The software aids in the assessment of human brain PET scans enabling automated analysis through quantification of tracer uptake and comparison with the corresponding tracer uptake in normal subjects. The resulting quantification is presented using volumes of interest, voxel-based or 3D stereotactic surface projection maps of the brain. The package allows the user to generate information regarding relative changes in PET-FDG glucose metabolism.

CortexID Suite additionally allows the user to generate information in PET brain amyloid load between a subject's images and a normal database, which may be the result of brain neurodegeneration.

PET co-registration and fusion display capabilities with CT and MR allow PET findings to be related to brain anatomy and offers visualization of structural abnormalities, which may result from brain injury, trauma, disorder, disease or dysfunction, such as subdural hematoma, tumor, stroke, or cerebrovascular disease, etc.

CortexID Suite may aid physicians in the image interpretation process of PET studies conducted on patients being evaluated for cognitive impairment, or other causes of cognitive decline, and is an adjunct to other diagnostic evaluations.

Device Description

CortexID, image analysis software, has been developed to aid clinicians in the assessment and quantification of pathologies derived from PET scans. The software enables the display, co-registration, and fusion of PET images with those from other modalities. It enables automated quantitative and statistical analysis of tracer uptake by registration to a standard template space and comparing intensity values. Additionally, CortexID assists with comparison of the activity in defined brain regions of individual scans relative to normal activity values as found in normal subjects. Quantification is presented using volumes of interest, voxel-based or 3D stereotactic surface projection maps of the brain.

Key features of the CortexID Suite include:
a. Integrated platform for FDG and Beta Amyloid analysis
b. PET-MR and PET-CT registration and fusion
c. Automatic reorientation and standardization
d. 3D SSP, Voxel based images and VOI statistics
e. Comparison with normals databases
f. Longitudinal Analysis
g. Q.Check
h. Summing input dynamic PET scan
i. Exam Summary (integrated report)
j. Easy Export
k. Multiple Reference Regions
l. Reoreintation
m. Region Overlay
n. Fully Customizable Interface
o. Preset Presentations
p. MR Template Image

The CortexID Suite is also made available as a standalone post processing application on the AW VolumeShare 5 workstation (K110834) that hosts advanced image processing applications.

AI/ML Overview

The provided document is a 510(k) summary for the GE Medical Systems CortexID Suite software. It declares substantial equivalence to a predicate device and does not contain a study section with acceptance criteria and a detailed study proving the device meets those criteria.

Instead, it functions as a submission to the FDA, asserting that CortexID Suite is substantially equivalent to a previously cleared device (K062393 - CortexID). The determination of substantial equivalence is based on non-clinical tests and the assertion that "The subject of this premarket submission, CortexID Suite software did not require clinical studies to support substantial equivalence since it introduces analysis of new PET image contrast agents only. The clinical utility for the analysis of the new image processing has not been studied since modification does not significantly affect the clinical safety and performance."

Therefore, based on the provided text, I cannot extract the information required to populate the requested table and answer the specific study-related questions. The document explicitly states that clinical studies were not required for this submission.

Summary of unavailable information:

Acceptance criteria and reported device performance table: Not provided in the document.
Sample size used for the test set and data provenance: Not applicable as no clinical test set was used for substantial equivalence.
Number of experts used to establish ground truth for the test set and qualifications: Not applicable.
Adjudication method: Not applicable.
MRMC comparative effectiveness study and effect size: Not applicable as no clinical studies were performed.
Standalone (algorithm only) performance: Not explicitly stated or evaluated in the provided text as a separate study. The document focuses on the software and its features.
Type of ground truth used: Not applicable.
Sample size for the training set: Not applicable (no explicit mention of training a new algorithm or clinical study).
How ground truth for the training set was established: Not applicable.

The document focuses on:

Identifying the device and its predicate.
Listing the key features of the CortexID Suite.
Stating the intended use/indications for use.
Explaining the technological similarity to the predicate device.
Detailing the non-clinical tests performed (compliance with DICOM standard, risk analysis, requirements reviews, design reviews, integration testing, performance testing, safety testing).
Asserting that clinical studies were not required for this specific submission's substantial equivalence determination.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of three human profiles facing to the right. The profiles are connected by a flowing line.

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

September 19, 2014

GE Medical Systems, LLC % Mr. David Duersteler Regulatory Affairs Leader 3000 North Grandview Blvd. WAUKESHA WI 53188

Re: K141074 Trade/Device Name: CortexID Suite Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS Dated: September 12, 2014 Received: September 15, 2014

Dear Mr. Duersteler:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D. O'Hara

for

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K141074

Device Name CortexID Suite

Indications for Use (Describe)

CortexID software has been developed to aid physicians in the evaluation of patient pathologies via assessment and quantification of PET brain scans.

The software aids in the assessment of human brain PET scans enabling automated analysis through guantification of tracer uptake and comparison with the corresponding tracer uptake in normal subjects. The resulting quantification is presented using volumes of interest, voxel-based or 3D stereotactic surface projection maps of the brain. The package allows the user to generate information regarding relative changes in PET-FDG glucose metabolism.

CortexID Suite additionally allows the user to generate information in PET brain amyloid load between a subject's images and a normal database, which may be the result of brain neurodegeneration.

PET co-registration and fusion display capabilities with CT and MR allow PET findings to be related to brain anatomy and offers visualization of structural abnormalities, which may result from brain injury, trauma, disease or dysfunction, such as subdural hematoma, tumor, stroke, or cerebrovascular disease, etc.

Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Image /page/4/Picture/1 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in white inside. The circle is surrounded by a white border with a stylized design that looks like water droplets. The logo is simple and recognizable, and it is often used to represent the company's products and services.

