DBSWIN and VistaEasy imaging software are intended for use by qualified dental professionals for windows based diagnostics. The software is a diagnostic aide for licensed radiologists, dentists and clinicians, who perform the actual diagnosis based on their training, qualification, and clinical experience. DBSWIN and VistaEasy are clinical software applications that receive images and data from various imaging sources (i.e., radiography devices and digital video capture devices) that are manufactured and distributed by DÜRR Dental and Air Techniques. It is intended to acquire, display, edit (i.e., resize, adjust contrast, etc.) and distribute images using standard PC hardware. In addition, DBSWIN enables the acquisition of still images from 3rd party TWAIN compliant imaging devices (e.g., generic image devices such as scanners) and the storage and printing of clinical exam data, while VistaEasy distributes the acquired images to 3rd party TWAIN compliant PACS systems for storage and printing.

DBSWIN and VistaEasy software are not intended for mammography use.

Device Description

DBSWIN and VistaEasy imaging software is an image management system that allows dentists to acquire, display, edit, view, store, print, and distribute medical images. DBSWIN and VistaEasy software runs on user provided PC-compatible computers and utilize previously cleared digital image capture devices for image acquisition. VistaEasy is included as part of DBSWIN. It provides additional interfaces for Third Party Software. VistaEasy can also be used by itself, as a reduced feature version of DBSWIN.

AI/ML Overview

The provided document is a 510(k) summary for DÜRR DENTAL SE's DBSWIN and VISTAEASY Imaging Software (K190629). This submission focuses on establishing substantial equivalence to a predicate device (K161444) rather than presenting a study to prove performance against specific acceptance criteria for a novel device. Therefore, much of the requested information about device performance and study details is not explicitly available in this document.

However, based on the information provided, here's an attempt to answer the questions:

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

The document does not specify quantitative acceptance criteria for device performance. Instead, it asserts substantial equivalence to a predicate device by comparing technological characteristics and functionalities. The performance is implied to be equivalent to the predicate.

Acceptance Criteria (Implied)	Reported Device Performance
Identical Indications for Use	Confirmed "SAME, unchanged"
Identical functionality (Patient Management, Image Management, Display, Enhance, etc.)	Confirmed "YES" for all listed functionalities compared to predicate.
Supported Devices	Similar to predicate, with additional integrated devices (ScanX Swift View, VistaScan Nano, ScanX Classic View, CamX Triton HD Proxi, CamX Triton HD Spectra).
Compatible Computer Operating Systems	Updated list of supported Microsoft Windows and Server OS, removing old and adding new versions.
Minimum CPU Requirements	Similar to predicate (≥ Intel Pentium IV compatible, 1.4 GHz).
Minimum RAM Requirements	Similar to predicate (≥ 1GB, 2GB recommended).
Hard Disk Requirements	Similar to predicate (Workstation (without database) ≥50 GB; memory requirements of database depend on image count).
DICOM Compliance	Confirmed "DBSWIN is DICOM compliant."
Compliance with medical device software life cycle requirements (IEC 62304)	Confirmed "DBSWIN/VistaEasy was developed in compliance with the harmonized standard of IEC 62304."
No new issues of safety or effectiveness	Verification testing demonstrated the device continues to meet performance specifications and no new issues were raised.

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

The document does not specify a separate "test set" or its sample size. The performance claims are based on "Bench testing, effectiveness, and functionality" and "Full functional software cross check testing." No information on data provenance (country of origin, retrospective/prospective) is provided, as no clinical study with patient data is mentioned.

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. The document does not describe a study involving expert-established ground truth for a test set, as it emphasizes technological equivalence and software verification/validation rather than clinical performance evaluation against a gold standard.

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

Not applicable. No expert-adjudicated test set is described.

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. This document is for imaging software that aids in acquiring, displaying, editing, and distributing images, rather than an AI diagnostic tool. No MRMC study is mentioned.

