The software displays medical images and data. It also includes functions for image review, image manipulation, basic measurements and 3D visualization.

Device Description

Viewer is a software for viewing DICOM data, such as native slices generated with medical imaging devices, axial, coronal and sagittal reconstructions, and data specific volume rendered views (e.g., skin, vessels, bone). Viewer supports basic manipulation such as windowing, reconstructions or alignment and it provides basic measurement functionality for distances and angles. Viewer is not intended for diagnosis nor for treatment planning. The Subject Device (Viewer) for which we are seeking clearance consists of the following software modules.

· Viewer 5.4 (General Viewing)
· Universal Atlas Performer 6.0
Universal Atlas Transfer Performer 6.0
Universal Atlas Performer: Software for analyzing and processing medical image data with Universal Atlas to create different output results for further use by Brainlab applications
Universal Atlas Transfer Performer: Software that provides medical image data autoseqmentation information to Brainlab applications
When installed on a server, Viewer can be used on mobile devices like tablets. No specific application or user interface is provided for mobile devices. In mixed reality, the data and the views are selected and opened via desktop PC. The views are then rendered on the connected stereoscopic head-mounted display. Multiple users in the same room can connect to the Viewer session and view/review the data (such as already saved surgical plans) on their mixed reality glasses.

AI/ML Overview

The Brainlab AG Viewer (5.4) and associated products (Elements Viewer, Mixed Reality Viewer, Smart Layout, Elements Viewer Smart Layout) are a medical image management and processing system. The device displays medical images and data, and includes functions for image review, manipulation, basic measurements, and 3D visualization.

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text details various tests performed to ensure the device's performance, particularly focusing on the mixed reality aspects and measurement accuracy. However, specific numerical "acceptance criteria" (e.g., "accuracy must be >95%") and corresponding reported performance values are not explicitly stated in a detailed quantitative manner in the summary. Instead, the document describes the types of tests conducted and generally states that they were successful or ensured certain qualities.

Test Category	Acceptance Criteria (Implied/General)	Reported Device Performance (General)
Software Verification & Validation	Successful implementation of product specifications, incremental testing for different release candidates, testing of risk control measures, compatibility testing, cybersecurity tests.	Documentation provided as recommended by FDA guidance. Successful implementation, testing of risk controls, compatibility, and cybersecurity acknowledged for an enhanced level.
Ambient Light	Sufficient visualization in a variety of ambient lighting conditions with Magic Leap 2.	Test conducted to determine Magic Leap 2 display quality for sufficient visualization in a variety of ambient lighting conditions. (Implied successful)
Hospital Environment	Compatibility with various hardware platforms and compatible software.	Test conducted to test compatibility of the Subject Device with various hardware platforms and compatible software. (Implied successful)
Display Quality	Seamless integration of real and virtual content; maintenance of high visibility and image quality (optical transmittance, luminance non-uniformity, Michelson contrast).	Tests carried out to measure and compare optical transmittance, luminance non-uniformity, and Michelson contrast of the head-mounted display to ensure seamless integration of real and virtual content and maintenance of high visibility and image quality, both with and without segmented dimming. (Implied successful)
Measurement Accuracy	Accurate 3D measurement placement using Mixed Reality user interface (Magic Leap control), comparable to mouse and touch input.	Tests performed to evaluate the accuracy of 3D measurement placement using a Mixed Reality user interface (Magic Leap control) in relation to mouse and touch as input methods. (Implied successful, and supports equivalence to predicate's measurement capabilities, with added 3D functionality in MR)

2. Sample Size for the Test Set and Data Provenance

The document does not explicitly state the sample sizes used for any of the described tests (Ambient Light, Hospital Environment, Display Quality, Measurement Accuracy).

Regarding data provenance, the document does not specify the country of origin for any data, nor whether the data used in testing was retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth

The document does not provide information on the number of experts used to establish ground truth for any of the described tests, nor their qualifications.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1, none) used for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The study is focused on the device's technical performance and accuracy, not on human reader improvement with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

The document describes the "Viewer" as software for displaying and manipulating medical images. While it's a software-only device, the tests described (e.g., display quality, measurement accuracy) inherently assess the algorithm's performance in its intended functions without direct human-in-the-loop impact on the results being measured during those specific tests. However, it's not explicitly framed as an "algorithm-only" performance study in contrast to human performance, but rather as instrumental performance validation. The Mixed Reality functionality, while requiring a human operator, still has its underlying software/hardware performance (e.g., accuracy of 3D measurement placement) evaluated.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for any of the tests. For "Measurement accuracy test," it can be inferred that a known, precisely measured physical or digital standard would have been used as ground truth for comparison. For other tests like display quality or compatibility, the ground truth would be conformance to established technical specifications or standards for optical properties and functional compatibility, respectively.

