The ResolutionMD™ 2.1 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, reformatting, rendering, and display of DICOM 3.0 compliant image data derived from various sources including CT and MRI.

The ResolutionMD™ 2.1 device incorporates a Calcium Scoring module which is used to identify and quantify calcified plaque within the coronary arteries. This protocol is performed on noncontrast enhanced cardiac CT data sets. It also includes the Coronary Artery Analysis protocol which is used to visually identify and measure stenoses in the coronary arteries. This protocol is performed on contrast-enhanced cardiac CTA data sets.

The ResolutionMD™ 2.1 software 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. Calgary Scientific recommends that users of the ResolutionMD™ 2.1 software consult the appropriate American College of Radiology Practice Guidelines pertaining to the anatomy and pathology being studied.

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 ResolutionMD™ 2.1 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™ software takes advantage of dedicated graphics hardware to speed the creation 3D rendered images.

The ResolutionMD™ 2.1 is available in a Microsoft Windows version, a Microsoft .NET software development kit version (SDK), a Linux Web server version and in a Macintosh OS version. All 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) and multiplanar reconstruction images (MIP/MPR), 2D and 3D image measurements, calcium scoring, and coronary artery analysis. The user controls these functions with a system of interactive menus and tools.

AI/ML Overview

The provided text describes the ResolutionMD™ 2.1, a software-based Picture Archiving and Communication System (PACS) for displaying and visualizing medical image data. However, it does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or quantitative performance metrics.

The document is a 510(k) summary submitted to the FDA, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance studies with acceptance criteria.

Here's a breakdown of what can be extracted and what is explicitly missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not available. The document does not specify any quantitative acceptance criteria for device performance (e.g., accuracy, precision, processing speed) or a study reporting such performance against those criteria. It focuses on functional equivalence to predicate devices.

2. Sample Size for the Test Set and Data Provenance

Not available. The document does not describe a test set, its sample size, or its data provenance. It mentions "extensive testing on supported platforms by members of the development and quality control team" and "Beta testing by trained cardiology professionals and potential customers" but provides no details on these tests.

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

Not available. Since no specific test set or performance evaluation study is described, there is no information on ground truth establishment or expert involvement for such a study. The document mentions "trained professionals such as physicians, technologists, and nurses" as intended users, and "trained cardiology professionals" for beta testing, but not for ground truth establishment.

4. Adjudication Method for the Test Set

Not available. No test set or corresponding adjudication method is described.

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

Not available. The document does not mention an MRMC study or any assessment of human reader improvement with or without AI assistance. The device is a PACS system with visualization and analysis tools, not an "AI" in the sense of an automated diagnostic algorithm that would typically be evaluated in an MRMC study for improved reader performance.

6. Standalone (Algorithm Only) Performance Study

Not available. The document describes a PACS system with various imaging and analysis functionalities (2D/3D imaging, measurements, calcium scoring, artery analysis). It doesn't detail a standalone performance study of any specific algorithm within the system. The focus is on the integrated system's functionality being substantially equivalent to predicate devices.

7. Type of Ground Truth Used

Not available. No specific performance study is detailed, therefore no ground truth type (e.g., expert consensus, pathology, outcome data) is specified.

8. Sample Size for the Training Set

Not available. The document does not mention any "training set" as it describes a software product, not a machine learning model that would typically require a training set.

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

Not available. As there is no mention of a training set, there is no information on how its ground truth might have been established.

Summary of what is present:

The document primarily serves as a 510(k) application, focusing on:

Device Description: ResolutionMD™ 2.1 is a software-based PACS for display and 3D visualization of medical image data (CT, MRI), with features like 2D/3D imaging, measurements, MIP/MPR, segmentation, calcium scoring, and coronary artery analysis.
Intended Use: Diagnostic, review, and analysis tool for trained professionals. Images reviewed by a trained physician may be used as an element for diagnosis.
Substantial Equivalence: Demonstrated against Vital Vitrea2™ and Vital Connect 4.1 in terms of platform, DICOM compliance, access, imaging features, measurement tools, and intended users.
Hazard Analysis: Conducted and classified as minor.
Testing: "Extensively tested on supported platforms" by development and QC teams, followed by "Beta testing by trained cardiology professionals and potential customers." However, no details on the scope, methodology, or results of this testing are provided beyond general statements about passing critical safety tests and demonstrating acceptable performance.

In conclusion, this document explicitly states that "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." However, it does not provide the specific "predefined release criteria" or the results of the study that proves the device meets them.

Summary

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

KOr2693

FEB 2 3 2009

510(k) Summary

Date Prepared:	August 15, 2008
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:	403.270 2771
Contact:	Pierre Lemire, President & Chief Operations Officer
Proprietary Name:	ResolutionMD™ 2.1
Common Name:	Software PACS
Classification:	892.2050 Picture archiving and communications system,Product Code LLZ, (Class II)
SubstantiallyEquivalent to:	Tradename: Vitrea, Version 4.0 and Vital Connect 4.1Manufacturer: Vital Images, Inc.510(k) Number: K071331 and K071362

Device Description:

A hazard analysis has been conducted and the level of concern has been classified as minor. The ResolutionMD™ 2.1 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.

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

Feature	ResolutionMDTM	VitalVitrea2™	Vital Connect4.1
Computer Platform	Windows OS, Microsoft.NET SDK, Linux OS, orMac OS	Windows OS	Windows OS
DICOMcompliance	DICOM 3.0	same	same
LAN, WAN andWeb access	Server with PC Clientaccess via the Internet, LANor WAN	N/A	same
2D Imaging	2D image viewer withinteractive user controls	same	same
3D Imaging	3D volume rendering withinteractive controls	same	same
Measurement	2D measurement tools	same	same
Maximum IntensityProjection (MIP)	MIP with interactivecontrols and clipping planes	same	same
MultiplanarReformatting(MPR)	MPR with oblique slicingand variable thicknessslabbing	same	same
Segmentation	Manual, semi-automatic andautomatic delineation of ansub-region within an image	same	same
Prescription Use	Yes	same	same
Intended Users	Trained professionals	same	same
Calcium Score	Agatston and volumetricscores	same	same
Artery detection	Automated and manualcenterline detection	same	same
Curved multi-planarreconstruction	Curved MPR of arterycenterline with cross-sectional images	same	same
Reporting	Report summary generationfrom Cardiac analysis	same	same

Substantial Equivalence Comparisons to Predicate Device:

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

Intended Use:

Confidential

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

Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Pierre Lemire President & Chief Technology Officer Calgary Scientific, Inc. Suite 208, 1210 20th Avenue SE Calgary, AB T2G 1MB CANADA

Re: K082693

Trade/Device Name: ResolutionMDTM 2.1 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 6, 2009 Received: February 10, 2009

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 (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.

8 9 3 2004

{4}------------------------------------------------

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 os 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.xxx	(Gastroenterology/Renal/Urology)	(240) 276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	(240) 276-0115
21 CFR 892.xxx	(Radiology)	(240) 276-0120
Other		(240) 276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry.suppot/index.html.

Sincerely yours,

Janine M. Morris

Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

{5}------------------------------------------------

Exhibit 1 - Revised Indications for Use statement

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™ 2.1

Indications for Use:

GE OF

Prescription Use(Part 21 CFR 801 Subpart D)	X
AND/OR
Over-The-Counter Use(21 CFR 801 Subpart C)

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

(Division Sign-Off)

Concurrent Division CDRH reproductive Devic Evaluation (ODE)

Radiological Devices

510(k) Number	K082693
---------------	---------

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).