Quentry Dose Review is a web based software for medical professionals that provides doctors, physicists and physicians with tools for secure online image (DICOM and DICOM RT) review including measurement and RT specific functions, such as display of dose distribution information, isodose lines, and dose volume histograms (DVH).

It is not intended for the review of mammographic images, detailed treatment planning, plan approval or treatment of patients. It is also not intended to be used on mobile systems.

For radiotherapy treatment plan approval, it is required to use the hospital specific workflows, tools and record&verify systems.

Device Description

Quentry Dose Review is part of the online collaboration platform Quentry to share, discuss and transfer medical image data. The viewer provides capabilities to visualize medical images (DICOM and DICOM RT) and dose information.

Quentry is a software platform consisting of a set of server-based components providing functions for transfer and storage of medical data, as well as user access via a web-based portal for data management, sharing, and download. The platform is integrated with desktop and server-based applications for upload and download of medical data from workstations and network-based image archive servers. The platform also provides interfaces for integration of third-party systems and applications. Quentry platform is an FDA class I product.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Quentry Dose Review device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific quantifiable acceptance criteria such as performance metrics (e.g., sensitivity, specificity, accuracy) or error rates that the device was tested against. Instead, the validation section focuses on demonstrating that the "design specifications are met" and that "all test reports were finally rated as successful according to their acceptance criteria."

Therefore, I can infer the "acceptance criteria" were qualitative, relating to functional compliance and usability.

Acceptance Criteria Category (Inferred)	Reported Device Performance (Summary from text)
Functional Compliance	- All design specifications were met through thorough verification at top and subsystem levels. - Successfully loads and imports DICOM images. - Successfully views DICOM images (converted to PNG). - Provides adjustment functionalities (pan, zoom, window, color scheme). - Supports reconstruction from different orientations. - Enables distance and point measurements (gray level, dose value). - Reviews imported DICOM objects and fused images. - Supports cine loop playing for multiframe DICOM. - Loads, displays, compares, and analyzes RT plan information (isodose lines, DVH, dose distribution, dose analysis, manual normalization).
Usability	- Usability tests performed to ensure useful workflow and user interface. - All usability test reports rated as successful. - Workflow included patient selection as an interface between Quentry.com Portal and Quentry Dose Review.
Substantial Equivalence	- Demonstrated similar functionality, intended use, technological characteristics, and typical users compared to predicate devices (Advanced Viewer and iPlan RT). - No new issues concerning safety and effectiveness were introduced.
Technical Environment Compatibility	- Verified compatibility with specified operating systems (Windows XP+, Mac OS X 10+). - Verified compatibility with specified browsers (IE 8+, FireFox 3.x+, Chrome 10+, Safari 5+). - Requires Microsoft® Silverlight® plugin. - Hardware recommendations met (2GB RAM+, 1024x768 screen+, mouse). - Network requirements met (2 Mbit/sec+ stable internet, open outbound port 80/443).

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

Sample Size for the Test Set: The document does not specify the sample size of the test set used for verification and validation. It mentions "All test reports" without providing a number of cases or datasets.
Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. It only mentions the device allows for "secure online image (DICOM and DICOM RT) review," implying diverse data sources, but no specifics are provided for the testing data.

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

The document does not specify the number of experts used to establish ground truth for the test set or their specific qualifications (e.g., "radiologist with 10 years of experience"). It mentions the intended users are "Physicians, Radiologists, Radio oncologists or their assistants" and that "usability tests" were conducted, suggesting clinical input, but no details on ground truth establishment are provided.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1, none) used for establishing ground truth or resolving discrepancies in the test set evaluation.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or at least not described in this 510(k) summary. The device, "Quentry Dose Review," is a viewing and review software, not an AI-assisted diagnostic tool designed to improve human reader performance in the sense of a standalone AI algorithm. Its purpose is to facilitate review and collaboration for medical professionals.

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

Yes, a form of "standalone" evaluation was done in the sense of functional verification and non-clinical validation of the software itself. The verification ensures the software meets its design specifications, and the non-clinical validation (usability tests) ensures the interface is useful. However, this is not a standalone diagnostic performance study typical for AI algorithms; it's a validation of software functionality and usability. The device is a "viewer" and "review" tool, not an AI for interpretation.

