(29 days)
No
The summary describes image processing and analysis software but does not mention AI, ML, or related terms, nor does it provide details about training or test sets typically associated with AI/ML development.
No.
The device is a software program for image acquisition, management, transfer, analysis, and display to support diagnostic processes and treatment planning, but it does not directly treat or alleviate a condition.
Yes
The "Intended Use / Indications for Use" section states that the software "displays and enhances digital images from various sources to support the diagnostic process and treatment planning." This explicitly indicates its role in diagnosis.
Yes
The device description explicitly states it is a "software interface" and processes imaging data from other devices, indicating it is a software-only component that relies on external hardware for image acquisition. The performance studies also focus on software validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description of DTX Studio Clinic clearly states its purpose is to acquire, manage, transfer, and analyze image information from various dental and craniomaxillofacial imaging modalities (X-rays, CT, scanners, cameras). It displays and enhances these images to support the diagnostic process and treatment planning.
- Lack of Biological Sample Analysis: There is no mention of the device analyzing biological samples or performing any tests on bodily fluids or tissues. Its function is solely focused on processing and displaying medical images.
Therefore, while DTX Studio Clinic is a medical device used in the diagnostic process, it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
LLZ
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).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
DICOM image data volumes, 2D and 3D images such as (CB)CT scans and 2D images such as 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 optical scanner.
Anatomical Site
dental and craniomaxillofacial anatomical area
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental/medical practitioners
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
1
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
2
Indications for Use
510(k) Number (if known) K203156
Device Name DTX Studio Clinic
Indications for Use (Describe)
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.
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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3
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
4
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
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).
V. Indications for Use
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.
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
5
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.
6
| Criteria | DTX Studio Clinic
(subject device) | CliniView (predicate device)
K162799 | DentiqAir (reference
device for airway
segmentation
functionality)
K183676 | DTX Studio Implant
(reference device for
dental implant
planning
functionality)
K163122 | Comments |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|
| Indications for
Use Statement | 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. | CliniView software program is
indicated for general dental and
maxillofacial diagnostic imaging. It
controls capture, display, enhancement,
and saving of digital images from
various digital imaging systems. It
stores and communicates these images
within the system or across computer
systems at distributed locations. | DentiqAir is a
software application
for the visualization
and segmentation of
imaging information
of the oral-
maxillofacial region.
The imaging data
originates from
medical scanners such
as CT or CBCT
scanners. The dental
professionals' planning
data may be exported
from DentiqAir and
used as input data for
CAD or Rapid
Prototyping Systems. | DTX Studio Implant is
a software interface for
the transfer and
visualization of 2D and
3D image information
from equipment such
as a CT scanner for the
purposes of supporting
the diagnostic process,
treatment planning and
follow-up in the dental
and cranio-
maxillofacial regions.
DTX Studio Implant
can be used to support
guided implant surgery
and to provide design
input for and review of
dental restorative
solutions. The results
can be exported to be
manufactured. | Different -
See
discussion
below |
| Classification
code | LLZ, NOF | LLZ | LLZ | LLZ | Same |
| Input
data/Image
acquisition | DICOM image data
volumes, 2D and 3D images
such as (CB)CT scans and | 2D (CB)CT scans and 2D images such
as OPG/ panorex images, | DICOM image data
volumes,
cephalometric images, | DICOM data from
(CB)Ct scanner | Different -
See |
| | 2D images such as | cephalometric images intra-oral images
and clinical pictures | optical impression
data visualization | | discussion
below |
| | 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 optical
scanner. | | | | |
| Output data | Data is stored locally or in
remotely accessible
database in the network
(DTX Studio Core). | Images and related data are stored in
the CliniView database or remotely
accessible database in the network.
Image export | A "Project" consisting
of planning data
(including
segmentation
information), volume
data, and optical
surface data may be
exported and imported
in a 3DII proprietary
format. | Export surgical
template design for
centralized production
in Nobel Biocare
facilities.
Export surgical
template design
(proprietary or open
format) to be
manufactured
Export treatment plan
for dental restoration
design in DTX Studio
design | Different -
See
discussion
below |
| | 2D and 3D image export
(DICOM image data
volumes, 2D and 3D images
such as (CB)CT scans and
2D images such as
OPG/panorex images,
acquisition of X-Ray
images from intra-oral
sensors, cephalometric
images, intra-oral images
and clinical pictures.), STL,
PLY, NXA file export.
Export implant or
restorative treatment plan
Diagnostic findings report
export. | | | | |
| Image | Enhancement (image filter | Enhancement (image filter | Image color | Enhancement (image | Different - |
| processing | application), annotations,
measurements (distance and
angular, volume and surface
area for data segmentation),
import/export.
