(87 days)
VARO Plan Software is a stand-alone Windows-based software application to support the treatment planning for dental implantation. It is designed for qualified dental practitioners, including dentists and lab technicians. The software imports the medical image dataset of the patient in DICOM format from medical CT or dental CBCT scanners for pre-operative planning and simulation of dental placement. It is intended for use as pre-operative planning software for the placement of dental implant(s) based on imported CT image data, optionally aligned to an optical 3D surface scan. Virtual Crowns can be used for optimized implant positioning under the prosthetic aspect. The digital three dimensional model of a surgical guide for a guided surgery can be designed based on the approved implant position. This 3D data can be exported to manufacture a separate physical product. Indications of the dental implants do not change with guided surgery compared to conventional surgery. Use of the software requires that the user has the necessary medical training in implantology and surgical dentistry.
VARO Plan is a pure software device.
VARO Plan is a dental implant surgical guide design software that is used to design surgical procedure guidelines for implanting one or more dental implants based on CT and the Tray data. Implant library, which includes certified implants, and sleeve libraries are provided. The guide model designed in accordance with the established dental implant operation plan can be exported as STL files.
The followings are the major functions of VARO Plan.
- Patient Management and Surgical Plan Management
- Data Management and Matching
- Crown Model Management and Mesh Edit
- Panoramic Screen Generation and Nerve Setting
- Implant Simulation
- Surgical Guide Design
- Results output.
- Report
- Project Information Management
Here is a summary of the acceptance criteria and study information for the VARO Plan device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Accuracy of Measurements on CT Datasets (using phantom) | Average Absolute Difference < 2% | Met |
| Length (phantom) | Maximum Absolute Difference < 2% | Met |
| Angle (phantom) | Maximum Absolute Difference < 2% | Met |
| HU (Hounsfield Units) (phantom) | Maximum Absolute Difference < 2% | Met |
| Surgical Guide Model (phantom) | Generated output surgical guide matches user input requirements (Guide thickness, Offset from teeth to guide, Offset from sleeve to guide) | Met |
| Accuracy of Implant Library Sizes | Average Absolute Difference < 2% | Met |
| Diameter (implant library) | Maximum Absolute Difference < 2% | Met |
| Length (implant library) | Maximum Absolute Difference < 2% | Met |
2. Sample Size Used for the Test Set and Data Provenance
The provided text only mentions accuracy testing using a phantom. It does not specify a sample size in terms of the number of patient cases or images, as the tests were conducted with a physical phantom.
- Sample Size for Test Set: Not specified in terms of distinct "cases" or "patients." The testing used a phantom.
- Data Provenance: Not applicable for phantom testing in terms of country of origin or retrospective/prospective. The data was generated from a phantom.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The ground truth for the phantom-based accuracy testing would be the known true values of the phantom itself. Therefore, no human experts were used to establish this ground truth:
- Number of Experts: 0 (Ground truth established by known physical phantom properties).
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
Not applicable, as the ground truth was based on the known physical properties of the phantom, not on expert consensus requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No.
- Effect Size: Not applicable, as no MRMC study was performed. The device is a planning and design software, not an AI-assisted diagnostic tool for human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, the studies described are standalone performance tests of the software's accuracy in measurements and guide generation against known phantom values. The device itself is described as a "standalone Windows-based software application."
7. Type of Ground Truth Used
Phantom-based true values: The ground truth for the accuracy tests was derived from the known physical dimensions, angles, and Hounsfield Units (HU) of a phantom, as well as the predefined design requirements for the surgical guide model.
8. Sample Size for the Training Set
The document does not provide information about a training set size. The VARO Plan is described as "pure software device" for dental implant planning and surgical guide design. This type of software, especially for its primary functions listed (MPR, panoramic generation, implant simulation, surgical guide design based on user input), might not involve a machine learning model that requires a distinct "training set" in the conventional sense. The verification and validation activities mentioned are typical for software engineering rather than AI/ML model development.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set or machine learning model requiring such a ground truth establishment process is described in the provided information.
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April 10, 2020
Image /page/0/Picture/1 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 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.
