FCA is an aiding tool for the clinicians to perform analysis of sets of stationary. dynamic, or gated PET transaxial images via a number of display, measurement and batch filming/archive features. The measurements include perfusion, enddiastolic & end-systolic volumes, stroke volume, ejection fraction, myocardial mass, and transient ischemic dilatation. Also included is to enable clinicians to visualize reformatted PET perfusion and viability data, make a comparison between the two. The perfusion or viability data could have been acquired under stress or rest conditions and they can be processed individually or simultaneously.

FCA allows users to customize their screens. Also, the users can export a selected set of short axis images in DICOM compliant format. These images can then be processed by an external software package to perform regional quantitative analysis, absolute and relative ratio maps of each region of the heart and topographic maps. Finally, it aids clinicians to capture the summary of quantitative and qualitative results from the study in a single summary page,

The physiological and functional data could come from the same scanner as in the case of PET/CT scanner; or they could come from separate scanners.

In summary, FCA is intended to aid clinicians in the assessment of physiological data and in refining their clinical decisions based on the quantitative and qualitative assessment of stationary, dynamic, and gated PET images.

Device Description

FullCard Analysis (FCA) is a post processing analysis software package designed to assist Radiologists, Nuclear Medicine Doctors, Cardiologists, and other clinicians by offering a totally integrated package including automated processing, visualization, quantification of parameters of myocardial perfusion and function, along with simple reporting capabilities. The parameters include perfusion, end-diastolic & end-systolic volumes, stroke volume, ejection fraction, myocardial mass, and transient ischemic dilatation.

FCA accepts Gated PET images in either transaxial or short axis orientations. The package processes images automatically but it allows the users to intervene and modify results when needed. FCA is a software post-processing package for the Advantage Workstation (AW) platform and PET/CT scanners.

AI/ML Overview

The provided document, K061587 for the GE Healthcare FullCard Analysis (FCA) device, is a 510(k) summary submitted for substantial equivalence to predicate devices. This type of submission focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than providing extensive details on novel performance studies to meet explicit acceptance criteria.

Therefore, the document does not contain the detailed information requested regarding specific acceptance criteria, a dedicated study proving performance against these criteria, sample sizes for test/training sets, expert qualifications, or multi-reader multi-case studies.

The "Conclusions" section explicitly states: "FullCard Analysis does not result in any new potential safety risks and performs as well as devices currently on the market. GE considers features of FCA to be equivalent to those of ECToolbox with HeartFusion and Xeleris 2 Processing and Review Workstation, Advantage Workstation 4.3, and Positron mPower."

Here's an attempt to answer your questions based on the limited information available in a 510(k) summary for substantial equivalence:

1. A table of acceptance criteria and the reported device performance

No explicit acceptance criteria or a direct performance table are provided in this 510(k) summary. The submission relies on demonstrating substantial equivalence to predicate devices. The "performance" is implicitly considered to be equivalent to the performance of the predicate devices.

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 provided in the 510(k) summary for this device. For substantial equivalence, specific performance studies with detailed test sets are often not required. The submission focuses on device description, indications for use, and comparison to predicates.

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)

This information is not provided in the 510(k) summary. Given the nature of a substantial equivalence submission, a dedicated "ground truth" establishment for a new test set is not typically detailed.

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

This information is not provided in the 510(k) summary.

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in the 510(k) summary. This type of study would typically be part of a more extensive performance evaluation, which is not the primary focus of a substantial equivalence filing for a post-processing software package like FCA.

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

A standalone performance study is not explicitly mentioned in the 510(k) summary. The device is described as an "aiding tool for the clinicians," suggesting human-in-the-loop is inherent to its intended use. The focus is on the software's ability to assist clinicians in analysis.

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

This information is not provided in the 510(k) summary.

8. The sample size for the training set

This information is not provided in the 510(k) summary.

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

This information is not provided in the 510(k) summary.

Summary

{0}------------------------------------------------

K061587

JUN 2 3 2006

Image /page/0/Picture/2 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined and enclosed within a circular shape. The logo is black and white.

