QCU ANALYTICAL SOFTWARE PACKAGE by MEDIS MEDICAL IMAGING SYSTEMS, B.V.

Supporting clinical diagnoses about stenosis and/or control of the placement of intervention devices;
Supporting subsequent clinical decision making purposes;
Supporting the use in clinical research trials, directed at studying changes in vessel conditions over time as a result of interventions and or medication.

QCU has been developed for the objective and reproducible analysis of tomograhic images of both lumen and arterial wall of a coronary or vascular segment, in particular the assessment of a stenosis or atherosclerotic plaque. This information supports the the aboutinent of intervention devices in these vessels. QCU-CMS enables an advanced assessment of vessel, lumen, and stent morphology. It also avoids the very time-consuming conventional manual tracing of boundaries, which suffers from high intro- and inter observer variability. QCU-CMS can be used to control stent placement ind to assess in-stent restenosis. QCU software package enables the automatically calculation and the display of various parameters such as: areas and diameters in individual slices; volumes over the segment of interest (Simpson's Rule) for the vessel, lumen and stent contours; plaque and in-stent restenosis parameters.

QCU-CMS analytical software is intended to support all clinicians, i.e. cardiologists, radiologists, and referring physicians involved in the assessment of ultrasound images. radiological, and refering ped physician these parameters may be useful in supporting the determination of a diagnosis.

Device Description

QCU-CMS is a state-of-the-art analytical software tool designed for Windows NT operating systems. QCU-CMS analytical software facilitates the import and visualization of ultrasound images via CD-ROM and digital network. The QCU-CMS functionality is independent of the ultrasound equipment vendor. QCU-CMS, using automated contour detection, provides quantitative analysis with objective and reproducible data of length and diameter, area and volume in regions of interest. The results of selected analysis 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

Here's an analysis of the provided text, focusing on the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific numerical acceptance criteria for the QCU-CMS analytical software. It focuses more on the intended use and qualitative benefits of the device in comparison to manual tracing.

However, based on the description of the device's capabilities and its intended use to provide "objective and reproducible analysis," the implicit acceptance criteria would likely revolve around aspects of accuracy, reproducibility, and agreement with established references (which are hinted at in the "Evaluation by hospitals and literature" and comparison to manual methods).

The reported device performance, similarly, is presented qualitatively rather than quantitatively against specific benchmarks.

Acceptance Criteria (Implicit/Derived)	Reported Device Performance (Qualitative)
Accuracy in quantitative analysis (length, diameter, area, volume)	QCU-CMS provides "quantitative analysis with objective and reproducible data of length and diameter, area and volume in regions of interest." It produces "automatically calculation and the display of various parameters such as: areas and diameters in individual slices; volumes over the segment of interest (Simpson's Rule) for the vessel, lumen and stent contours; plaque and in-stent restenosis parameters." The device "enables an advanced assessment of vessel, lumen, and stent morphology."
Reproducibility of analysis	The device is designed for "objective and reproducible analysis." It "avoids the very time-consuming conventional manual tracing of boundaries, which suffers from high intro- and inter observer variability." This implies the device aims to reduce this variability, thus improving reproducibility.
Support for clinical diagnoses and decision making	The device's output (stenosis, plaque assessment, changes in vessel conditions) is intended to "Support clinical diagnoses about stenosis and/or control of the placement of intervention devices," "Supporting subsequent clinical decision making purposes," and for "use in clinical research trials, directed at studying changes in vessel conditions over time as a result of interventions and or medication." Its parameters "may be useful in supporting the determination of a diagnosis."
Equivalence to predicate device (TomTec K993394)	The QCU-CMS software is stated to be "substantially equivalent to the predicate devices of TomTec K993394 'Echo-Scan 4.x and Easy-Scan 1.x' by using the same technological characteristics and intended use."

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

The document does not provide details on the sample size used for the test set. It mentions "Evaluation by hospitals and literature," but without specifying the number of cases or the nature of this evaluation. Therefore, the data provenance (e.g., country of origin, retrospective/prospective) for a formal test set is also not specified.

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

The document does not specify the number of experts or their qualifications used to establish ground truth for a test set.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method used for a test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not describe an MRMC comparative effectiveness study. It mentions that the software "avoids the very time-consuming conventional manual tracing of boundaries, which suffers from high intro- and inter observer variability," implying an improvement over manual methods, but no formal comparative study with human readers (with or without AI assistance) is detailed. Therefore, an effect size of human readers improving with AI vs. without AI assistance is not reported.

