QVA-CMS is developed for the quantitative analysis of vascular morphology in peripheral arteries and is applicable in both research studies and during interventions in the vascular lab. The automated contour detection can be used to standard digital, subtracted and inverted images. The package reduces significantly the intra- and inter-observer variability associated with conventional visual assessment. It also avoids the very time-consuming conventional manual tracing of boundaries. QVA-CMS analytical software is intended to support clinicians. i.e. cardiologists. radiologists, and referring physicians involved in the assessment of X-ray images. When interpreted by trained physicians these parameters may be useful in supporting a clinical decision process.

Device Description

QVA-CMS is a state-of-the-art analytical software tool designed for Windows operating systems. QVA-CMS analytical software facilitates the import and visualization of X-ray images via CD-ROM and digital network. The QVA-CMS functionality is independent of the X-ray acquisition equipment vendor. QVA-CMS, performing automated contour detection, provides quantitative analysis with objective and reproducible assessment of vascular lesions in selected regions of interest. The analysis results of user's selection can be reported in user-defined configuration, exported in general formats and transported for storage via communication with standard Microsoft office packages.

AI/ML Overview

The provided document, a 510(k) notification for the QVA-CMS analytical software package, is a regulatory submission to the FDA. It declares the device's substantial equivalence to a predicate device (QCA-CMS, K993763) and outlines its intended use and safety. However, this document does not contain the detailed information necessary to fully answer the request regarding acceptance criteria and a specific study proving the device meets those criteria.

Here's an analysis of what can and cannot be extracted from the provided text based on your request:

1. A table of acceptance criteria and the reported device performance

The document states: "It is the opinion of MEDIS medical imaging systems B.V. that QVA-CMS is safe and potential hazards are controlled by the risk management plan for the software development process (see Appendix C), including hazard analysis (see Appendix D), verification and validation tests (see Appendix E)."
It also mentions: "Evaluation by hospitals and literature (see Appendix F) supports this statement."

Missing Information: The actual acceptance criteria (e.g., specific quantitative thresholds for accuracy, precision, sensitivity, specificity) and the reported performance values that demonstrate these criteria were met are not detailed within this document. Appendices C, D, E, and F are referenced as containing this information, but they are not included in the provided text.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Missing Information: The document explicitly mentions "verification and validation tests" and "Evaluation by hospitals and literature," but it does not specify the sample size of any test set, the provenance of the data (e.g., country of origin), or whether the study was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Missing Information: The document describes the device's function as providing "objective and reproducible assessment of vascular lesions" and improving "interpretation of vascular images for decisions by the clinicians." It also mentions "reducing the risks, due to user variability associated with conventional visual assessment." However, it does not detail the number or qualifications of experts used to establish ground truth for any validation study.

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

Missing Information: The document does not describe any adjudication method used for establishing ground truth or evaluating test set results.

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

The document states: "The package reduces significantly the intra- and inter-observer variability associated with conventional visual assessment." and "QVA-CMS analytical software is intended to support clinicians, i.e. cardiologists, radiologists, and referring physicians involved in the assessment of X-ray images. When interpreted by trained physicians these parameters may be useful in supporting a clinical decision process."

Missing Information: While the text hints at a reduction in inter-observer variability, it does not explicitly describe an MRMC comparative effectiveness study where human readers' performance with and without AI assistance was measured. Therefore, an effect size for human improvement with AI cannot be determined from this text. The statement about reduced variability suggests that such a study might have been performed (or is conceptually implied), but the details are not here.

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

The document describes QVA-CMS as "performing automated contour detection, provides quantitative analysis with objective and reproducible assessment of vascular lesions." This implies the algorithm's ability to operate in a standalone capacity to perform its core function.
"It is the opinion of MEDIS medical imaging systems B.V. that QVA-CMS is safe and potential hazards are controlled by the risk management plan for the software development process (see Appendix C), including hazard analysis (see Appendix D), verification and validation tests (see Appendix E)." This "verification and validation tests" section would likely include evaluation of the algorithm's standalone performance.

Partial Information: The core function of "automated contour detection" and "quantitative analysis" inherently refers to the algorithm's standalone capability. The document alludes to "verification and validation tests" which would assess this, but does not provide direct results or details of a specific standalone study.

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

Missing Information: The document mentions "objective and reproducible assessment" and "quantify medical images," but does not specify how the ground truth for comparison was established (e.g., whether it was expert consensus, invasive measurement, pathology, or clinical outcomes).

