(356 days)
No
The summary describes a software for visualization and measurement of imaging data, with no mention of AI, ML, or related concepts in the device description, intended use, or performance studies. The performance studies focus on measurement accuracy and software verification, not on the performance of an AI/ML algorithm.
No
DentiqAir is a software application for visualizing imaging information and planning, not for providing therapy or treatment directly. It supports diagnosis and treatment planning.
Yes
Explanation: The "Intended Use / Indications for Use" states that the device is for "visualization of imaging information," and the "Mentions image processing" section explicitly labels it as "Radiological Visualization Software for Diagnosis and Treatment Planning," indicating its use in diagnosing medical conditions.
Yes
The device description explicitly states "DentiqAir is a pure software device". The performance studies focus on software verification and validation, and accuracy measurements based on loaded datasets, further supporting its software-only nature.
Based on the provided information, DentiqAir is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- DentiqAir's Function: DentiqAir is a software application that visualizes and processes imaging data from medical scanners (CT, CBCT, optical impression systems). It works with images of the oral-maxillofacial and ENT regions, not with biological specimens.
- Intended Use: The intended use is for visualization and planning based on imaging data, not for analyzing biological samples.
- Device Description: The description reinforces that it's a software device for visualizing imaging information.
- Input: The input is imaging data, not biological specimens.
Therefore, DentiqAir falls under the category of medical imaging software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
DentiqAir is a software application for the visualization of imaging information of the oralmaxillofacial 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.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
DentiqAir is a pure software device applied for the visualization of imaging information of the ear-nose-throat (ENT) region and oral-maxillofacial region.
The imaging data originates from medical scanners such as CT or Cone Beam - CT (CBCT) scanners. This information can be complemented by the imaging information from optical impression systems.
The medical professionals' input information and planning data may be exported from Dentiq Air to be used for CAD or Rapid Prototyping Systems.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or CBCT scanners
optical impression systems
Anatomical Site
oral-maxillofacial region
ear-nose-throat (ENT) region
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dental professionals.
Specialized dental practices.
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)
Non clinical Testing:
In order to establish the performance, functionality and reliability characteristics of the subject device, SW verification and validation testing activities such as code review, integration review, and dynamic tests were conducted in accordance with the FDA Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (Issued on May 11, 2005).
Also the following performance tests were conducted to verify the performance of the subject device and find out any limitations.
- Accuracy test for measurement made in the subject device from loaded CT datasets using phantom by comparing the true values of the phantom and the measured values (Length, Angle, HU, Volume) in the subject device. The P/F criteria for Length, Angle, HU was less than 2% average and maximum absolute difference. The P/F criteria for Volume was less than True Value and more than Dolphin Imaging average.
The testing results support that the subject device is substantially equivalence to the predicate or reference devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy test for measurement:
Length, Angle, HU: less than 2% average and maximum absolute difference.
Volume: less than True Value and more than Dolphin Imaging average.
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 19, 2019
3D Industrial Imaging Co., Ltd. % Sanglok Lee Manager Wise Company Inc. #1005, 11-19, Gamasan-ro 27a-gil Guro-Gu, 08301 REPUBLIC OF KOREA
Re: K183676
Trade/Device Name: DentiqAir Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: LLZ Dated: November 8, 2019 Received: November 13, 2019
Dear Sanglok Lee:
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.
1
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) 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.
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
2
Indications for Use
510(k) Number (if known)
Device Name
Indications for Use (Describe)
Type of Use (Select one or both, as applicable)
_ Prescription Use (Part 21 CFR 801 Subpart D)
_ | Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
3
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Bldg.138, Rm.413, Seoul National University,
1 Gwanak-ro, Gwanak-gu, Seoul, Republic of Korea (08826)
510(k) Summary - Traditional 510(K)
The assigned 510(k) Number: K183676
01. Date of Submission: 2019.11.08
02. Applicant / Submitter
3D Industrial Imaging Co., Ltd. Bldg.138, Rm.413, Seoul National University, 1 Gwanak-ro, Gwanak-gu, Seoul, Republic of Korea (08826) Tel. +82-70-8766-9192
03. Submission Correspondent
Sanglok, Lee Wise COMPANY Inc. #303, 142, Gasan digital 1-ro, Geumcheon-gu, Seoul, Korea TEL: +82 70 8812 3619 / +82 2 831 3615 FAX: +82 50 4031 3619 Email: info@wisecompany.org
04. Proposed Device Identification
Device Identification and Regulatory information
Proprietary Name: DentiqAir Common/Usual Name: Radiological Visualization Software for Diagnosis and Treatment Planning Classification Name: System, Image Processing, Radiological Regulation Description: Picture archiving and communications system Product Code: LLZ Regulation Number: 21 CFR 892.2050 Classification Class: Class II Product
Indications for use:
DentiqAir is a software application for the visualization of imaging information of the oralmaxillofacial 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.
