DTX Studio diagnose is a software program for the transfer and visualization of dental and craniomaxillofacial image information. It displays and enhances digital images from various sources to support the diagnostic process It stores and communicates these images within the system or across computer systems at distributed locations.

Device Description

DTX Studio diagnose is a software solution used to support the image-based diagnostic process of dental and cranio-maxillofacial cases.

DTX Studio diagnose has specific functionalities to visualize imaging information for facilitating diagnosis, e.g. 2D and 3D X-ray information, and to perform specific measurements on the data to support users with the diagnostic process.

The types of digital image data which are supported by the DTX Studio diagnose include, for example, 3D (CB)CT images, orthopantomograph(OPG)/panorex images, intraoral images, cephalograms and clinical pictures.

DTX Studio diagnose allows the user to view and inspect the patient images, and to add findings and measurements. Indicated findings can be saved within the patient profile in DTX Studio. For the purposes of diagnosis, different workspaces are available within the diagnostic module.

The DTX Studio diagnose software is compatible with both Windows and Mac OS X operating systems. Two different software versions/installers are available based on the user's operating system.

AI/ML Overview

This FDA 510(k) clearance document for the DTX Studio diagnose software does not include detailed acceptance criteria or a study proving that the device meets specific performance criteria in terms of diagnostic accuracy or clinical effectiveness.

The document primarily focuses on demonstrating substantial equivalence to predicate devices (CliniView (K162799) and Sidexis 4 (K132773)) based on technological characteristics and non-clinical performance data (software verification and validation).

Here's a breakdown of the requested information based on the provided text:

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

This information is not provided in the document. The submission focuses on software validation and verification against its own requirements, not against pre-defined clinical performance acceptance criteria.

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

This information is not provided. The document mentions "testing which demonstrates that the requirements for the features have been met" (Page 8, Section VII) but does not detail the nature of this testing, the size of any test sets (e.g., images), or data provenance.

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)

This information is not provided. As no clinical or diagnostic performance study is described with a ground truth, this is not applicable.

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

This information is not provided. As no clinical or diagnostic performance study is described, adjudication methods are not relevant to this submission.

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 comparative effectiveness study was done or reported. The document explicitly states: "No clinical data was used to support the decision of substantial equivalence." (Page 9, Section VII).

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

The device is described as "software solution used to support the image-based diagnostic process" (Page 3, Section IV) and to "support the diagnostic process" (Page 5, Section V). Its functions include "visualize imaging information for facilitating diagnosis" and "perform specific measurements on the data to support users with the diagnostic process" (Page 3, Section IV). This indicates it is intended to be used with human-in-the-loop, not as a standalone diagnostic algorithm. No standalone validation is described.

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

This information is not provided. Since no clinical performance study aiming to establish diagnostic accuracy is detailed, no ground truth type is mentioned. The "performance data" referred to is non-clinical software verification and validation against functional requirements.

8. The sample size for the training set

This information is not provided. As "No clinical data was used to support the decision of substantial equivalence" and the software's functionality revolves around image visualization and measurement tools (rather than automated diagnostic algorithms requiring extensive training), no training set is mentioned.

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

This information is not provided. As no training set is discussed, the method for establishing its ground truth is not applicable.

In summary:

This 510(k) clearance is based on substantial equivalence to legally marketed predicate devices, primarily focusing on the software's functional verification and validation against its own requirements as per FDA guidance for software, rather than a clinical performance study with specific diagnostic accuracy acceptance criteria. The document explicitly states that "No clinical data was used to support the decision of substantial equivalence."

Summary

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Image /page/0/Picture/0 description: The image contains 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 the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.

January 11, 2018

Nobel Biocare AB % Charlemagne Chua Senior Regulatory Affairs Manager Nobel Biocare USA LLC 22715 Sasvi Ranch Parkway Yorba Linda, California 92887

Re: K172224

Trade/Device Name: DTX Studio diagnose Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: LLZ Dated: December 13, 2017 Received: December 14, 2017

Dear Charlemagne Chua:

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 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);

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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-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

Robert A. 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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A.4.

