The Cardiac Function Analysis (CFA) is a software package that can be used in conjunction with CT cardiac images to semi-automatically calculate and display various Left Ventricular and Right Ventricular functional parameters such as End Systolic and End Diastolic volumes, stroke volume, LV ejection fraction to include peak filling and ejection rates, Myocardial Mass calculations, regional wall motion display and analysis. When interpreted by a trained physician, the software aids in the assessment and in determination of cardiovascular disease diagnosis and management.

Device Description

The Cardiac Function Analysis software is used to post-process cardiac CT images on the display console of the CT system. Using these post-processed images various measurements can be initiated by the user to obtain clinically relevant information pertaining to the heart. Additionally this information can be used in the detection of cardiovascular disease diagnosis and risk management. Support functions are:

Generation of Multi-Planar Reconstructed images based upon ECG gated data.
Manual or semi-automatic contour detection of the ventricular heartwalls.
Measure and display ventricular wall motions, wall thickness, myocardium mass, ventricle volume and ejection fraction.
Various data outputs can be selected by the user to generate reports of the above measurements.

AI/ML Overview

The provided 510(k) summary for the Toshiba CT Cardiac Function Analysis Software (CSCF-001A, CSCF-001B) does not contain specific acceptance criteria or details of a study proving the device meets those criteria.

However, I can extract information related to the device and its intended use, and then explain why the requested study details are absent.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not specified	Not specified

Explanation: The 510(k) summary focuses on demonstrating "substantial equivalence" to a predicate device rather than presenting specific performance metrics against pre-defined acceptance criteria. The document describes the device's functions but does not provide quantitative results of its accuracy, precision, or reliability.

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

Sample Size: Not specified.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).

Explanation: As no specific study details are provided, information about the test set's sample size or provenance is absent.

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

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

Explanation: No information is given regarding the establishment of ground truth for any testing, as a detailed performance study is not presented.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable/Not specified.

Explanation: Since no test set or ground truth establishment process is described, no adjudication method is mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.

MRMC Study: Not mentioned as performed.
Effect Size: Not applicable.

Explanation: The document does not describe any MRMC study comparing human reader performance with or without AI assistance. This type of study is more common for AI-driven diagnostic aids that directly impact reader decision-making in a comparative setting. The device described is a post-processing tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done

Standalone Study: Not mentioned as performed.

Explanation: The 510(k) summary does not present a standalone performance study of the algorithm's accuracy for its various functions (e.g., contour detection, volume calculation) against a gold standard.

7. The Type of Ground Truth Used

Type of Ground Truth: Not specified.

Explanation: As no specific performance study is detailed, the type of ground truth used for such a study is not mentioned.

8. The Sample Size for the Training Set

Sample Size: Not applicable/Not specified.

Explanation: This device, introduced in 2002, predates the widespread use of deep learning and large-scale training datasets for medical image analysis as we understand them today. The software likely uses rule-based algorithms or traditional image processing techniques rather than a training set in the modern AI sense. Therefore, a "training set" as defined for contemporary AI devices is unlikely to have been used or reported.

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

Ground Truth Establishment: Not applicable/Not specified.

Explanation: For the reasons stated above (predates common AI training methodologies), information on how a training set's ground truth was established is not provided.

Summary of the Device and Submission Context:

The Toshiba CT Cardiac Function Analysis Software (CSCF-001A, CSCF-001B) is a post-processing software package for cardiac CT images. Its purpose is to semi-automatically calculate and display various Left Ventricular and Right Ventricular functional parameters (e.g., End Systolic/Diastolic volumes, stroke volume, LV ejection fraction, myocardial mass, regional wall motion). This information is intended to aid trained physicians in the assessment and diagnosis/management of cardiovascular disease.

The submission is a 510(k) for a "new device (software package)" where the primary goal is to demonstrate substantial equivalence to an already legally marketed predicate device (General Electric CardIQ Function [K013422]). The basis for substantial equivalence is that both devices are post-processing analysis software packages providing clinically relevant anatomical and functional information from cardiac CT images.

