CardIQ Analysis III is a CT image analysis software package, which allows the visualization of 2D and 3D medical image data of the heart derived from DICOM 3.0 compliant CT scans for the purpose of cardiovascular disease assessment. It provides functionally for 2D/3D rendering, assessment of calcified and non-calcified plaque to determine the densities of the plaque within a coronary artery, ventricular function of the heart, and measurement tools to detect coronary artery stenosis. This product can be used to aid a trained physician for to process, render, review, archive, print and visualizing cardiac anatomy and coronary vessels. CardIQ Analysis III will run on the AW workstation, scanner operator console and PACS system.

Device Description

CardIO Analysis III is a post processing software option that can be used in the analysis of CT angiographic images to display structures of the heart in a MIP, reformat or volume rendering view. When the heart is displayed the software has the ability to measure the diameter of the vessel or hounsfield units within a coronary arteries to determine the size of a vessel or plaque density within a vessel. Functional parameters of the heart can also be determined when images of end systole and end diastole are present. Diarneters, densities, functional parameters and images can all be printed to reports or saved to the AW workstation. It is a software option for the GE family of LightSpeed multi-slice CT scanners.

AI/ML Overview

The provided text for K041267 describes a device called CardIQ Analysis III, a post-processing software option for analyzing CT angiographic images of the heart. However, it does not include specific information regarding acceptance criteria, a dedicated study proving device performance against those criteria, or details such as sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies.

The document primarily focuses on establishing substantial equivalence to previously cleared predicate devices (CardIQ Analysis II and CardIQ Function) based on functional features and safety. It states that "The CardIQ Analysis III does not result in any new potential safety risks and performs as well as devices currently on the market." This suggests that the primary "proof" of meeting acceptance criteria for this 510(k) submission relies on the established performance and safety of its predicate devices, rather than a new, detailed performance study with explicit acceptance criteria.

Therefore, many of the requested details cannot be extracted from the provided text.

Here's a breakdown of what can be inferred or directly stated, and what is missing:

Table of acceptance criteria and reported device performance:
- Acceptance Criteria: Not explicitly stated in terms of quantitative metrics (e.g., sensitivity, specificity, accuracy, measurement error). The "acceptance criteria" here implicitly refer to demonstrating equivalence in functionality and safety to predicate devices.
- Reported Device Performance: No quantitative performance metrics are provided for CardIQ Analysis III itself. The performance is stated to be "as well as devices currently on the market," referring to its predicates.

Acceptance Criteria (Implied)	Reported Device Performance
Performs "as well as" predicate devices (CardIQ Analysis II and CardIQ Function) in terms of:	"Performs as well as devices currently on the market" (meaning CardIQ Analysis II and CardIQ Function).
- Visualization of 2D/3D medical image data	Provides functionality for 2D/3D rendering.
- Assessment of calcified/non-calcified plaque densities	Provides assessment of calcified and non-calcified plaque to determine densities.
- Ventricular function determination	Provides ventricular function assessment.
- Measurement tools for coronary artery stenosis	Provides measurement tools to detect coronary artery stenosis.
- No new potential safety risks	"Does not result in any new potential safety risks."

Sample size used for the test set and the data provenance:
- Sample size: Not specified.
- Data provenance: Not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified.
Adjudication method for the test set:
- Not specified.
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:
- Not mentioned. The document focuses on the device's standalone features as a visualization and analysis tool, not on its impact on human reader performance in an MRMC study.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The device is a standalone software package for analysis and visualization. However, no specific "standalone performance study" with quantitative metrics is described beyond the assertion that it performs "as well as" its predicates. The device's "performance" is inherently linked to its ability to process, render, and display data for a "trained physician," making the "human-in-the-loop" an integral part of its intended use.
The type of ground truth used:
- Not specified. Given the nature of the device (analysis and visualization features consistent with predicates), an explicit "ground truth" for a performance study is not detailed in this submission. Its equivalence to predicates likely implies the functionality was deemed acceptable based on engineering verification and validation against specified requirements derived from the predicate devices, rather than a clinical ground truth study.
The sample size for the training set:
- Not applicable as this is a 2004 510(k) for a software update to an existing product line. It details post-processing software, not a machine learning or AI algorithm that would typically require a "training set" in the modern sense. The term "training set" for AI/ML algorithms is not relevant to this historical submission for a traditional software device.
How the ground truth for the training set was established:
- Not applicable (see point 8).

Summary of Study Information Provided:

The provided document does not describe a specific clinical or performance study for CardIQ Analysis III with defined acceptance criteria. Instead, the submission relies on demonstrating substantial equivalence to existing predicate devices (CardIQ Analysis II, K020796; and CardIQ Function, K013422). The "study" implicitly involves a comparison of the functional features and safety considerations with those of the predicate devices. The conclusion that "CardIQ Analysis III does not result in any new potential safety risks and performs as well as devices currently on the market" serves as the proof for meeting the implied "acceptance criteria" of equivalence. The underlying data and studies for the predicate devices would have established their performance, which is then extrapolated to the new device through the equivalence claim.

Summary

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K041267

MAY 2 7 2004

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GE Medical Systems

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 Medical Systems W-400 3000 North Grandview Blvd. Waukesha, WI 53188 USA Date Prepared: February 13, 2004.

PRODUCT IDENTIFICATION

Name:	CardIQ Analysis III
Classification Name:	Accessory to Computed Tomography System
Manufacturer :	General Electric Medical Systems283, rue de la Minière78533 Buc Cedex, FRANCE
Distributor:	General Electric Medical Systems, Buc, France.

The CardIQ Analysis III is substantially equivalent to the devices listed below: Marketed Devices

Model:	CardIQ Analysis II
Manufacturer:	General Electric Medical Systems, Buc, France
510(k) #:	K020796
Model:	CardIQ Function
Manufacturer:	General Electric 3200 N. Grandview Blvd. Waukesha, WI 53188
510(k) #:	K013422

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Device Description:

Indications for Use:

Comparison with Predicate:

The functional features of the CardI() Analysis III software package are substantially equivalent to that of the following device:

Device Name	FDA Clearance Number
CardIQ Analysis II	K020796
CardIQ Function	K013422

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.

Conclusions:

The CardIQ Analysis III does not result in any new potential safety risks and performs as well as devices currently on the market. GE considers features of the CardIQ Analysis III to be equivalent to those of CardIQ Analysis II (K020796) and CardIQ Function (K013422).

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Image /page/2/Picture/1 description: The image contains the logo for the U.S. Department of Health & Human Services. The logo features the department's seal, which includes a stylized depiction of an eagle with three lines representing its wings. The seal is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 27 2004

Mr. Tamas Borsai Program Manager 510(k) Review TUV Rheinland of North America, Inc. Medical Division, Newton Office 12 Commerce Road NEWTON CT 06470

Re: K041267

Trade/Device Name: CardIQ Analysis III Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography

x-ray system

Regulatory Class: II Product Code: 90 JAK Dated: May 3, 2004 Received: May 12, 2004

Dear Mr. Borsai:

We have reviewed your Section 510(k) premarket notification of intent to market the device wo never reviewed your 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 for ass surve in the encrease 1976, the enactment date of the Medical Device Amendments, or to conniner of they to rialy 2011 accordance with the provisions of the Federal Food, Drug, de nocs that have boom require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, ate. En orovisions 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 (PMA), 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.

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.

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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 the letter:

8xx. 1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brigdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Page 2

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K041267

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General Electric Medical Systems

STATEMENT OF INTENDED USE

Device name: CardIQ Analysis III

Intended 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
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(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number	2041267

1/1PAGENOMFICHIER

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.