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 optimisation of the display of 2D and 3D images for improved diagnosis
Acquisition, storage, management, display, analysis, editing and supporting diagnosis of digital/digitised 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 3.0 imaging software is an image management system that allows dentists to acquire, display, edit, view, store, print, and distribute medical images. VisionX 3.0 software runs on user provided PCcompatible computers and utilize previously cleared digital image capture devices for image acquisition.

AI/ML Overview

The VisionX 3.0 device includes new AI-powered functions such as automatic nerve canal tracing, automatic image rotation, and improved panoramic curve detection. The 510(k) summary provided does not contain a specific study demonstrating the device meets acceptance criteria for these AI functions. Instead, it states that "Full functional software cross check testing was performed." and that "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." This implies that the internal performance specifications were met, but details on these specifications and the testing methodology are not provided in the summary.

Here's the information that can be extracted from the provided text, along with details that are explicitly stated as not available or not applicable based on the given document:

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Function	Acceptance Criteria (Implied/General)	Reported Device Performance (as per 510(k) summary)
General software functionality and effectiveness	No specific quantitative acceptance criteria are provided in the document. Implied: Device meets its performance specifications.	"Full functional software cross check testing was performed." "The verification testing demonstrates that the device continues to meet its performance specifications."
AI Functions (Automatic nerve canal calculation, Automatic image rotation, In-line automatic image plate quality checks, Improved panoramic curve detection)	No specific quantitative acceptance criteria (e.g., accuracy, sensitivity, specificity) for these AI functions are provided in the document. Implied: Functions operate as intended.	The new functions were added and underwent "Full functional software cross check testing." The modifications did not raise new issues of safety or effectiveness.
Cybersecurity	Compliance with FDA guidance for "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices."	"Cybersecurity was addressed according to the FDA guidance document."
DICOM compliance	Compliance with DICOM standards.	"VisionX 3.0 is DICOM compliant."
Software life cycle requirements	Compliance with IEC 62304 standard.	"VisionX 3.0 was developed in compliance with the harmonized standard of IEC 62304."

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not specified in the provided document.
Data Provenance: Not specified in the provided document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not specified or implied in the provided document.
Qualifications of Experts: Not specified or implied in the provided document.

4. Adjudication method for the test set

Adjudication Method: Not specified or implied in the provided document.

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

MRMC Study: No, an MRMC comparative effectiveness study is not mentioned in the provided document.
Effect Size: Not applicable, as no MRMC study was mentioned.

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

The document implies that the AI features (e.g., automatic nerve canal tracing) operate in a standalone capacity within the software, as they are listed as "new functions." However, no specific standalone performance metrics (e.g., accuracy, sensitivity, specificity of the algorithm alone) are provided in the summary. The "full functional software cross check testing" suggests validation of the software's operation, but without specific performance data for the AI components in isolation.

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

Type of Ground Truth: Not specified in the provided document.

8. The sample size for the training set

Sample Size for Training Set: Not specified in the provided document.

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

Ground Truth Establishment for Training Set: Not specified in the provided document.

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). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 2, 2021

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

Re: K213326

Trade/Device Name: VisionX 3.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: October 1, 2021 Received: October 5, 2021

Dear Mr. 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-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)

K213326

Device Name VisionX 3.0

Indications for Use (Describe)

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

Filter optimisation of the display of 2D and 3D images for improved diagnosis
Acquisition, storage, management, display, analysis, editing and supporting diagnosis of digital/digitised 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)

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

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

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510(k) Summary, DÜRR DENTAL SE, Device Name: VisionX 3.0 K213326

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

1. Submitter

Submitter:	DÜRR DENTAL SEHöpfigheimer Str. 1774321 Bietigheim-Bissingen, GermanyPhone: + 49 (0) 7142 70 5-0Fax: + 49 (0) 7142 705-500E-Mail: info@duerr.de	Establishment Registration Name in FURLS:	Duerr DENTAL SE
Establishment RegistrationNumber:	3015509619
Contact Person:	Mr. Oliver LangeDirector of Quality ManagementDÜRR DENTAL SEHöpfigheimer Str. 1774321 Bietigheim-Bissingen, GermanyPhone: + 49 (0) 7142 70 5-190Email: oliver.lange@duerrdental.com
U.S. Agent & Contact:	Mr. Joseph LatkowskiDirector of Quality and RegulatoryAir Techniques, Inc.1295 Walt Whitman RoadMelville, NY 11747, USAU.S. Phone: 516-214-5574E-Mail: Joseph.Latkowski@airtechniques.com

Date summary prepared: Thursday, September 30, 2021

2. Device:

Trade /Proprietary Name:	VisionX 3.0
Device:	Medical Imaging Software
Regulation Description:	Medical image management and processing system.
Regulation Medical Specialty:	Radiology
Review Panel	Radiology
Product Code	LLZ
Regulation Number	892.2050
Device Class	2

3. Predicate Device:

Legally Marketed Predicate Device Information:
510(k) Number:	K192743
Manufacturer:	DÜRR DENTAL SE
Trade /Proprietary Name	VisionX 2.4

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Device:	Medical Imaging Software
Regulation Description:	Medical image management and processing system.
Regulation Medical Specialty:	Radiology
Review Panel	Radiology
Product Code	LLZ
Regulation Number	892.2050
Device Class	2

4. Device Description:

5. 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 image-generating 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.