05. Predicate Device Identification
-
Reference predicate device 510(k) Number: K110430 Device Name: Dolphin Imaging Manufacturer: PATTERSON DENTAL SUPPLY, INC
-
Primary predicate device 510(k) Number: K133320 Device Name: SICAT Function Manufacturer: SICAT GmbH & Co, KG
06. Device Description
DentiqAir is a pure software device applied for the visualization of imaging information of the ear-nose-throat (ENT) region and oral-maxillofacial region.
The imaging data originates from medical scanners such as CT or Cone Beam - CT (CBCT) scanners. This information can be complemented by the imaging information from optical impression systems.
The medical professionals' input information and planning data may be exported from Dentiq Air to be used for CAD or Rapid Prototyping Systems.
5
Bldg.138, Rm.413, Seoul National University,
1 Gwanak-ro, Gwanak-gu, Seoul, Republic of Korea (08826)
07. Technological Characteristics:
DentiqAir requires Windows 7 64 bit OS or above. To ensure proper operation, we recommend installing the subject device on a system with the following specifications or higher.
| Item | Specifications |
|---|---|
| Processor | Intel i3 Dual Core |
| System Memory | 2 GB |
| HDD | 2 GB free hard disk space |
| Graphics Card | Graphics cards compatible with DirectX 10.1 or Higher |
| Display | 1600 x 900 or Higher |
Table 1. Minimum PC Specification Requirements for DentiqAir.
08. Substantially Equivalent
DentiqAir has the same intended uses, principle of operation and similar technical characteristics and functionality as predicate devices.
| Feature name | Subject Device | Reference predicate Device | Primary
predicate
Device | SE
Decision |
|-----------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | DentiqAir | Dolphin Imaging | SICAT
Function | - |
| Common/Usual
Name | Radiological Visualization
Software for Diagnosis
and Treatment Planning | Not available | Radiological
Visualization
Software for
Diagnosis and
Treatment
Planning | - |
| 510K number | - | K110430 | K133320 | - |
| Classification | Regulation number: 21
CFR 892.2050
Product code: LLZ | Regulation number: 21 CFR
892.2050
Product code: LLZ | Regulation
number: 21
CFR
892.2050
Product code:
LLZ | Equivalent
with
primary
and
reference
device |
| Manufacturer | 3D Industrial Imaging Co.
Ltd | PATTERSON DENTAL
SUPPLY, INC. | SICAT
GmbH & Co,
KG | - |
| Supported
anatomic areas | Maxilla, Mandible | Maxilla, Mandible | Maxilla,
Mandible | Equivalent
with
primary
and
reference
device |
| Indications for Use | | | | |
| Indications for
Use | DentiqAir: 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.
Intended Use Statement of 510(k) Summary K110430: “Dolphin Imaging
software is designed for use by specialized dental practices for capturing,
storing and presenting patient images and assisting in treatment planning and
case diagnosis. Results produced by the software's diagnostic and treatment
planning tools are dependent on the interpretation of trained and licensed
practitioners.” | | | primary
device |
| | Indications for Use Statement of 510(k) Summary K133320: SICAT Function
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. It is also used as a software
system to aid qualified dental professionals with the evaluation of dental
treatment options. The dental professionals' planning data may be exported
from SICAT Function and used as input data for CAD or Rapid Prototyping
Systems | | | |
| contraindicatio
ns | none | unknown | none | Equivalent
with
primary
device |
| | Medical Data Viewing | | | |
| Data types
visualized | 3D volume data, optical
impressions | 3D volume data, 2D
radiological x-ray data,
images and photographs | 3D volume
data, optical
impressions,
jaw motion
tracking data | Equivalent
with
primary
and
reference
device |
| Imaging data
visualization
region | ENT region including the
oral-maxillofacial region | ENT region including the
oral-maxillofacial region | Oral-
maxillofacial
region | Equivalent
with
primary
and
reference
device |
| Viewing Modes | | | | |
| Orthogonal
slices | Axial, coronal, sagittal | Axial, coronal, sagittal | Axial,
coronal,
sagittal | Equivalent
with
primary
and
reference
device |
| Special Dental
View:
Panoramic | No | Yes | Panoramic
view (ray
sum) | DentiqAir
does not
support |
| View | | | | View |
| Special dental view:
Cephalometric View | No | Yes | panoramic curve.