8. Sample Size for the Training Set

The document does not provide any information regarding a training set sample size. This is consistent with the device being primarily a viewing, manipulation, and measurement tool rather than an AI/ML diagnostic algorithm that requires a "training set" in the conventional sense. The "Universal Atlas Performer" and "Universal Atlas Transfer Performer" modules do involve "analyzing and processing medical image data with Universal Atlas to create different output results" and "provides medical image data autosegmentation information," which might imply some form of algorithmic learning or rule-based processing. However, no details on training sets for these specific components are included.

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

As no training set is mentioned or detailed, there is no information on how its ground truth might have been established.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Brainlab AG Sadwini Suresh OM Consultant Olof-Palme-StraBe 9 Münich, BY 81829 GERMANY

May 21, 2024

Re: K232759

Trade/Device Name: Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: September 8, 2023 Received: April 25, 2024

Dear Sadwini Suresh:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Jessica Lamb

Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K232759

Device Name

Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout

Indications for Use (Describe)

The software displays medical images and data. It also includes functions for image review, image manipulation, basic measurements and 3D visualization.

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 Brainlab logo. The logo consists of a stylized pink symbol on the left, resembling three interconnected shapes. To the right of the symbol, the word "BRAINLAB" is written in pink, using a bold, sans-serif font. The overall design is clean and modern.

K232759 510(k) Summary

May 17, 2024

General Information
Manufacturer	Brainlab AG; Olof-Palme-Str.9, 81829, Munich, Germany
Establishment Registration	8043933
Trade Name	Viewer 5.4;Elements Viewer;Mixed Reality Viewer;Smart Layout ;Elements Viewer Smart Layout
Classification Name	System, Image Processing, Radiological
Product Code	LLZ
Regulation Number	892.2050
Regulatory Class	II
Panel	Radiology
Predicate Device(s)	K191014; Viewer
Contact Information
Primary Contact	Alternate Contact
Sadwini SureshQM Consultant - Regulatory AffairsPhone: +49 89 99 15 68 0Email: regulatory.affairs@brainlab.com	Chiara CunicoPhone: +49 89 99 15 68 0Fax: +49 89 99 15 68 5033Email: chiara.cunico@brainlab.com

1. Indications for Use

The software displays medical images and data. It also includes functions for image review, image manipulation, basic measurements and 3D visualization.

2. Device Description

· Viewer 5.4 (General Viewing)
· Universal Atlas Performer 6.0
Universal Atlas Transfer Performer 6.0

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Image /page/4/Picture/0 description: The image shows the Brainlab logo. The logo consists of a stylized symbol on the left and the word "BRAINLAB" on the right. The symbol appears to be a stylized representation of the brain. The word "BRAINLAB" is written in a bold, sans-serif font. The color of the logo is pink.

Universal Atlas Performer: Software for analyzing and processing medical image data with Universal Atlas to create different output results for further use by Brainlab applications

Universal Atlas Transfer Performer: Software that provides medical image data autoseqmentation information to Brainlab applications

When installed on a server, Viewer can be used on mobile devices like tablets. No specific application or user interface is provided for mobile devices. In mixed reality, the data and the views are selected and opened via desktop PC. The views are then rendered on the connected stereoscopic head-mounted display. Multiple users in the same room can connect to the Viewer session and view/review the data (such as already saved surgical plans) on their mixed reality glasses.

1. Substantial Equivalence
  For the Substantial Equivalence determination, comparison of the Subject Device features with the following predicate device(s) was carried out:

Viewer 5.0; K191014

The predicate was chosen since its similar to the subject device w.r.t the indications for use, technological characteristics and use cases.

The main differences compared to the predicate device are the version of the Maqic Leap glasses and Launcher app compatibility as well as the segmented dimming functionality. For the rest of the features, they existed in the predicate and have been improved/ modified.