Airway volume
segmentation.
Alignment of surface scans,
such as intra-oral or dental
cast scans .STL/.PLY files
with (CB)CT data for
accurate implant planning | application), annotations,
measurements (distance and angular),
import/export and printing. | manipulation tools,
view manipulation
tools, 3D volume
clipping, length and
angle measurements,
segmentation of
anatomical structures,
airway segmentation,
segmentation of
mandible and fossa | filter application),
annotations,
measurements
(distance and angular).
Alignment of intra-oral
scan or dental cast scan
STL files with (CB)CT
data for accurate
implant planning. | See
discussion
below |
| Software
Features | Scan data:
The software can directly
acquire images from
supported imaging
modalities or allow manual
import of images by import
dialog. The data can be
manually adjusted with the
wizard editor.
The data can be also
imported from 3rd party
patient management
systems via standard
protocol - VDDS, or via
Nobel Biocare proprietary
OPP protocol. | Scan data:
The software can directly acquire
images or allow manual import of
images by drag and drop or import
dialog. The data can be manually
adjusted with the panorama curves
editor | Scan data:
Software allow only
manual import of
images. | Scan data:
Software allow only
manual import of
images. | Different -
See
discussion
below |
| | Diagnostic: | Diagnostic: | Diagnostic: | Diagnostic: | Different -
See |
| The diagnostic module
allows to review and
diagnose 2D and 3D image
data as well as clinical
images. The user can apply
image filters and can
measure length, angles and
HU units.
The software allows to
compare 3D images and 2D
intraoral images in the same
workspace
Visualization of airways,
volume segmentation,
volume measurement and
maximum constriction point
determination. | The diagnostic module allows to
review and diagnose 2D and 3D (by
using 3rd party applications) image
data. The user can apply image filters
and can measure length, print function,
diagnosis
The software allows to compare 3D
(by using 3rd party applications)
images and 2D images in one
workspace. | The user can apply
image filters and can
measure length and
angles.
Segmentation of
anatomical structures. | The user can apply
image filters and can
measure length, angles
and HU units. | discussion
below | |
| Intraoral scanner:
DTX Studio ioscan module
is a user interface
supporting a dental optical
impression system, more
specifically an intraoral
scanning device.
Review of STL, PLY, NXA
type data within dedicated
workspace | N/A | N/A | N/A | Different –
See
discussion
below | |
| Automatic sorting
algorithm:
Intraoral radiograph (IOR)
automatic image sorting to | N/A | N/A | N/A | Different –
See
discussion
below | |
| | an FMX template (dental
X-ray image layout). | | | | |
| | Implant Planning:
Functionality for implant
planning treatment. Adding
dental implant shapes to
DICOM data for treatment
planning. | N/A | N/A | Implant planning:
Adding an implant,
abutments and anchor
pins to a planning.
Surgical template
calculation from intra-
oral surface data. | Different -
See
discussion
below |
| | Virtual tooth setup:
Algorithm calculates and
visualizes a 3D tooth shape
for a missing tooth position,
based on a set of indicated
landmarks and the loaded
intra-oral scan | N/A | N/A | N/A | Different -
See
discussion
below |
| Operating
system
requirements | Windows 10 64-bit
macOS Mojave, macOS
Catalina | Windows 7
Professional/Ultimate/Enterprise
SP1 (32 or 64-bit)
Windows 8/8.1
Professional/Enterprise (32 or
64-bit)
Windows 10 | Windows 7,8 and
10(64bit) | PC – Windows based
MAC - OS | Different -
See
discussion
below |
| Recommended
hardware
requirements | CPU: quad-core of 2.8 GHz
or more (such as Intel Core
i5 or i7)
RAM: 8GB
Graphics card with support
of OpenGL 3.3 and 2GB
memory or more (4GB or
more for 4K displays)
HDD: 10GB of free space | HDD ≥ 8 GB
RAM ≥ 4GB
CPU Intel Core i3 or better | CPU : Intel i3 Dual
Core
RAM : 2 GB
HDD : 2 GB free
space
Graphic card that
supports
DirectX 10.1
Monitor: 1600 x 900
pixels | CPU: dual-core of
3GHz or more
RAM: 8GB
Graphics card with
support of OpenGL 3.3
and 1GB memory or
more (2GB or more for
4K displays)
HDD: 5GB of free
space | Different -
See
discussion
below |
7
8
9
10
11
| Monitor: FullHD
(1920x1080) or higher | resolution
Monitor: FullHD
(1920x1080) or higher |
| ------------------------------------------ | -------------------------------------------------------- |
|---|
12
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
13
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
14
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.