CardIQ Function Xpress is intended to provide an optimized noninvasive application to analyze cardiovascular anatomy and pathology and aid in determining treatment paths from a set of Computed Tomography (CT) Angiographic images.

CardIQ Function Xpress in conjunction with CT cardiac images to automatically calculate and display various left ventricular and right ventricular functional parameters as ejection fraction, end systolic and end diastolic volumes, stroke volumes, wall motion, wall thickening, cardiac output, myocardial mass, systemic and pulmonary vascular resistance. Volume measurement of each chamber of the heart is also available. With CardIQ Function Xpress atrium volumes may be used to determine volume assessment of atrial disease to include but not limited to atrial fibrillation. CardIQ Function Xpress is a CT, non-invasive image analysis software package, which aids in the assessment of cardiac function and in determination of cardiovascular disease diagnosis and management.

CardIQ Function Xpress is for use on the Advantage Workstation (AW) platform, CT Scanner, PAC or Centricity stations, which can be used in the analysis of 2D or 3D CT angiography images/data derived from DICOM 3.0 CT scans.

Device Description

The GE Medical Systems CardIQ Function Xpress software is a post processing software option for the Advantage Workstation (AW) Platform, CT scanner, PACS or Centricity systems. This product can be used in the analysis of CT angiographic images to calculate and display ventricular analysis of several functional cardiac parameters. The software has the ability to select the chambers of the heart and diastolic and/or systolic phases to determine the hearts function. CardIQ Function Xpress contains both graphic and text report capabilities with predefined templates for ease of use.

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding the GE CardIQ Function Xpress, focusing on acceptance criteria and the study details:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly list specific numerical acceptance criteria for device performance (e.g., minimum accuracy, precision, or agreement with a reference standard). Instead, it states that "The results concluded the device was acceptable for use" after "Medical device design included testing and evaluation of previously acquired diagnostic images." This implies a qualitative assessment rather than a quantitative one, at least in the summary provided.

Acceptance Criteria (Not explicitly stated with quantitative metrics in the document)	Reported Device Performance
Device functions as intended for analysis of cardiac parameters.	"The results concluded the device was acceptable for use." (Qualitative statement, no specific performance metrics provided in this document)
Software stability and reliability.	Software and medical device design validation have been completed.
Compliance with relevant standards.	Software designed to meet DICOM (PS 3.1 - 3.18) and AAMI/ANSI SW68 standards.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not specified. The document only mentions "testing and evaluation of previously acquired diagnostic images."
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). It only states "previously acquired diagnostic images."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and the Effect Size

MRMC Study: The document does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was performed to assess the improvement of human readers with AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Standalone Performance Study: The document describes the software as an "optimized noninvasive application to analyze cardiovascular anatomy and pathology and aid in determining treatment paths" and to "automatically calculate and display various left ventricular and right ventricular functional parameters." While it implies the algorithm performs these actions, the provided summary does not contain details of a standalone performance study with specific metrics (e.g., accuracy, sensitivity, specificity of the algorithm's calculations compared to a reference). The statement "The results concluded the device was acceptable for use" is a general conclusion, not a detailed standalone performance report.

7. The Type of Ground Truth Used

Type of Ground Truth: Not specified. The document refers to "previously acquired diagnostic images," but does not explicitly state how the "true" values for cardiac parameters or disease presence were established for these images (e.g., expert consensus, pathology, follow-up outcomes data).

8. The Sample Size for the Training Set

Sample Size for Training Set: Not specified. The document does not mention a distinct "training set" or "training data" in the conventional sense of machine learning algorithm development. It refers to "medical device design included testing and evaluation of previously acquired diagnostic images," which could imply a testing phase, but no separate training phase is detailed. Given the date (2008), the development might have relied more on rule-based programming and traditional image processing rather than extensive machine learning requiring large, labeled training sets as is common today.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not specified, as a distinct training set is not explicitly mentioned or detailed in the summary.

In summary:

This 510(k) summary for CardIQ Function Xpress (K073153), cleared in 2008, is quite brief on the specifics of the performance study. It emphasizes design validation and compliance with general software and imaging standards rather than providing detailed quantitative performance metrics or extensive study design information typical of later AI/ML-driven device submissions. The "acceptance criteria" are implied as meeting the general usability and functionality requirements for a post-processing software option, concluding qualitatively that the "device was acceptable for use." Specific details on sample sizes, data provenance, expert qualifications, ground truth establishment, and comparative effectiveness studies are not present in this document.

