ResolutionMD™ Mobile 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 medical images as well as reports on the mobile device.

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.

ResolutionMD Mobile is not to be used for mammography.

Device Description

The ResolutionMD™ Mobile 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 on the mobile device.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in a quantifiable manner (e.g., "accuracy must be >90%"). Instead, the primary acceptance criterion for the clinical testing appears to be agreement among radiologists that the mobile devices running ResolutionMD Mobile provide image quality and diagnostic confidence equivalent or comparable to a predicate PACS workstation for clinical use across various modalities, leading to the same diagnosis.

Criteria Category	Acceptance Criteria (Implied)	Reported Device Performance
Clinical Performance	Image quality and diagnostic confidence on mobile devices with ResolutionMD Mobile must be equivalent or comparable to a predicate PACS workstation for diagnostic radiology across X-ray, ultrasound, PET, and SPECT modalities. Radiologists must be comfortable with diagnoses made on the mobile devices. The overall clinical image display quality on mobile devices must be equivalent to the PACS workstation for identification of clinically-relevant pathology. Radiologists must indicate acceptable quality for regular use and comfort reviewing images on the devices. The same diagnosis should be made on mobile devices with ResolutionMD as on the predicate PACS workstation in both office and low light conditions.	All nine radiologists agreed that the iOS and Android mobile devices (smartphones and tablets) were either "equivalent" or "comparable" to the predicate PACS workstation across all four modalities (X-ray, ultrasound, PET, SPECT) and of adequate quality for clinical use. They were comfortable with the diagnoses made on the mobile devices using the ResolutionMD Mobile software. All agreed that the overall clinical image display quality on the iOS and Android devices was equivalent to the PACS workstation for the identification of clinically-relevant pathology. All nine radiologists indicated that the software and devices provide acceptable quality for regular use and they were comfortable reviewing images on the devices. For all individual cases, there was agreement by all reviewers that the same diagnosis would be made on the mobile devices with ResolutionMD as on the predicate PACS workstation in office lighting conditions and in low light conditions. None noted perception differences between lighting conditions.
Technical Performance	Mobile device performance (iOS/Android, smartphones/tablets) in combination with ResolutionMD Mobile must provide acceptable image quality for diagnostic radiology, particularly concerning luminance response as per AAPM guidelines.	Specific results regarding measured luminance from mobile devices with respect to target luminance response using JND plots were provided to the FDA as requested. (The specific numerical values or pass/fail thresholds are not detailed in the summary, but the implication is they met an acceptable standard.)
Software Verification/Validation	The software must undergo functional, smoke, and regression tests, and beta tests with minimal critical defects. Clinical workflows must be validated for usability and consistency across client platforms (Web, iOS, Android).	Verification testing included over 160 separate tests, executed multiple times by different testers (functional, smoke, regression). Beta tests were performed. Most tests passed. Defects were either fixed or logged as unresolved anomalies with impact on safety/effectiveness annotated. Validation testing was performed by trained radiology personnel based on typical clinical workflows, including usability assessment and consistency across Web, iOS, and Android platforms.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: The document mentions "a series of typical yet challenging X-ray, ultrasound, PET and SPECT cases." The exact number of cases is not specified, only that there were "individual cases" for which agreement was reached.
Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It just refers to "typical yet challenging X-ray, ultrasound, PET and SPECT cases."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Nine (9) board-certified radiologists.
Qualifications of Experts: Board-certified radiologists in the United States. No further detail on experience (e.g., "10 years of experience") is provided, but board-certification implies a certain level of expertise.

4. Adjudication method for the test set

The adjudication method appears to be a form of consensus or agreement. The study states, "All nine radiologists agreed that the iOS and Android mobile devices... were either 'equivalent' or 'comparable'..." and "For all the individual cases, there was agreement by all reviewers that the same diagnosis would be made..." This suggests a process where all radiologists had to concur, but the specific mechanics (e.g., independent review followed by discussion, or a sequential review) are not detailed. It is not explicitly a 2+1 or 3+1 method where disagreements are resolved by an additional reader.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance

MRMC Comparative Effectiveness Study: Yes, a comparative assessment was done. The study specifically compared diagnostic confidence on mobile devices with ResolutionMD Mobile to a predicate PACS workstation. This constitutes a comparison of human readers using different display/interpretation systems.
Effect Size of Human Readers Improvement with AI vs. without AI Assistance: This device is a PACS (Picture Archiving and Communication System) viewer for mobile devices, not an AI-powered diagnostic assist tool. Therefore, the study does not evaluate improvement with AI assistance. It evaluates the equivalence of a mobile viewing platform to a full workstation. The "effect size" is expressed qualitatively as being "equivalent" or "comparable" to the predicate PACS workstation.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

No, a standalone (algorithm only) performance study was not done for diagnostic interpretation. ResolutionMD Mobile is a display and communication system, intended for use by trained professionals, not to autonomously interpret images. The clinical testing specifically involved human radiologists making diagnoses using the device.

