MRA-CMS has been developed for the objective and reproducible analysis of vessels from MRA data sets. The MRA software parameters may be used to semi-automatically determine lumen length, cross sectional parameters and percent stenosis. When interpreted by a trained physician these parameters may be useful in supporting the determination of clinical diagnoses and subsequent clinical decision making processes.

Device Description

MRA-CMS can be utilized to determine lumen lengths; minimum and maximum cross sectional diameters and percent stenosis. MRA-CMS improves productivity of the clinician by semi-automating the measurement function for routine vascular measurements.

AI/ML Overview

The provided text is a 510(k) summary for the MRA-CMS device. It does not contain the detailed study results, acceptance criteria, or performance data required to complete the requested table and answer many of the questions.

The submission focuses on establishing substantial equivalence to a predicate device (Vital Images, K002519 "Vitrae 2, version 2.1") and discusses general safety and effectiveness without presenting specific quantitative performance metrics beyond the device's capability to measure lumen lengths, cross-sectional diameters, and percent stenosis.

Therefore, I can only provide information based on what is available in the text. Many sections will indicate "Not provided in the text."

Here's the breakdown of the information that can be extracted:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Not explicitly stated (no specific performance targets or thresholds are mentioned)	MRA-CMS can be utilized to determine lumen lengths; minimum and maximum cross sectional diameters and percent stenosis.
	The device improves productivity of the clinician by semi-automating the measurement function for routine vascular measurements.
	Provides objective and reproducible analysis of MRA data.

2. Sample size used for the test set and the data provenance

Sample size for the test set: Not provided in the text.
Data provenance (e.g., country of origin of the data, retrospective or prospective): Not provided in the text. The document mentions "Evaluations by hospitals and literature (See Appendix F)" but does not detail the nature or source of these evaluations.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of experts: Not provided in the text.
Qualifications of experts: Not provided in the text.

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

Adjudication method: Not provided in the text.

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

MRMC study: Not provided in the text. The document refers to the device as "semi-automating the measurement function" and that the "regions-of-interest will be interpreted by the operator, who can choose to accept or reject the outlines, and then decide to use the derived data." This implies a human-in-the-loop workflow, but no comparative effectiveness study results are presented.
Effect size: Not provided in the text.

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

Standalone study: Not explicitly stated. The description of MRA-CMS as "semi-automating the measurement function" and requiring operator interpretation and acceptance/rejection of outlines suggests it's not purely a standalone device in its intended clinical use. No standalone performance study metrics are provided.

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

Type of ground truth: Not provided in the text.

8. The sample size for the training set

Sample size for the training set: Not provided in the text.

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

Ground truth establishment for training set: Not provided in the text.

Summary

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

Ko4o746

JUN = 8 2004

MRA-CMS 510(k) Pre-market Notification

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	: March 17, 2004
2. Device Name	: MRA-CMS
Common Name	: MRA
Classification Name	: 90 LLZ (21 CFR 892.2050)

3. Predicate Device(s)

4. Description of the device:

5. Intended use:

MRA has been developed for the objective and reproducible analysis of MRA data The intended 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.

6. Substantial equivalence Information:

MRA-CMS is substantially equivalent to the Predicate Device of Vital Images, K002519 "Vitrae 2, version 2.1", using the same technological technique for the same intended use.

Conclusion respecting safety and effectiveness:

It is the opinion of Medical imaging systems bv that MRA-CMS 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 MRA-CMS itself will not have any adverse effects on health. This tool calculates and displays the anatomy and function of the left and right ventricular contours and regions-of-interest will be interpreted by the operator, who can choose to accept 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 MRA-CMS software does not change the intended use of MR scanners in practice, nor does the use of software result in any new potential hazards.

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

Image /page/1/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 that resembles a stylized human figure or a bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 8 2004

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

Re: K040746 Trade/Device Name: MRA-CMS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: March 17, 2004 Received: March 23, 2004

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.

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

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgin manieting your and equivalence of your device to a legally premarket nothcation. The PDA miding of bassification 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 desire specific advise to: your are 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 Adultionally, 101 questions on the prosses note the regulation entitled, "Misbranding Other of Comphanoo at (2017 ->>>>>>>>>>>>>>> (21CFR Part 807.97) you may obtain. Other general by relefence to premarket notification - (21 cc may be obtained from the Division of Small miorination on your responsionities and its toll-free number (800) 638-2041 or Manufacturers, Titlemational and Colress http://www.fda.gov/cdrh/dsma/dsmamain.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

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

-510(k) Number (if known): ソバイダイアイ

Device Name: - MRA-CMS

Indications For Use

MRA-CMS has been developed for the objective and reproductble
analysis of vessels from MRA data sets. The MRA software parameters be used to semi-automatically only sectional parameters and percent stenosis.
Such as: Jumen length, cross sectional parameters and percent may bo nee such as tumen reign, cross sectional physician these parameters may be useful.
When interpreted by a trained physician these parameters may be useful.
in supporting the deter

(Please do not write below this line-continue on another Page I EDED)

Concurrence of CDRH, Office of Device Evaluation (ODE

escription Use

David H. Lehman

(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices K () 4) 510(k) Number

(Optional Format 3-10-98)

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).