Viewer is a software device for display of medical images and other healthcare data. It includes functions for image review, image manipulation, basic measurements and 3D visualization (Multiplanar reconstructions and 3D volume rendering). It is not intended for primary image diagnosis or the review of mammographic images.

Device Description

Viewer is a software for viewing of DICOM data. The device provides basic measurement functionality for distances and anqles.

These are the operating principles:

On desktop PCs the interaction with the software is mainly performed with mouse and/or keyboard. -
On touch screen PCs and on mobile devices the software is mainly used with a touch screen interface. -
-On Mixed Reality qlasses the interaction is performed with a dedicated pointing device.

The subject device provides or integrates the following frequently used functions:

-Select medical images and other healthcare data to be displayed
-Select views (e.g. axial, coronal & sagittal reconstruction views and 3D volume rendering views)
Change view layout (e.g. maximize / minimize views, close / open / reorder views) -
Manipulate views (e.g. scroll, zoom, pan, change windowing) -
Perform measurements (e.g. distance or angle measurements) -
-Place annotations at points of interests

AI/ML Overview

The provided document is a 510(k) summary for the "Viewer" device from Brainlab AG. It describes the device, its intended use, and its comparison to a predicate device and a reference device to demonstrate substantial equivalence. However, it does not contain the detailed information required to fill out the table of acceptance criteria and the study that proves the device meets those criteria, specifically regarding device performance metrics (e.g., sensitivity, specificity, accuracy), sample sizes, ground truth establishment, or multi-reader multi-case studies for AI components.

The document primarily focuses on verifying the software's functionality, user interface, DICOM compatibility, and integration, rather than clinical performance metrics of an AI algorithm. The device is a "Picture Archiving And Communications System" (PACS) that displays medical images and other healthcare data and is not intended for primary image diagnosis. This indicates that the regulatory requirements for performance metrics such as sensitivity and specificity, which are common for AI algorithms involved in diagnosis, would not apply to this specific device.

Therefore, most of the information requested in your prompt cannot be extracted from this document because the device described is not an AI diagnostic algorithm, and the provided text focuses on software functionality verification rather than clinical performance studies.

Here's what can be extracted and what cannot:

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

Acceptance Criteria Category	Test Method Summary	Reported Device Performance
User interface	Interactive testing of user interface	All tests passed
DICOM compatibility	Interactive testing with companywide test data, which are identical for consecutive version of the SW	All tests passed
Views	Interactive testing of user interface	All tests passed
Unit test /Automatic tests	Automated or semi-automated cucumber tests or unit tests are written on the applicable level for new functionalities of the Viewer in respect to previous versions. Existing tests have to pass.	All tests passed
Integration test	Interactive testing on various platforms and combination with other products following test protocols, combined with explorative testing. The software is developed with daily builds, which are explanatively tested.	All tests passed
Usability	Usability tests (ensure user interface can be used safely and effectively)	All tests passed
Communication & Cybersecurity	Verification of communication and cybersecurity between Viewer and Magic Leap Mixed Reality glasses	Successfully passed

Missing Information/Not Applicable: The document does not provide acceptance criteria or performance metrics related to diagnostic accuracy (e.g., sensitivity, specificity, AUC) because the device is explicitly stated as not intended for primary image diagnosis.

2. Sample sized 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 specified. The verification tests mention "companywide test data" and "various platforms and combination with other products" but do not provide specific numbers of cases or images.
Data Provenance: Not specified. The document mentions "companywide test data" but does not detail the country of origin or whether it was retrospective or prospective.

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 applicable/Not specified. Since the device is not for primary diagnosis and the tests focus on software functionality, there is no mention of experts establishing ground truth for diagnostic purposes. The "ground truth" for the software functionality tests would be the expected behavior of the software.

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

Not specified. The testing methods described are interactive testing, automated/semi-automated tests, and usability tests. There is no mention of an adjudication method typical for diagnostic performance studies.

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

Not applicable. The document does not describe an AI algorithm intended to assist human readers in diagnosis. It's a DICOM viewer. Therefore, an MRMC study comparing human readers with and without AI assistance was not performed or reported.

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

Not applicable. This device is a viewer, not a standalone diagnostic algorithm.

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

The concept of "ground truth" in the context of diagnostic accuracy (e.g., pathology, expert consensus) does not apply here as the device is not for primary diagnosis. For its stated functions, the "ground truth" would be the expected, correct functioning of the software features (e.g., correct display of DICOM data, accurate measurements of distance/angle).

8. The sample size for the training set

Not applicable/Not specified. The device is a viewer, not an AI model that undergoes a "training" phase with a dataset.

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

Not applicable. (See point 8).

Summary

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January 23, 2020

Brainlab AG % Chiara Cunico Manager Regulatory Affairs Olof-Palme-Str. 9 81829 Munich, De GERMANY

Re: K191014

Trade/Device Name: Viewer Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: LLZ Dated: December 16, 2019 Received: December 26, 2019

Dear Chiara Cunico:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K191014

Device Name Viewer

Indications for Use (Describe)

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)

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510 (K) SUMMARY VIEWER

IN ACCORDANCE WITH REQUIREMENTS OF 21 CFR PART 807.92

General Information
Manufacturer	Brainlab AG, Olof-Palme-Straße 9, 81829 Munich, Germany
Establishment Reg. #	8043933
Device name:	Viewer
Trade name:	Elements Viewer
Common name	DICOM Viewer
Classification name:	Picture archiving and communications system (21 CFR 892.2050)
Review Panel	Radiology
Product Code:	LLZ
Device Class:	Class II
Predicate Device:	K153653 DICOM Viewer
Reference Device	K172418 OpenSight
Date of preparation	23 September 2019

Contact Information
Primary contact person	Alternate contact person
Chiara Cunico	Regulatory Affairs Brainlab
Manager RA	phone: +49 89 99 15 68 0
phone: +49 89 99 15 68 1738	fax: +49 89 99 15 68 5033
Email: Chiara.cunico@brainlab.com	Email: regulatory.affairs@brainlab.com

Intended use:

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Device description

Viewer is a software for viewing of DICOM data. The device provides basic measurement functionality for distances and anqles.

