(356 days)
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.
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.
The provided text describes the 510(k) premarket notification for the DentiqAir device. While it mentions performance tests, it does not include a detailed table of acceptance criteria and reported device performance for all features, nor does it provide a full breakdown of the test set, expert involvement, or MRMC study results typically found in comprehensive performance studies for AI/ML-driven devices.
However, based on the non-clinical testing section, we can infer some information regarding the performance and acceptance criteria for specific functionalities.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and the Reported Device Performance:
The document primarily focuses on accuracy tests for measurements made using the device against phantom data. It does not provide performance metrics for segmentation accuracy (e.g., Dice score, Jaccard index) which might be expected for segmentation features.
| Feature Tested | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Length | Average and maximum absolute difference less than 2% compared to true value | "The testing results support that the subject device is substantially equivalence to the predicate or reference devices." (Implicitly met the criteria) |
| Angle | Average and maximum absolute difference less than 2% compared to true value | "The testing results support that the subject device is substantially equivalence to the predicate or reference devices." (Implicitly met the criteria) |
| HU (Hounsfield Unit) | Average and maximum absolute difference less than 2% compared to true value | "The testing results support that the subject device is substantially equivalence to the predicate or reference devices." (Implicitly met the criteria) |
| Volume | Less than True Value and more than Dolphin Imaging average (for Airway volume, based on context) | "The testing results support that the subject device is substantially equivalence to the predicate or reference devices." (Implicitly met the criteria) |
Note: The phrasing "Less than True Value and more than Dolphin Imaging average" for Volume is a bit ambiguous regarding exact numerical targets, but it implies a comparative target against a predicate device's expected performance. The document states that the test results support substantial equivalence, implying these criteria were met.
2. Sample Size Used for the Test Set and the Data Provenance:
- Sample Size: The document states that accuracy tests were conducted "from loaded CT datasets using phantom." It does not specify the number of CT datasets or phantoms used for this testing.
- Data Provenance: The data used was from "phantom" studies, meaning simulated or controlled anatomical models, not human patient data. The country of origin is not explicitly stated for the phantom data, but the submitter is from the Republic of Korea. It is retrospective in nature, as it's a pre-market submission based on completed testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- Number of Experts: Not applicable. The ground truth for the phantom accuracy tests was established by the known true values of the phantom itself, not by expert consensus.
- Qualifications of Experts: N/A as expert consensus was not the method for establishing ground truth for the stated performance tests.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. Given the ground truth for the measurement accuracy tests was based on the known physical properties of the phantom, no human adjudication was necessary for these specific performance metrics.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- MRMC Study: No. The document explicitly states: "Clinical testing is not a requirement and has not been performed." The performance tests described are strictly non-clinical and focus on software functionality and measurement accuracy. This type of study would be highly relevant for devices intended to assist human readers in diagnosis or treatment planning.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: For the measurement accuracy tests (Length, Angle, HU, Volume), the described testing does reflect standalone performance as it compares the device's measurements directly to the phantom's true values, without human intervention in the measurement process itself.
- The software also includes "segmentation features," and the document states, "Performance testing has been used to validate the safety and effectiveness of the DentiqAir segmentation features in comparison to the predicate devices." However, no specific quantitative standalone performance metrics (e.g., Dice coefficient, precision, recall) for segmentation are provided in this summary.
7. The Type of Ground Truth Used:
- Ground Truth: For the measurement accuracy tests, the ground truth was based on the known physical properties (true values) of the phantom used for testing.
8. The Sample Size for the Training Set:
- Training Set Sample Size: Not provided. The document is a 510(k) summary for a software device. While it mentions "software verification and validation testing activities" including "code review, integration review, and dynamic tests," and "performance tests," it does not discuss the training or development of any AI/ML models within the software or the data used for such purposes. The device's segmentation algorithm is mentioned as "Water Shed (a type of graph-cut algorithm)," which is a traditional image processing algorithm rather than a deep learning model requiring a specific training set with labelled data in the sense of modern AI/ML.