Feature	Predicate Device	Subject Device
Indications foruse	Viewer is a software device fordisplay of medical images andother healthcare data. It includesfunctions for image review,image manipulation, basicmeasurements and 3Dvisualization (Multiplanarreconstructions and 3D volumerendering). It is not intended forprimary image diagnosis or thereview of mammographicimages.	The software displays medicalimages and data. It also includesfunctions for image review,image manipulation, basicmeasurements and 3Dvisualization. The device itselfdoes not have clinicalindications.
Computerhardwarerequirements	- Graphics: DirectX 11compatible with 512 MBgraphics memory	- Graphics: DirectX 11compatible with 512 MBgraphics memory
Feature	Predicate Device	Subject Device
	- Display resolution:1280x1024	- Display resolution:1280x1024
	- Processor: 4 physical cores	- Processor: 4 physical cores
	- RAM: 4GB, 8GB for 3DStereo	- RAM: 4GB, 8GB for 3DStereo
	- With a mouse or touchscreenas pointing device	- With a mouse or touchscreenas pointing device
Mixed RealityGlasses	Magic Leap 1	Magic Leap 2
OperatingSystem	Windows Server 2008, 2012,2016min Windows 7MacOS	Windows Server 2012, 2016, 2019min Windows 10MacOS
Buzz VirtualViewer RemoteControl	Viewer can be mirrored tomobile devices. It is alsopossible to interact with theViewer remotely.	The views streamed to BuzzVirtual from Viewer, can beinteracted through mobiledevices with a special layout.This remote control layoutconsists of predefinedessentials tools:• Scroll• Switch• Pan• Rotate• Zoom• Scroll• Windowing• reset
Feature	Predicate Device	Subject Device
Mixed RealitySegmentedDimming	Not included	The background of the 2D areaMixed Reality scene is displayedin real black (instead of darktransparent) in Mixed Reality,depending on distance betweenuser and 2D area.
Distance Display	Distance measurements are setand displayed on 2D Slices onlyon desktop Viewer.	Distance measurements can beset and displayed on 2D Sliceson desktop viewer and also on3D mixed reality views.Moreover, 3D distancemeasurements can be displayedover multiple 2D views.

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Image /page/5/Picture/0 description: The image shows the Brainlab logo. The logo consists of a stylized pink symbol on the left, resembling interconnected shapes, followed by the word "BRAINLAB" in pink, block letters. The overall design is clean and modern.

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Image /page/6/Picture/0 description: The image shows the Brainlab logo. The logo consists of a stylized symbol on the left and the word "BRAINLAB" in capital letters on the right. Both the symbol and the word are in a bright pink color. The symbol appears to be three curved lines stacked on top of each other.

4. Performance Data

Software Verification and Validation Testing a.
Software verification and validation testing has been conducted and documentation is provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Device Software Functions". These include successful implementation of product specifications, incremental testing for different release candidates, testing of risk control measures, compatibility testing or cybersecurity tests. The documentation submitted is for enhanced level.
b. Bench Tests
The following performance bench tests were carried out:

Ambient Light Test: To determine the Magic Leap 2 display quality for sufficient visualization in a variety of ambient lighting conditions

Hospital Environment Tests: To test compatibility of the Subject Device with various hardware platforms and compatible software's.

c. Display Quality Tests
Tests were carried out to measure and compare the optical transmittance, and luminance non-uniformity and Michelson contrast of the head mounted display to ensure seamless integration of real and virtual content, and maintenance of high visibility and image quality. The tests were carried out with and without segmented dimming.

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Image /page/7/Picture/0 description: The image shows the Brainlab logo. The logo consists of a stylized brain symbol on the left and the word "BRAINLAB" in capital letters on the right. The color of the logo is pink.

d. Measurement accuracy test

Additionally, tests were performed to evaluate the accuracy of 3D measurement placement using a Mixed Reality user interface, specifically Magic Leap control in relation to mouse and touch as input methods.

1. Conclusion
  The comparison of the Subject Device with the predicate device shows that the Viewer 5.4 has similar functionality, intended use and technological characteristics as the predicate devices. Based on the comparison to the predicate and the performance testing conducted, the Subject Device is considered substantially 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).