6. Comparison of technological characteristics with the predicate device

VisionX 3.0 represents these enhancements as compared to our predicate:

-Automatic nerve canal calculation
Automatic imaging plate quality check ।
-Improved 3D panoramic display
-VisionX Connect
Automatic image rotation -
-User management

A detailed comparison table is provided on the next page.

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	VisionX 2.4 K192743	VisionX 3.0	Evaluation
Manufacturer	DÜRR DENTAL SE	DÜRR DENTAL SE	Identical
Clinical:	Indications for use	The software is intended for the viewingand diagnosis of image data in relationto dental issues. Its proper use isdocumented 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 external software(third-party software)The software is not intended formammography use.	Identical
Specifications:
Functions	- Imaging application including aviewer and job interface- Viewer- Test module- Implant visualization- 3D imaging module- Layouts (structured displays)- DICOM-Workflow (RIS & PACS)	- Imaging application including aviewer and job interface- Image viewer- Inspect test module- Implant visualization- 3D imaging module- Layouts (structured displays)- DICOM-Workflow (RIS & PACS &Print)- User management- Automatic rotation (AI)- Automatic nerve canal tracing (AI)- In-line automatic image platequality checks (AI)- Improved panoramic curvedetection (AI)- VistaSoft/VisionX Connect tointegrate Dürr Dental and AirTechniques devices into 3rd partysoftware	New functionswere added
Patient	Yes	Yes	Identical
	VisionX 2.4 K192743	VisionX 3.0	Evaluation
Manufacturer	DÜRR DENTAL SE	DÜRR DENTAL SE	Identical
Image Management	Yes	Yes	Identical
Acquisition sourcesX-ray (i.e. PhosphorPlate, DigitalPanoramic)	Yes	Yes	Identical
LaserFluorescenceCaries Detection Aid	Yes	Yes
Display images	Yes	Yes
Safe/Store images	Yes	Yes
Produce reports	Yes	Yes
Enhance images
Brightness	Yes	Yes
Contrast	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 PCcompatiblecomputers	Yes	Yes	Identical
Computer operatingsystems	Microsoft Windows 7Microsoft Windows 8.1Microsoft Windows 10Microsoft Windows Server 2016Microsoft Windows Server 2019	64-bit operating system:Microsoft Windows 8.1 (not Windows RT)Microsoft Windows 10 (Pro or higher)Microsoft Windows Server 2016Microsoft Windows Server 2019	Identical(except ofWindows 7,which is nolongersupported byMicrosoft)
Supportive devices	- ScanX- ProVecta S-Pan- ProVecta 3D- CamX	- ScanX- ProVecta S-Pan- ProVecta 3D- CamX- SensorX	Added Device:SensorX(K203116)
System requirements:
CPU	$\ge$ Intel Core i3	$\ge$ Intel Core i3	Identical
RAM	$\ge$ 4 GB	$\ge$ 4 GBFor automatic nerve canal detection: $\ge$ 8 GB	Similar
Drive	DVD ROM	USB, DVD-ROM or download	Similar
Hard disk	Workstation (without database) $\ge$ 50 GBThe database memory requirementsdepend on the number of images takenat the surgery in question. (Cameraimage: approx. 1 MB, X-ray image:approx. 2 MB – 10 MB, CBCT: 200 – 300MB)	Workstation (without database) $\ge$ 50 GBThe database memory requirementsdepend on the number of images takenat the surgery in question. (Cameraimage: approx. 1 MB, X-ray image:approx. 2 MB - 10 MB, CBCT: 200 - 300MB)	Identical
Data backup	Daily data back-up	Daily data back-up	Identical
	VisionX 2.4 K192743	VisionX 3.0	Evaluation
Manufacturer	DÜRR DENTAL SE	DÜRR DENTAL SE	Identical
Diagnostic Monitor	In accordance with DIN 6868-157, roomcategory 5 or 6 (depending on therequirements)	In accordance with DIN 6868-157, roomcategory 5 or 6 (depending on therequirements)	Identical
Resolution / graphics	Resolution ≥ 1280 x 1024Depth of color 32-bit, 16.7 million colorsRecommended for 3D X-ray images:NVIDIA GeForce 750 2 GB	Resolution ≥ 1280 x 1024Depth of color 32-bit, 16.7 million colorsFor display of 3-D X-ray images:NVIDIA GeForce ≥ 1 GBFor automatic nerve canal tracing:NVIDIA GeForce ≥ 4 GB	Similar

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7. Non-Clinical Data and Performance Testing

VisionX 3.0 was developed in compliance with the harmonized standard of IEC 62304 for medical device software life cycle requirements.

Software testing, effectiveness, and functionality were successfully conducted and verified between VisionX 3.0 and image capture devices. Software was documented using the FDA guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" using a moderate level of concern. Cybersecurity was addressed according to the FDA guidance document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff." VisionX 3.0 is DICOM compliant.

Risk Analysis based design development and design reviews were conducted. Full functional software cross check testing was performed.

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

9. 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 VisionX 3.0 Imaging Software is substantially equivalent to the predicate device as described herein.

The device modifications to VisionX 3.0 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 3.0 can be found substantially equivalent to the predicate device as cleared in K192743.

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).