3D Industrial Imaging Co., Ltd. % Sanglok Lee Manager, Wise Company Inc. #303, 142, Gasan digital 1-ro Geumcheon-Gu 08507 REPUBLIC OF KOREA
Re: K200078
Trade/Device Name: VARO Plan Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: LLZ Dated: January 8, 2020 Received: January 14, 2020
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.
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
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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 mediation-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 Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
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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K200078
3D Industrial Imaging Co. Ltd
Bldg.138, Rm.413, Seoul National University,
1 Gwanak-ro, Gwanak-qu, Seoul, Republic of Korea (08826)
510(k) Summary - Traditional 510(K)
The assigned 510(k) Number: Not yet assigned
- Date of Submission: 2020.01.08
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 2 831 3615 Email: info@wisecompany.org
04. Proposed Device Identification
Device Identification and Regulatory information
Proprietary Name: VARO Plan Common Name: Radiological Imaging Software Device Class: Class II Requlation Number: 21 CFR 892.2050 Product Code: PNN (Orthodontic Software); LLZ
Indication for use: VARO Plan Software is a stand-alone Windows-based software application to support the treatment planning for dental implantation. It is designed for qualified dental practitioners, including dentists and lab technicians. The software imports the medical image dataset of the patient in DICOM format from medical CT or dental CBCT scanners for pre-operative planning and simulation of dental placement. It is intended for use as pre-operative planning software for the placement of dental implant(s) based on imported CT image data, optionally aligned to an optical 3D surface scan. Virtual Crowns can be used for optimized implant positioning under the prosthetic aspect. The digital three dimensional model of a surgical quide for a quided surgery can be designed based on the approved implant position. This 3D data can be exported to manufacture a separate physical product. Indications of the dental implants do not change with quided surgery compared to conventional surgery. Use of the software requires that the user has the necessary medical training in implantology and surgical dentistry.
05. Predicate Device Identification
-
Predicate device 1 510(k) Number: K180629 Device Name: Dentiq Guide Manufacturer: 3D Industrial Imaging Co. Ltd
-
Predicate device 2 510(k) Number: K152078 Device Name: Implant Studio™ Manufacturer: 3Shape Medical A/S
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Bldg.138, Rm.413, Seoul National University,
- 1 Gwanak-ro, Gwanak-qu, Seoul, Republic of Korea (08826)
06. Device Description
VARO Plan is a pure software device.
VARO Plan is a dental implant surgical guide design software that is used to design surgical procedure guidelines for implanting one or more dental implants based on CT and the Tray data. Implant library, which includes certified implants, and sleeve libraries are provided. The guide model designed in accordance with the established dental implant operation plan can be exported as STL files.
The followings are the major functions of VARO Plan.
- Patient Management and Surgical Plan Management ●
- Data Management and Matching
- Crown Model Management and Mesh Edit
- Panoramic Screen Generation and Nerve Setting
- Implant Simulation
- . Surgical Guide Design
- Results output.
- Report
- Project Information Management
07. Technological Characteristics:
VARO Plan requires Windows 7 64bit OS or above. To ensure proper operation, we recommend installing the subject device on a system with the following specifications or higher.
| ltem | Specifications |
|---|---|
| Processor | Intel i3 Dual Core or Higher |
| System Memory | 16 GB or Higher |
| HDD | 2 GB free hard disk space or Higher |
| Graphics Card | Graphics cards compatible with DirectX 11 or Higher |
| Display | 1600 x 900 or Higher |
Table 1. Minimum PC Specification Requirements for VARO Plan
The device does not contact the patient, nor does it control any life sustaining devices.
VARO Plan is a software device that does not contact the patient, nor does it control any life sustaining devices. Results produced by the software's diagnostic, treatment planning and simulation tools are dependent on the interpretation of trained and licensed radiologists, clinicians and referring physicians as an adjunctive to standard radiology practices for diagnosis.
