The Vantage software has been developed to aid clinicians in the assessment and quantification of pathologies derived from PET and PET-CT brain scans. The software is deployed via Advantage Windows Workstation and PET-CT scanner console and is organized as a series of workflows steps, which are specific to use with particular drug and disease combination.

The software aids in the assessment of human brain scans enabling automated analysis through quantification of the comparison of local peak activity values at standardized anatomical locations with the corresponding reference normal peak activity in age stratified control subjects. The resulting quantification is presented to the user through 3D stereotactic surface projection maps of the brain. The package allows the user to generate information regarding relative changes in PET-FDG metabolic activity between a subjects images and age stratified controls, which may be resulting from brain function alterations by neurodegenerative processes.

CT fusion to PET offers visualization of structural abnormalities, which may result from brain injury, trauma, disease or dysfunction, such as subdural heratom tumor, stroke (or cerebrovascular disease) etc. Such tools may aid the physician in the rule out process.

Device Description

The Vantage package includes automated analysis and review of PET and PET-CT brain scans. It has been developed to aid in assessment of human brain scans hrough quantification of the comparison of local peak activity values at standardized anatomical locations with the corresponding reference normal peak activity in age stratified normal database (or asymptomatic control subjects as defined). It rage a basic review of any PET brain scan, realignment of the PET volume to a standard attas and comparison to brain scans derived from control subjects or prior PET and/or MR scans. Results are displayed in user-friendly graphical format as Z-score, where Zscore is the scale of the deviation from the normal mean, relative to corresponding standard deviation.

AI/ML Overview

The provided text does not contain detailed information about a specific study with acceptance criteria and its outcomes. It primarily describes the GE Vantage PET Neuro Software, its indications for use, and its substantial equivalence to predicate devices (Syntermed NeuroQ and Mirada Solutions Scenium) for 510(k) clearance.

Therefore, I cannot populate the table of acceptance criteria and reported device performance, nor can I provide details on sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

The document only briefly mentions aspects relevant to some of your questions but does not provide the specific details requested to answer them thoroughly.

Here's an analysis of what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance: This information is not present in the document provided. There are no explicit acceptance criteria or performance metrics reported.
2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): This information is not present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): The document states that the "asymptomatic control group is as defined and age stratified by a neurologist with medical expertise." This suggests a neurologist was involved in defining the control group for the normal database, which serves as a reference. However, it does not specify the number of experts, their qualifications for establishing ground truth for a test set, or details about the actual ground truth establishment process for a validation study.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: This information is not present.
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: This information is not present. The document describes a "post processing tool" that "assists in regional assessment," implying it's an aid, but no MRMC study or effect size is mentioned.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done: The device description hints at standalone functionality by providing "automated analysis through quantification" and Z-scores. However, specific standalone performance metrics or studies are not detailed. The focus is on assisting clinicians.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for comparison appears to be a "reference normal peak activity in age stratified normal database (or asymptomatic control subjects as defined)." This implies a clinical definition of "normal" or "asymptomatic" individuals, likely established by clinical experts (neurologists). It doesn't explicitly mention pathology or direct outcomes data for individual patient cases in a test set.
8. The sample size for the training set: This information is not present. The product uses an "age stratified normal database," which would conceptually serve a similar purpose to a training/reference set, but its size is not stated.
9. How the ground truth for the training set was established: The "asymptomatic control group is as defined and age stratified by a neurologist with medical expertise." This suggests the ground truth was established by expert definition and selection of control subjects, rather than a case-by-case ground truth labeling for a complex pathology scenario.

In summary, the provided K062393 document is a 510(k) summary focused on substantial equivalence to predicate devices, not a detailed clinical study report. It lacks the specific study design, performance metrics, and acceptance criteria you've requested.