Summary

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K073153

510(K) Summary As Required by 21 CFR 807.92

510(k) Number: ___________________

1. Submitter Information

FEB 26 20CB

GE Medical Systems SCS Submitter Name: 283, rue de la Minière 78533 Buc Cedex, FRANCE
9611343 Establishment Reg:

Contact Person: Stephen Slavens Global RA Premarket Director 3000 N Grandview Blvd. Waukesha, WI 53188 Tel: 262-548-4992 Fax: 262-548-4710 stephen.slavens@ge.com

August 22nd, 2007 Date Prepared:

2. Device information

Trade Name:	CardIQ Function Xpress
Common Name:	Picture Archiving and Communication Device
Classification Name:	System, Image Processing, Radiological
Procode:	JAK
Class:	Class II per 21 CFR 892.1750

3. Predicate Devices

CardIQ Function Xpress is substantially equivalent to the predicate devices listed below:

Device Name	FDA Clearance
GE CardIQ Analysis III	K041267
GE CardIQ Function	K013422

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4. Device Description

The GE Medical Systems CardIQ Function Xpress software is a post processing software option for the Advantage Workstation (AW) Platform, CT scanner, PACS or Centricity systems. This product can be used in the analysis of CT angiographic images to calculate and display ventricular analysis of several functional cardiac parameters. The software has the ability to select the chambers of the heart and diastolic and/or systolic phases to determine the hearts function. CardIO Function Xpress contains both graphic and text report capabilities with predefined templates for ease of use.

5. Indication for Use

CardIQ Function Xpress is for use on the Advantage Workstation (AW) platform. CT Scanner, PAC or Centricity stations, which can be used in the analysis of 2D or 3D CT angiography images/data derived from DICOM 3.0 CT scans.

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6. Summary of non-clinical and/or clinical tests and results

The software was designed to meet the following standards:

Standard	StandardsOrganization	Standard Title
PS 3.1 - 3.18	NEMA	Digital Imaging and Communicationsin Medicine (DICOM)
SW68	AAMI/ANSI	Medical Device Software - Softwarelife cycle processes

Software and medical device design validation have been completed. Medical device design included testing and evaluation of previously acquired diagnostic images.

The results concluded the device was acceptable for use.

7. Statement of Equivalence

The General Electric CardIQ Function Xpress workstation software is equivalent to a combination of the predicate General Electric CardIQ Analysis III and CardIQ Function devices and is safe and effective for use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, with three curved lines forming the body and wings. The logo is black and white.

FEB 26 2008

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

GE Medical Systems SCS % Mr. Jay Y. Kogoma Senior Staff Engineer - Medical Devices Intertek Testing Services 2307 E. Aurora Road, Unit B7 TWINSBURG OH 44087

Re: K073153

Trade/Device Name: CardIQ Function Xpress Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK, LLZ Dated: February 8, 2008 Received: February 11, 2008

Dear Mr. Kogoma:

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 circular logo or emblem. The text "1906-2006" is at the top of the circle. The letters "FDA" are in the center of the circle. The word "Centennial" is at the bottom of the circle. There are stars below the word "Centennial".

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 Actor 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/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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Indications for Use

510(k) Number (if known): 073153

Device Name: CordIO Function Xpress

Indications For Use: CardIQ Function Xpress is intended to provide an optimized noninvasive application to analyze cardiovascular anatomy and pathology and aid in determining treatment paths from a set of Computed Tomography (CT) Angiographic images.

Cardia Function Xpress in conjunction with CT cardiac images to automatically calculate and display various left ventricular and right ventricular functional parameters as ejection fraction, end systolic and end diastolic volumes, stroke volumes, wall motion, wall thickening, cardiac output, myocardlal mass, systemic and pulmonary vascular resistance. Volume measurement of each chamber of the heart is also available. With CardiQ Function Xpress atrium volumes may be used to determine volume assessment of atrial disease to include but not limited to atrial fibrillation. CardIQ Function Xpress is a CT, non-Invasive image analysis software package, which alds in the assessment of cardiac function and in determination of cardlovascular disease diagnosis and management.

CardIQ Function Xpress is for use on the Advantage Workstation (AW) platform, CT Scanner, PAC or Centricity stations, which can be used in the analysis of 2D or 3D CT anglography images/data derived from DICOM 3.0 CT scans.

Prescription Use (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Homi Khan
(Division Sign-Off)

Division of Reproductive, Abdomina and Radiological Device 510(k) Number

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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.