The ResolutionMD™ Mobile software is a software-based Picture Archiving and Communication System (PACS) used with general purpose computing servers and specific mobile devices. It provides for communication, storage, reformatting, rendering on the server component and communication and display of DICOM 3.0-compliant CT and MR medical images as well as reports on the mobile device.

The ResolutionMD Mobile provides wireless and portable access to medical images. The device is intended for use as a diagnostic, review, and analysis tool by trained professionals such as radiologists, physicians and technologists. This device is not intended to replace full workstations and should be used only when there is no access to a workstation.

The ResolutionMD Mobile is not to be used for mammography.

Device Description

The ResolutionMD™ Mobile 3.1 software is a software-based Picture Archiving and Communication System (PACS) used with general purpose computing servers and highresolution Apple Inc. iOS and Google Inc. Android OS-based wireless mobile devices for the display and advanced visualization of medical image data. It provides for communication, storage, processing, rendering on the server and the display of DICOM 3.0 compliant image data derived from CT and MRI on the mobile device.

AI/ML Overview

The ResolutionMD Mobile 3.1 is a software-based Picture Archiving and Communication System (PACS) intended for use as a diagnostic, review, and analysis tool for CT and MR medical images on specific mobile devices. It is not intended to replace full workstations and should not be used for mammography.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA submission for ResolutionMD Mobile 3.1 (K123186) primarily focuses on establishing substantial equivalence to a predicate device (ResolutionMD Mobile, K111346). The acceptance criteria for the new version, specifically supporting Android devices, revolve around demonstrating that the image quality and diagnostic confidence achieved on Android platforms are comparable to the previously cleared iOS platforms (predicate device) and adequate for clinical use.

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Technical Performance	Adherence to AAPM Assessment of Display Performance for Medical Imaging Devices (2005) for image quality standards.	Nine tests of display performance, conducted by an ISO 17025-certified third party, were performed for each mobile device (Android smartphone and Android tablet) running ResolutionMD Mobile. Both devices passed all of the tests, ensuring high-quality laboratory results and traceable calibration to NIST.
Clinical Equivalence	Image quality and diagnostic confidence on Android mobile devices running ResolutionMD Mobile must be comparable to predicate iOS devices and of adequate quality for clinical use, particularly for the identification of clinically-relevant pathology. Comfort level with diagnoses made on Android devices.	All three board-certified radiologists agreed that: - The Android mobile devices (smartphone and tablet) were comparable to the predicate iPhone and iPad devices. - The devices were of adequate quality for clinical use. - They were comfortable with the diagnoses made on the Android mobile devices using the ResolutionMD Mobile software. - The overall clinical image display quality on the Android devices was equivalent to the iOS devices for the identification of clinically-relevant pathology. - Comments on image contrast and sharpness included "very comparable" and "is diagnostic." - No image artifacts were noted by the reviewers. - The software and devices provide acceptable quality for regular use, and they were comfortable reviewing images.

Study Proving Acceptance Criteria:

The study combined Performance Testing and Clinical Testing to demonstrate the device meets the acceptance criteria.

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

Performance Testing Test Set: The sample size for the display performance tests was two mobile devices: an Android smartphone and an Android tablet.
- Data Provenance: The tests were conducted by an ISO 17025-certified third party, implying controlled laboratory conditions and objective measurements. The data is "prospective" in the sense that the tests were specifically designed and executed to evaluate the new device's performance. The country of origin of the data is not explicitly stated, but the ISO certification and NIST traceability suggest an internationally recognized standard of testing.
Clinical Testing Test Set: Not explicitly stated, but it involved a "series of typical CT and MR cases."
- Data Provenance: The cases were reviewed by a panel of radiologists in the United States. The specific nature (retrospective/prospective) of the "series of typical CT and MR cases" is not detailed, but it likely involved retrospective cases from clinical archives for evaluation.

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

Performance Testing: Ground truth was established by adherence to the AAPM Assessment of Display Performance for Medical Imaging Devices (2005) document. The "experts" in this context are the authors and contributors of the AAPM document, representing a consensus of medical physics and imaging professionals on display performance standards. The testing was carried out by an ISO 17025-certified third party, ensuring expertise in calibration and measurement.
Clinical Testing: Three board-certified radiologists in the United States. Their specific years of experience are not mentioned, but "board-certified" indicates a recognized high level of expertise in diagnostic radiology.