Key takeaway for this specific 510(k): For medical devices submitted via the 510(k) pathway, especially older submissions, the focus is often on demonstrating substantial equivalence to a predicate device in terms of intended use, technological characteristics, and safety/effectiveness concerns, rather than providing extensive de novo performance studies with detailed acceptance criteria and expert validation, unless the device presents novel technology or significant differences from predicates. The document explicitly states: "This package is similar in uses and applications as those of the predicate devices. The main difference is in the method used to obtain the final results." This implies that the method might be different, but the resulting output and clinical utility are considered equivalent to the predicate.

Summary

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NOV 2 2 2002

510(k) Summary

	K023760
Date:	October 31, 2002
Submitter's Name:	Toshiba America Medical Systems, Inc.
Submitter's Address:	P.O. Box 2068, 2441 Michelle Drive,Tustin, CA 92781-2068
Submitter's Contact:	Paul Biggins, Regulatory Affairs Manager (714) 730-5000
Establishment RegistrationNumber:	2020563
Device Proprietary Name:	CT Cardiac Function Analysis SoftwareCSCF-001A, CSCF-001B
Common Name:	Scanner, Computed Tomography, X-Ray[Fed. Reg. No. 892.1750, Pro. Code: 90JAK]
Regulatory Class:	II (per 21 CFR 892.1750)
Performance Standard:	21 CFR Subchapter J,Federal Diagnostic X-ray Equipment Standard
Predicate Device(s):	General Electric CardIQ Function [K013422]
Reason For Submission	new device (software package)

Description of this Device:

Generation of Multi-Planar Reconstructed images based upon ECG gated data. ●
Manual or semi-automatic contour detection of the ventricular heartwalls. ●
Measure and display ventricular wall motions, wall thickness, myocardium mass, ventricle volume and ejection fraction.
. Various data outputs can be selected by the user to generate reports of the above measurements.

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Summary of Intended Uses:

The Cardiac Function Analysis (CFA) is a software package that can be used in conjunction with CT cardiac images to semi-automatically calculate and display various Left Ventricular and Right Ventricular functional parameters such as End Systolic and End Diastolic volumes, stroke volume, LV ejection to include peak filling and ejection rates, Myocardial Mass calculations, regional wall motion display and analysis. When interpreted by a trained physician, the software aids in the assessment and in determination of cardiovascular disease diagnosis and management.

Technological Characteristics:

This package is similar in uses and applications as those of the predicate devices. The main difference is in the method used to obtain the final results. Both this and the predicate devices are used as post-processing software to images collected by the parent CT Scanner.

Safety and Effectiveness Concerns:

This device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820. All requirements of the Federal Diagnostic Equipment Standard, as outlined in 21 CFR § 1020.30 and 1020.33, that apply to this upgrade, will be met and reported via a supplement to the initial report for the predicate device. Additionally this system is in conformance with the applicable parts of the IEC-60601 -Medical Device Safety standards.

Substantial Equivalence:

CT Cardiac Function Analysis Software (CFA), Model Numbers CSCF-001A, CSCF-001B is substantially equivalent to the predicate device. This package, and the predicate device, are both post-processing analysis software packages that allow the user to obtain clinically relevant anatomical and functional information from CT images of the cardiac region.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human profile.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 22 2002

Toshiba America Medical Systems, Inc. % Mr. Mark Job 510(K) Program Manager TÜV Product Service 1775 Old Highway 8, Suite 104 NEW BRIGHTON MN 55112-1891 Re: K023760 Trade/Device Name: Model CGCF-001A/CSCF-001B

Cardiac Function Analysis Software Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: 90 JAK

Dated: November 7, 2002 Received: November 8, 2002

Dear Mr. Job:

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 (PMA). it may be subject to 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 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:

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" (21 CFR Part 807.97). 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,

Verny 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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510(k) Number (if known):

Device Name: Cardiac Function Analysis: Model Number CSCF-001A/CSCF-001 B

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 V (Per 21 CFR 801.109) (Optional Format 1-2-96)

B - 5

Over-The-Counter Use

David G. Lyon

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

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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.