8. The sample size for the training set

Missing Information: The document is primarily focused on regulatory submission and equivalency. It does not provide any details regarding the training set's sample size used for the development of the automated contour detection algorithms.

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

Missing Information: Similar to point 8, the document does not detail how ground truth was established for any training data used in the development of the QVA-CMS software.

In summary:

This 510(k) submission establishes the device's intended use and its substantial equivalence to a predicate device. It references internal validation and testing documents (Appendices C, D, E, F) that would likely contain the specifics requested. However, the provided text itself lacks the detailed technical and clinical study information required to populate a comprehensive table of acceptance criteria, study methodologies, and results. You would need to access those referenced appendices or a more detailed technical report to get this information.

Summary

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JAN 2 4 2003

023970

QVA-CMS 510(k) Notification

12. SUMMARY OF SAFETY AND EFFECTIVENESS:

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

1) Submitter:	MEDIS medical imaging systems B.V.
Address:	Poortgebouw Rijnsburgerweg 102333 AA LeidenThe Netherlands
Telephone:	+31 71 5223244
Fax:	+31 71 5215617
Contact Person:	J.I. Hollander, Quality Coordinator
Prepared:	November 25, 2002
2) Device Name:	QVA-CMS analytical software package
Common Name:	QVA-CMS
Device Class. Name:	System, X-ray, Angiographic
Regulation Number:	21 CFR 892.1600 (90 IZI; Class II)

QCA-CMS: 510(k) K993763 3) Predicate Device:

4) Device Description:

5) Intended use:

The analytical QVA-CMS software, serves a medical purpose and its intended use is:

a) To quantify medical images of peripheral arteries in an objective and reproducible way by presenting graphs with calculated data of user's selected regions of interest. Quantification is performed by automated contour detection;
b) To improve the interpretation of vascular images for decisions by the clinicians in hospitals, facilitated by image quantification;
c) To improve the analysis of the vascular morphology during research trials by analysts in Core Labs on intervention effects, facilitated by image quantification;
d) To train users for correct interpretation and analysis of images of peripheral arteries, using the objective and reproducible quantified images;
e) To reduce the risks, due to user variability associated with conventional visual assessment, facilitated by objective and reproducible quantified images;
To gain more benefits in post-processing activities, avoiding the very timef) consuming conventional manual tracing of boundaries, using the automated contour detection of the analytical software package.

Substantial equivalence Information:

The QVA-CMS software is substantially equivalent to the predicate device of QCA-CMS, K993763, using the same technological characteristics and intended use.

QVA-CMS 510(k) Notification

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CONCLUSIONS RESPECTING SAFETY and EFFECTIVENESS:

It is the opinion of MEDIS medical imaging systems B.V. that QVA-CMS is safe and potential hazards are controlled by the risk management plan for the software development process (see Appendix C), including hazard analysis (see Appendix D), verification and validation tests (see Appendix E). Evaluation by hospitals and literature (see Appendix F) supports this statement.

In MEDIS' opinion the level of concern for the stand-alone software to quantify images is 'minor' and that the use of QVA-CMS analytical software does not influence the use of X-ray image acquisition equipment 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 a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.

JAN 2 4 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. J. I. Hollander Quality Coordinator MEDIS Medical Imaging Systems, B. V. Poortgebouw, Rijnsburgerweg 10 2333 AA Leiden NETHERLANDS

Re: K023970

Trade/Device Name: Ouantitative Vascular Angiography - CMS Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic x-ray system Regulatory Class: II Product Code: 90 IZI Dated: November 25, 2002 Received: November 29, 2002

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 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. 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): K023970

Device Name: Quantitative Vascular Angiography - CMS

Indications For Use: QVA-CMS is developed for the quantitative analysis of vascular morphology in peripheral arteries and is applicable in both research studies and during interventions in the vascular lab. The automated contour detection can be used to standard digital, subtracted and inverted images. The package reduces significantly the intra- and inter-observer variability associated with conventional visual assessment. It also avoids the very time-consuming conventional manual tracing of boundaries. QVA-CMS analytical software is intended to support clinicians. i.e. cardiologists. radiologists, and referring physicians involved in the assessment of X-ray images. When interpreted by trained physicians these parameters may be useful in supporting a clinical decision process.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_

Nancy C. Brogdon

Regulation Number and Section

§ 892.1600 Angiographic x-ray system.

(a)
Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.