6. Standalone Performance Study

The document implies a standalone performance for the algorithm. The description states it provides "automated contour detection" and "automatically calculation and the display of various parameters." The "Evaluation by hospitals and literature" mentioned might indirectly relate to standalone performance, but no dedicated standalone study with quantitative results like sensitivity, specificity, or accuracy is explicitly presented.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for any formal testing. Given its intended use for analyzing intravascular ultrasound images, it is highly likely that comparison would be made against:

Expert Consensus: Manual tracings and measurements performed by highly experienced clinicians (cardiologists, radiologists). The mention of "manual tracing of boundaries, which suffers from high intro- and inter observer variability" strongly implies this as a baseline.
Pathology/Histology: For very specific cases, tissue analysis could be a gold standard for plaque characterization, but this is less common for routine IVUS measurements.
Other established imaging modalities: Comparison to other well-validated imaging techniques for vessel dimensions.

8. Sample Size for the Training Set

The document does not mention the sample size used for a training set. As an early submission (2001), the concept of distinct training and test sets as rigidly defined in modern AI/ML development might not have been as systematically applied or documented in this type of submission.

9. How Ground Truth for the Training Set Was Established

The document does not provide information on how ground truth was established for any training set.

Summary

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

JUL 3 1 2001

K011582

QCUCMS 510(k) Premarket Notification

12 SUMMARY OF SAFETY AND EFFECTIVENESS: Submission in accordance with the requirements of 21 CFR Part 807.87(h)

: MEDIS medical imaging systems B.V. 1) Submitter : Poortgebouw Rijnsburgerweg 10 Address : 2333 AA Leiden : The Netherlands Telephone : + 31 71 5223244 : + 31 71 5215617 Fax Contact Person : May 21, 2001 Prepared 2) Device Name : QCU-CMS analytical software package

2) Device Name	: QCU-CMS analytical software package
Common Name	: QCU-CMS
Device Class. Name	: System, Image Processing
Regulation Number	: 21 CFR 892.1560 (90 LLZ; Class II)

: TomTec: 510(k) K993394 3) Predicate Device

4) Description of the device:

5) Intended use:

QCU has been developed for the objective and reproducible analysis of intravascular ultrasound images. Intended purposes are:

1. Supporting clinical diagnoses about stenosis and/or control of the placement of intervention devices;
1. Supporting subsequent clinical decision making purposes;
1. Supporting the use in clinical research trials, directed at studying changes in vessel conditions over time as a result of interventions and or medication.

Substantial equivalence Information:

The QCU-CMS software is substantially equivalent to the predicate devices of TomTec K993394 "Echo-Scan 4.x and Easy-Scan 1.x" by using the same technological characteristics and intended use.

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

CONCLUSIONS RESPECTING SAFETY and EFFECTIVINESS:

It is the opinion of MEDIS medical imaging systems B.V. that QCU-CMS is safe and it is the opinion of MED found by a risk management plan for the software potential nazards are oonlined by including hazard analysis (see Appendix D), development procode (600 Appendix E), Evaluation by hospitals and literature (see Appendix F) support this statement.

(See Appendix 1 ) Support this Statement.
In MEDIS' opinion the level of concern for the stand-alone software to view images is in MLDIS opinion the lever of ochoon for the stare does not change the intended use mindr and the use of &o- analytoar own the use of software result in any new potential hazards.

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

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 a stylized caduceus, with three wavy lines representing snakes intertwined around a staff.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 3 1 2001

Re: K011582

OCU-CMS Analytical Software Dated: May 21, 2001 Received: May 23, 2001 Regulatory Class: II 21 CFR 892.2050/Procode: 90 LLZ 21 CFR 892.1560/Procode: 90 IYO

Dear Mr. Hollander:

Mr. J.I. Hollander

2333 AA Leiden

The Netherlands

Quality Coordinator

MEDIS Medical Imaging Systems B.V.

Poortgebouw, Rijnsburgerweg 10

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the we have reviewed your Scholl 210x) notifications of muse stated in the enclosure) to legally marketed predicate devices device is substantaly courabile for the markent in the enactment date of the Medical Device Amendments, or to devices mat have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, to such additional controls. Exisune mayor regulatent determination assumes compliance with the Current Good Manufacturing THE 21, Patis 800 00 072. A Substantian Ostan an Regulation (QS) for Medical Devices: General regulation (21 CFR Part Placice requirements, a scriour in the Quality of the Rog Administration (FDA) will verify such assumptions. Failure o comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements to concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not concenting your device in the Feations 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 and additionally 809.10 for in vitro 11 you done spontio davice to: Jose of Compliance at (301) 594-4639. 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 807.97). Other general information on your churces, "Misolanding of Televisor of Since the Division of Small Manufacturers Assistance at its toll-free number (800) 138-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely vours

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 (s)

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

510(k) NUMBER (IF KNOWN): K011582
DEVICE NAME: Geli Analytical Software Package

INDICATIONS FOR USE:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

ાર

Prescription Use (Per 21 CFR 801 109) Over - The - Counter - Use ef (Optional Format 1-

Nancy hogdon

[Division Ston-Off)
Division of Reproductive, Abdominal,
and Radiological Devices K011382
1510(k) Number

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).