9. How the Ground Truth for the Training Set Was Established:
- Ground Truth for Training Set: Not applicable. As the document does not describe the use of an AI/ML model that requires a labelled training set in the contemporary sense, the establishment of ground truth for a training set is not discussed. The Water Shed algorithm does not require labeled training data in the same way a deep learning model would.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is 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.
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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
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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)
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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.
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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 | PrimarypredicateDevice | SEDecision |
|---|---|---|---|---|
| Device Name | DentiqAir | Dolphin Imaging | SICATFunction | - |
| Common/UsualName | Radiological VisualizationSoftware for Diagnosisand Treatment Planning | Not available | RadiologicalVisualizationSoftware forDiagnosis andTreatmentPlanning | - |
| 510K number | - | K110430 | K133320 | - |
| Classification | Regulation number: 21CFR 892.2050Product code: LLZ | Regulation number: 21 CFR892.2050Product code: LLZ | Regulationnumber: 21CFR892.2050Product code:LLZ | Equivalentwithprimaryandreferencedevice |
| Manufacturer | 3D Industrial Imaging Co.Ltd | PATTERSON DENTALSUPPLY, INC. | SICATGmbH & Co,KG | - |
| Supportedanatomic areas | Maxilla, Mandible | Maxilla, Mandible | Maxilla,Mandible | Equivalentwithprimaryandreferencedevice |
| Indications for Use | ||||
| Indications forUse | DentiqAir: DentiqAir is a software application for the visualization andsegmentation 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 andused as input data for CAD or Rapid Prototyping Systems.Intended Use Statement of 510(k) Summary K110430: “Dolphin Imagingsoftware is designed for use by specialized dental practices for capturing,storing and presenting patient images and assisting in treatment planning andcase diagnosis. Results produced by the software's diagnostic and treatmentplanning tools are dependent on the interpretation of trained and licensedpractitioners.” | primarydevice | |||
| Indications for Use Statement of 510(k) Summary K133320: SICAT Functionis a software application for the visualization and segmentation of imaginginformation of the oral-maxillofacial region. The imaging data originates frommedical scanners such as CT or CBCT scanners. It is also used as a softwaresystem to aid qualified dental professionals with the evaluation of dentaltreatment options. The dental professionals' planning data may be exportedfrom SICAT Function and used as input data for CAD or Rapid PrototypingSystems | ||||
| contraindications | none | unknown | none | Equivalentwithprimarydevice |
| Medical Data Viewing | ||||
| Data typesvisualized | 3D volume data, opticalimpressions | 3D volume data, 2Dradiological x-ray data,images and photographs | 3D volumedata, opticalimpressions,jaw motiontracking data | Equivalentwithprimaryandreferencedevice |
| Imaging datavisualizationregion | ENT region including theoral-maxillofacial region | ENT region including theoral-maxillofacial region | Oral-maxillofacialregion | Equivalentwithprimaryandreferencedevice |
| Viewing Modes | ||||
| Orthogonalslices | Axial, coronal, sagittal | Axial, coronal, sagittal | Axial,coronal,sagittal | Equivalentwithprimaryandreferencedevice |
| Special DentalView:Panoramic | No | Yes | Panoramicview (raysum) | DentiqAirdoes notsupport |
| View | View | |||
| Special dental view:Cephalometric View | No | Yes | panoramic curve.Panoramic curve can bemanually adjusted. | Panoramic View.Equivalent withprimary device |