Summary

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K062393

510(k) Summary of Safety and Effectiveness (in accordance to 21

SEP - 1 200

CFR 807.87(h))

Device Name Proprietary Device Name: Date prepared:

GE Vantage PET Neuro Software May 26, 2006

Establishment Name and Registration Number of Submitter
Name:	GE Healthcare (Formerly GE Medical Systems)
Registration Number:	2126677
Corresponding Official:	D. DuerstelerGE HealthcareP.O. Box 414Milwaukee, WI 53201Phone: 262-312-7029FAX: 262-312-7144Email: david.duersteler@med.ge.com
Device Classification
Classification Code:	90 KPS
Panel Identification:	Radiology
Classification Name:	Emission Computed Tomography Syst(Per 21CFR 892.1200)

Common Name: Classification Class: Reason for 510(k) Submission:

em (Per 21CFR 892.1200) PET/CT Imaging Software Class II Product New device

Device Description

Identification of Legally Marketed Equivalent Devices

NeuroQ	Syntermed, Inc.	K04102
Scenium	Mirada Solutions, Ltd.	K042863

General Electric Company

Image /page/0/Picture/14 description: The image shows a black and white logo. The logo appears to be a stylized design, possibly representing a company or brand. The design is circular and contains intricate patterns and shapes within it. The image is somewhat pixelated, suggesting it may be a low-resolution or scanned image.

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Image /page/1/Picture/0 description: The image contains the word "Gammailhouse". The text is in a simple, sans-serif font. The image is a simple black and white picture.

Image /page/1/Picture/1 description: The image shows a logo with the letters 'GE' in a stylized font inside a circle. To the left of the circle are the letters 'P' and 'M' stacked vertically. To the right of the circle is the number '53201'. The logo appears to be a company or brand identifier, with the number possibly representing a product code or identifier.

510(k) Summary of Safety and Effectiveness May 26, 2006 Page 2

Comparison with Predicate Devices

Vantage as compared with the above predicate devices provides a clinically focused software solution for brain analysis with PET and PET/CT imaging. Similar to Scenium and Neuro Q, Vantage™ is a post processing tool that assists in regional assessment of human brain scans by providing comparison between a patient brain scan to a brain scan derived from FDG-PET studies of a defined group of control subjects, where the asymptomatic control group is as defined and age stratified by a neurologist with medical expertise. The algorithms used in Vantage™ to calculate quantitative measures compares local peak activity values instead of average peak activity values used by predicate devices; at standardized anatomical locations with the corresponding reference normal peak activity in age stratified control subjects.

Indications for Use of Device

The GE Vantage PET Neuro Software has been developed to aid clinicians in the assessment and quantification of pathologies derived from PET and PET-CT brain scans. The software is deployed via Advantage Windows Workstation and PET-CT scanner console and is organized as a series of workflows steps, which are specific to use with particular drug and disease combination.

CT fusion to PET 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. Such tools may aid the physician in the rule out process.

Conclusion

In the opinion of General Electric Medical Systems, the GE Vantage PET Neuro Software is substantially the same in design, materials, energy sources, and technology, does not introduce new safety concerns, performs as well as currently marketed devices, and is therefore substantially equivalent in terms of safety and effectiveness to the currently marketed Syntermed NeuroQ (K041022) and Miraga Solutions Scenium (K042863) products.

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General Electric Company
P.O. Box 414
Milwaukee, WI 53201

、

・

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its wing and tail feathers. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

SEP - 1 2006

GE Healthcare % Mr. Tamas Borsai Responsible Third Party Official TÜV Rheinland of North America 12 Commerce Road NEWTON CT 06470

Re: K062393

Trade/Device Name: Vantage Regulation Number: 21 CFR 8892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS Dated: August 11, 2006 Received: August 16, 2006

Dear Mr. Borsai:

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 (Premarket Approval), 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.

Image /page/3/Picture/10 description: The image is a black and white circular logo or seal. The text "1906 - 2006" is at the top of the logo. The letters "FDA" are in a bold, stylized font in the center of the logo. Below the letters, the word "Centennial" is written in a cursive font. Three stars are below the word "Centennial".

Promoting Public Hoalth

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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 proctice 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.

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 logal|| 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" (21CFR Part 807.97). 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/cdrl/industry/support/index.html.

Sincerely yours.

Nancy C. Brogdon

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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STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known): _ Ob23393 Device Name: Vantage Indications for Use:

(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)

OR Over-The-Counter Use_

David E. Lyon

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices K062393 510(k) Number

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.