4. Adjudication Method for the Test Set

Performance Testing: The adjudication method was based on whether the devices "passed all of the tests" as defined by the AAPM document. This implies a pass/fail threshold for each of the nine display performance tests.
Clinical Testing: The adjudication method was based on consensus among all three radiologists. The document repeatedly states "All three radiologists agreed that..." and refers to their collective findings. This indicates a form of unanimous consensus. There's no mention of a 2+1 or 3+1 rule; rather, it appears all three came to the same conclusion directly.

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

No, an MRMC comparative effectiveness study was not done in the context of AI assistance. This submission is for a PACS visualization device, not an AI diagnostic algorithm. The clinical testing was a comparative assessment between human readers using the Android mobile devices vs. human readers using the predicate iOS devices to establish equivalence in image display quality and diagnostic confidence. It did not involve comparing human readers with and without AI assistance to measure an effect size related to AI improvement. The device itself is a display and analysis tool, not an AI-powered diagnostic aid.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone (algorithm-only) performance was not done. This device is a software-based PACS for image display and review by trained professionals. Its intended use inherently involves a "human-in-the-loop" for interpretation and diagnosis. The performance testing focused on the display capabilities of the device, and the clinical testing assessed human readers' diagnostic confidence and image quality perception when using the device.

7. The Type of Ground Truth Used

Performance Testing: The ground truth was based on established technical standards and objective measurements as outlined in the AAPM Assessment of Display Performance for Medical Imaging Devices (2005). The test equipment and calibration were certified traceable to NIST, further solidifying the objectivity of the ground truth.
Clinical Testing: The ground truth for comparative image quality and diagnostic confidence was expert consensus among the three board-certified radiologists comparing the Android display to the predicate iOS display for "clinically-relevant pathology." While the "clinically relevant pathology" implies there was a true pathological state in the cases, the primary "ground truth" for the equivalence assessment was the radiologists' agreement on the adequacy of the display for identifying that pathology.

8. The Sample Size for the Training Set

Not Applicable / Not Provided. This submission primarily addresses the substantial equivalence of a new version of a PACS viewing software on Android devices to a previously cleared version on iOS. It describes the software's design and testing relative to established display standards and clinical usability. There is no mention of machine learning or AI components that would require a distinct "training set" in the traditional sense. The software's development would involve standard software engineering practices, verification, and validation, rather than a machine learning training phase.

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

Not Applicable / Not Provided. As there's no mention of a distinct "training set" for a machine learning algorithm, there's no information on how a ground truth for such a set was established.

Summary

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K123186

MAR 1 4 2013

5 510(k) Summary As required by 21 CFR Part 807 87(h)

Submitter:	Kyle PetersonDirector, Regulatory & Corporate AffairsCalgary Scientific Inc.Suite 208, 1210 - 20th Ave. SECalgary, AlbertaT2G 1M8CANADA
Telephone Number:	(403) 767-7945
Fax Number:	(403) 270-2771
Name / Address of Manufacturer:	Calgary Scientific Inc.Suite 208, 1210 - 20th Ave. SECalgary, AlbertaT2G 1M8CANADA
Date of Submission:	September 14, 2012
Identification of the Device
Device Proprietary Name:	ResolutionMD Mobile 3.1
Common Name:	Picture Archiving and Communication System
Classification Name:	Picture Archiving and Communication System per21 CFR 892.2050
Product Code:	LLZ
Device Class:	Class II

Marketed Device to which Equivalence is claimed:

Device	Manufacturer	510(k) Number
ResolutionMD Mobile	Calgary Scientific Inc.	K111346

ﺘﻲ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍ

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Device Description:

Indications for Use:

The ResolutionMD Mobile is not to be used for mammography.

Technological Characteristics

The ResolutionMD™ Mobile 3.1 software adds support for mobile devices running the Android operating system and has the same uses and applications as the predicate device. Both the device and predicate are used by the clinician as a diagnostic, review, and analysis tool for radiological images.