| Special dental views:TSA and LSA | Single transversal slicesare generated. | Single transversal slices aregenerated. | Transversal slice (TSA)and longitudinalslice (LSA), both withrespect to panoramiccurve. | Equivalent withreference device |
| 3D volume rendering | Yes, volume renderingusing a standard and wellestablished ray-castingalgorithm with integrationalong rays, and volumerendering utilizingstandard shader basedslicing algorithmsavailable on typicalconsumer graphicshardware. | Yes | Yes | Equivalent withprimary andreference device |
| 3D surface rendering ofvolume data | Yes, using a standard andWell established front-to-back ray-casting algorithmwith an iso-surfacethreshold. | Yes | No | Equivalent withreference device |
| Volume Data Navigation and Manipulation | ||||
| View manipulatingtools | Zoom, Pan, Change oforientation | Yes | Zoom, Pan, Change oforientation | Equivalent withprimary andreference device |
| Color manipulatingtools | Brightness, Contrast | Yes | Brightness, Contrast | Equivalent withprimary andreference device |
| Scrollingthroughslices | For all slices(withoutpanoramic slicingwindow) | Yes | For all slices(includingpanoramicslicingwindow) | EquivalentwithprimaryandreferencedevicebutDentiqAirdoes notsupportpanoramicslicingwindow |
| 3D volumeClipping | Yes, Features andAlgorithms identical toSICAT Function | Yes | Yes | Equivalentwithprimaryandreferencedevice |
| Measurements | ||||
| Lengthmeasurement | Yes | Yes | Yes | Equivalentwithprimaryandreferencedevice |
| Areameasurement | No | Yes | No | Equivalentwithprimarydevice |
| Anglemeasurement | Yes | Yes | Yes | Equivalentwithprimaryandreferencedevice |
| Overall LengthMeasurementAccuracy | 100 μm | Unknown | 100 μm | Equivalentwithprimarydevice |
| OverallAngularMeasurementAccuracy | 1 degree | Unknown | 1 degree | Equivalentwithprimarydevice |
| Segmentation of Anatomical Structures | ||||
| Segmentationofanatomicalstructures | Yes, using a segmentationwizard.Algorithm: Water Shed (atype of graph-cutalgorithm) | YesSegmentation algorithm isunknown | Yes, using asegmentationwizard.Algorithm:Water Shed (atype of graph-cut algorithm) | Equivalentwithprimaryandreferencedevice |
| AirwaySegmentation | Airway Segmentation ofthe Airway using thesegmentation wizard. | YesSegmentation algorithm isunknown | No | Equivalentwithreferencedevice |
| Segmentationofmandible andfossa | Yes, using a segmentationwizard.Algorithm: Water Shed (atype of graph-cutalgorithm) | No | Yes, using asegmentationwizard.Algorithm:Water Shed (atype of graph-cut algorithm) | Equivalentwithprimarydevice |
| Mesh texturingof thesegmentedAirway | The Airway is texturizedby a standard algorithm.Or The Airway istexturized by the cross-sectional | Yes | No | Equivalentwithreferencedevice |
| Optical Impression Data Visualization | ||||
| Opticalimpression(maxilla,mandible, or apart thereof) | Optical impression(maxilla, mandible, or apart thereof)Polygonal mesh in 3Dview, cutthrough polygonal mesh(contour) in slice view | No | Opticalimpression(maxilla,mandible, or apart thereof)Polygonalmesh in 3Dview andpanoramaview, cutthroughpolygonalmesh(contour) inslice view | Equivalentwithprimarydevice |
| Opticalimpressionname | No | No | A list view ina dedicatedtoolbarcontains thenamesof all loadedoptical | Equivalentwithreferencedevice |
| impressions. | ||||
| Show/Hide an optical impression | YesVisibility applies to all views simultaneously. | No | YesVisibility 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 andopticalsurface datamay beexported andimported in aSICATproprietaryformat.Lossless ZIPcompression | ||||
| Export of datafor CAD andrapid proto-typing | Yes | No | Yes | Equivalentwithprimarydevice |
| Misc. functions | ||||
| Soft tissuesimulation withphoto mapping | No | Yes | No | Equivalentwithprimarydevice |
| Cross sectionsinMultiple PlanarView (MPV) | No | Yes | No | Equivalentwithprimarydevice |