GE Healthcare

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).

Larry A. Kroger, Ph.D. Submitter Senior Regulatory Programs Manager Tel: (262) 544-3894 Fax: (262) 544-4768 GE Healthcare W-400 3000 North Grandview Blvd. Waukesha, WI 53188 USA Date Prepared: November 18, 2005.

PRODUCT IDENTIFICATION

Name: FullCard Analysis

Classification Name: Emission computed tomography system per 21 CFR 892- 1200

Manufacturer: General Electric Medical Systems 283, rue de la Minière 78533 Buc Cedex, FRANCE

Distributor: GE Healthcare, P.O. Box 414, Milwaukee, WI 53210

FullCard Analysis is substantially equivalent to the devices listed below: Marketed Devices

. Model: ECToolbox with HeartFusion; K040141
Manufacturer: . General Electric Medical Systems, Buc, France
Model: Xeleris 2 Processing and Review Workstation;4K051673 �
. Manufacturer: General Electric Medical Systems, Haifa, Israel
. Model: Advantage Workstation 4.3; K052995
General Electric Medical Systems, Buc, France . Manufacturer:
Model: Positron mPower: K022001 ●
. Manufacturer: Positron Corporation, Houston, TX, USA
.

Device Description:

1/3

{1}------------------------------------------------

perfusion, end-diastolic & end-systolic volumes, stroke volume, ejection fraction, myocardial mass, and transient ischemic dilatation.

Indications for Use:

FCA is an aiding tool for the clinicians to perform analysis of stationary, dynamic, or gated PET transaxial images via a number of display, measurement and batch filming/archive features. The measurements include perfusion, end-diastolic volumes, stroke volume, ejection fraction, myocardial mass, and transient ischemic dilatation. Also included is to enable clinicians to visualize reformatted PET perfusion and viability data, make a comparison between the two. The perfusion or viability data could have been acquired under stress or rest conditions and they can be processed individually or simultaneously.

The physiological and functional data could come from the same scanner as in the case of PET/CT scanner; or they could come from separate scanners.

Comparison with Predicate:

Device Name	FDA Clearance Number
ECToolbox with HeartFusion	K040141
Xeleris 2 Processing and ReviewWorkstation	K051673
Advantage Workstation 4.3	K052995
Positron mPower	K022001

FullCard Analysis is substantially equivalent to the predicate devices listed above :

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.

{2}------------------------------------------------

Conclusions:

FullCard Analysis does not result in any new potential safety risks and performs as well as devices currently on the market. GE considers features of FCA to be equivalent to those of ECToolbox with HeartFusion and Xeleris 2 Processing and Review Workstation, Advantage Workstation 4.3, and Positron mPower.

and the comments

の 2007年の 2007年の 2007年 10月 10時間 10月 2007 1000 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

JUN 2 3 2006

GE Healthcare % Mr. Neil E. Devine Responsible Third Party Intertek Testing Services NA, Inc. 2307 East Aurora Rd., Unit B7 TWINSBURG OH 44087

Re: K061587

Trade/Device Name: Fullcard Analysis Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS Dated: June 6, 2006 Received: June 8, 2006

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 shows the FDA Centennial logo, which includes the years 1906-2006. The logo is circular and contains the letters "FDA" in bold, with the word "Centennial" underneath. Below the logo, the text "Protecting and Promoting Public Health" is written in an elegant, cursive font. The image appears to be a commemorative emblem celebrating the FDA's 100th anniversary.

{4}------------------------------------------------

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 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/cdrlv/industry/support/index.html.

Sincerely vours.

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

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a circular frame. The letters and the frame are black, contrasting with the white background. The logo is simple and recognizable, representing the well-known multinational conglomerate.

Indications for Use

510(k) Number (if known): _ K 0 6 l 5 8 7

Device Name: Fullcard Analysis

Indications for Use:

The physiological and functional data could come from the same scanner as in the case of PET/CT scanner; or they could come from separate scanners.

Prescription Use	X
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use
(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)

David L. Dickson

Page 1 of 1

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K0061587

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.