Software Verification and Validation Testing

Verification testing consisting of more 160 separate testers, each executed multiple times by different testers, was performed for this device. Testing included functional, smoke and regression tests and was complemented by beta tests performed by Calgary Scientifie's OEM distribution partners. The vast majority of tests passed our testing criteria. Any defects found or reported were either fixed or logged in the Unresolved Anomalies report included with this submission and annotated as to any impact on safety or effectiveness including applicable workarounds.

Validation testing based on typical clinical workflows was performed by trained radiology personnel. Validation includes usability assessment and consistency across three client platforms; Web, iOS and Android (the subject of this submission and both phone and tablet devices.

Image /page/1/Picture/11 description: The image shows the text 'K123186' enclosed in a rounded rectangular box. The text is in a simple, sans-serif font and is horizontally centered within the box. The box is outlined with a thin, dark line, providing a clear boundary for the text.

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Performance Testing

Performance testing was conducted to qualify an Android smartphone and an Android as devices whose off-the-shelf performance in combination with the overall attributes of the ResolutionMD Mobile solution provides acceptable image quality for diagnostic radiology.

The tests were performed in accordance with the description and requirements described in the AAPM Assessment of Display Performance for Medical Imaging Devices (2005) document by an ISO 17025-certified third party to ensure high quality laboratory results. The test equipment and calibration was certified traceable to NIST.

Nine tests of display performance were conducted for each mobile device running ResolutionMD Mobile and both devices passed all of the tests.

Clinical Testing

Clinical testing was conducted by a panel of three board-certified radiologists in the United States. The radiologists conducted a side-by-side comparative assessment of the Android mobile devices running ResolutionMD Mobile with the predicate iOS devices. A series of typical CT and MR cases were reviewed on each device. Comparative assessments of image quality and diagnostic confidence were made by each radiologist.

All three radiologists agreed that the Android mobile devices, both the smartphone and tablet, were comparable to the predicate iPhone and iPad devices and of adequate quality for clinical use. They were comfortable with the diagnoses made on the Android mobile devices using the ResolutionMD Mobile software. All agreed that the overall clinical image display quality on the Android devices was equivalent to the iOS devices for the identification of clinically-relevant pathology. There were similar comments on image contrast and sharpness with comments including "very comparable" and "is diagnostic". No image artifacts were noted by the reviewers.

All three radiologists indicated that the software and devices provide acceptable quality for regular use and they were comfortable reviewing images on the devices.

Safety and Effectiveness

The device is designed and manufactured under Quality System Regulations as outlined in 21 CFR 820. All requirements of Picture Archiving and Communications System (21 CFR 892.2050) are met, and software is in compliance with ISO 14971 and ISO 62304.

Substantial Equivalence:

Based on the above considerations, Calgary Scientific Inc. believes that the ResolutionMD Mobile 3.1 software is substantially equivalent to the predicate device. The device and the predicate are both post-processing and provide the same features of visualization of radiological data on mobile devices.

Image /page/2/Picture/12 description: The image contains the text 'K123186'. The text appears to be a code or identifier, possibly related to a product or document. The text is in a simple, sans-serif font and is presented in a straightforward manner.

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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three wavy lines representing the branches of government. The seal is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The overall design is simple and conveys the department's focus on health and human welfare.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 14, 2013

Kyle Peterson Director, Regulatory and Corporate Affairs Calgary Scientific Inc. Suite 208, 1210 - 20th Avenue SE CALGARY, ALBERTA T2G 1M8 CANADA

Re: K123186

Trade/Device Name: ResolutionMD™MD™ Mobile 3.1 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 14, 2013 Received: February 19, 2013

Dear Mr. Peterson:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading,

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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Page 2-Mr. Peterson

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Sm.h.P)

for

Janine M. Morris Director. Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement 4

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

510(k) Number: K123186

Device Name: ResolutionMD™ Mobile 3.1

Indications for Use:

The ResolutionMD™ Mobile software is a software-based Picture Archiving and Communication System (PACS) used with general purpose computing servers and specific mobile devices. It provides for communication, storage, reformatting, rendering on the server component and communication and display of DICOM 3.0compliant CT and MR medical images as well as reports on the mobile device.

The ResolutionMD Mobile is not to be used for mammography.

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

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

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

Concurrence of CDRH, Office of In-Vitro Diagnostics and Radiological Health (OIR)

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

510 (k) K123186

Page 1 of 1

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).