The GSI Viewer accepts images from a CT System that can acquire CT images using different kV levels of the same anatomical region of a patient in a single rotation from a single source. The differences in the energy dependence of the attenuation coefficient of the different materials provide information about the chemical composition of body materials. This approach enables images to be generated at energies selected from the available spectrum to visualize and analyze information about anatomical and pathological structures.

GSI provides information of the chemical composition of renal calculi by calculation and graphical display of the spectrum of effective atomic number. GSI Kidney stone characterization provides additional information to aid in the characterization of uric acid versus non-uric acid stones. It is intended to be used as an adjunct to current standard methods for evaluating stone etiology and composition.

The GSI Viewer with VUE option employs the same technology as the Technology: that of the GSI Viewer on its predicate device.

GSI provides information of the chemical composition of renal calculi by calculation and graphical display of the spectrum of effective atomic number. GSI Kidney stone characterization provides additional information to aid in the characterization of uric acid versus non-uric acid stones. It is intended to be used on non-contrast studies as an adjunct to current standard methods for evaluating stone etiology and composition.

Device Description

The unmodified device Discovery CT750 HD (K120833) offers the Gemstone Spectral Imaging (GSI) capability that uses rapid kV switching to acquire the dual energy samples almost simultaneously. This enables generation of material density data that can be used for the separation of materials and derivation of monochromatic spectral images using a projection based reconstruction algorithm.

GSI Viewer is a post processing visualization tool on the Discovery CT750 HD system that allows users to view and process spectral images acquired by the GSI scan modes. It allows for the review of monochromatic energy images at user selectable energy levels, detailed analysis using material decomposed images (such as water-iodine, water calcium, etc.), and complementary information using the Effective-Z images by providing an estimate of the protons' effective atomic number in a voxel.

The modification being introduced is the VUE (Virtual Unenhanced Exam) option that produces a material suppressed image at a given monochromatic energy in the conventional CT Hounsfield Units.

This modification is based on the existing capability of the predicate device that generates material separated images in the Material density (MD) space and is the subject of this pre-market notification.

AI/ML Overview

The provided 510(k) summary for the GE Healthcare GSI Viewer with VUE Option does not include a study that proves the device meets specific acceptance criteria related to its performance.

Instead, the submission states that:

The device did not require clinical studies to support substantial equivalence.
GE Healthcare considers the device to be as safe, as effective, and its performance substantially equivalent to the predicate device.

Therefore, many of the requested details cannot be extracted from this document, as a performance study with defined acceptance criteria was not conducted or reported in this summary.

Here's a breakdown of the specific points based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The document explicitly states: "The subject of this premarket submission, GSI Viewer with VUE option, did not require clinical studies to support substantial equivalence." Therefore, no specific acceptance criteria for performance and no reported performance metrics for these criteria are provided.

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

Not applicable. No clinical or performance study involving a test set was reported as part of this 510(k) summary.

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

Not applicable. No ground truth establishment activity was reported, as no clinical or performance study was conducted.

4. Adjudication method for the test set

Not applicable. No test set adjudication method was reported, as no clinical or performance study was conducted.

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. An MRMC comparative effectiveness study was not done. The device description indicates it's a "post processing visualization tool" and a "material suppressed image" option, rather than an AI-assisted diagnostic tool designed to directly improve human reader performance. No human-in-the-loop performance improvement data is provided.

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

Not applicable. No standalone performance study was reported. The device is described as a "GSI Viewer" and an "Option" within an existing viewing system, performing "generation of material density data" and "material suppressed images." No algorithm-only performance metrics were provided.

7. The type of ground truth used

Not applicable. No clinical or performance study requiring ground truth was reported.

8. The sample size for the training set

Not applicable. The document does not describe the development of a machine learning or AI model that would typically require a training set. The modification "is based on the existing capability of the predicate device that generates material separated images in the Material density (MD) space." This suggests an algorithmic modification rather than a data-driven model.

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

Not applicable. As no training set was reported (see point 8), there is no information on how its ground truth might have been established.

Summary of what was done instead of a performance study:

The submission focuses on demonstrating substantial equivalence to a predicate device (K120833 Discovery CT750 HD) based on:

The GSI Viewer with VUE Option employing the "same technology" as the GSI Viewer on its predicate device.
Compliance with voluntary standards.
Application of standard quality assurance measures during development: Risk Analysis, Requirements Reviews, Design Reviews, Performance testing (Verification), Safety testing (Verification), and Final acceptance testing (Validation). (Note: "Performance testing (Verification)" and "Final acceptance testing (Validation)" here refer to engineering/software testing against functional requirements, not clinical performance against acceptance criteria in a comparative study).

