DICOM 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 (MPR reconstructions and 3D volume rendering).

It is not intended for primary image diagnosis or the review of mammographic images.

Device Description

The DICOM Viewer is software for web based viewing of DICOM data.

AI/ML Overview

The provided document is a 510(k) summary for a DICOM Viewer. It describes the device's intended use, features, and declares substantial equivalence to predicate devices. However, it does not contain information about specific acceptance criteria or a detailed study proving the device meets those criteria, especially in terms of diagnostic performance metrics.

The document states that the "DICOM Viewer is a software device for display of medical images and other healthcare data," and explicitly clarifies: "It is not intended for primary image diagnosis or the review of mammographic images." This means the device is for general viewing and not for a specific diagnostic task that would require rigorous performance metrics like sensitivity, specificity, or AUC, as these would be associated with a "primary image diagnosis" function.

Therefore, many of the requested details, such as specific performance metrics, sample sizes for test and training sets, ground truth establishment, expert qualifications, and MRMC studies, would not be applicable or expected for a device with this stated intended use.

Here's an attempt to answer the questions based only on the provided text, highlighting where information is absent or not relevant given the device's purpose:

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

Based on the provided text, the device's intended use is not for primary image diagnosis. As such, the acceptance criteria are focused on functionality, safety, and substantial equivalence to predicate devices, rather than diagnostic performance metrics (e.g., sensitivity, specificity, accuracy) that would be relevant for a diagnostic AI device.

Acceptance Criterion (Inferred from Text)	Reported Device Performance (Inferred from Text)
Display medical images and other healthcare data	DICOM Viewer is software for web-based viewing of DICOM data.
Functions for image review, manipulation, basic measurements, 3D visualization (MPR, VRT)	Includes these functions.
Not intended for primary image diagnosis or mammography review	Explicitly stated (this is a limitation, not a performance metric).
Safety and effectiveness similar to predicate devices	Verified and validated activities ensure design specifications met and no new safety/effectiveness issues.
Substantial equivalence to predicate devices (K093117, K130624)	Found to have similar functionality, intended use, technological characteristics, and typical users.
Software risks analyzed, no non-acceptable risks identified	Stated directly.
User interface is substantially equivalent to previous version (2.2)	Formative usability tests performed, prototype substantially equivalent to final device with minimal changes.
Meets design specifications	Verification of the System DICOM Viewer thoroughly carried out.

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

Not applicable. This device is not an AI/ML algorithm performing a diagnostic task that typically involves a defined "test set" of patient data for performance evaluation in the way an AI diagnostic tool would. The validation focused on functional verification and safety, not on diagnostic accuracy on a dataset. The document mentions reviews of MAUDE, BfArM, and Brainlab internal complaint databases for incidents of similar products, but this is not a test set for performance.

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. As the device is for viewing and not primary diagnosis, there is no "ground truth" establishment for diagnostic accuracy purposes on a test set mentioned in the document.

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

Not applicable. No test set for diagnostic performance requiring adjudication is mentioned.

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. This document does not suggest an MRMC study was performed, nor would it be expected given the device's stated intended use (not for primary diagnosis). The device displays images but does not actively assist in interpretation beyond basic viewing tools.

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

This question is largely irrelevant for a DICOM Viewer whose primary function is image display. The device is a "standalone" software in the sense that it operates independently to display images, but it doesn't perform diagnostic interpretations that would be measured for standalone performance as an AI algorithm would.

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

Not applicable. No ground truth for diagnostic accuracy is mentioned in context of performance evaluation.

8. The sample size for the training set

Not applicable. This device is a software viewer, not an AI/ML algorithm that requires a "training set" in the conventional sense for learning and inference.

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

Not applicable. (See #8)

Summary

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

April 13, 2016

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

Re: K153653

Trade/Device Name: DICOM Viewer Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 2, 2016 Received: March 7, 2016

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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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.

Michael D.'Hara

For

Robert Ochs, Ph.D. 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) K153653

Device Name

DICOM Viewer

Indications for Use (Describe)

It is not intended for primary image diagnosis or the review of mammographic images.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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FOR FDA USE ONLY

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

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510 (K) SUMMARY DICOM VIEWER

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:	11/5/2015
Device:	Image Viewer
Trade name:	DICOM Viewer
Device ClassificationRegulation:	892.2050 - Picture archiving and communications system
Regulatory Class:	Class II
Product Code:	LLZ - System, Image Processing, Radiological
Main Predicate Device:	Digital Lightbox (K093117)
Secondary PredicateDevice:	CONI (K130624)

INTENDED USE: 1

It is not intended for primary image diagnosis or the review of mammographic images.