Panoramic curve can be
manually adjusted. | Panoramic View.
Equivalent with
primary device |
| Special dental views:
TSA and LSA | Single transversal slices
are generated. | Single transversal slices are
generated. | Transversal slice (TSA)
and longitudinal
slice (LSA), both with
respect to panoramic
curve. | Equivalent with
reference device |
| 3D volume rendering | Yes, volume rendering
using a standard and well
established ray-casting
algorithm with integration
along rays, and volume
rendering utilizing
standard shader based
slicing algorithms
available on typical
consumer graphics
hardware. | Yes | Yes | Equivalent with
primary and
reference device |
| 3D surface rendering of
volume data | Yes, using a standard and
Well established front-to-
back ray-casting algorithm
with an iso-surface
threshold. | Yes | No | Equivalent with
reference device |
| Volume Data Navigation and Manipulation | | | | |
| View manipulating
tools | Zoom, Pan, Change of
orientation | Yes | Zoom, Pan, Change of
orientation | Equivalent with
primary and
reference device |
| Color manipulating
tools | Brightness, Contrast | Yes | Brightness, Contrast | Equivalent with
primary and
reference device |
| Scrolling
through
slices | For all slices(without
panoramic slicing
window) | Yes | For all slices
(including
panoramic
slicing
window) | Equivalent
with
primary
and
reference
device
but
DentiqAir
does not
support
panoramic
slicing
window |
| 3D volume
Clipping | Yes, Features and
Algorithms identical to
SICAT Function | Yes | Yes | Equivalent
with
primary
and
reference
device |
| Measurements | | | | |
| Length
measurement | Yes | Yes | Yes | Equivalent
with
primary
and
reference
device |
| Area
measurement | No | Yes | No | Equivalent
with
primary
device |
| Angle
measurement | Yes | Yes | Yes | Equivalent
with
primary
and
reference
device |
| Overall Length
Measurement
Accuracy | 100 μm | Unknown | 100 μm | Equivalent
with
primary
device |
| Overall
Angular
Measurement
Accuracy | 1 degree | Unknown | 1 degree | Equivalent
with
primary
device |
| Segmentation of Anatomical Structures | | | | |
| Segmentation
of
anatomical
structures | Yes, using a segmentation
wizard.
Algorithm: Water Shed (a
type of graph-cut
algorithm) | Yes
Segmentation algorithm is
unknown | Yes, using a
segmentation
wizard.
Algorithm:
Water Shed (a
type of graph-
cut algorithm) | Equivalent
with
primary
and
reference
device |
| Airway
Segmentation | Airway Segmentation of
the Airway using the
segmentation wizard. | Yes
Segmentation algorithm is
unknown | No | Equivalent
with
reference
device |
| Segmentation
of
mandible and
fossa | Yes, using a segmentation
wizard.
Algorithm: Water Shed (a
type of graph-cut
algorithm) | No | Yes, using a
segmentation
wizard.
Algorithm:
Water Shed (a
type of graph-
cut algorithm) | Equivalent
with
primary
device |
| Mesh texturing
of the
segmented
Airway | The Airway is texturized
by a standard algorithm.