I. SUBMITTER

Nobel Biocare AB Västra Hamngatan 1 Goteborg, SE-411 17 Sweden

Submitted by Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda, CA 92887

Contact Person: Charlemagne Chua, Senior Regulatory Affairs Manager Phone: (714) 282-4800 x 7830 Fax: (714) 998-9348

Date Prepared: December 12, 2017

II. DEVICE

Name of Device: DTX Studio diagnose Common or Usual Name: System, Image Processing, Radiology Classification Name: Picture Archiving and Communications System (21 CFR 892.2050) Requlatory Class: II Product Code: LLZ

III. PREDICATE DEVICE

Primary predicate: Palodex Group Oy - Cliniview (K162799)

Reference predicate: Sirona Dental Systems - Sidexis 4 (K132773)

IV. DEVICE DESCRIPTION

DTX Studio diagnose is a software solution used to support the image-based diagnostic process of dental and cranio-maxillofacial cases.

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The DTX Studio diagnose software is compatible with both Windows and Mac OS X operating systems. Two different software versions/installers are available based on the user's operating system.

V. INDICATIONS FOR USE

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VI. Comparison of Technological Characteristics

	SUBJECT	Primary Predicate	Reference Predicate	Comments
Technologicalcharacteristics	DTX Studio diagnose	Cliniview(K162799)	Sidexis 4(K132773)	Except as notedcomparison is made tothe primary predicate
Trade name	DTX Studio diagnose	Cliniview	Sidexis 4
FDA productcode	LLZ	LLZ	LLZ	Same
Classification	Class II	Class II	Class II	Same
Indications foruse / IntendedUse	DTX Studio diagnose is asoftware program for thetransfer and visualization ofdental and craniomaxillofacialimage information. It displaysand enhances digital imagesfrom various sources tosupport the diagnostic processIt stores and communicatesthese images within thesystem or across computersystems at distributedlocations.	Cliniview software program isindicated for general dental andmaxillofacial diagnostic imaging.It controls capture, display,enhancement, and saving ofdigital images from variousdigital imaging systems. Itstores and communicates theseimages within the system oracross computer systems atdistributed locations.	SIDEXIS 4 is software that offersfunctions for the acquisition,administration, analysis,diagnosis, presentation andtransfer of digital or digitizedimage data, e.g. X-ray images orvideo recordings, for medicaluse, predominantly in dentistry.	Different - Seediscussion below
Input data/Imageacquisition	2D and 3D images such as(CB)CT scans and 2D imagessuch as OPG/ panoreximages, cephalometric imagesintra-oral images and clinicalpictures	2D (CB)CT scans and 2Dimages such as OPG/ panoreximages, cephalometric imagesintra-oral images and clinicalpictures	2D and 3D images such as(CB)CT scans and 2D imagessuch as OPG/ panorex images,cephalometric images intra-oralimages and clinical pictures	Same as referencepredicate
Imageprocessingfunctionality	Enhancement, annotation,measurement, import/export	Enhancement, annotation,measurement, import/exportand printing	Enhancement and presentation,import/export	Same
Technologicalcharacteristics	SUBJECT	Primary Predicate	Reference Predicate	Comments
DTX Studio diagnose	Cliniview(K162799)	Sidexis 4(K132773)	Except as notedcomparison is made tothe primary predicate
Output data	Data is stored locally or inremotely accessible databasein the network (DTX core)	Images and related data arestored in the Cliniview databaseor remotely accessibledatabase in the network.Image export	2D Views/images export tospecified location or via e-mailDICOM exam/report/volumeexportFacescan OBJ exportImage and workspace printing	Same
Softwarefeatures	The software provides severalworkspaces to review theimages. It provides specificworkspaces to review (aselection of) the importedimages like e.g. full mouthseries template for intraoralimages, and it providesworkspaces to review aspecific set of images tosupport diagnosis of a selectedarea combining several imagetypes.	A workspace is available towork with imported images. It isalso possible to load and view3D images or multilayer panimages by using 3rd partysoftware.	The software provides severallayouts to review the images. Itprovides specific layout to review(a selection of) the importedimages like e.g. full mouth seriestemplate for intraoral images.	Same as referencepredicate
	Access images from DTX coredatabase or allow manualimport	Access images from databaseor allow manual import	Acquire images from x-raydevices or allow manual import	Same
	Scan requests creation forimage acquisition	Image acquisition fromconnected devices	X-ray exposure creation torequest image acquisition	Different - Seediscussion below
	2D and 3D data visualization	2D data visualizationCliniview is able to send 2D and3D images to 3rd party viewersand is also able to receivepatient information from 3rdparty patient managementsoftware	2D and 3D data visualization	Same as referencepredicate
	SUBJECT	Primary Predicate	Reference Predicate	Comments
Technologicalcharacteristics	DTX Studio diagnose	Cliniview(K162799)	Sidexis 4(K132773)	Except as notedcomparison is made tothe primary predicate
	Adjust patient positioning inthe software and optimizecross-sections and projectedimages	Not available	Adjust data with the panoramacurves editor	Same as referencepredicate
	Apply image filters, makeannotations	Apply image filters, makeannotations	Apply image filters, makeannotations	Same
	Length and anglesmeasurement	Length, angle and free anglemeasurements	Length and angles measurement	Same
SystemRequirements	Workstation:Operating System: Windows®7, 8.1, 10 (64 bit), Mac OS® X(Yosemite, El Capitan); MacOS® SierraHDD ≥ 5 GB of free disk spaceRAM ≥ 8 GBCPU ≥ 2.8 GHz QuadCoreGraphic Card ≥ 2 GBScreen Full HD (1920 x 1080)or higher	Workstation PC:Operating system:Windows 7Professional/Ultimate/EnterpriseSP1 (32 or 64-bit)Windows 8/8.1Professional/Enterprise (32 or64-bit)Windows 10HDD ≥ 8 GBRAM ≥ 4GBCPU Intel Core i3 or better	Workstation PC:Operating System:Windows 7 Pro SP1 (32 o. 64bit)Windows 8.1 Pro (64 bit)Windows 10 Pro (64 bit)HDD ≥ 5 GBRAM ≥ 4 GBCPU ≥ 2 GHz DualCoreGraphic Card ≥ 512 MBScreen 1280 x 1024 Pixel	Different - Seediscussion below

