CT-MASS has been developed for the objective and reproducible analysis of multi-slice, multi-phase left and right ventricular function from cardiac CT data sets. The CT-MASS software package can be used to semi-automatically calculate and display various parameters such as: EDV, BSV, stroke volume, ejection factor, peak ejection and filling rates, myocardial mass, regional wall thickness, as well as well as wall thickening/thinning, and regional wall motion. This is including the axial to short axis reformat.

When interpreted by a trained physician these parameters may be useful in supporting the determination of a diagnosis.

Device Description

CT-MASS is a professional state-of-the-art analytical software tool designed for UNIX, Linux as well as Windows platforms. CT-MASS facilitates the import and visualization of multi-slice, multi-phase CT data sets encompassing the cardiac chambers via CD-Rom and digital network. This CT-MASS functionality is independent of the CT equipment vendor. CT-MASS provides objective and reproducible global and regional two-, three- and four-dimensional clinically relevant parameters describing left and right ventricular heart function, such as ventricular volumes, regional wall thickness and wall thickening/thinning CT-MASS is intended to support all clinicians, i.e. cardiologists, radiologists, and referring physicians involved in the noninvasive assessment of heart function.

AI/ML Overview

This 510(k) submission for CT-MASS does not contain a specific section detailing the acceptance criteria and a study proving the device meets those criteria with a table of performance metrics. The submission focuses on substantial equivalence to predicate devices and provides general information about verification and validation tests and evaluations by hospitals and literature, but it lacks the granular detail requested.

However, based on the provided text, we can infer some information due to the device's nature as an analytical software tool for cardiac function. The core of its safety and effectiveness relies on its ability to objectively and reproducibly analyze cardiac CT data.

Here’s an attempt to construct the response based on the available information and typical expectations for such a device, while clearly identifying what is stated and what is inferred or missing:

Acceptance Criteria and Device Performance Study for CT-MASS

This 510(k) submission (K033774) for CT-MASS does not explicitly define a table of acceptance criteria or present a detailed study with specific performance metrics against those criteria. The submission primarily focuses on demonstrating substantial equivalence to predicate devices (K013422 "CardIQ Function" and K020796 "CardIQ Analysis III") and asserts that "potential hazards are controlled by a risk management plan for the software development process... including hazard analysis, verification and validation tests." It also mentions "Evaluations by hospitals and literature" support the safety and effectiveness.

Given the intended use of "objective and reproducible analysis of multi-slice, multi-phase left and right ventricular function," the acceptance criteria would implicitly relate to the accuracy and reproducibility of the calculated cardiac parameters.

1. Table of Acceptance Criteria and Reported Device Performance

As specific acceptance criteria and detailed performance metrics are not provided in the submitted document, the table below represents inferred or expected criteria for this type of device, with no reported performance values available in this submission.

Acceptance Criterion (Inferred/Expected)	Reported Device Performance (Not provided in submission)
Accuracy of Ventricular Volumes	(e.g., within X% of ground truth)
- End-Diastolic Volume (EDV)	Not reported
- End-Systolic Volume (ESV)	Not reported
Accuracy of Ejection Fraction (EF)	(e.g., within X% of ground truth)
- EF	Not reported
Accuracy of Myocardial Mass	(e.g., within X% of ground truth)
- Myocardial Mass	Not reported
Reproducibility of Measurements	(e.g., CV < X% for inter-observer/intra-observer variability)
- Volumes, EF, Mass	Not reported
Interoperability (Import/Export)	(e.g., successful import/export of data)
- Import/Export of CT data	Implied by "facilitates the import and visualization"
User Interface Usability	(e.g., successful task completion)
- Clinical workflow ease	Implied by "supporting clinicians"
Robustness (Error Handling)	(e.g., no critical errors during defined use cases)
- Software stability / error rates	Not reported

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

The submission does not specify a sample size for a test set or provide details on data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "verification and validation tests" and "Evaluations by hospitals."

3. Number of Experts Used to Establish Ground Truth and Qualifications

The submission does not specify the number of experts used to establish ground truth or their qualifications. It mentions the software is "intended to support all clinicians, i.e. cardiologists, radiologists, and referring physicians."

4. Adjudication Method for the Test Set

The submission does not describe any adjudication method (e.g., 2+1, 3+1, none) for a test set. It states that "The ventricular contours and regions-of-interest will be interpreted by the operator, who can choose to accept or reject the outlines," implying a human-in-the-loop scenario where the operator ultimately validates or corrects the automated outlines.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned in this submission. The effectiveness is primarily asserted through substantial equivalence to predicate devices and general claims of supporting clinical diagnosis and decision-making. No effect size for human reader improvement with AI assistance is provided.