Or The Airway is
texturized by the cross-
sectional | Yes | No | Equivalent
with
reference
device |
| Optical Impression Data Visualization | | | | |
| Optical
impression
(maxilla,
mandible, or a
part thereof) | Optical impression
(maxilla, mandible, or a
part thereof)
Polygonal mesh in 3D
view, cut
through polygonal mesh
(contour) in slice view | No | Optical
impression
(maxilla,
mandible, or a
part thereof)
Polygonal
mesh in 3D
view and
panorama
view, cut
through
polygonal
mesh
(contour) in
slice view | Equivalent
with
primary
device |
| Optical
impression
name | No | No | A list view in
a dedicated
toolbar
contains the
names
of all loaded
optical | Equivalent
with
reference
device |
| | | | impressions. | |
| Show/Hide an optical impression | Yes
Visibility applies to all views simultaneously. | No | Yes
Visibility applies to all views simultaneously. | Equivalent with primary device |
| Optical Impression Data Manipulation | | | | |
| Registration of surface data (from optical impressions) to volume data | Semi-automatic, using user specified reference points. | No | Semi-automatic, using user specified reference points. | Equivalent with primary device |
| Fine tuning the accuracy of the registration | Yes, Restart of the registration with a different set of reference points and Move/Rotate in MPR cross-section image. (Axial/Sagittal/Coronal) | No | Restart of the registration with a different set of reference points. | Equivalent with primary device |
| Delete | Yes | No | Yes | Equivalent with primary device |
| I/O | | | | |
| Volume Data Import | DICOM | DICOM | DICOM | Equivalent with primary and reference device |
| Optical surface data/optical impression import | Standard STL format | No | Standard STL format and proprietary SSI or SIXD container format. | DentiqAir support only STL Format |
| Data Import/Export Data Compression | 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. | No | A “study” consisting of planning data (including segmentation information), volume data, jaw motion | Equivalent with primary device |
| | | | data and
optical
surface data
may be
exported and
imported in a
SICAT
proprietary
format.
Lossless ZIP
compression | |
| Export of data
for CAD and
rapid proto-
typing | Yes | No | Yes | Equivalent
with
primary
device |
| Misc. functions | | | | |
| Soft tissue
simulation with
photo mapping | No | Yes | No | Equivalent
with
primary
device |
| Cross sections
in
Multiple Planar
View (MPV) | No | Yes | No | Equivalent
with
primary
device |
| Volume
stitching:
Combine two
separate
volumes
into one | No | Yes | No | Equivalent
with
primary
device |
| 2D facial photo
wrap onto
volume | No | Yes | No | Equivalent
with
primary
device |
| Volume-to-
volume
Superimposition | No | Yes | No | Equivalent
with
primary
device |
| 3D nerve
marking | No | Yes | No | Equivalent
with
primary
device |
| Generate
panoramic
radiographs | No | Yes | Yes | DentiqAir
does not
support
Generate
panoramic |
| | | | | radiographs |
| Generate
cephalometric
radiographs | No | Yes | No | Equivalent
with
primary
device |
| Create
animated
movies with
automated
scripts | No | Yes | No | Equivalent
with
primary
device |
| Design and
print
handout reports | No | Yes | No | Equivalent
with
primary
device |
| Image export to
other
application | No | Yes | Yes | DentiqAir
can't
export
images to
other
application. |
| Main Functions | | | | |
| Three-
dimensional
airway
segmentation
and
analysis in the
ear-nose throat-
region | Yes
Image: [airway segmentation 1] | Yes
Image: [airway segmentation 2] | No | Equivalent
with
reference
device |
| Airway
Visualization | 3D surface rendering | 3D surface rendering | No | Equivalent
with
reference
device |
| Airway
Analysis:
Calculation of
airway volume | Yes | Yes | No | Equivalent
with
reference
device |
| | | | | |
| Airway
Analysis:
Calculation of
the position and size of the
area with
minimum cross
section in
airway | Yes | Yes | No | Equivalent
with
reference
device |
| Simulation of
orthodontic
procedures,
osteotomies
and distraction | No | Yes | No | Equivalent
with
primary
device |
| Cephalometric
analysis | No | Yes | No | Equivalent
with
primary
device |
| TMJ analysis | Yes | Yes | Yes | Equivalent
with
primary
and
reference
device |
| 3D implant
treatment
planning and
simulation | No | Yes | No | Equivalent
with
primary
device |
| | Programming Language | | | |
| | C# and C++ | Unknown | C# and C++ | Equivalent
with
primary
device |
| | System Requirements | | | |
| Material | Pure software device | Pure software device | Pure software device | Equivalent
with
primary
and
reference
device |
| Supported PC
formats | Windows | Windows | Windows | Equivalent
with
primary
and
reference
