PET VCAR (Volume Computer Assisted Reading) is a PET/CT software package which can be used by the clinician to assist in diagnosis, staging, treatment planning and monitoring treatment response. The PET VCAR automatically highlights and bookmarks PET defined regions of interest based on user-defined threshold settings. The software can be used for visualization and analytical monitoring of disease progression or response to treatment or therapy using multiexam comparison. The software is designed to measure Standard Uptake Value (SUV) and volume for any PET defined metabolic activity. The software automatically propagates bookmarks from one time point to another for the purpose of improving analysis and workflow. PET VCAR offers a tool called Interactive Data Analysis (IDA) spreadsheet that compiles and manages all the analytical information in an organized and interactive design. The IDA is synchronized with the image display layouts offering quick measurement / image visual validation. PET VCAR's workflow is designed to allow clinicians to make informed follow-up decisions in an efficient manner. PET VCAR does not provide or claim any automatic detection or automatic diagnosis of abnormal anatomy, structure or function.

Device Description

The GE PET VCAR has to ensure relations with the following external systems:
Data Import: Image, exam and patient data can be imported in accordance with the DICOM Standard.
Data Export: Finding, exam and patient information can be exported in the Secondary Capture format of the DICOM standard that enables its storage on PACS systems. Finding, exam and patient information can be exported in the Structured Report format of the DICOM standard that enables its display with DICOM SR compatible viewers. Finding, exam and patient information can be exported in standard formats like HTML, XML, PDF, CSV, that enables its display with viewers compatible with the mentioned formats.
Configuration Requirements: PET VCAR is compatible with Advantage Windows Workstation™ 4.4 or higher

AI/ML Overview

This submission is a 510(k) summary for GE Healthcare's PET VCAR, focusing on its substantial equivalence to previously marketed devices. The document does not contain acceptance criteria or a study that extensively describes device performance against such criteria. The 510(k) clearance process primarily relies on demonstrating substantial equivalence to a predicate device rather than undergoing extensive clinical trials with predefined acceptance criteria as might be seen for novel devices requiring PMA.

Therefore, many of the requested details about acceptance criteria, specific performance studies, sample sizes, ground truth establishment, and MRMC studies are not present in the provided text.

Based on the available text, here's what can be inferred or explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly define acceptance criteria in terms of numerical performance thresholds (e.g., sensitivity, specificity, accuracy, or quantitative measurement error) that the PET VCAR device needed to meet. Instead, the "performance" discussed is related to its functional capabilities and equivalence to predicate devices.

Acceptance Criteria	Reported Device Performance
Functional equivalence to predicate devices (Volume Viewer Plus, Advantage Lung Analysis II, Advantage Fusion).	Device stated to be "substantially equivalent" in functional features to listed predicate devices.
Software Development, Validation, and Verification Process ensures performance to specifications, Federal Regulations, and user requirements.	Acknowledges that these processes are in place to ensure performance and control potential hazards.
No new potential safety risks compared to marketed devices.	Stated that "The PET VCAR does not result in any new potential safety risks and performs as well as devices currently on the market."
Ability to assist in diagnosis, staging, treatment planning, and monitoring treatment response.	Device description outlines these capabilities (highlighting, bookmarking, SUV/volume measurement, multiexam comparison, IDA spreadsheet).
Automatic highlighting and bookmarking based on user-defined threshold settings.	Explicitly stated as a feature.
Measurement of Standard Uptake Value (SUV) and volume for PET defined metabolic activity.	Explicitly stated as a feature.
Automatic propagation of bookmarks from one time point to another.	Explicitly stated as a feature.
Interactive Data Analysis (IDA) spreadsheet for compiling and managing analytical information.	Explicitly stated as a feature.

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

Not provided in the document. The 510(k) summary focuses on substantial equivalence based on technical characteristics and intended use, rather than a detailed performance study with a specific test set.

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

Not provided in the document. Since no explicit test set or ground truth establishment is detailed for clinical performance, this information is absent.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not provided in the document. No adjudication method is mentioned as a dedicated performance study is not described.

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:

No, an MRMC comparative effectiveness study was not explicitly mentioned or detailed. The device's role is described as "assist in diagnosis" and "improving analysis and workflow," but no quantitative measure of human reader improvement with the AI assistance is provided. The 510(k) submission does not include data on the effectiveness of human readers with AI versus without AI assistance.