7. The type of ground truth used

The ground truth was established by expert consensus among the panel of nine board-certified radiologists. They made comparative assessments and agreed on the diagnostic equivalence between the mobile device and the predicate PACS workstation for the tested cases. There is no mention of pathology or outcomes data being used as the definitive ground truth reference.

8. The sample size for the training set

The document does not provide information on a "training set" for the ResolutionMD Mobile software in the context of diagnostic interpretation. As a PACS viewer, it's not a machine learning model that is "trained" on images in the same way an AI algorithm for disease detection would be. The software is developed and verified through standard software engineering practices.

9. How the ground truth for the training set was established

Not applicable, as there is no mention of a training set for the diagnostic function of the device in the context of machine learning. The "ground truth" for the software's functionality would be adherence to DICOM standards, performance metrics (like luminance), and usability, as confirmed by verification and validation testing, rather than medical ground truth established from labeled medical images for training purposes.

Summary

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MAR 26 2014

K133508
Page 1 of 4

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 ofManufacturer:	Calgary Scientific Inc.Suite 208, 1210 - 20th Ave. SECalgary, AlbertaT2G 1M8CANADA
Date of Submission:	November 12, 2013
Identification of the Device
Device Proprietary Name:	ResolutionMD Mobile
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 3.1ResolutionMD MobileMobile MIMCentricity PACS	Calgary Scientific Inc.Calgary Scientific Inc.MIM Software Inc.GE Healthcare	K123186 K111346 K112930 K110875

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Device Description:

Based on benchmark testing by radiologists comparing diagnostic confidence on the X-ray, ultrasound, PET and SPECT modalities on mobile devices with ResolutionMD Mobile to a predicate PACS workstation, this version amends the Indications for Use to include all DICOM 3.0 images.

Indications for Use:

ResolutionMD Mobile is not to be used for mammography.

Technological Characteristics

The ResolutionMD™ Mobile software has the same technological characteristics as the predicate ResolutionMD Devices and has the same uses and applications as the predicate devices. Both the device and predicates 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 tests, 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 Scientific'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.

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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.

Performance Testing

Performance testing was conducted to qualify iOS and Android mobile devices, both smartphones and tablets, 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.

The specific results regarding the measured luminance from the mobile devices with respect to the target luminance response using JND plots was provided to the FDA as requested.

Clinical Testing

Clinical testing was conducted by a panel of nine board-certified radiologists in the United States. The radiologists conducted a side-by-side comparative assessment of the iOS and Android mobile devices running ResolutionMD Mobile with the predicate PACS workstation. A series of typical yet challenging X-ray, ultrasound, PET and SPECT cases were reviewed on each device. Comparative assessments of image quality and diagnostic confidence were made by each radiologist.

All nine radiologists agreed that the iOS and Android mobile devices, both smartphones and tablets, were either "equivalent" or "comparable" to the predicate PACS workstation across all four modalities and of adequate quality for clinical use. They were comfortable with the diagnoses made on the mobile devices using the ResolutionMD Mobile software. All agreed that the overall clinical image display quality on the iOS and Android devices was equivalent to the PACS workstation for the identification of clinically-relevant pathology.

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

For all the individual cases, there was agreement by all reviewers that the same diagnosis would be made on the mobile devices with ResolutionMD as on the predicate PACS workstation in office lighting conditions and in the low light conditions. None of the reviewers noted any differences in their perception of the images between the low light and office lighting conditions.

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K133508
Page 4 of 4

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 software is substantially equivalent to the predicate devices. The device and the predicates are post-processing and provide the same or similar essential features of visualization of radiological data on mobile devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the emblem in a circular fashion.

Public Health Service

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

March 26, 2014

Calgary Scientific, Inc. % Mr. Kyle Peterson Director, Regulatory & Corporate Affairs Suite 208, 1210 -20th Avenue SE Calgary, Alberta T2G 1 M8 CANADA

Re: K133508

Trade/Device Name: ResolutionMD Mobile Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Il Product Code: LLZ Dated: February 27, 2014 Received: March 6, 2014

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, listing 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.lda.gov/Medicall.cc/Resourcesfor You/Industrv/default.htm. 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/ReportalProblem/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.hum.

Sincerely yours,

Sm.h.7)

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

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

510(k) Number: K133508

Device Name: ResolutionMD™ Mobile

Indications for Use:

ResolutionMD Mobile is not to be used for mammography.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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 (OlR)

Smh.7)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k) K133508

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).