device |
| | | Minimum Imaging
Requirements
(Rev 05/15) | CPU : 1 GHz | |
| PC Hardware
Requirements
(Minimum) | CPU : Intel i3 Dual Core | CPU : Intel® Core 2
RAM: 2 GB (4 GB for
Dolphin 3D) | RAM : 1 GB | Equivalent
with
primary
and
reference
device |
| | RAM : 2 GB | HDD: 20 GB fee space | HDD : 5 GB
free space | |
| | HDD : 2 GB free space | Video card:
resolution 1024 x768
at 24-bit color | Video card:
Dedicated,
128 MB
video
memory
Shader Model
3
"INTZ"-
Surfaces
Current driver | |
| | Graphic card that supports
DirectX 10.1 | Monitor: 17" | Monitor:
1280 x 1024
pixels
resolution | |
| | Monitor: 1600 x 900
pixels
resolution | Network: none | Network:
Ethernet, 100
Mbit/s | |
| | Input devices: Keyboard,
mouse | Printer: 720 dpi color inkjet
Camera: 3 mega pixel
with camera card reader | Input devices:
Keyboard,
mouse | |
| | | Internet Broadband
connection | | |
| | | Virus protection coverage | | |
| | | DVD-Rom drive required | | |
| | | Scanner: 150dpi for x-rays,
300dpi for photos | | |
| PC Software
Requirements
(Minimum) | | | Operating
system:
Windows XP
(32 bit) with
SP3 | Equivalent
with
primary
and
reference
device |
| | Operating System :
Windows 7,8 and
10(64bit) | Operating system:
Windows Vista or higher
Word processor:
MS-Word 2003 or higher | Windows
Vista (32 bit
or 64
bit) | |
| | | | Windows 7
(32 bit or 64
bit) | |
| | | | Windows 8
(32 bit or 64-
bit) | |
| | | | | |
| User Interface | Monitor, Mouse, Keyboard | Monitor,
Mouse, | Monitor,
Mouse, | Equivalent
with |
| | | Keyboard | Keyboard | primary
and
reference
device |
6
Bldg.138, Rm.413, Seoul National University,
7
Bldg.138, Rm.413, Seoul National University,
8
Bldg.138, Rm.413, Seoul National University,
9
Bldg.138, Rm.413, Seoul National University,
10
Bldg.138, Rm.413, Seoul National University,
11
Bldg.138, Rm.413, Seoul National University,
12
Bldg.138, Rm.413, Seoul National University,
13
Bldg.138, Rm.413, Seoul National University,
14
Bldg.138, Rm.413, Seoul National University,
15
Bldg.138, Rm.413, Seoul National University,
1 Gwanak-ro, Gwanak-qu, Seoul, Republic of Korea (08826)
The missing features of DentigAir are orthodontic procedures and distractions. Panoramic view, Generate panoramic radiographs, Area measurement, cephalometric analysis, Optical impression name and 3D implant treatment planning and simulation and Misc. functions as identified in the comparison table above. Primary device, SICAT Function supports STL,SSI,SIXD Format, while DentiqAir only supports STL Format. This does not have an impact on the safety and effectiveness of DentiqAir concerning the visualization and segmentation of imaging information and the evaluation of treatment options.
DentiqAir has also the same function to aid qualified dental professionals with the evaluation of dental treatment options as primary device (SICAT Function). Also, DentigAir has also the same function (Analysis in the earnose-throat region, particularly the airway analysis, including the three-dimensional airway segmentation and visualization) as reference predicate device (Dolphin Imaging). Performance testing has been used to validate the safety and effectiveness of the DentiqAir segmentation features in comparison to the predicate devices
09. Non clinical Testing
In order to establish the performance, functionality and reliability characteristics of the subject device, SW verification and validation testing activities such as code review, integration review, and dynamic tests were conducted in accordance with the FDA Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (Issued on May 11, 2005).
Also the following performance tests were conducted to verify the performance of the subject device and find out any limitations.
- Accuracy test for measurement made in the subject device from loaded CT datasets using phantom by comparing the true values of the phantom and the measured values (Length, Angle, HU, Volume) in the subject device. The P/F criteria for Length, Angle, HU was less than 2% average and maximum absolute difference. The P/F criteria for Volume was less than True Value and more than Dolphin Imaging average.
The testing results support that the subject device is substantially equivalence to the predicate or reference devices.
10. Clinical Testing
Clinical testing is not a requirement and has not been performed.
11. Conclusion
The subject device and the predicate device are substantially equivalent in the areas of technical characteristics. general function, application, and intended use. The new device does not introduce a fundamentally new scientific technology. Therefore, it is our opinion that the DentiqAir described in this substantially equivalent to the predicate devices.