| Volumestitching:Combine twoseparatevolumesinto one | No | Yes | No | Equivalentwithprimarydevice |
| 2D facial photowrap ontovolume | No | Yes | No | Equivalentwithprimarydevice |
| Volume-to-volumeSuperimposition | No | Yes | No | Equivalentwithprimarydevice |
| 3D nervemarking | No | Yes | No | Equivalentwithprimarydevice |
| Generatepanoramicradiographs | No | Yes | Yes | DentiqAirdoes notsupportGeneratepanoramic |
| radiographs | ||||
| Generatecephalometricradiographs | No | Yes | No | Equivalentwithprimarydevice |
| Createanimatedmovies withautomatedscripts | No | Yes | No | Equivalentwithprimarydevice |
| Design andprinthandout reports | No | Yes | No | Equivalentwithprimarydevice |
| Image export tootherapplication | No | Yes | Yes | DentiqAircan'texportimages tootherapplication. |
| Main Functions | ||||
| Three-dimensionalairwaysegmentationandanalysis in theear-nose throat-region | YesImage: [airway segmentation 1] | YesImage: [airway segmentation 2] | No | Equivalentwithreferencedevice |
| AirwayVisualization | 3D surface rendering | 3D surface rendering | No | Equivalentwithreferencedevice |
| AirwayAnalysis:Calculation ofairway volume | Yes | Yes | No | Equivalentwithreferencedevice |
| AirwayAnalysis:Calculation ofthe position and size of thearea withminimum crosssection inairway | Yes | Yes | No | Equivalentwithreferencedevice |
| Simulation oforthodonticprocedures,osteotomiesand distraction | No | Yes | No | Equivalentwithprimarydevice |
| Cephalometricanalysis | No | Yes | No | Equivalentwithprimarydevice |
| TMJ analysis | Yes | Yes | Yes | Equivalentwithprimaryandreferencedevice |
| 3D implanttreatmentplanning andsimulation | No | Yes | No | Equivalentwithprimarydevice |
| Programming Language | ||||
| C# and C++ | Unknown | C# and C++ | Equivalentwithprimarydevice | |
| System Requirements | ||||
| Material | Pure software device | Pure software device | Pure software device | Equivalentwithprimaryandreferencedevice |
| Supported PCformats | Windows | Windows | Windows | Equivalentwithprimaryandreferencedevice |
| Minimum ImagingRequirements(Rev 05/15) | CPU : 1 GHz | |||
| PC HardwareRequirements(Minimum) | CPU : Intel i3 Dual Core | CPU : Intel® Core 2RAM: 2 GB (4 GB forDolphin 3D) | RAM : 1 GB | Equivalentwithprimaryandreferencedevice |
| RAM : 2 GB | HDD: 20 GB fee space | HDD : 5 GBfree space | ||
| HDD : 2 GB free space | Video card:resolution 1024 x768at 24-bit color | Video card:Dedicated,128 MBvideomemoryShader Model3"INTZ"-SurfacesCurrent driver | ||
| Graphic card that supportsDirectX 10.1 | Monitor: 17" | Monitor:1280 x 1024pixelsresolution | ||
| Monitor: 1600 x 900pixelsresolution | Network: none | Network:Ethernet, 100Mbit/s | ||
| Input devices: Keyboard,mouse | Printer: 720 dpi color inkjetCamera: 3 mega pixelwith camera card reader | Input devices:Keyboard,mouse | ||
| Internet Broadbandconnection | ||||
| Virus protection coverage | ||||
| DVD-Rom drive required | ||||
| Scanner: 150dpi for x-rays,300dpi for photos | ||||
| PC SoftwareRequirements(Minimum) | Operatingsystem:Windows XP(32 bit) withSP3 | Equivalentwithprimaryandreferencedevice | ||
| Operating System :Windows 7,8 and10(64bit) | Operating system:Windows Vista or higherWord processor:MS-Word 2003 or higher | WindowsVista (32 bitor 64bit) | ||
| Windows 7(32 bit or 64bit) | ||||
| Windows 8(32 bit or 64-bit) | ||||
| User Interface | Monitor, Mouse, Keyboard | Monitor,Mouse, | Monitor,Mouse, | Equivalentwith |
| Keyboard | Keyboard | primaryandreferencedevice |
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Bldg.138, Rm.413, Seoul National University,
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Bldg.138, Rm.413, Seoul National University,
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Bldg.138, Rm.413, Seoul National University,
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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.
§ 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).