The ResolutionMD™ Cardiac Product Family is a software based Picture Archiving and Communication System (PACS) used with general purpose computing hardware for the display and 3D visualization of medical image data. It provides for communication, storage, processing, rendering, and display of DICOM 3.0 compliant image data derived from various sources including CT and MRI.

The ResolutionMD™ Cardiac Product Family is intended for use as a diagnostic, review. and analysis tool by trained professionals such as physicians, technologists, and nurses. When interpreted by a trained physician, reviewed images may be used as an element for diagnosis. It is the user's responsibility to ensure that the software is installed on appropriate hardware and that image quality is suitable for the clinical application.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

Device Description

The ResolutionMDTM Cardiac Product Family is available in a Microsoft Windows version and in a Macintosh OS version. Both versions offer similar functionality. Available functions include DICOM communication, display of 2D images in original planes, computation and display of rendered 3D images and maximal intensity projection (MIP) images, 2D and 3D image measurements, calcium scoring, and coronary artery analysis. The user controls these functions with a system of interactive menus and tools.

A hazard analysis has been conducted and the level of concern has been classified as minor. The ResolutionMD™ Cardiac Product Family software will be extensively tested on supported platforms by members of the development and quality control team prior to beta testing. Beta testing by trained cardiology professionals and potential customers will be completed prior to product release. The release version of the software will be required to pass all tests considered critical in terms of patient safety and demonstrate an overall acceptable performance for release as determined by the predefined release criteria.

AI/ML Overview

The provided 510(k) summary for the ResolutionMD™ Cardiac Product Family does not contain specific acceptance criteria or a dedicated study demonstrating the device's performance against such criteria. Instead, it focuses on establishing substantial equivalence to a predicate device (Vitrea2) based on functional and technical similarities.

However, based on the information provided, we can infer some aspects and highlight what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state acceptance criteria in terms of quantitative performance metrics (e.g., accuracy, sensitivity, specificity, processing time, etc.). The "performance" described is largely a comparison of features and capabilities with the predicate device.

Feature/Criterion (Inferred)	Acceptance Criteria (Not explicitly stated, inferred from comparison)	Reported Device Performance (ResolutionMD™ Cardiac Product Family)
Functional Equivalence	Match or exceed predicate device functionality	DICOM 3.0 compliance, 2D/3D imaging, measurements, MIP, Calcium Score, Artery detection, Curved MPR, Reporting
Platform Compatibility	Support for common operating systems	Microsoft Windows OS, Macintosh OS
Intended Use	Diagnostic, review, analysis tool for trained professionals	Same as predicate device
Safety	Classified as minor level of concern	Hazard analysis conducted, classified as minor concern
Software Quality	Pass all critical tests, acceptable overall performance	Extensively tested by development/QC, beta testing by professionals, release version to pass critical tests and demonstrate acceptable performance

Missing Information: There are no quantitative performance metrics such as accuracy for calcium scoring, precision of measurements, speed of rendering, or comparison of diagnostic outcomes using the device versus the predicate or traditional methods.

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

The document mentions "beta testing by trained cardiology professionals and potential customers" as part of the validation process. However, it does not provide any details regarding:

The sample size of medical images or patient cases used in this testing.
The data provenance (e.g., country of origin of the data, retrospective or prospective nature of the beta testing data).

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

The document states that "beta testing by trained cardiology professionals" will be completed. However, it does not specify:

The number of experts involved in establishing ground truth for the test set.
The qualifications of these experts (e.g., "radiologist with 10 years of experience" is not mentioned, only "trained cardiology professionals").

4. Adjudication Method:

The document does not mention any specific adjudication method (e.g., 2+1, 3+1, none) used for the test set during beta testing or any other validation.

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

The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. Therefore, there is no information on the effect size of how much human readers improve with AI vs. without AI assistance, as this is a PACS software and not strictly an AI-driven diagnostic aid in the modern sense.

6. Standalone Performance Study:

Since this is a PACS system designed for human-in-the-loop use by trained professionals, a standalone (algorithm only) performance study in the sense of an AI algorithm making a diagnosis without human intervention is not applicable or mentioned. The "device performance" relies on the trained professional's interpretation using the software.

