The software is intended for the viewing and diagnosis of image data in relation to dental issues. Its proper use is documented in the operating instructions of the corresponding image-generating systems. Image-generating systems that can be used with the software include optical video cameras, image plate scamers, extraoral X-ray devices, intraoral scanners and TWAIN compatible image sources. The software must only be used by authorized healthcare professionals in dental areas for the following tasks:

Filter optimization of the display of 2D and 3D images for improved diagnosis
Acquisition, storage, management, display, analysis, editing and supporting diagnosis of digital/digitized 2D and 3D images and videos
Forwarding of images and additional data to external software (third-party software)

The software is not intended for mammography use.

Device Description

VisionX 2.4 imaging software is an image management system that allows dentists to acquire, display, edit, view, store, print, and distribute medical images. VisionX 2.4 software runs on user provided PC-compatible computers and utilizes previously cleared digital image capture devices for image acquisition. This software was cleared in K181432 as part of the x-Ray system ProVecta 3D Prime. With this submission VisionX will be established as standalone software. Additionally, new hardware was integrated: Support of the ScanX Touch / Duo Touch (K191623)

AI/ML Overview

This document is a 510(k) premarket notification for the VisionX 2.4 imaging software. It primarily focuses on demonstrating substantial equivalence to a predicate device (DBSWIN and VistaEasy Imaging Software, K190629), rather than presenting a detailed study with specific acceptance criteria and performance metrics for an AI/algorithm-driven diagnostic aid.

Here's an analysis based on the provided text, highlighting what is available and what is not:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly define acceptance criteria as a table with numerical thresholds for performance metrics (e.g., accuracy, sensitivity, specificity) for algorithm performance. Instead, it relies on the concept of "substantial equivalence" to a predicate device that has established safety and effectiveness.

The "device performance" reported is at a high level, stating:

"Software testing, effectiveness, and functionality were successfully conducted and verified between VisionX 2.4 and image capture devices."
"Full functional software cross check testing was performed."
"The verification testing demonstrates that the device continues to meet its performance specifications and the results of the testing did not raise new issues of safety or effectiveness."

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

This information is not provided in the document. The submission is for an imaging software that manages and displays images, and while it mentions "supporting diagnosis," it does not seem to include a specific AI/algorithm for automated diagnosis where a test set with performance metrics would typically be required.

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

This information is not provided. Given the nature of the submission (imaging software for viewing and management, rather than a novel AI diagnostic algorithm), such detailed ground truth establishment is not typically a requirement for this type of 510(k). The document mentions a "Clinical Evaluation" which included "detailed review of literature data, data from practical tests in dental practices, and safety data," to conclude suitability for dental use, but this is distinct from establishing ground truth for an AI algorithm's performance.

4. Adjudication Method for the Test Set:

This information is not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not reported. The submission focuses on the functionality and safety of the imaging software itself and its equivalence to other legally marketed imaging software, not on an AI's impact on human reader performance.

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

Given that VisionX 2.4 is described as "imaging software" for "viewing and diagnosis of image data" and includes "Filter optimization of the display of 2D and 3D images for improved diagnosis" and "supporting diagnosis," it functions as a tool for clinicians. The text explicitly states that "The software must only be used by authorized healthcare professionals in dental areas for the following tasks." This indicates a human-in-the-loop scenario. The document does not describe a standalone algorithm performance study in the way typically expected for an AI diagnostic tool.

7. The Type of Ground Truth Used:

This information is not explicitly stated as traditionally understood for AI performance. The nearest concept mentioned is that the "Clinical Evaluation" concluded that the software is suitable for dental use, based on "literature data, data from practical tests in dental practices, and safety data." This points more towards usability and safety in a clinical context rather than a specific ground truth for an automated diagnostic task.

8. The Sample Size for the Training Set:

This information is not provided. As this is an imaging and management software, not a deep learning AI model requiring a distinct training set for diagnostic capabilities, such data is not expected or presented.

9. How the Ground Truth for the Training Set was Established:

This information is not provided, as it's not a submission for a deep learning AI model with a training set requiring ground truth establishment in the typical sense.

Summary of what is present and relevant to the request:

The submission focuses on the functionality and software development process of VisionX 2.4, an imaging management and display software for dental use, seeking substantial equivalence to a predicate device (K190629). It highlights:

Compliance with IEC 62304 and FDA guidance for software in medical devices.
Successful software testing for effectiveness and functionality.
DICOM compliance.
Risk analysis, design reviews, and full functional cross-check testing.
A "Clinical Evaluation" assessing suitability for dental use based on literature and practical tests.

