DTX Studio Clinic by Nobel Biocare AB

DTX Studio Clinic is a software program for the acquisition, management, transfer and analysis of dental and craniomaxillofacial image information, and can be used to provide design input for dental restorative solutions. It displays and enhances digital images from various sources to support the diagnostic process and treatment planning. It stores and provides these images within the system or across computer systems at different locations.

Device Description

DTX Studio Clinic is a software interface for dental/medical practitioners used to analyze 2D and 3D imaging data, in a timely fashion, for the treatment of dental, craniomaxillofacial and related conditions. DTX Studio Clinic displays and processes imaging data from different devices (i.e. Intraoral and extraoral X-rays, (CB)CT scanners, intraoral scanners, intraoral and extraoral cameras).

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the DTX Studio Clinic device, based on the provided text:

Important Note: The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, not necessarily a comprehensive clinical study report. Therefore, some information requested (like specific sample sizes for test sets, the number and qualifications of experts for ground truth, adjudication methods, MRMC study effect sizes, and detailed information about training sets) is not explicitly stated in this document. The focus here is on software validation and verification.

Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical "acceptance criteria" in the format of a table with specific metrics (e.g., sensitivity, specificity, accuracy thresholds). Instead, the acceptance is based on demonstrating that the DTX Studio Clinic software performs its intended functions reliably and safely, analogous to the predicate and reference devices, as verified through software validation and engineering testing.

The "reported device performance" is primarily described through the software's functionality and its successful verification and validation.

Feature/Criterion	Reported Device Performance (DTX Studio Clinic)	Comments (Based on 510(k) Summary)
Clinical Use	Supports diagnostic and treatment planning for craniomaxillofacial anatomical area.	"Primarily the same" as the predicate device CliniView (K162799). Differences in wording do not alter therapeutic use.
Image Data Import & Acquisition	Acquires/imports DICOM, 2D/3D images (CBCT, OPG/panorex, intra-oral X-ray, cephalometric, clinical pictures). Also imports STL, NXA, PLY files from intraoral/optical scanners. Directly acquires images from supported modalities or allows manual import. Imports from 3rd party PMS systems via VDDS or OPP protocol.	Similar to CliniView, with additional capabilities (STL, NXA, PLY, broader PMS integration). Subject device does not control imaging modalities directly for acquisition settings, distinguishing it from CliniView.
Data Visualization & Management	Displays and enhances digital images. Provides image filters, annotations, distance/angular measurements, volume and surface area measurements (for segmentation). Stores data locally or in DTX Studio Core database. Comparison of 3D images and 2D intraoral images in the same workspace.	Core functionality is similar to CliniView. Enhanced features include volume/surface area measurements and comparison of different image types within the same workspace.
Airway Volume Segmentation	Allows volume segmentation of indicated airway, volume measurements, and constriction point determinations.	Similar to reference device DentiqAir (K183676), but specifically limited to airway (unlike DentiqAir's broader anatomical segmentation).
Automatic Image Sorting (IOR)	Algorithm for automatic sorting of acquired or imported intra-oral X-ray images to an FMX template. Detects tooth numbers (FDI or Universal).	This is a workflow improvement feature, not for diagnosis or image enhancement.
Intraoral Scanner Module (ioscan)	Dedicated intraoral scanner workspace for acquisition of 3D intraoral models (STL, NXA, PLY). Supports dental optical impression systems.	Classified as NOF, 872.3661 (510(k) exempt). Does not impact substantial equivalence.
Alignment of Intra-oral/Cast Scans with (CB)CT Data	Imports 3D intraoral models or dental cast scans (STL/PLY) and aligns them with imported CB(CT) data for accurate implant planning.	Similar to reference device DTX Studio Implant (K163122).
Implant Planning	Functionality for implant planning treatment. Adds dental implant shapes to imported 3D data, allowing user definition of position, orientation, type, and dimensions.	Similar to reference device DTX Studio Implant (K163122), which also adds implants and computes surgical templates.
Virtual Tooth Setup	Calculates and visualizes a 3D tooth shape for a missing tooth position based on indicated landmarks and loaded intra-oral scan. Used for prosthetic visualization and input for implant position.	A new feature not explicitly present in the predicate devices but supported by the overall diagnostic and planning workflow.
Software Validation & Verification	Designed and manufactured under Quality System Regulations (21 CFR § 820, ISO 13485:2016). Conforms to EN IEC 62304:2006. Risk management (ISO 14971:2012), verification testing performed. Software V&V testing conducted as per FDA guidance for "Moderate Level of Concern." Requirements for features have been met.	Demonstrated through extensive software engineering and quality assurance processes, not clinical performance metrics.