Summary

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.510K Summary

K12/827

1 3 2012

GE Healthcare GSI Viewer with VUE Option 510(k) Premarket Notification

In accordance with 21 CFR 807.92 the following summary of information is provided:

Date:	June 20th, 2012
Submitter:	GE Medical Systems SCS283, rue de la Minière78530 Buc Cedex - FRANCE
Primary Contact Person:	Helen Peng, RACRegulatory Affairs LeaderGE HealthcareTEL: 262-548-5091FAX: 262-364-2506
Secondary Contact Person:	Stephen G. Slavens, RACRegulatory Affairs DirectorGE HealthcareTEL: (262) 548-4992FAX: (262) 364-2506
Device:
Trade Name:	GSI Viewer with VUE Option
Common/Usual Name:	GSI Viewer with MSI Option
Classification Name:	21CFR 892.1750 Computed Tomography X-Ray system
Product Code:	JAK
Predicate Devices:	K120833 Discovery CT750 HD
Device Description:	The unmodified device Discovery CT750 HD (K120833) offers theGemstone Spectral Imaging (GSI) capability that uses rapid kVswitching to acquire the dual energy samples almostsimultaneously. This enables generation of material density datathat can be used for the separation of materials and derivation o

reconstruction algorithm.

monochromatic spectral images using a projection based

The modification being introduced is the VUE (Virtual Unenhanced Exam) option that produces a material suppressed image at a given

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GE Healthcare GSI Viewer with VUE Option 510(k) Premarket Notification

monochromatic energy in the conventional CT Hounsfield Units.

Indication for Use:

The GSI Viewer accepts images from a CT System that can acquire CT images using different kV levels of the same anatomical region of a patient in a single rotation from a single source. The differences in the eneray dependence of the attenuation coefficient of the different materials provide information about the chemical composition of body materials. This approach enables images to be generated at energies selected from the available spectrum to visualize and analyze information about anatomical and pathological structures.

The GSI Viewer with VUE option employs the same technology as the Technology: that of the GSI Viewer on its predicate device.

Determination of Substantial Summary of Non-Clinical Tests: Equivalence:

The GSI Viewer with VUE Option complies with voluntary standards as detailed in Section 9, 11 and 16 of this premarket submission. The following quality assurance measures were applied to the development of the system:

Risk Analysis .
Requirements Reviews .
. Design Reviews
Performance testing (Verification) .
Safety testing (Verification) .
Final acceptance testing (Validation) .

Summary of Clinical Tests:

The subject of this premarket submission, GSI Viewer with VUE option, did not require clinical studies to support substantial

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Image /page/2/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circle. The letters and the inner part of the circle are black, while the outer part of the circle is white.

GE Healthcare GSI Viewer with VUE Option 510(k) Premarket Notification

equivalence.

GE Healthcare considers the GSI Viewer with VUE Option software Conclusion: application to be as safe, as effective, and its performance is substantially equivalent to the predicate device.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

GE Medical Systems SCS % Ms. Helen Peng Regulatory Affairs Leader GE Medical Systems, LLC dba GE Healthcare 3000 N Grandview. W1140 WAUKESHA WI 53188

SEP 13 2012

Re: K121827

Trade/Device Name: GSI Viewer with VUE Option Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: June 18, 2012 Received: June 21, 2012

Dear Ms. Peng:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use saled in the encrosule) is regarry manet date of the Medical Device Amendments, or to conimeres prior to May 20, 1978, the eccordance with the provisions of the Federal Food, DNAA devices that have been recuire approval of a premarket approval application (PMA). alla Cosment Act (Act) that do not require approvince to the general controls provisions of the Act. The 1 ou may, merciole, market the act include requirements for annual registration, listing of general condols provisions of the fiel 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 If your device is classified (see asor regulations affecting your device can be found in Title 21, additional controls. Existing major regulations and to 895. In addition, FDA may publish further Sode of Pourial concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualled of a succession in other requirements of the Act that FDA has made a determination that your steered by other Federal agencies. You must of any Federal Statutes and regulations animatives but not limited to: registration and listing (21 comply with all the Act 3 requirements, theraung, Surnet Called of the Parting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice medical device related adverses viality systems (QS) regulation (21 CFR Part 820). This letter requirents as set form in are quarty -device as described in your Section 510(k) premarket with anow you to begal mading 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 If you desire speedile ad ree for your viro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket 9 120. Thise note 1000 in 100.000. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/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 Tou may 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,

Janine M. Morris

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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GE Healthcare GSI Viewer with VUE Option 510(k) Premarket Notification

Indications for Use

510(k) Number (if known):

GSI Viewer with VUE Option Device Name:

Indications for Use:

GSI provides information of the chemical composition of renal calculi by calculation and graphical display of the spectrum of effective atomic number. GSI Kidney stone characterization provides additional information to aid in the characterization of uric acid versus non-uric acid stones. It is intended to be used on non-contrast studies as an adjunct to current standard methods for evaluating stone etiology and composition.

AND/OR Prescription Use X {Part 21 CFR 801 Subpart D}

Over-The-Counter Use (Part 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)

Mund D. Phm

Division S Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) Number K121827

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.