6. If a Standalone Performance Study Was Done

A standalone performance study (algorithm only without human-in-the-loop performance) is not explicitly detailed in this submission. The description emphasizes the software's ability to "semi-automatically calculate" parameters and that the operator "can choose to accept or reject the outlines," indicating a human-in-the-loop design. However, the "verification and validation tests" could conceptually include aspects of standalone algorithm testing.

7. The Type of Ground Truth Used

The type of ground truth used is not specified. For cardiac function analysis, ground truth typically involves:

Expert Consensus: Manual expert tracings/measurements from cardiac imaging (e.g., CT, MRI, echocardiography) often used as a reference.
Pathology: Less common for structural/functional parameters, but might be relevant for mass if biopsy correlations were involved.
Outcomes Data: Unlikely to be the direct ground truth for individual parameter accuracy, but could be used in larger clinical utility studies.
Given the device's function, expert consensus on cardiac contours and measurements from high-quality imaging would be the most probable, albeit unstated, ground truth.

8. The Sample Size for the Training Set

The submission does not specify the sample size for a training set. As a 510(k) from 2004, the concept of "training set" for AI/ML validation was less formalized in regulatory submissions compared to today. The device is described as an "analytical software tool" and not explicitly termed an AI/ML product, although algorithms are inherently involved.

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

The submission does not describe how the ground truth for a training set (if one was used) was established.

Summary

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MAR - 2 2004

CT-MASS 510(k) Pre-market Notification

K033774

12. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Submission in accordance with the requirements of 21 CFR Part 807.87(h)

1. Submitter	: MEDIS medical imaging systems bv
Address	: Schuttersveld 9: 2316 XG Leiden, The Netherlands
Telephone	: +31 71 522 3244
Fax	: +31 71 521 5617
Contact Person	: J.I. Hollander, Quality Coordinator
Prepared	: December 01, 2003
2. Device Name	: Medis CT-MASS
Common Name	: CT-MASS
Device Class. Name	: Computed Tomography x-ray systems
Regulation Number	: 21 CFR 892.1750 (90 JAK; Class II)
3. Predicate Device(s)	: GEMS: 510(k) K013422: K020796

4. Description of the device:

5. Intended use:

CT-MASS has been developed for the objective and reproducible analysis of multislice, multi-phase left and right ventricular function from cardiac CT data sets. The itended purposes are:

1. Supporting clinical diagnoses about the status of the global and regional function and anatomy of the human heart;
1. Supporting the subsequent clinical decision making processes;
1. Supporting the use in clinical research trials, directed at studying changes in function and anatomy of the heart chambers as a result of treatment.

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CT MASS 510(k) Premarket Notification

6. Substantial equivalence Information:

CT-MASS is substantially equivalent to the Predicate Devices of General Electric Medical Systems, K013422 "CardIQ Function" and K020796 "CardIQ Analysis III", using the same technological technique for the same intended use.

Conclusion respecting safety and effectiveness:

It is the opinion of Medis medical imaging systems bv that CT-MASS is safe and potential hazards are controlled by a risk management plan for the software development process (See Appendix C), including hazard analysis (See Appendix D), verification and validation tests (See Appendix E). Evaluations by hospitals and literature (See Appendix F) support this statement. The software package CT-MASS itself will not have any adverse effects on health. This tool calculates and displays the anatomy and function of the left and right ventricles. The ventricular contpurs and regions-of-interest will be interpreted by the operator, who can choose to acceet or reject the outlines, and then decide to use the derived data to compare against earlier images or images from other patients.

It is the opinion of Medis medical imaging systems bv that the level of concern for the stand alone software to view images is 'minor' and that the use of CT-MASS software does not change the intended use of computed tomography scanners in practice, nor does the use of software result in any new potential hazards.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 2 2004

Mr. J.I. Hollander Quality Coordinator Medis Medical Imaging Systems, B.V. Schuttersveld 9 2316XG Leiden P.O. Box 384 2300 AJ Leiden THE NETHERLANDS

Re: K033774 Trade/Device Name: CT-MASS Analytical Software Package Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: 90 JAK Dated: December 1, 2003 Received: December 3, 2003

Dear Mr. Hollander:

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 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) I his letter will and in you ve organization of substantial equivalence of your device to a legally premarket noticate 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 If you doom bpooms 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 Addisonaly and Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding Other of Compharios as ( notification" (21CFR Part 807.97) you may obtain. Other general of receibled to premainted new rehe Act may be obtained from the Division of Small ntormation on your respond and Consumer Assistance at its toll-free number (800) 638-2041 or 11andiaetarere, Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brydon

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: CT-MASS

Indications For Use:

When interpreted by a trained physician these parameters may be useful in supporting the determination of a diagnosis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE

(Optional Format 3-10-98)

Prescription Use

Manayc Brogdon

(Division Sign-Off) Division of Reproductive, Abdo and Parliological Devices 5 (O(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.