Study Information

Sample sizes used for the test set and the data provenance:
- Not explicitly stated in the provided text. The document mentions "verification testing" and "validation testing" but does not detail the specific sample sizes of images or patient cases used for these tests.
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It focuses on the software's functionality and its comparison to predicate devices, rather than the performance on specific clinical datasets.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not explicitly stated in the provided text. The 510(k) summary primarily addresses software functionality verification and validation, not a diagnostic accuracy study involving expert ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not explicitly stated in the provided text.
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, an MRMC comparative effectiveness study was not done or reported. The document explicitly states: "No clinical data was used to support the decision of substantial equivalence." This type of study would involve clinical data and human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in spirit. The software validation and verification described are for the algorithm and software functionalities operating independently. While the device does not make autonomous diagnoses (it "supports the diagnostic process and treatment planning"), its individual features (like airway segmentation, image sorting, virtual tooth setup) are tested in a standalone manner in terms of their computational correctness and adherence to specifications. However, this is distinct from standalone clinical performance (e.g., an AI algorithm making a diagnosis without human input). The document focuses on the technical performance of the software.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the software verification and validation, the implicit "ground truth" would be the software's functional specifications and requirements. For features like measurements or segmentation, this would likely involve mathematical correctness checks or comparison to pre-defined anatomical models or manually delineated reference segmentations. It is not based on expert consensus, pathology, or outcomes data in a clinical diagnostic sense, as no clinical data was used for substantial equivalence.
The sample size for the training set:
- Not explicitly stated in the provided text. The document describes a medical device software for image management and analysis, not a machine learning model that typically requires a large 'training set' in the deep learning sense. If any features (like the automatic image sorting or virtual tooth setup) utilize machine learning, the details of their training (including sample size) are not provided in this 510(k) summary.
How the ground truth for the training set was established:
- Not explicitly stated in the provided text. As mentioned above, details about training sets are absent. If machine learning is involved in certain features, the ground truth would typically be established by expert annotation or curated datasets, but this is not detailed here.

Summary

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November 20, 2020

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Nobel Biocare AB % Vladislavs Mihailovs Regulatory Affairs Manager Medicim NV Stationsstraat 102 Mechelen, Antwerp 2800 BELGIUM

Re: K203156

Trade/Device Name: DTX Studio Clinic Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: October 13, 2020 Received: October 22, 2020

Dear Vladislavs Mihailovs:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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) K203156

Device Name DTX Studio Clinic

Indications for Use (Describe)

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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8. 510(k) Summary

I. Submitter

Submitted by: Nobel Biocare c/o Medicim NV Stationsstraat 102 Mechelen, 2800, Belgium Establishment Registration No. 3005739655 Telephone: +32 15 44 32 00 Facsimile: +32 15 44 32 09 Email: vladislavs.mihailovs@nobelbiocare.com

Submitted for: Nobel Biocare AB Vastra Hamngatan 1 Göteborg, SE-411 17, Sweden Establishment Registration No. 9611992 Date Prepared: 13 October 2020

II. Device

Name of Device: DTX Studio Clinic Common or Usual Name: Picture Archiving and Communications System Classification Name: System, Image Processing, Radiological (21 CFR 892.2050) Regulatory Class: 2 Product Code: LLZ

III.Predicate Device

Substantial equivalence is claimed to the following device:

Main predicate

Predicate Device: CliniView Predicate 510(k): K162799 Compay: Palodex Group Classification name: System, Image Processing, Radiological Regulatory Class: 2 Regulation number: 892.2050 Product Code: LLZ

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Reference device 1:

Predicate Device: DentiqAir Predicate 510(k): K183676 Compay: 3D Industrial Imaging Co., Ltd Classification name: System, Image Processing, Radiological Regulatory Class: 2 Regulation number: 892.2050 Product Code: LLZ

Reference device 2:

Predicate Device: DTX Studio Implant Predicate 510(k): K163122 Company: Nobel Biocare AB Classification name: System, Image Processing, Radiological Regulatory Class: 2 Regulation number: 892.2050 Product Code: LLZ

IV. Device Description

V. Indications for Use

VI. Comparison of Technological Characteristics

The subject and predicate devices are software-based data visualization tools which allow for transfer of medical images and enhancement with intention to support diagnostic process and treatment planning of craniomaxillofacial patients.

Summary comparison of technological similarities and differences

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The subject device DTX Studio Clinic and the predicate device CliniView share following characteristics:

. Clinical Use - intended to support the diagnostic and treatment planning process of craniomaxillofacial anatomical area
. Clinical image data import and acquisition from supported devices, data visualization, distance and angular measurements
Image enhancement - image filter application, annotations
Patient data management features

DTX Studio Clinic is different from the predicate device CliniView as follows:

Airway volume segmentation (same with the reference device DentigAir (K183676)) ●
Intraoral radiograph (IOR) automatic image sorting to an FMX template
DTX Studio Clinic ioscan module a dedicated intraoral scanner workspace for ● acquisition of 3D intraoral models in STL, NXA, PLY file formats (classification NOF, 872.3661)
Alignment of intra-oral scan or dental cast scan STL files with (CB)CT data for ● accurate implant planning (same with the reference device DTX Studio Implant (K163122))
. Scan request - scheduling and reservation of supported imaging modalities for image acquisition. The predicate device CliniView controls settings of imaging modalities for image acquisition, whereas DTX Studio Clinic does not control connected imaging modalities.
Image data and patient file import from 3rd party Patient Management Systems (PMS) ●
Adding dental implant shapes to DICOM data for treatment planning (same with the ● reference device DTX Studio Implant (K163122))
Virtual tooth setup - an algorithm for calculation and visualization of a 3D tooth model for missing teeth (same as with the reference device DTX Studio Implant (K163122))

A comparison of the subject and predicate devices is provided in the table below.