7. The Type of Ground Truth Used

The document does not explicitly state the type of ground truth used. Given that it's a software for viewing and reviewing DICOM and DICOM RT images, the "ground truth" for its functional verification would likely be the accuracy of rendering the provided medical data and the correctness of its measurements and display features against known input data (e.g., a DICOM image with known dimensions, a DICOM RT plan with calculated dose distributions and DVH data). For usability, the ground truth would be user feedback and adherence to usability best practices.

8. The Sample Size for the Training Set

The document does not mention a training set because Quentry Dose Review is not described as a machine learning or AI algorithm that requires training data. It is a software application for displaying and interacting with medical images and RT plans based on predetermined functionalities.

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

As no training set is mentioned or implied for this type of device, the method for establishing its ground truth is not applicable.

Summary

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JUN 2 0 2014

510 (K) SUMMARY QUENTRY DOSE REVIEW

・

IN ACCORDANCE WITH REQUIREMENTS OF 21 CFR PART 807.92

Manufacturer:	Brainlab AGKapellenstrasse 1285622 FeldkirchenGermany
	Phone: +49 89 99 15 68 0Fax: +49 89 99 15 68 33
Submitter:	Rainer Birkenbach
Contact person:	Alexander Schwiersch
Summary date:	4/30/2014
Device:	QUENTRY DOSE REVIEW
Trade name:	QUENTRY DOSE REVIEW
Common/ClassificationName:	Picture archiving and communications systemSystem,Planning,Radiation Therapy Treatment
Main Predicate Device:	Advanced Viewer (K132763)
Secondary PredicateDevice:	iPlan RT (K103246)
Device classificationname:	system, image processing, radiological
Regulatory Class:	Class II
Regulation Number:	892.2050, 892.5050
Product Code:	LLZ, MUJ
Intended use:	Quentry Dose Review is a web based software for medical professionals thatprovides doctors, physicists and physicians with tools for secure online image(DICOM and DICOM RT) review including measurement and RT specificfunctions, such as display of dose distribution information, isodose lines, anddose volume histograms (DVH).It is not intended for the review of mammographic images, detailed treatmentplanning, plan approval or treatment of patients. It is also not intended to beused on mobile systems.For radiotherapy treatment plan approval, it is required to use the hospitalspecific workflows, tools and record&verify systems.
Device description:	Quentry Dose Review is part of the online collaboration platform Quentry toshare, discuss and transfer medical image data. The viewer providescapabilities to visualize medical images (DICOM and DICOM RT) and doseinformation.

REVISION 1

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The device is generally used by medical professionals such as doctors, their assistants or nursing staff, within a clinic or at a doctor's office, or even at home.

Quentry Dose Review is a pure web application that is embedded in the Quentry web portal which is accessible from any computer with an appropriate internet connection.

Operator Profile

The intended users are Physicians, Radiologists, Radio oncologists or their assistants. Typical use cases of the embedded viewer together with the functionality of the web portal are:

Physicians asking/providing colleagues for/with 2nd opinion .
Radiologists comparing two RT plans for better patient treatment results
. Physicians refer patients to other hospitals and send pictures and/or RT plans upfront
Expert service: Several hospitals share one radiology department

Patient Population

There are no demographic, regional or cultural limitations for patients. It is up to the user to decide if the system shall be used to assist a certain procedure.

Conditions of use

The system can be used in a hospital environment, in a doctor's office, at home or any place with internet access.

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Device Features:

Quentry Dose Review provides the following functions

Feature	Detail
Load and import DICOM images	Load DICOM images from cloud database
View DICOM images	Viewer converts DICOM images to PNG format for viewing
Adjustment (pan, zoom, window, color scheme adjustment)	Review patient data with various adjustment
Reconstruction	Review patient data from different orientation
Measurement - distance	Viewer provides distance measurement between two arbitrary points
Measurement - point	Viewer provides gray level and dose value measurement for an arbitrary point
Voxel object	Review imported DICOM objects
Fused images	Review aligned patient data, e.g. CT, PT and so on
Cine loop playing	Display multiframe DICOM images
RT plan	Load RT planRT plan informationRT plan comparisonDVH comparison
Review dose distribution	Dose distribution viewDose analysis viewDVH (PTVs & OARs)Manual input of normalization value

