed Computed Tomography X-ray Systems. The Veo Reconstruction Option was developed under GE's Quality System and will be initially introduced as an option for the Discovery CT750 HD system (K081105), The GE CT system when using the GE Veo Reconstruction Option remains compliant with the same standards as the CT system.

ADVERSE EFFECTS ON HEALTH

The Veo Reconstruction Option is designed and manufactured under the Quality System Regulations, 21 CFR Part 820. Additionally, risk management is employed through hazard analysis, which identifies potential hazards. These hazards are mitigated through adherence to software development lifecycle procedures aligned with IEC 62304 and through product labeling including user instructions. Functional requirements are demonstrated via testing.

CONCLUSION

The Veo Reconstruction Option when used with a GE CT system is an evolutionary modification and performs as well as or better than the computed tomography devices currently on the market. In addition, when the CT system and the Veo option are combined they remain compliant with the same standards as the CT system alone. The combination of the Veo option and the CT System uses virtually the same materials and identical CT imaging principles as our existing marketed product, Discovery CT750 HD (K081105).

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Image /page/4/Picture/0 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle-like symbol with three horizontal bars representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the symbol.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Mr. Andrew Menden Regulatory Affairs Leaser, MI&CT GE Healthcare GE Medical Systems, LLC 3000 N. Grandview Blvd. WAUKESHA WI 53188

ු 2011

Re: K103489

Trade/Device Name: GE Veo Reconstruction Option Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: June 1, 2011 Received: June 2, 2011

Dear Mr. Menden:

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, l'isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish fruther 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 not the Act or any Federal statutes and regulations administered by other Federal agencies. Your must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting of

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Page 2

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse evenis under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/Reportal?roblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Mary Patel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K103489

Device Name: GE Veo Reconstruction Option

Indications for Use:

Currently, Veo is for use with the Discovery CT750 HD CT Scanner.

Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary S. Patil

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K103489

Page 1 of

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.