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Criteria	DTX Studio Clinic(subject device)	CliniView (predicate device)K162799	DentiqAir (referencedevice for airwaysegmentationfunctionality)K183676	DTX Studio Implant(reference device fordental implantplanningfunctionality)K163122	Comments
Indications forUse Statement	DTX Studio Clinic is asoftware program for theacquisition, management,transfer and analysis ofdental andcraniomaxillofacial imageinformation, and can beused to provide design inputfor dental restorativesolutions. It displays andenhances digital imagesfrom various sources tosupport the diagnosticprocess and treatmentplanning. It stores andprovides these imageswithin the system or acrosscomputer systems atdifferent locations.	CliniView software program isindicated for general dental andmaxillofacial diagnostic imaging. Itcontrols capture, display, enhancement,and saving of digital images fromvarious digital imaging systems. Itstores and communicates these imageswithin the system or across computersystems at distributed locations.	DentiqAir is asoftware applicationfor the visualizationand segmentation ofimaging informationof the oral-maxillofacial region.The imaging dataoriginates frommedical scanners suchas CT or CBCTscanners. The dentalprofessionals' planningdata may be exportedfrom DentiqAir andused as input data forCAD or RapidPrototyping Systems.	DTX Studio Implant isa software interface forthe transfer andvisualization of 2D and3D image informationfrom equipment suchas a CT scanner for thepurposes of supportingthe diagnostic process,treatment planning andfollow-up in the dentaland cranio-maxillofacial regions.DTX Studio Implantcan be used to supportguided implant surgeryand to provide designinput for and review ofdental restorativesolutions. The resultscan be exported to bemanufactured.	Different -Seediscussionbelow
Classificationcode	LLZ, NOF	LLZ	LLZ	LLZ	Same
Inputdata/Imageacquisition	DICOM image datavolumes, 2D and 3D imagessuch as (CB)CT scans and	2D (CB)CT scans and 2D images suchas OPG/ panorex images,	DICOM image datavolumes,cephalometric images,	DICOM data from(CB)Ct scanner	Different -See
	2D images such as	cephalometric images intra-oral imagesand clinical pictures	optical impressiondata visualization		discussionbelow
	OPG/panorex images,
	acquisition of X-Ray
	images from intra-oral
	sensors, cephalometric
	images, intra-oral images
	and clinical pictures.
	STL, NXA, PLY files from
	intraoral and opticalscanner.
Output data	Data is stored locally or inremotely accessibledatabase in the network(DTX Studio Core).	Images and related data are stored inthe CliniView database or remotelyaccessible database in the network.Image export	A "Project" consistingof planning data(includingsegmentationinformation), volumedata, and opticalsurface data may beexported and importedin a 3DII proprietaryformat.	Export surgicaltemplate design forcentralized productionin Nobel Biocarefacilities.Export surgicaltemplate design(proprietary or openformat) to bemanufacturedExport treatment planfor dental restorationdesign in DTX Studiodesign	Different -Seediscussionbelow
	2D and 3D image export(DICOM image datavolumes, 2D and 3D imagessuch as (CB)CT scans and2D images such asOPG/panorex images,acquisition of X-Rayimages from intra-oralsensors, cephalometricimages, intra-oral imagesand clinical pictures.), STL,PLY, NXA file export.Export implant orrestorative treatment planDiagnostic findings reportexport.
Image	Enhancement (image filter	Enhancement (image filter	Image color	Enhancement (image	Different -
processing	application), annotations,measurements (distance andangular, volume and surfacearea for data segmentation),import/export.Airway volumesegmentation.Alignment of surface scans,such as intra-oral or dentalcast scans .STL/.PLY fileswith (CB)CT data foraccurate implant planning	application), annotations,measurements (distance and angular),import/export and printing.	manipulation tools,view manipulationtools, 3D volumeclipping, length andangle measurements,segmentation ofanatomical structures,airway segmentation,segmentation ofmandible and fossa	filter application),annotations,measurements(distance and angular).Alignment of intra-oralscan or dental cast scanSTL files with (CB)CTdata for accurateimplant planning.	Seediscussionbelow
SoftwareFeatures	Scan data:The software can directlyacquire images fromsupported imagingmodalities or allow manualimport of images by importdialog. The data can bemanually adjusted with thewizard editor.The data can be alsoimported from 3rd partypatient managementsystems via standardprotocol - VDDS, or viaNobel Biocare proprietaryOPP protocol.	Scan data:The software can directly acquireimages or allow manual import ofimages by drag and drop or importdialog. The data can be manuallyadjusted with the panorama curveseditor	Scan data:Software allow onlymanual import ofimages.	Scan data:Software allow onlymanual import ofimages.	Different -Seediscussionbelow
	Diagnostic:	Diagnostic:	Diagnostic:	Diagnostic:	Different -See
The diagnostic moduleallows to review anddiagnose 2D and 3D imagedata as well as clinicalimages. The user can applyimage filters and canmeasure length, angles andHU units.The software allows tocompare 3D images and 2Dintraoral images in the sameworkspaceVisualization of airways,volume segmentation,volume measurement andmaximum constriction pointdetermination.	The diagnostic module allows toreview and diagnose 2D and 3D (byusing 3rd party applications) imagedata. The user can apply image filtersand can measure length, print function,diagnosisThe software allows to compare 3D(by using 3rd party applications)images and 2D images in oneworkspace.	The user can applyimage filters and canmeasure length andangles.Segmentation ofanatomical structures.	The user can applyimage filters and canmeasure length, anglesand HU units.	discussionbelow
Intraoral scanner:DTX Studio ioscan moduleis a user interfacesupporting a dental opticalimpression system, morespecifically an intraoralscanning device.Review of STL, PLY, NXAtype data within dedicatedworkspace	N/A	N/A	N/A	Different –Seediscussionbelow
Automatic sortingalgorithm:Intraoral radiograph (IOR)automatic image sorting to	N/A	N/A	N/A	Different –Seediscussionbelow
	an FMX template (dentalX-ray image layout).
	Implant Planning:Functionality for implantplanning treatment. Addingdental implant shapes toDICOM data for treatmentplanning.	N/A	N/A	Implant planning:Adding an implant,abutments and anchorpins to a planning.Surgical templatecalculation from intra-oral surface data.	Different -Seediscussionbelow
	Virtual tooth setup:Algorithm calculates andvisualizes a 3D tooth shapefor a missing tooth position,based on a set of indicatedlandmarks and the loadedintra-oral scan	N/A	N/A	N/A	Different -Seediscussionbelow
Operatingsystemrequirements	Windows 10 64-bitmacOS Mojave, macOSCatalina	Windows 7Professional/Ultimate/EnterpriseSP1 (32 or 64-bit)Windows 8/8.1Professional/Enterprise (32 or64-bit)Windows 10	Windows 7,8 and10(64bit)	PC – Windows basedMAC - OS	Different -Seediscussionbelow
Recommendedhardwarerequirements	CPU: quad-core of 2.8 GHzor more (such as Intel Corei5 or i7)RAM: 8GBGraphics card with supportof OpenGL 3.3 and 2GBmemory or more (4GB ormore for 4K displays)HDD: 10GB of free space	HDD ≥ 8 GBRAM ≥ 4GBCPU Intel Core i3 or better	CPU : Intel i3 DualCoreRAM : 2 GBHDD : 2 GB freespaceGraphic card thatsupportsDirectX 10.1Monitor: 1600 x 900pixels	CPU: dual-core of3GHz or moreRAM: 8GBGraphics card withsupport of OpenGL 3.3and 1GB memory ormore (2GB or more for4K displays)HDD: 5GB of freespace	Different -Seediscussionbelow