Substantial equivalence:

Both Quentry Dose Review and Advanced Viewer are cloud-based software for viewing and manipulating DICOM images. Both of the proposed and predicate devices are to be used with any computer with appropriate internet connection. Equivalent with the predicate device, Quentry Dose Review is software installed in a web server that will communicate with the client via internet connection. Both devices utilize encrypted browser communication and provide image viewing and manipulation. However Quentry Dose Review enables DICOM RT images viewing functions, which Advanced Viewer does not provide.

iPlan RT is a radiation treatment planning system. This system generates treatment plans and simulates the dose delivery for external beam radiotherapy. One common function of iPlan RT and Quentry Dose Review is to review DICOM RT images. Quentry Dose Review and iPlan RT provide equivalent functions in viewing DICOM RT images. Equivalent to the predicate device, Quentry Dose Review is intended for medical professionals to review DICOM RT plans.

Conclusion:

Quentry Dose Review and Advanced Viewer have identical functionalities in DICOM viewing and identical technical characteristic. Quentry Dose Review is in addition capable of reviewing DICOM RT images. The RT functionalities are equivalent to these of iPlan RT.

FORM 04-195

REVISION 1

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Quentry Dose Review has similar functionality, intended use, technological characteristics, and typical users as the predicate devices. Hence Quentry Dose Review does not introduce any new issues concerning safety and effectiveness, and is substantially equivalent to the predicate devices.

Verification/validation Verification summary:

The verification of the system Quentry Dose Review has been carried out thoroughly both at the top level and on the underlying subsystems. The verification was done to demonstrate that the design specifications are met.

Non-clinical validation

The validation contained usability tests which should ensure that workflows or user interface result in a useful interface.

All test reports were finally rated as successful according to their acceptance criteria. The non-clinical validation has been performed with software and units that are considered equivalent to the final version of the product, as warranted by 21 CFR 820.30 (g) and which have the UI as planned for the release.

The user tests were done in combination with the Quentry.com Portal which is developed and released by Voyant Health, a Brainlab company. The Quentry Dose Review workflow included also patient selection as interface between Quentry.com Portal and Quentry Dose Review.

Intended operational Environment

Standard computer with internet connection and mouse.

Operating System

The following versions or higher:

Windows XP .
Mac OS X 10 .

Browser

The following 32 bit versions or higher:

Internet Explorer 8 ◆
· · FireFox 3.x
. Chrome 10
. Safari 5

Microsoft® Silverlight® Plugin needed

Hardware

2GB RAM recommended .
. Screen resolution: 1024x768 or higher
. Mouse with scroll wheel recommended

Network

Internet connection with at least 2 Mbit/sec. The internet connection must be stable. You may need to restart the viewer if the internet connection is unstable.
Firewall with open outbound port 80/443 (http and https)

Known Exceptions

FORM 04-195

REVISION 1

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K141199
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form 04-195

REVISION 1

PAGE 5 OF 5

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circle around the eagle. The text is in all caps and appears to be a sans-serif font. The logo is black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Contral Center - WO66-Go(1) Silver Spring, MD 20993-0002

June 20, 2014

Brainlab AG % Mr. Alexander Schwiersch Regulatory Allairs Manager Kapellenstrasse 12 Feldkirchen 85622 GERMANY

Re: K141199 Trade/Device Name: Quentry Dose Review Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 12, 2014 Received: May 14, 2014

Dear Mr. Schwiersch:

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. Schwiersch

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/ResourcesforYou/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,

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

510(k) Number (if known)

K141199

Device Name Quentry Dose Review

Indications for Use (Describe)

Quentry Dose Review is a web based software for medical professionals that provides doctors, physicians with tools for secure online image (DICOM RT) review including measurement and RT specific functions. such as display of dose distribution information, isodose lines, and dose volume histograms (DVH),

It is not intended for the review of mammographic images, detailed treatment planning, plan approval or treatment of patients. It is also not intended to be used on mobile systems.

For radiotherapy treatment plan approval, it is required to use the hospital specific workflows, tools and record&verify systems.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure)

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This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@lda.hhs.gov

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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).