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

No, a standalone performance study was not explicitly mentioned or detailed. The device is described as a "software package which can be used by the clinician to assist," indicating a human-in-the-loop design. It explicitly states, "PET VCAR does not provide or claim any automatic detection or automatic diagnosis of abnormal anatomy, structure or function." This confirms it's not a standalone diagnostic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not provided in the document. As no specific performance study with a test set is detailed, the type of ground truth used is not mentioned.

8. The sample size for the training set:

Not provided in the document. The document does not discuss the training of the software's algorithms, and therefore, no training set size is mentioned.

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

Not provided in the document. Similar to point 8, this information is absent from the 510(k) summary.

Summary

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K063324/

GE Healthcare

PET VCAR

MAR 2 3 2007

510 (k) Summary of Safety and Effectiveness

This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87 (h)

1. Identification of submitter: Larry A. Kroger, Ph.D. Senior Regulatory Program Manager 3000 N. Grandview Blvd Waukesha, 53188 USA Telephone: 262-544-3894 Fax: 262-548-4768 Date Prepared: August 23, 2006

2. Identification of Product:

Device name	PET VCAR.
Classification name	Computed tomography x-ray system per21 CFR 892.1750Emission computed tomography systemper 21 CFR 892.1200
Manufacturer/Distributor	General Electric Medical Systems SAS283, Rue de la Minière78533 BUC Cedex France

3. Marketed Devices

PET VCAR is substantially equivalent to the devices listed below:

Model:	Volume Viewer Plus
Manufacturer:	General Electric Medical Systems
510 (k):	K041521
Model:	Advanced Lung Analysis II
Manufacturer:	General Electric Medical Systems
510 (k):	K042694
Model:	Advantage Fusion
Manufacturer:	General Electric Medical Systems
510 (k):	K983256

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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 letters are stylized with curved lines and serifs, and the circle has decorative swirls around its perimeter.

4. Device Description :

The GE PET VCAR has to ensure relations with the following external systems:

Data Import

Image, exam and patient data can be imported in accordance with the DICOM Standard.

Data Export

Finding, exam and patient information can be exported in the Secondary Capture format of the DICOM standard that enables its storage on PACS systems.

Finding, exam and patient information can be exported in the Structured Report format of the DICOM standard that enables its display with DICOM SR compatible viewers.

Finding, exam and patient information can be exported in standard formats like HTML, XML, PDF, CSV, that enables its display with viewers compatible with the mentioned formats.

Configuration Requirements

PET VCAR is compatible with Advantage Windows Workstation™ 4.4 or higher

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Image /page/2/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 logo is black and white.

5. Indications for Use

6. Comparison with Predicate Device

The functional features of PET VCAR software package are substantially equivalent to that of the following devices:

Device Name	FDA Clearance Number
Volume Viewer Plus	K041521
Advantage Lung Analysis II	K042694
Advantage Fusion	K983256

7. Adverse Effects on Health

The potential hazards are identified in a risk management summary (hazard analysis) and are controlled by:

. Software Development. Validation and Verification Process to ensure performance to specifications, Federal Regulations and user requirements.
Adherence to industry and international standards. .

8. Conclusions

The PET VCAR does not result in any new potential safety risks and performs as well as devices currently on the market. GE considers features of the PET VCAR to be equivalent to those of Volume Viewer Plus (K041521), Advanced Lung Analysis II (K042694) and Advantage Fusion (K983256).

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Image /page/3/Picture/0 description: The image shows a circular seal with text around the perimeter and a stylized graphic in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The central graphic consists of three curved lines that resemble a stylized human figure.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

GE Healthcare % Mr. Neil E. Devine, Jr. Sr. Staff Engineer - Medical Devices Intertek Testing Services NA, Inc. 2307 East Aurora Rd., Unit B7 TWINSBURG OH 44087

MAR 2 3 2007

Re: K063324

Trade/Device Name: PET VCAR Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: JAK and KPS Dated: March 7, 2007 Received: March 8, 2007

Dear Mr. Devine:

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. The logo has the letters "FDA" in the center, with the word "Centennial" underneath. Above the letters "FDA" are the numbers "1906-1906". The logo is surrounded by a dotted border.

Protecting and Promoting Public Health

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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 (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 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" (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 vours.

Nancy C. Hogdon

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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Indications for Use

510(k) Number (if known): _长0633 at

Device Name: PET VCAR

Indications for Use:

Prescription Use Over-The-Counter Use X ANDIOR (Part 21 CFR 801 Subpart D) (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)

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David A. Sygman

(Division Sign-Off) Division of Reproductive, A and Radiological Devices 510/k) Number

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.