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

Not applicable. The device is referred to as "clinical software applications" and a "diagnostic aide for licensed radiologists, dentists and clinicians," indicating a human-in-the-loop context. It processes and presents images, it does not perform standalone diagnosis.

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

Not applicable. As no clinical study validating diagnostic accuracy is presented, there is no mention of a ground truth type. The focus is on software functionality and technical specifications.

8. The sample size for the training set

Not applicable. This device is not described as an AI/machine learning model where a training set size would be relevant. It's a general imaging software.

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

Not applicable, for the same reason as above.

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: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and consists of the letters "FDA" stacked on top of the words "U.S. FOOD & DRUG ADMINISTRATION".

April 1, 2019

Durr Dental SE % Mr. Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct NAPLES FLORIDA 34114

Re: K190629

Trade/Device Name: DBSWIN and VISTAEASY Imaging Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: March 4, 2019 Received: March 12, 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Michael D. O'Hara
For

Thalia Mills, 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) K190629

Device Name DBSWIN and VISTAEASY Imaging Software

Indications for Use (Describe)

DBSWIN and VistaEasy software are not intended for mammography use.

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, DÜRR DENTAL SE,

DBSWIN and VISTAEASY Imaging Software

K190629

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

1. Date Summary Prepared:

March 5, 2019

Submitter's Identification: 2.

DÜRR 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, Head Director of Quality Management DÜRR DENTAL SE Höpfigheimer Str. 17 74321 Bietigheim-Bissingen Deutschland/Germany Phone: 49-7142-705-190 Email: lange.o@duerr.de oliver.lange@duerrdental.com

U.S. Agent Contact: Vincent Vega Air Techniques, Inc. 1295 Walt Whitman Road Melville, NY 11747 Phone: 516 2145512 Fax: 516 4336171 Email: Vincent.Vega@airtechniques.com

3. Device:

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

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4. Predicate Device:

Legally Marketed Predicate Device Information:
510(k) Number:	K161444
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

DBSWIN and VistaEasy software are not intended for mammography use.

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

DBSWIN and VistaEasy imaging software by DÜRR DENTAL SE are two software components that are substantially equivalent to DBSWIN and VistaEasy Imaging Software K161444 software applications that have identical indications for use, functionality, performance, and features as shown in the following comparison Table.

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Comparison of the Technological Characteristics