These are the operating principles:

On desktop PCs the interaction with the software is mainly performed with mouse and/or keyboard. -
On touch screen PCs and on mobile devices the software is mainly used with a touch screen interface. -
-On Mixed Reality qlasses the interaction is performed with a dedicated pointing device.

The subject device provides or integrates the following frequently used functions:

-Select medical images and other healthcare data to be displayed
-Select views (e.g. axial, coronal & sagittal reconstruction views and 3D volume rendering views)
Change view layout (e.g. maximize / minimize views, close / open / reorder views) -
Manipulate views (e.g. scroll, zoom, pan, change windowing) -
Perform measurements (e.g. distance or angle measurements) -
-Place annotations at points of interests

Changes to Predicate Device

Convenience function have been added for view and object selection.

Magic Leap Mixed reality glasses have been added to the Subject Device as additional means of display. The Mixed Reality views are started from within the desktop version of Viewer. The view selection is done on the desktop, the views are cloned into the virtual space of Mixed Reality. The 2D views are shown on a 2D view pane in Mixed Reality. The 3D views are placed as virtual objects in to the real world.

	Cleared devicefeature/specificationDICOM Viewer (K153653)	Modified devicefeature/specificationViewer 5.0	SubstantialEquivalent
HW Environment	Server based, for viewing viaHTML5 client or RDP onindividual client computer	Server and local installation, ,for viewing via HTML5 clientor RDP, or local execution onindividual client computer	yes
Data inputs	DICOM		yes
Viewing Data	• Skin• Bone• Skin/Bone• Vessels• Bone/Vessels• Skin/Vessels• Skin/Bone/Vessels• Maximum Intensity Projection (MIP)• Digital Reconstructed Radiograph (DRR)		yes
	Cleared devicefeature/specificationDICOM Viewer (K153653)	Modified devicefeature/specificationViewer 5.0	SubstantialEquivalent
Measurement	Distance in slice sets•Diameter•Angle•	Distance in slice setsand X-ray images•Diameter•Angle (incl. openangle)	yes
"Smart View"	Individual selectable visibilityof objects (tumor, fibers etc.)	Individual selectable visibilityof objects (tumor, fibers etc.)Additional view: with a sliderit is possible to changevisibility of objects.	yes
View Layouts	Manual selection ofappropriate view.	Manual selection ofappropriate view.Additional: Cranial, Spineand Angio layouts load viewsin the presence of certainmodalities in the SubjectDevice.	yes
Probe's Eye View(available in MixedReality)	Align crop box to any desireddirection for the display ofMPR perpendicular andparallel (inline) to the givendirection.	Align crop box to any desireddirection for the display ofMPR perpendicular andparallel (inline) to the givendirection.In Mixed Reality the user canpoint in a desired direction andview MPR perpendicular andparallel (inline) to the givendirection.	yes

Technological Characteristics of the Subject Device in comparison to the Predicate Device

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Technological Characteristics of the Subject Device in comparison to the Reference Device:

	Cleared devicefeature/specificationOpenSight K172418	Modified devicefeature/specificationViewer 5.0	SubstantialEquivalent
Supported MixedReality Device	Microsoft HoloLens	Magic Leap One	yes
Supported deviceelectrical medicaldevice according toIEC 60601-1	No	No	yes
Mixed Reality	2D slices and MPRs3D Views	2D slices and MPRs3D Views	yes
Registration topatient	yes	no	No, this is not part ofthe Subject Device.Equivalence is notclaimed

Verification summary:

Verification of communication and cybersecurity between Viewer and Magic Leap Mixed Reality glasses has been tested. All interactive testing of user interface have successfully passed.

Validation summary:

The validation comprises usability tests which ensure that the user interface can be used safely and effectively. All tests were rated as successfully passed according to their acceptance criteria.

As conclusion, the nonclinical and clinical tests (discussed above) demonstrate that the device is as safe, as effective, and performs as well as the predicate device.

Test	Test Method Summary	Results
User interface	Interactive testing of user interface	All tests passed
DICOM compatibility	Interactive testing with companywide test data, which areidentical for consecutive version of the SW	All tests passed
Views	Interactive testing of user interface	All tests passed
Unit test /Automatic tests	Automated or semi-automated cucumber tests or unittests are written on the applicable level for newfunctionalities of the Viewer in respect to previousversions. Exiting tests have to pass.	All tests passed

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Test	Test Method Summary	Results
Integration test	Interactive testing on various platforms and combinationwith other products following test protocols, combinedwith explorative testing.	All tests passed
	The software is developed with daily builds, which areexplanatively tested.

Substantial equivalence

The comparison of the Viewer with the predicate device shows that the Viewer has similar functionality, intended use, technological characteristics, and typical users as the predicate device. Verification activities ensure that the design specifications are met and that the Viewer does not introduce new issues concerning safety and effectiveness. Hence the Viewer is substantial equivalent to the predicate device.

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).