ResolutionMD™ 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.

ResolutionMD™ 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

ResolutionMDTM 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, and 2D and 3D image measurements. The user controls these functions with a system of interactive menus and tools.

AI/ML Overview

The provided text describes a 510(k) summary for the ResolutionMD™ software, a Picture Archiving and Communication System (PACS). However, it does not contain information about specific acceptance criteria for a study proving device performance, nor details of such a study.

The text focuses on the device description, its intended use, a comparison to predicate devices, and the FDA's clearance letter acknowledging its substantial equivalence.

Therefore, for aspects related to acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, and comparative effectiveness studies, the provided document does not contain the requested information.

Here's what can be extracted and what is explicitly not available from the provided text, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "The release version of the software passed all tests considered critical in terms of patient safety and demonstrated an overall acceptable performance for release as determined by the predefined release criteria."
No specific acceptance criteria (e.g., quantifiable metrics like sensitivity, specificity, or error rates) or reported device performance data are provided. The comparison table lists features and functionality against predicate devices, not performance metrics.

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

Not available. The document states "ResolutionMD™ software has been extensively tested on a variety of platforms by both members of the development and quality control team and by potential customers serving as beta testers." This describes testing activities but does not provide details about a formal test set, its sample size, or data provenance.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not available. There is no mention of ground truth establishment methodology or the use of experts for this purpose in the context of performance evaluation.

4. Adjudication Method for the Test Set

Not available.

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

Not available. No mention of an MRMC study or an effect size for human readers with and without AI assistance is present. As this is a PACS viewing and processing software, not an AI diagnostic tool, such a study would generally not be expected.

6. Standalone (Algorithm Only) Performance Study

Not available. The document describes a software PACS for display and visualization, which inherently involves human interaction, so a "standalone" algorithm-only performance might not be directly applicable in the same way it would for an AI-driven diagnostic algorithm. The testing described is focused on the software's functionality and safety.

7. Type of Ground Truth Used

Not available.

8. Sample Size for the Training Set

Not available. This device is a PACS viewing software, not an AI model that typically requires a 'training set' in the machine learning sense. The software's development likely involved standard software engineering and quality assurance practices, rather than machine learning training.

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

Not available. (See point 8)

Summary of available information related to validation:

Testing Philosophy: The software underwent testing by development, quality control teams, and beta testers. A hazard analysis was conducted, classifying the level of concern as "minor."
Outcome of Testing: The release version "passed all tests considered critical in terms of patient safety and demonstrated an overall acceptable performance for release as determined by the predefined release criteria."
Substantial Equivalence: The ultimate proof of the device's acceptability for market clearance is its "substantial equivalence" to legally marketed predicate devices (Lucion™, Plug 'n View 3D™, Vitrea 2™), based on intended use and technological characteristics. The provided table highlights functional similarities (e.g., DICOM compliance, 2D/3D imaging, measurement tools, MIP).

In conclusion, while the document confirms the device passed internal tests and was deemed substantially equivalent, it lacks the detailed quantitative performance data and study methodologies typically found in submissions for AI-powered diagnostic devices or those requiring specific performance metrics against a clinical ground truth. This is consistent with a PACS software device submission from 2006, where the focus would be more on functionality, safety, and equivalence to existing cleared devices rather than a detailed clinical performance study comparing against ground truth in a large cohort.

Summary

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Kol 2164

5 510(k) Summary

Date Prepared:	July 21, 2006
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, Chief Technology Officer
Proprietary Name:	ResolutionMD™
Common Name:	Software PACS
Classification:	892.2050 Picture archiving and communications system,Product Code LLZ, (Class II)
SubstantiallyEquivalent to:	Tradename: LucionManufacturer: Mevisys510(k) Number: K050033
	Tradename: Plug 'n View 3DManufacturer: Voxar Limited510(k) Number: K992654
	Tradename: Vitrea 2Manufacturer: Vital Images, Inc.510(k) Number: K032748

Device Description:

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The ResolutionMD™ software has been extensively tested on a variety of platforms by both members of the development and quality control team and by potential customers serving as beta testers. A hazard analysis has been conducted and the level of concern has been classified as minor. The release version of the software passed all tests considered critical in terms of patient safety and demonstrated an overall acceptable performance for release as determined by the predefined release criteria.

Feature	ResolutionMD™	MevisysLucion™	Voxar Plug'n View 3D™	VitalVitrea 2™
ComputerPlatform	Windows OS orMac OS	Windows OS	Windows OS	Windows OS
DICOMcompliance	DICOM 3.10	DICOM 3.0	DICOM 3.0	DICOM 3.0
2D Imaging	2D image viewerwith interactiveuser controls	same	same	same
3D Imaging	3D volumerendering withinteractive controls	same	same	same
Measurement	2D measurementtools	same	same	same
MaximumIntensityProjection (MIP)	MIP withinteractive controlsand clipping planes	same	same	same
Prescription Use	Yes	same	same	same
Intended Users	TrainedProfessionals	same	same	same

Substantial Equivalence Comparisons to Predicate Devices:

Intended Use:

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

SEP 2 2 2006

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

Re: K062164

Trade/Device Name: ResolutionMDTM Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 25, 2006 Received: July 28, 2006

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/3/Picture/10 description: The image is a circular logo with the letters "FDA" in the center. Above the letters, the numbers "1876-1976" are displayed, and below the letters, the word "Centennial" is written. Three stars are located at the bottom of the circle. The logo appears to be a commemorative emblem for the centennial of the FDA.

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.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

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 from the Division of Small Manufacturers, 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/cdrl/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

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):

ResolutionMD™M Device Name:

Indications for Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________ X (Part 21 CFR 801 Subpart D)

ADD/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)

David C. Lyymm

Division of Reproductive, Abdon and Radiological Devices 510(k) Number _

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).