Visage Ease Pro is a mobile client for diagnostic image viewing of radiological images from the following modalities: Xray, CT, MRI, PET, SPECT, Ultrasound and XA. It is based on the Visage 7 product for distributing, viewing, processing, and archiving medical images within and outside health care environments.

Visage Ease Pro must only be used by trained health care professionals. It may support physicians and/or the medical staff by providing mobile access to relevant medical images. Any diagnostic decision resides with the doctors and/or the medical staff in their respective area of responsibility.

Visage Ease Pro is not intended to replace full radiologic reading workstations. It must not be used in the context of diagnostic or therapeutic decisions if a radiologic reading workstation with appropriate display hardware is available. The user must make sure that the reading environment complicable diagnostic requirements and the state-of-the-art.

Visage Ease Pro must not be used for primary image diagnosis in mammography or digital breast tomosynthesis.

Device Description

Visage Ease Pro is a mobile client for diagnostic image viewing of radiological images, image review by clinicians and image display for illustration and educational purposes. It is based on the Visage 7 product for distributing, viewing, processing, and archiving medical images within and outside health care environments.

Visage Ease Pro has a graphical user interface which is optimized for mobile devices with a touch screen. The app allows searching for studies and viewing images and reports. The user may zoom and pan images, adjust the window level, browse through a stack of images or play a cine animation. Patient and image information is displayed as viewer text. The app supports voice memos, image attachments and push notifications.

Visage Ease Pro is designed as a thin client in a single module and allows to remotely access the images on a Visage 7 server. The communication between the mobile client and the server is encrypted. The user must authenticate himself with username and password. A connection can only be established, if the user has the appropriate permissions for using the mobile client. These permissions are configurable on the Visage 7 server.

AI/ML Overview

The provided document does not contain the specific acceptance criteria and detailed study results that would typically be found in a performance study report. This document is a 510(k) summary for the Visage Ease Pro, which primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed performance study with quantitative acceptance criteria and results against those criteria.

However, based on the information available, I can extract and infer some details:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria or report specific performance metrics like sensitivity, specificity, or reader agreement percentages. Instead, the "clinical validation" described is qualitative and focused on functional equivalence.

Acceptance Criteria (Inferred from "Summary of testing")	Reported Device Performance
Primary operating functions are equivalent to predicate devices for clinical use cases:	Clinically validated as equivalent to predicate devices Visage 7® and Mobile MIM™
Loading of images	Functionality is equivalent
Selecting a series of images	Functionality is equivalent
Adjusting the window level	Functionality is equivalent
Zooming and panning an image	Functionality is equivalent
Browsing through a stack of images	Functionality is equivalent
Playing cine animations	Functionality is equivalent
No new clinical functionality compared to Visage 7	Confirmed
Identical behavior and leading to same diagnosis as predicate devices	Confirmed by clinical validation

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not explicitly stated. The document mentions "The data sets for the modalities CT, CR, DX, MRI, PET, SPECT, US, and XA are viewed with the predicate devices and Visage Ease Pro." This implies a set of diverse radiological images, but the exact number is not provided.
Data Provenance: Not explicitly stated.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not explicitly stated. The "clinical validation" implies expert review, but the number and qualifications of the experts or how ground truth was established are not detailed in this summary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not explicitly stated. Given the qualitative nature of the validation described, it's unlikely a formal adjudication method for ground truth was applied in a traditional sense for quantitative performance metrics. The validation seems to involve expert comparison of functionalities.

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 such study was mentioned. The device is a mobile viewing client and not an AI-powered diagnostic tool, so an MRMC comparative effectiveness study regarding "human readers improve with AI" would not be applicable here. The validation focused on functional equivalence to other viewing platforms.

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

This question is not entirely applicable as the Visage Ease Pro is a mobile client for viewing images, not an algorithm that performs standalone diagnostic functions. Its performance is tied to its ability to display images accurately and provide viewing functionalities comparable to predicate devices. The "standalone" performance, in this context, would be the consistent and correct execution of its stated functionalities. The document states it was "clinically validated" for its primary operating functions, which is a form of standalone functional verification.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not explicitly stated. Given the device's function as an image viewer, the "ground truth" for its functional validation would likely be the correctness and completeness of image display and manipulation features compared to the known characteristics of the images and the performance of the predicate devices. This would involve technical specifications and potentially expert-confirmed visual accuracy.

8. The sample size for the training set

This device appears to be a software client for viewing images rather than a machine learning algorithm that requires a training set in the typical sense. Therefore, "training set" is not applicable.

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

Not applicable (see point 8).

In Summary:

The provided document is a 510(k) summary for a medical image viewing client. Its "acceptance criteria" and "study" are primarily focused on demonstrating substantial equivalence to existing predicate devices in terms of functionality for viewing radiological images. It does not contain quantitative performance metrics, detailed study designs (like MRMC), or information typically associated with AI/CAD systems that require extensive annotated datasets and statistical performance evaluations. The clinical validation appears to be a qualitative assessment of the device's ability to perform its viewing functions similarly to already cleared devices.

Summary

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Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, with flowing lines beneath them.