The document does not provide specific quantitative acceptance criteria or detailed studies on the performance of a novel AI/algorithm in terms of diagnostic accuracy, sensitivity, or specificity against established ground truth, or its impact on human reader performance. This is consistent with the device being primarily an image management and viewing system with features that "support diagnosis" through display optimization, rather than a standalone AI diagnostic tool.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is a stylized image of a human figure, and the text on the right is in blue. The words "U.S. FOOD & DRUG" are in a larger font than the word "ADMINISTRATION".

October 31, 2019

Durr Dental SE % Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct Naples, FLORIDA 34114

Re: K192743

Trade/Device Name: VisionX 2.4 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: September 26, 2019 Received: September 30, 2019

Dear Mr. Daniel Kamm:

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

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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 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) K192743

Device Name VisionX 2.4

Indications for Use (Describe)

Filter optimization of the display of 2D and 3D images for improved diagnosis
Acquisition, storage, management, display, analysis, editing and supporting diagnosis of digital/digitized 2D and 3D images and videos
Forwarding of images and additional data to external software (third-party software)

The software is not intended for mammography use.

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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510(k) Summary, DÜRR DENTAL SE,

Device Name: VisionX 2.4

K192743

This 510(k) is being submitted in accordance with the requirements of 21 CFR §807.92.

1. Date Summary Prepared:

September 19, 2019

2. Submitter's Identification:

DÜRR DENTAL SE (Registered as DUERR DENTAL SE) Höpfigheimer Str. 17 74321 Bietigheim-Bissingen Deutschland/Germany Phone: + 49 (0) 7142 70 5-0 Fax: + 49 (0) 7142 705-500 E-Mail info@duerr.de Internet: www.duerrdental.com

Responsible Individual Contact/Prepared by: Oliver Lange, Director of Quality Management DÜRR DENTAL SE Höpfigheimer Str. 17 74321 Bietigheim-Bissingen Deutschland/Germany Phone: 49-7142-705-190 Email: oliver.lange@duerrdental.com

Mr. Joseph Latkowski Director of Quality and Regulatory Air Techniques, Inc. 1295 Walt Whitman Road Melville, NY 11747, USA U.S. Phone: 516-214-5574 E-Mail: Joseph.Latkowski@airtechniques.com

3. Device:

Trade /Proprietary Name: VisionX 2.4 Device: Medical Imaging Software Regulation Description: Picture archiving and communications system. Regulation Medical Specialty: Radiology Review Panel Radiology Product Code LLZ 892.2050 Regulation Number Device Class 2

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4. Predicate Device:

Legally Marketed Predicate Device Information:

510(k) Number:	K190629
Manufacturer:	DÜRR DENTAL SE
Trade /Proprietary Name	DBSWIN and VistaEasy Imaging Software
Device:	Medical Imaging Software
Regulation Description:	Picture archiving and communications system.
Regulation Medical Specialty:	Radiology
Review Panel	Radiology
Product Code	LLZ
Regulation Number	892.2050
Device Class	2

5. Device Description:

6. Indications for Use

The software is intended for the viewing and diagnosis of image data in relation to dental issues. Its proper use is documented in the operating instructions of the corresponding imagegenerating systems. Image-generating systems that can be used with the software include optical video cameras, digital X-ray cameras, image plate scanners, extraoral X-ray devices, intraoral scanners and TWAIN compatible image sources.

The software must only be used by authorized healthcare professionals in dental areas for the following tasks:

Filter optimization of the display of 2D and 3D images for improved diagnosis
Acquisition, storage, management, display, analysis, editing and supporting diagnosis of digital/digitized 2D and 3D images and videos
Forwarding of images and additional data to external software (third-party software) The software is not intended for mammography use.

7. Summary of the technological characteristics of the device compared to the predicate device:

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Comparison of the Technological Characteristics