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Monitor: FullHD(1920x1080) or higher	resolutionMonitor: FullHD(1920x1080) or higher
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Discussion

Similarities:

The subject device DTX Studio Clinic and primary predicate device CliniView (K162799) have the same Intended Use and share most software functions/features. Other software features such as airway volume segmentation or implant planning are shared with the reference predicate device DentiqAir (K183676) and DTX Studio Implant (K163122). Difference in indications for use and software features are discussed below.

Both softwares utilize a graphic user interface with a large 3D based main window, several dedicated workspaces for various imaging modalities, several visualization and image processing tools for the purpose of facilitating diagnostic and treatment planning process for craniomaxillofacial anatomical area.

Both DTX Studio Clinic and CliniView share functionality of clinical image data import and acquisition from supported devices, data visualization, distance and angular measurements.

Differences:

Indications for 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 Clinic and the primary predicate device CliniView 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 Clinic allows transfer of images and patient data (store and retrieval) to and from the DTX Studio Core database, thus making the data available at different locations. The primary predicate Clini View (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.

One of the differences within the Indications for Use statement is that the subject device can provide design input data for restorative solutions to 3rd party software or software from DTX Studio Ecosystem (DTX Studio Implant and DTX Studio Lab), but it does not provide

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functionality of designing restorations within the software itself. Hence, this difference does not impact the therapeutic use of the device.

Another difference in wording within the Indications for Use statement is support of treatment planning. Because diagnostic process naturally leads to a treatment, software contains functionality of storing patient files and their diagnostic history. It is also possible to compare different set of imaging data, for example pre-op and post-op of craniomaxillofacial situation. Because subject device does not contain functionality to signal a necessity of treatment and the decision of treatment planning and execution is taken by the user as a logical outcome of diagnostic process, this difference in wording does not impact therapeutic use of software and it's Intended Use.

Differences in software features/functionality

Airway volume segmentation

Another difference between subject device and the predicate device is that DTX Studio Clinic allows volume segmentation of indicated airway on the image data, volume measurements and constriction point determinations. Such functionality is available in the reference device DentiqAir (K183676).

The difference between the subject device and the reference device is that the latter is intended for segmentation and measurements of various anatomical structures and specifically segmentation of mandible and fossa, while the segmentation and measurements in the subject device are intended and limited to airway.

