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 Duerr 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 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 defeatured version of DBSWIN.

AI/ML Overview

The provided text describes a 510(k) premarket notification for "DBSWIN and VistaEasy Imaging Software." This submission is a "Special 510(k) Summary" for minor modifications to an already cleared predicate device (K143290). Therefore, the document focuses on demonstrating that the new version is substantially equivalent to the previous one and primarily relies on non-clinical testing rather than extensive new clinical studies for acceptance criteria.

Based on the provided text, a detailed breakdown of acceptance criteria and a study proving those criteria is challenging because the document primarily asserts substantial equivalence through a comparison to a predicate device and relies on generalized non-clinical testing rather than specific new performance metrics for the modified device.

Here's an attempt to extract the requested information based on the available text:

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

The document does not explicitly state numerical acceptance criteria like sensitivity, specificity, or accuracy for diagnostic performance. Instead, the "acceptance criteria" are implied to be the continued equivalent functionality and safety to the predicate device and compliance with relevant standards. The "reported device performance" is a confirmation that these functionalities are maintained.

Acceptance Criteria (Implied)	Reported Device Performance
Compliance with medical device software life cycle requirements (IEC 623304)	Developed in compliance with IEC 62304.
Maintains intended use functionality as predicate	"Continues to meet its performance specifications."
Hardware compatibility interfaces (especially with 3rd party software)	"Same intended use, functionality, and hardware compatibility interfaces with 3rd party software."
Effective and functional with image capture devices	"Bench testing, effectiveness, and functionality were successfully conducted and verified."
DICOM compliance	DBSWIN is DICOM compliant.
No new issues of safety or effectiveness	"The results of the testing did not raise new issues of safety or effectiveness."
Meets minimum system requirements	Hardware requirements table provided for various OS, CPU, RAM, etc.

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 sample size for a test set in the context of clinical performance evaluation. The testing described is primarily non-clinical: "Bench testing," "Full functional software cross check testing." There is no mention of data provenance (country of origin, retrospective/prospective) because clinical data are not discussed.

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)

No information is provided regarding experts, ground truth establishment, or their qualifications because the document does not describe a clinical study requiring such a test set. The software is described as a "diagnostic aide for licensed radiologists, dentists and clinicians, who perform the actual diagnosis based on their training, qualification, and clinical experience." This implies that the human expert is the ultimate arbiter of diagnosis, not the software.

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

No information is provided regarding adjudication methods as no clinical test set requiring such expert review 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

No MRMC study was mentioned or implied. The device is imaging software, not explicitly an AI-assisted diagnostic tool in the sense of providing automated interpretations or significant decision support that would require such a study. It's a tool for acquiring, displaying, and editing images.

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

A "standalone" performance study for an algorithm in a diagnostic sense was not done. The software's performance is gauged through non-clinical functional testing and its ability to process images. Its role is as a "diagnostic aide" to a human professional.

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

No specific type of "ground truth" (e.g., pathology, expert consensus) is mentioned because the document does not describe the evaluation of a diagnostic algorithm against such a truth. The testing focuses on functional verification and compliance with standards.

8. The sample size for the training set

No information about a training set is provided. This type of submission (Special 510(k)) does not typically involve the training of new algorithms but rather the verification of modified software versions against established functionalities of previously cleared devices.

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

Not applicable, as no training set or specific diagnostic algorithm requiring ground truth for training is mentioned. The document describes a software update for an image management system.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other, with flowing lines extending from the bottom profile.

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

June 21, 2016

Duerr Dental AG %Ms. Suzanne Lucas Quality Specialist/ Regulatory Affairs Air Techniques, Inc. 1295 Walt Whitman Road MELVILLE NY 11747

Re: K161444

Trade/Device Name: DBSWIN and VistaEasy Imaging Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 16, 2016 Received: May 25, 2016

Dear Ms. Lucas:

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/ResourcesforYou/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 O'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) K161444

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)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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General Information

Special 510(k) SUMMARY

Submitted by: Duerr Dental AG Höpfigheimer Strasse 17 D-74321 Bietigheim-Bissingen Deutschland / Germany Email: lange.o@duerr.de Contact Person: Oliver Lange Quality Director Duerr Dental AG Höpfigheimer Strasse 17 D-74321 Bietigheim-Bissingen Deutschland / Germany Phone: + 49 (0) 7142 / 705-0 Fax: + 49 (0) 7142 / 705-500 Email: lange.o@duerr.de U.S.A. Contact Person: Suzanne Lucas 1295 Walt Whitman Road Melville, NY 11747 Email: slucas@airtechniques.com Phone: 516-214-5514 Fax: 516-433-6171 May 13, 2016 Date Prepared:

Device

Name of Device:	DBSWIN and VistaEasy Imaging Software
Common or Usual Name:	Radiological Image Processing System
Classification Name:	Picture archiving and communications system (21 CFR 892.2050)
Regulatory Class:	II
Primary Product Code:	LLZ

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Predicate Device

Manufacturer	Product Name	510(k) No.
Duerr Dental AG	DBSWIN and VistaEasy ImagingSoftware	K143290

Device Description

VistaEasy is included as part of DBSWIN. It provides additional interfaces for Third Party Software. VistaEasy can also be used by itself, as a defeatured version of DBSWIN.