DescriptiveInformation:	Predicate Device:	Subject Device:
	DBSWIN and VistaEasy Imaging Software	VisionX 2.4
	K190629
Indications forUse	DBSWIN and VistaEasy imaging softwareare intended for use by qualified dentalprofessionals for windows-baseddiagnostics. The software is a diagnosticaide for licensed radiologists, dentistsand clinicians, who perform the actualdiagnosis based on their training,qualification, and clinical experience.DBSWIN and VistaEasy are clinicalsoftware applications that receiveimages and data from various imagingsources (i.e., radiography devices anddigital video capture devices) that aremanufactured and distributed by DÜRRDental and Air Techniques. It is intendedto acquire, display, edit (i.e., resize,adjust contrast, etc.) and distributeimages using standard PC hardware. Inaddition, DBSWIN enables theacquisition of still images from 3rd partyTWAIN compliant imaging devices (e.g.,generic image devices such as scanners)and the storage and printing of clinicalexam data, while VistaEasy distributesthe acquiredimages to 3rd party TWAIN compliantPACS systems for storage and printing.DBSWIN and VistaEasy software are notintended for mammography use.	The software is intended for theviewing and diagnosis of image data inrelation to dental issues. Its proper useis documented in the operatinginstructions of the correspondingimage-generating systems. Image-generating systems that can be usedwith the software include optical videocameras, digital X-ray cameras, imageplate scanners, extraoral X-ray devices,intraoral scanners and TWAINcompatible image sources.The software must only be used byauthorized healthcare professionals indental areas for the following tasks:- Filter optimization of the display of2D and 3D images for improveddiagnosis- Acquisition, storage, management,display, analysis, editing andsupporting diagnosis ofdigital/digitized 2D and 3D imagesand videos- Forwarding of images andadditional data to externalsoftware (third-party software)The software is not intended formammography use.
PatientManagement	Yes	Yes
ImageManagement	Yes	Yes
X-ray(i.e., PhosphorPlate, DigitalPanoramic)	Yes	Yes
LaserFluorescenceCariesDetection Aid	Yes	Yes
Video	Yes	No
Photos	Yes	Yes
Documents	Yes	No
Import	Yes	Yes
Display Images	Yes	Yes
Save/Store Images	Yes	Yes
Produce Reports	Yes	Yes
Print/Export Images	Yes	Yes
Brightness	Yes	Yes
Contrast	Yes	Yes
Colorize	Yes	No
Crop	Yes	Yes
Rotate	Yes	Yes
Zoom In/Out	Yes	Yes
Invert	Yes	Yes
Sharpen	Yes	Yes
Measure	Yes	Yes
Annotate	Yes	Yes
Run on standard PC compatible computers	Yes	Yes
Operating Systems	Microsoft Windows 7, 32-bit (from Home to Premium)Microsoft Windows 7, 64-bit (from Home to Premium)Microsoft Windows 8.1, 64-bitMicrosoft Windows 10, 64-bitMicrosoft Windows Server 2012Microsoft Windows Server 2016	Microsoft Windows 7, 64-bitMicrosoft Windows 8.1, 64-bitMicrosoft Windows 10, 64-bitMicrosoft Windows Server 2016Microsoft Windows Server 2019Same but since Windows 7 is no longer supported by Microsoft we no longer recommend using this OS..
Supported Devices	Supported Device Families:• ScanX• ProVecta S-Pan• CamX	Supported Device Families:• ScanX• ProVecta S-Pan• CamXAdded Device Family:• ProVecta 3D

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8. Discussion of Similarities and Differences:

VisionX 2.4 represents these enhancements as compared to our predicate:

VisionX as standalone software. Currently the VisionX is cleared as part of the System of ● ProVecta 3D prime only.
. 3D functionality: 3D images and videos for acquisition, storage, management, display, analysis, editing and supporting diagnosis of digital/digitized.
Integration of the device family ProVecta 3D (x-ray system, cleared in K181432).
Integration of new variants of image plate scanner of the "ScanX" device family.
. Integration of a new interface for an intraoral scanner.

9. Non-Clinical Data and Performance Testing

VisionX 2.4 was developed in compliance with the harmonized standard of IEC 62304 for medical device software life cycle requirements. We consulted this FDA guidance document during the software development: Guidance for Industry and FDA Staff- Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. Software testing, effectiveness, and functionality were successfully conducted and verified between VisionX 2.4 and image capture devices. VisionX 2.4 is DICOM compliant. Risk Analysis based design development and design reviews were conducted. Full functional software cross check testing was performed.

Labeling and internal procedures have been updated to assure compliance with the FDA Guidance: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices-Guidance for Industry and Food and Drug Administration Staff Document. In addition, we performed what we call a "Clinical Evaluation." This was an extensive detailed review of literature data, data from practical tests in dental practices, and safety data. It concluded that the software is suitable for an effective, efficient and safe dental use for the indications mentioned.

1. Clinical Data: Not required for a finding of substantial equivalence.

11. Conclusion:

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the similarity to the predicate device in terms of technology, performance and indications for use, DÜRR DENTAL SE concludes that the VisionX 2.4 Imaging Software is substantially equivalent to the predicate device as described herein. The device modifications to VisionX 2.4 do not alter the fundamental scientific technology of the predicate device and summary level information is adequate to assess the modifications. The verification testing demonstrates that the device continues to meet its performance specifications and the results of the testing did not raise new issues of safety or effectiveness. Therefore, the modified VisionX 2,4 can be found substantially equivalent to the predicate device as cleared in K190629.

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).