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Analysis of Differences Between Subject Device and Predicates

The subject device DTX Studio diagnose and primary predicate Cliniview (K162799) have the same intended use and share most software features. Other software features are shared with the reference predicate Sidexis 4 (K132773). Differences in indications for use and software features are discussed below.

Indications for Use/ Intended Use

The Indications for Use statement between the subject and the primary predicate devices (K162799) are primarily the same. Minor differences in wording do not alter the intended therapeutic use of the subject device.

Both DTX Studio diagnose and the primary predicate Cliniview (K162799) allow display and enhancement of medical images from various sources, i.e. from various digital imaging systems. In addition, they also allow for retrieving and storage of image within the system (locally) or across computer systems at distributed locations. DTX Studio diagnose allows transfer of images and patient data (store and retrieval) to and from the DTX core database, thus making the data available at different locations. The primary predicate Cliniview (K162799) allows to store and retrieve patient data and related image data in a local or central database called Data Warehouse.

Both the subject and primary predicate are software solutions indicated for the display and processing of medical image information and are intended to support the diagnostic process predominately within dentistry. Oral and maxillofacial surgeons offer treatments which can cover the complete cranio-maxillofacial area (including the dental area). For this reason, the subject device allows the user to visualize and evaluate data for the entire cranio-maxillofacial area, as a support for the diagnostic process.

Software features

Scan request - The subject DTX Studio diagnose allows to request scans through DTX core by selecting the scanner device, e.g. 3D scan or OPG / panorex. Cliniview (K162799) controls image capturing of imaging devices for image acquisition and image exposure. Both devices allow for the placing of scan requests and retrieval of scan data. The difference between the subject and the primary predicate is that the predicate software controls the acquisition of scan data including the exposure settings. The subject device allows placing of a scan request where the exposure is set or confirmed and the scanning started by the operator directly on the scanner. The change in scanner operation does not affect the scan output or the use of the scan data in the software.

System requirements - The subject device DTX Studio diagnose is available for both Windows and Mac OS X operating systems. The primary predicate Cliniview (K162799) is only available for the Windows operating system. This change is supported by verification and validation testing conducted on both operating systems.

VII. PERFORMANCE DATA

Summary of Non-Clinical Testing:

The performance of the subject device was verified and validated following the guidance provided in FDA Guidance General Principles of Software Validation", issued on January 11, 2002. This documentation includes testing which demonstrates that the requirements for the features have been met. Software Documentation for a Moderate Level of Concern, per the FDA guidance

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document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005, is also included as part of this submission.

No clinical data was used to support the decision of substantial equivalence.

VIII. CONCLUSIONS

The DTX Studio diagnose was evaluated for substantial equivalence using standard testing. Based on technological characteristics and non-clinical test data included in this submission, the DTX Studio diagnose was shown to be substantially equivalent to the Cliniview software (K162799).

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).