Indication for Use

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 Duerr 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 3°° 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 300 party TWAIN compliant PACS systems for storage and printing.

DBSWIN and VistaEasy software are not intended for mammography use.

Predicate Similarities and Technological Comparison:

DBSWIN and VistaEasy are software devices that do not come in contact with patients, and do not control life sustaining devices. The technological differences between the subject device (DBSWIN/VistaEasy 5.10) and the predicate device (DBSWIN/VistaEasy 5.6) that are the subject of this Special 510(k) can be grouped into two main categories: 1) Support for additional devices; and 2) Software changes to improve functionality. The following table provides a comparison of the subject device and the predicate device.

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Device Comparison Table

Parameters	Predicate Device	Subject Device
	DBSWIN/VistaEasy v5.6	DBSWIN/VistaEasy v5.10
	K143290
Indications for Use	DBSWIN and VistaEasy imaging software areintended for use by qualified dentalprofessionals for windows based diagnostics.The software is a diagnostic aide for licensedradiologists, dentists and clinicians, whoperform the actual diagnosis based on theirtraining, qualification, and clinical experience.DBSWIN and VistaEasy are clinical softwareapplications that receive images and data fromvarious imaging sources (i.e., radiographydevices and digital video capture devices) thatare manufactured and distributed by DuerrDental and Air Techniques. It is intended toacquire, display, edit (i.e., resize, adjustcontrast, etc.) and distribute images usingstandard PC hardware. In addition, DBSWINenables the acquisition of still images from3rd party TWAIN compliant imaging devices(e.g., generic image devices such as scanners)and the storage and printing of clinical examdata, while VistaEasy distributes the acquiredimages to 3rd party TWAIN compliant PACSsystems for storage and printing.DBSWIN and VistaEasy software are notintended for mammography use.	Identical
Patient Management*	Yes	Yes
Image Management	Yes	Yes
Acquire Images
X-ray(i.e., Phosphor Plate, DigitalPanoramic)	Yes	Yes
Laser Fluorescence CariesDetection Aid	Yes	Yes
Video	Yes	Yes
Photos	Yes	Yes
Documents	Yes	Yes
Import*	Yes	Yes
Display Images	Yes	Yes
Save/Store Images*	Yes	Yes
Parameters	Predicate DeviceDBSWIN/VistaEasy v5.6	Subject DeviceDBSWIN/VistaEasy v5.10
	K143290
Produce Reports*	Yes	Yes
Print/Export Images*	Yes	Yes
Enhance Images
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
Annotate*	Yes	Yes
Run on standard PC-compatible computers	Yes	Yes
Supported Devices	VistaCam iX ProofVistaCam iX CamVistaCam iX MacroVistaPano SProVecta S-PanScanX Swift	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

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*Denotes features that are unavailable on VistaEasy.

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Clinical and Non-Clinical Testing include:

. 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 15 years serving and performing the same intended use, functionality, and hardware compatibility interfaces with 310 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. ●

Minimum System Requirement for Computer Imaging Systems and Differences between DBSWIN and VistaEasy:

HardwareRequirements	DBSWIN/ VistaEasy
Platform	Microsoft Windows 7, 32 bit (from Home Premium),Microsoft Windows 7, 64 bit (from Home Premium),Microsoft Windows 8, 64 bit (not Windows RT),Microsoft Windows 10, 64-bitMicrosoft Windows Server 2012
CPU	≥ Intel Pentium IV compatible, 1.4 GHz,≥ Intel Core i3
RAM	≥ 1GB (2GB recommended), ≥ 4 GB
Drive	DVD-ROM
Hard Disk	Workstation (without database) ≥50 GB
Data Backup1	Daily data back up
Interface	Ethernet ≥ 100 Mbit
Diagnostic Monitor	SVGA ≥ 17", ≥ 1024 x 768 pixel, 24/32 bit color depth
Resolution /Graphics	≥ 1024 x 768
Run on standard PC-compatible computers	Yes

Daily data backup is not required for VistaEasy since it does not allow the storage of data.

Conclusions

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 K143290.

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).