7. Type of Ground Truth Used:

While "beta testing by trained cardiology professionals" implies a form of expert review, the exact "type of ground truth used" (e.g., expert consensus, pathology, outcomes data) for validating the software's features like calcium scoring or artery detection is not explicitly stated. It's likely that established clinical reporting for calcium scores and visual assessment for artery detection would serve as the implicit ground truth.

8. Sample Size for the Training Set:

The document does not mention a training set sample size. This is expected as the device, introduced in 2007, is a PACS software for visualization and analysis, not an AI/machine learning model in the contemporary sense that typically requires a large training set. Its development would have focused on engineering robust algorithms for image processing and rendering, rather than learning from data.

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

As there is no mention of a "training set" in the context of machine learning, the question of how ground truth was established for a training set is not applicable. The underlying algorithms for features like calcium scoring would be based on established clinical methodologies (e.g., Agatston method) rather than being "trained" on data with ground truth.

Summary

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K071086

510(k) Summary

Date Prepared:	April 12, 2007	JUN - 1 2007
Submitter's Name:	Calgary Scientific, Inc.
Submitter's Address:	1210 20th Ave. SE, Calgary, Alberta, Canada T2G 1M8
Submitter's Phone:	403.270.7159
Submitter's Fax:	403.668.1689
Contact:	Pierre Lemire, President & Chief Operations Officer
Proprietary Name:	ResolutionMD™ Cardiac Product Family
Common Name:	Software PACS
Classification:	892.2050 Picture archiving and communications system,Product Code LLZ, (Class II)
SubstantiallyEquivalent to:	Tradename: Vitrea2, Version 3.8Manufacturer: Vital Images, Inc.510(k) Number: K052632

Device Description:

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Feature	ResolutionMDTM	VitalVitrea2TM
Computer Platform	Windows OS or Mac OS	Windows OS
DICOMcompliance	DICOM 3.0	same
2D Imaging	2D image viewer withinteractive user controls	same
3D Imaging	3D volume rendering withinteractive controls	same
Measurement	2D measurement tools	same
Maximum IntensityProjection (MIP)	MIP with interactivecontrols and clipping planes	same
Prescription Use	Yes	same
Intended Users	Trained professionals	same
Calcium Score	Agatston and volumetricscores	same
Artery detection	Automated and manualcenterline detection	same
Curved multi-planarreconstruction	Curved MPR of arterycenterline with cross-sectional images	same
Reporting	Report summary generationfrom Cardiac analysis	same

Substantial Equivalence Comparisons to Predicate Device:

Intended Use:

The ResolutionMD™ Cardiac Product Family is intended for use as a diagnostic, review, and analysis tool by trained professionals such as physicians, technologists, and nurses. When interpreted by a trained physician, reviewed images may be used as an element for diagnosis. It is the user's responsibility to ensure that the software is installed on appropriate hardware and that image quality is suitable for the clinical application.

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Image /page/2/Picture/0 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 an eagle or bird-like figure with three curved lines representing its wings or body.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

JUN - 1 2007

Mr. Pierre Lemire President & Chief Operations Officer Calgary Scientific, Inc. Suite 208 - 1210 20th Avenue., SE Calgary, Alberta CANADA T2G 1M8

Re: K071086

Trade/Device Name: ResolutionMD™ Cardiac Product Family Regulation Number: 21 CFR §892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 12, 2007 Received: April 17, 2007

Dear Mr. Lemire:

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 (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, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/2/Picture/10 description: The image is a black and white circular logo. The logo has the text "1906-2006" at the top, and the letters "FDA" in a large font in the center. Below the letters are the words "Centennial" and three stars. The text "U.S. Food & Drug Administration" is written around the border of the circle.

Protecting and Promoting Public Health

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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.

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 this letter:

21 CFR 876.xxxx 21 CFR 884.xxxx 21 CFR 892 xxxxx Other

(Gastroenterology/Renal/Urology) (Obstetrics/Gynecology) (Radiology)

240-276-0115 240-276-0115 240-276-0120 240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.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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Indications for Use

Applicant: Calgary Scientific, Inc., Suite 208 - 1210 20th Ave. SE, Calgary, Alberta, CANADA T2G 1M8

510(k) Number (if known):

Device Name: ResolutionMD™ Cardiac Product Family

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hulu Remunduz
(Division Sign Off)

e. Abdomina

Confidential

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).