DescriptiveInformation	DBSWIN and VistaEasy ImagingSoftware K161444	DBSWIN and VistaEasy ImagingSoftware (Modified)
Indications for Use	DBSWIN and VistaEasy imagingsoftware are intended for use byqualified dental professionals forwindows based diagnostics. Thesoftware is a diagnostic aide forlicensed radiologists, dentists andclinicians, 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 isintended to acquire, display, edit (i.e.,resize, adjust contrast, etc.) anddistribute images using standard PChardware. In addition, DBSWIN enablesthe acquisition of still images from 3rdparty TWAIN compliant imaging devices(e.g., generic image devices such asscanners) and the storage and printingof clinical exam data, while VistaEasydistributes the acquired images to 3rdparty TWAIN compliant PACS systemsfor storage and printing.DBSWIN and VistaEasy software are notintended for mammography use.	SAME, unchanged.
PatientManagement	YES	YES
Image Management	YES	YES
Acquisition SourcesX-ray(i.e., PhosphorPlate, DigitalPanoramic)	YES	YES
LaserFluorescenceCariesDetection Aid	YES	YES
Video	YES	YES
DescriptiveInformation	DBSWIN and VistaEasy ImagingSoftware K161444	DBSWIN and VistaEasy ImagingSoftware (Modified)
Photos	YES	YES
Documents	YES	YES
Import*	YES	YES
Display Images	YES	YES
Safe/Store Images*	YES	YES
Produce Reports*	YES	YES
Print/ExportImages*	YES	YES
EnhanceImages
Brightness	YES	YES
Contrast	YES	YES
Colorize*	YES	YES
Crop	YES	YES
Rotate	YES	YES
Zoom In/Out	YES	YES
Invert*	YES	YES
Sharpen*	YES	YES
Measure*	YES	YES
Over/UnderExposure	YES	YES
Annotate*	YES	YES
Run onstandard PCcompatiblecomputers	YES	YES
DescriptiveInformation	DBSWIN and VistaEasy ImagingSoftware K161444	DBSWIN and VistaEasy ImagingSoftware (Modified)
Supported Devices	VistaCam iX ProofCamX SpectraVistaCam iX CamCamX ElaraCamX PolarisVistaCam iX HDCamX Triton HDCamX Luna HDVistaCam iX MacroVistaPano SProVecta S-PanVistaPano S CEPHProVecta S-PAN CEPHScanX SwiftScanX DuoScanX ClassicScanX OrthoScanX Intraoral	Same, plus these newly integrateddevices:ScanX Swift ViewVistaScan NanoScanX Classic ViewCamX Triton HD ProxiCamX Triton HD Spectra
Computeroperating systems	Microsoft Windows 7, 32 bit (from HomePremium),Microsoft Windows 7, 64 bit (from HomePremium),Microsoft Windows 8, 64 bit MicrosoftWindows 10, 64-bitMicrosoft Windows Server 2012	Microsoft Windows 7, 32-bit (from Home toPremium)Microsoft Windows 7, 64-bit (from Home toPremium)Microsoft Windows 8.1, 64-bitMicrosoft Windows 10, 64-bitMicrosoft Windows Server 2012Microsoft Windows Server 2016
CPU	≥ Intel Pentium IV compatible, 1.4 GHz,≥ Intel Core i3	≥ Intel Pentium IV compatible, 1.4 GHz
RAM	≥ 1GB (2GB recommended), ≥ 4 GB	≥ 1GB (2GB recommended)
Drive	DVD-ROM	No change
Hard Disk	Workstation (without database) ≥50 GB	Workstation (without database) ≥50 GBThe memory requirements of the databasedepend on the number of images taken atthe office. (Camera image: Approx. 1 MB, X-ray image: Approx. 2 MB - 10 MB)
Data Backup	Daily data back up	No change
Interface	Ethernet ≥ 100 Mbit	No change
Diagnostic Monitor	SVGA ≥ 17", ≥ 1024 x 768 pixel, 24/32 bit colordepth	No change
Resolution /Graphics	≥ 1024 x 768	≥ 1024 x 768Depth of color 32-bit, 16.7 million colors
Run on standard PCcompatiblecomputers	Yes	No change

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Not available on VistaEasy

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8. Discussion of Similarities and Differences:

The list of compatible operating systems has changed. We no longer support Windows XP and Windows 8. We now support these additional operating systems: Microsoft Windows 8.1, 64bit, Microsoft Windows 10, 64-bit Microsoft Windows Server 2016.

We have added Cybersecurity precautions and information.

Compatibility with these additional image sources has been added: ScanX Swift View; VistaScan Nano; ScanX Classic View; CamX Triton HD Proxi; CamX Triton HD Spectra.

Firmware Files for DÜRR Dental SE and Air Techniques scanner devices has been updated. UDI information display has been added.

9. Non-Clinical Data and Performance Testing

DBSWIN/VistaEasy was developed in compliance with the harmonized standard of IEC 62304 for medical device software life cycle requirements.

DBSWIN product has been in sales and distribution in the European dental market for over 19 years serving and performing the same intended use, functionality, and hardware compatibility interfaces with 3rd party software.

Bench testing, effectiveness, and functionality were successfully conducted and verified between DBSWIN and VistaEasy, and image capture devices.

DBSWIN is DICOM compliant.

Risk Analysis based design development and design reviews were conducted.

Full functional software cross check testing was performed.

Labeling has 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 Issued on: October 2, 2014

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, DURR DENTAL SE concludes that the DBSWIN and VistaEasy Imaging Software is substantially equivalent to the predicate device as described herein.

The minor device modifications to DBSWIN/VistaEasy 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 DBSWIN/VistaEasy can be found substantially equivalent to the predicate device as cleared in K161444.

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).