510(k) Summary

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

Date:	April 23, 2014
Submitter:	GE Medical Systems, LLC
	3000 North Grandview Blvd.Waukesha, WI 53188, USA
Primary Contact Person:	Peter Uhlir
	Regulatory Affairs Leader
	Tel: 00 36 23 410121Fax: 1-847-277-4506
Secondary ContactPerson:	Jeme WallaceRegulatory Affairs DirectorGE HealthcareTel: 1-847-277-4468Fax: 1-847-277-4506
Device Trade Name:	CortexID Suite
Common/Usual Name:	CortexID Suite
Classification Names:	21CFR 892.1200, Radiology
Product Code:	KPS
Predicate Device(s):	K062393 - CortexID (originally called GE Vantage PET Neuro)
Device Description:	CortexID, image analysis software, has been developed to aidclinicians in the assessment and quantification of pathologiesderived from PET scans. The software enables the display, co-registration, and fusion of PET images with those from othermodalities. It enables automated quantitative and statisticalanalysis of tracer uptake by registration to a standard templatespace and comparing intensity values. Additionally, CortexIDassists with comparison of the activity in defined brain regionsof individual scans relative to normal activity values as found innormal subjects. Quantification is presented using volumes ofinterest, voxel-based or 3D stereotactic surface projection mapsof the brain.
Key features of the CortexID Suite include:
a. Integrated platform for FDG and Beta Amyloid analysis
b. PET-MR and PET-CT registration and fusion
c. Automatic reorientation and standardization
d. 3D SSP, Voxel based images and VOI statistics
e. Comparison with normals databases
f. Longitudinal Analysis
g. Q.Check
h. Summing input dynamic PET scan
i. Exam Summary (integrated report)
j. Easy Export
k. Multiple Reference Regions
l. Reoreintation
m. Region Overlay
n. Fully Customizable Interface
o. Preset Presentations
p. MR Template Image
The CortexID Suite is also made available as a standalone post processing application on the AW VolumeShare 5 workstation (K110834) that hosts advanced image processing applications.
Indications for Use /Intended Use:	CortexID software has been developed to aid physicians in the evaluation of patient pathologies via assessment and quantification of PET brain scans.
	The software aids in the assessment of human brain PET scans enabling automated analysis through quantification of tracer uptake and comparison with the corresponding tracer uptake in normal subjects. The resulting quantification is presented using volumes of interest, voxel-based or 3D stereotactic surface projection maps of the brain. The package allows the user to generate information regarding relative changes in PET-FDG glucose metabolism.
	CortexID Suite additionally allows the user to generate information in PET brain amyloid load between a subject's images and a normal database, which may be the result of brain neurodegeneration.
	PET co-registration and fusion display capabilities with CT and
	MR allow PET findings to be related to brain anatomy and offersvisualization of structural abnormalities, which may result frombrain injury, trauma, disorder, disease or dysfunction, such assubdural hematoma, tumor, stroke, or cerebrovascular disease,etc.CortexID Suite may aid physicians in the image interpretationprocess of PET studies conducted on patients being evaluatedfor cognitive impairment, or other causes of cognitive decline,and is an adjunct to other diagnostic evaluations.
Technology:	The CortexID Suite software employs the same fundamentalscientific technology as its predicate device.
Determination ofSubstantial Equivalence:	Summary of Non-Clinical Tests:The CortexID Suite software complies with NEMA PS 3.1 - 3.20(2011) Digital Imaging and Communications in Medicine (DICOM)Set (Radiology) standard.CortexID Suite employs the same fundamental scientifictechnology as its predicate device, CortexID. CortexID Suite usesthe equivalent DICOM image data input requirements. It hasequivalent display, formatting, archiving and visualizationtechnologies compared to the predicate device. CortexID Suiteutilizes essentially the same methodology to quantify andassess uptake of FDG and beta amyloid tracers. The informationis presented using volumes of interest, voxel-based or 3Dstereotactic surface projection maps of the brain. CortexID Suiteutilizes existing PET & CT co-registration and fusiontechnologies and provides for PET & MR co-registration andfusion capabilities. Thorough testing of these capabilities hasnot raised any safety or effectiveness issues.The following quality assurance measures were applied to thedevelopment of the system:■ Risk Analysis■ Requirements Reviews■ Design Reviews■ Integration testing (System verification)■ Performance testing (Bench testing, verification)■ Safety testing (Verification)
	Summary of Clinical tests:The subject of this premarket submission, CortexID Suitesoftware did not require clinical studies to support substantialequivalence since it introduces analysis of new PET imagecontrast agents only. The clinical utility for the analysis of thenew image processing has not been studied since modification
	does not significantly affect the clinical safety and performance.The substantial equivalence determination is based on thesoftware documentation for a MODERATE level of concerndevice.
Conclusion:	GE Healthcare considers the CortexID Suite softwareapplication to be as safe, as effective, and performance issubstantially equivalent to the predicate device.

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Image /page/5/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a blue circle. The circle has a series of white, curved lines around it, resembling water droplets or stylized waves, giving the logo a dynamic and recognizable appearance.

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Image /page/6/Picture/1 description: The image shows the logo for General Electric (GE). The logo consists of the letters 'GE' written in a stylized script, enclosed within a blue circle. There are small, white, teardrop-shaped elements surrounding the circle, giving it a dynamic and recognizable appearance. The logo is simple, yet distinctive, and is widely recognized as the symbol of the General Electric company.

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Image /page/7/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a blue circle. The circle has a series of white, curved lines around it, resembling water droplets or stylized waves, which gives the logo a dynamic and modern appearance.

Regulation Number and Section

§ 892.1200 Emission computed tomography system.

(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.