Automatic image sorting algorithm

In addition, DTX Studio Clinic has an algorithm for automatic sorting of acquired or imported intra-oral X-Ray images. The user has an option to disable this feature. Automatically sorted images are displayed in an FMX layout in software intraoral workspace window. This functionality detects tooth numbers in accordance with either the FDI or the Universal tooth numbering system and sorts it accordingly. This function does not provide any image enhancement or processing capabilities and does not intended to be a part of diagnostic process. This functionality is related to workflow improvement of software, as well as an effective data management tool.

Dedicated software module for intraoral 3D scan acquisition – DTX Studio Clinic ioscan

Another difference from the subject device is an intra-oral workspace and DTX Studio Clinic ioscan module which allows for acquisition of intra-oral surface data using an Intraoral Scanner (IOS) system. It supports a dental optical impression system to record the topographical characteristics of teeth, soft tissue, preparations, scan bodies and existing restorations, or dental impressions or stone models by dental professionals. The resulting three-dimensional (3D) model is intended to be used as part of the digital patient record and design of dental restorations. This module is classified as NOF, 872.3661 (510(k) exempt) and is intended to serve as a CAD/CAM

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input for dental restorations. Since this software functionality is 510(k) exempt, this difference does not impact the substantial equivalence between the subject and the predicate devices.

Alignment of intraoral scan with CBCT scan(s)

The subject device DTX Studio Clinic allows import of 3D intraoral models or 3D scans of dental casts for the purpose of aligning them with an imported CB(CT) data for the same patient. This alignment is intended to provide input for accurate implant planning. Same functionality is available in the reference device DTX Studio Implant (K163122)

Scan request

The subject DTX Studio Clinic allows to request scans through DTX Studio Core database by selecting the supported scanner device. 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.

Image data and patient file import from 3rd party PMS systems

The subject device DTX Studio Clinic allows import of image data and patient files not only from a native to DTX Studio ecosystem storage and archiving solution (DTX Studio Core), but also from 3rd party PMS systems via VDDS common communication protocol, or via Nobel Biocare proprietary OPP protocol. This difference does not impact the substantial equivalence between the subject and the predicate devices

Implant planning – Another difference between subject device and the predicate device is that DTX Studio Clinic has an implant planning functionality. Such functionality is available in the reference device DTX Studio Implant (K163122).

Implant planning in DTX Studio Clinic allows adding implant shapes to imported 3D data. Position and orientation as well as the implant type and dimensions are defined by user upon adding an implant to imported data. User can enter implant diameter and implant length and visualize the resulting shape on the imported data.

Virtual tooth setup

After importing an intraoral scan, users can calculate a virtual tooth shape for any missing tooth. Where there is a missing tooth, the Virtual Tooth setup algorithm calculates a 3D tooth shape based on the captured intraoral scan. This 3D calculated tooth shape is then used for prosthetic visualization purposes for patient communication or as input for defining implant position. The calculated virtual tooth is visualized in the 3D scene. This visualization can be used for patient communication or as input for defining the preferred implant position.

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Minor differences:

Various operating systems are currently supported by DTX Studio Clinic, due to release of new versions of these operating systems during the lifecycle of DTX Studio Clinic. Also, with the advancement of computer hardware technologies and increase in resolution of modern monitors, recommended hardware requirements for computers were adjusted accordingly. DTX Studio Clinic was tested and validated on all these operating systems and hardware variations.

VII. Performance Data

DTX Studio Clinic is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820 and ISO 13485:2016 Standards. This device is in conformance with the applicable parts of EN IEC 62304:2006 standards. Design Control Activities, including risk management following the ISO 14971:2012, verification testing, were conducted and are included in this submission.

The performance of the subject device was verified and validated following the guidance provided in FDA Guidance General Principles of Software Validation. This documentation includes testing which demonstrates that the requirements for the features have been met. Software documentation for Moderate Level of Concern and description of respective V&V activities, per the FDA guidance 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.

Software Validation

Software verification and validation testing was conducted on the subject device and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".

VIII. Conclusion

Based on the comparison of the intended use, the features and workflows, the user interface, the technical characteristics, and based on the software verification activities described in this submission, DTX Studio Clinic is found to be substantially equivalent to the identified Predicate Device.

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).