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

April 28, 2015

Visage Imaging GmbH % Mr. Stefan Strowich Manager of Quality Systems and Regulatory Affairs Lepsiustrasse 70 Berlin 12163 GERMANY

Re: K142196 Trade/Device Name: Visage Ease Pro Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 11, 2015 Received: February 12, 2015

Dear Mr. Strowich:

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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,

Robert A Ochs

Robert Ochs. Ph.D. Acting 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

510(k) Number (if known) K142196

Device Name Visage Ease Pro

Indications for Use (Describe)

Visage Ease Pro must not be used for primary image diagnosis in mammography or digital breast tomosynthesis.

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for Visage Imaging. The logo consists of a green and gray geometric shape on the top left, with the words "Visage Imaging" in black font to the right of the shape. The word "Imaging" is in bold font, and there is a registered trademark symbol after the word.

510(k) Summary of Safety and Effectiveness

In accordance with the requirements of the Safe Medical Device Act, Visage Imaging GmbH herewith submits a Summary of Safety and Effectiveness. This 510(k) summary for the Visage Ease Pro meets the requirements of 21 CFR 807.92.

Submitter Information:	Visage Imaging GmbHLepsiusstrasse 7012163 BerlinGermanyPhone: +49 30 700968 41Fax: +49 30 700968 11Registration Number: 9616251Owner/Operator Number: 9040273
Official Correspondent:	Stefan StrowichVisage Imaging GmbHLepsiusstrasse 7012163 BerlinGermanyPhone: +49 30 70096841Fax: +49 30 70096811E-Mail: sstrowich@visageimaging.com
US Agent (Contact):	Brad LevinVisage Imaging, Inc.12250 El Camino Real, Suite 230San Diego, California, 92130, United StatesPhone: +1 703 8585758Fax: +1 858 4082717E-mail: blevin@visageimaging.com
Date Prepared:	August 04st, 2014

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Image /page/4/Picture/0 description: The image shows the logo for Visage Imaging. The logo consists of a geometric shape in the upper left corner, with green and gray colors. The text "Visage Imaging" is written in a bold, sans-serif font below the geometric shape. The word "Imaging" has a trademark symbol next to it.

Device(s) Identification:

Device Trade Name:	Visage Ease Pro
Release Version:	1.5
Device Classification Name:	System, Image Processing, Radiological
Regulation Description:	Picture archiving and communications system
Product Code:	LLZ
Reference:	per 21 CFR 892.2050
Review Panel:	Radiology
Device Class:	II

Device Description:

Intended Use:

Visage Ease Pro must only be used by trained health care professionals. It may support physicians and/or the medical staff by providing mobile access to relevant medical images. Any diagnostic or therapeutic decision resides with the doctors and/or the medical staff in their respective area of responsibility.

Visage Ease Pro must not be used in the context of diagnostic or therapeutic decisions if a radiologic reading workstation with appropriate display hardware is available. The user must make sure that the reading environment complies with any applicable diagnostic requirements and the state-of-the-art.

Visage Ease Pro must not be used for primary image diagnosis in mammography.

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Image /page/5/Picture/0 description: The image shows the logo for Visage Imaging. The logo consists of a geometric shape in the upper left corner, with green and gray colors. The text "Visage Imaging" is written in a serif font below the geometric shape. The word "Imaging" has a trademark symbol next to it.

Visage Imaging GmbH Lepsiusstrasse 70 12163 Berlin Germany

Predicate devices:

1.Device Trade Name:Applicant:510(k) No.:	Visage PACS 6.0 / CS 3.1 (Visage 7)Visage Imaging, INC.K082269
2.Device Trade Name:Applicant:510(k) No.:	Mobile MIM (RT)MIM Software Inc.K112930

The Visage Ease Pro is considered substantial equivalent to the Visage PACS 6.0 / CS 3.1 (K082269), Mobile MIM (RT) (K112930).

Intended use, medical application and treatment method as well as the basic parameter settings are equivalent for the Visage Ease Pro, the Visage PACS 6.0 / CS 3.1 and the Mobile MIM (RT).

Summary of Technological Characteristics

The relevant clinical functions and technological characteristics of Visage Ease Pro are also included in the Mobile MIM (RT) software. The typical work flow is very similar for both devices. Both software devices show an identical behavior and would lead to the same diagnosis. Visage Ease Pro did not have any additional clinical functionality in comparison to Visage 7.

Summary of testing:

Visage Ease Pro is clinically validated against predicate devices. The clinical validation focuses on primary operating functions for clinical use cases. Visage Ease Pro is clinically validated against the predicate devices Visage 7® and Mobile MIM™

The primary operating functions covered by the clinical validation are loading of images, selecting a series of images, adjusting the window level, zooming and panning an image, browsing through a stack of images, and playing cine animations.

The data sets for the modalities CT, CR, DX, MRI, PET, SPECT, US, and XA are viewed with the predicate devices and Visage Ease Pro.

Conclusion:

Visage Imaging GmbH believes that the Visage Ease Pro is substantially equivalent to the currently legally marketed devices. The Visage Ease Pro does not introduce new indications for use, have the same technological characteristics and does not introduce new potential hazards or safety risks.

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).