DEVICE DESCRIPTION: 2

The DICOM Viewer is software for web based viewing of DICOM data.

Operator profile

The device is generally used by medical professionals such as doctors, their assistants or nursing staff which are in need of displaying medical (DICOM) images and other healthcare data for non-diagnostic purposes.

Patient population

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The device is software which allows viewing of DICOM data. Hence there is no specific patient population.

Intended use environment

The software is intended to be used:

. in Operating Rooms
in Office environments within hospitals or at any other location offering a computer
at any location on tablet devices ●

Operating principle

There are different operating principles:

On desktop PCs the interaction with the software is mainly performed with mouse and/or kevboard
-On touch screen PCs and on mobile devices the software is mainly used with a touch screen interface.

Primary operating functions

Non-diagnostic viewing of medical images and other healthcare data in DICOM format.

Use scenarios

A user wants to review DICOM data in an OR before or during a surgery in order to think about the procedure or to talk about the procedure with his colleagues.
-A user wants to review DICOM data of patients in a reqular board meeting in order to discuss aspects of treatments with his colleaques
-A user wants to review DICOM data of patients in a meeting where the participants are not in the same room in order to discuss aspects of treatments with his colleagues or to get the opinion of an external expert

Intended part of the body or type of tissue applied to or interacted with

The device is software only which allows viewing of DICOM data. Hence it does not interact with any body/tissue part and the viewing is not limited to any body/tissue part.

Essential performance characteristics

Image Viewer is essentially software for medical image visualization. A hardware shutdown, power failure or other hardware issue that makes the software inoperable does not cause harm. Hence, no unacceptable risk arises if the hardware loses performance. Therefore, the hardware does not have any essential performance characteristics.

The software risks were analyzed to find risks in the non-acceptable area. No risks have been identified in the non-acceptable area. Hence, no measures are considered essential performance characteristics. In summary, the Image Viewer software does not have any essential performance characteristics.

6 SUBSTANTIAL EQUIVALENCE

DICOM Viewer has similar functionality, intended use, technological characteristics, and typical users as

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the predicate devices.

Both DICOM Viewer and the primary predicate device, Digital Lightbox (K093117) are used to display medical images including multiplanar reconstructions and 3D volume rendering, perform basic image manipulations and measurements, and load and visualize planning data as fusions, objects and trajectories. Both devices are Brainlab products, have been developed by the same R&D team and use the same software framework. Both DICOM Viewer and all two predicate devices (Digital Lightbox (K093117) and CONi (K130624)) are intended to view medical images.

In contrast to the primary predicate device. Digital Lightbox (K093117), the DICOM Viewer has a web frontend which is available on multiple devices (computers, Android tablets and iPads); whereas, the Digital Lightbox is accessible and running on a dedicated system only. However the other predicate device CONi (K130624) is also web-based software for viewing DICOM Images.

In addition the DICOM Viewer can display fiber objects generated by other Brainlab applications and align images sets and persist the align state. These enhancements in respect to the predicate devices do not affect the intended use, alter the fundamental technology of the primary predicate device, Digital Lightbox (K093117) nor do they introduce any new issues concerning safety and effectiveness.

4 VERIFICATION/VALIDATION SUMMARY

Verification

The verification of the System DICOM Viewer has been carried out thoroughly both at the top level and on underlying modules. The verification was done to demonstrate that the design specifications are met.

Non-clinical validation

. DICOM Viewer 2.2 and DICOM Viewer 3.0 are substantially equivalent regarding user group, use scenario, use related risks and the user interface being nearly identical. Thus safe use of the device can be posed on post-market evaluation for the DICOM Viewer 2.2.
Validation contained reviews of the MAUDE, BfArM and Brainlab internal complaint databases ● regarding incidents of similar products including the DICOM Viewer 2.2. The search results did not result in any necessary actions for the DICOM Viewer.
. The validation of the intended use, user needs and primary operating functions of the DICOM Viewer 3.0 is additionally covered by specific sections in the verification protocols.
. Formative usability tests have been performed as listed in the Usability Evaluation Summary. The prototype is substantially equivalent with the user interface being nearly identical to the final device. Only bug fixes and minor improvements of the software with no effect on the results of the formative usability tests have been incorporated afterwards.

CONCLUSION 5

The comparison of the DICOM Viewer with the predicate devices using available labelling (Digital Lightbox K093117 and CONi K130624) and Brainlab internal specifications (Digital Lightbox K093117) shows that the DICOM Viewer has similar functionality, intended use, technological characteristics, and typical users as the predicate devices. Verification and validation activities ensure that the design specifications are met and that the DICOM Viewer does not introduce new issues concerning safety and effectiveness. Hence DICOM Viewer is substantial equivalent to the predicate devices.

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).