08. Substantially Equivalent
VARO Plan has the same intended uses, principle of operation and similar technical characteristics and functionality as predicate devices.
| Subject Device | Predicate Device 1 | Predicate Device 2 | SubstantialEquivalence | |
|---|---|---|---|---|
| Device Name | VARO Plan | Dentiq Guide | Implant Studio™ | - |
| 510K number | - | K180629 | K152078 | - |
| Classification | Regulation number:21 CFR 892.2050Product code: LLZ | Regulation number:21 CFR 892.20503Product code: LLZ | Regulation number:21 CFR 892.2050Product code: LLZ | Equivalent |
| Manufacturer | 3D IndustrialImaging Co. Ltd | 3D IndustrialImaging Co. Ltd | 3Shape MedicalA/S | - |
| VARO Plan Software is a stand-alone Windows-based software | Equivalent | |||
| Indicationsfor Use | application to support the treatment planning for dentalimplantation. It is designed for qualified dental practitioners,including dentists and lab technicians. The software imports themedical image dataset of the patient in DICOM format frommedical CT or dental CBCT scanners for pre-operative planningand simulation of dental placement. It is intended for use as pre-operative planning software for the placement of dentalimplant(s) based on imported CT image data, optionally alignedto an optical 3D surface scan. Virtual Crowns can be used foroptimized implant positioning under the prosthetic aspect. Thedigital three dimensional model of a surgical guide for a guidedsurgery can be designed based on the approved implant position.This 3D data can be exported to manufacture a separate physicalproduct. Indications of the dental implants do not change withguided surgery compared to conventional surgery. Use of thesoftware requires that the user has the necessary medicaltraining in implantology and surgical dentistry.Dentiq Guide Software is a stand-alone Windows-based softwareapplication to support the treatment planning for dentalimplantation. It is designed for qualified dental practitioners,including dentists and lab technicians. The software imports themedical image dataset of the patient in DICOM format frommedical CT or dental CBCT scanners for pre-operative planningand simulation of dental placement. It is intended for use as pre-operative planning software for the placement of dentalimplant(s) based on imported CT image data, optionally alignedto an optical 3D surface scan. Virtual Crowns can be used foroptimized implant positioning under the prosthetic aspect. Thedigital three dimensional model of a surgical guide for a guidedsurgery can be designed based on the approved implant position.This 3D data can be exported to manufacture a separate physicalproduct.Implant Studio™ is indicated for use as medical front-endsoftware that can be used by medically trained professionals forthe purpose of visualizing gray value images.It is intended for use as pre-operative planning software for theplacement of dental implant(s) based on imported CT image data,optionally aligned to an optical 3D surface scan. Virtual Crownscan be used for optimized implant positioning under theprosthetic aspect. The digital three dimensional model of asurgical guide for a guided surgery can be designed based on theapproved implant position. This 3D data can be exported tomanufacture a separate physical product.Indications of the dental implants do not change with guidedsurgery compared to conventional surgery.Use of the software requires that the user has the necessarymedical training in implantology and surgical dentistry. | application to support the treatment planning for dentalimplantation. It is designed for qualified dental practitioners,including dentists and lab technicians. The software imports themedical image dataset of the patient in DICOM format frommedical CT or dental CBCT scanners for pre-operative planningand simulation of dental placement. It is intended for use as pre-operative planning software for the placement of dentalimplant(s) based on imported CT image data, optionally alignedto an optical 3D surface scan. Virtual Crowns can be used foroptimized implant positioning under the prosthetic aspect. Thedigital three dimensional model of a surgical guide for a guidedsurgery can be designed based on the approved implant position.This 3D data can be exported to manufacture a separate physicalproduct. Indications of the dental implants do not change withguided surgery compared to conventional surgery. Use of thesoftware requires that the user has the necessary medicaltraining in implantology and surgical dentistry.Dentiq Guide Software is a stand-alone Windows-based softwareapplication to support the treatment planning for dentalimplantation. It is designed for qualified dental practitioners,including dentists and lab technicians. The software imports themedical image dataset of the patient in DICOM format frommedical CT or dental CBCT scanners for pre-operative planningand simulation of dental placement. It is intended for use as pre-operative planning software for the placement of dentalimplant(s) based on imported CT image data, optionally alignedto an optical 3D surface scan. Virtual Crowns can be used foroptimized implant positioning under the prosthetic aspect. Thedigital three dimensional model of a surgical guide for a guidedsurgery can be designed based on the approved implant position.This 3D data can be exported to manufacture a separate physicalproduct.Implant Studio™ is indicated for use as medical front-endsoftware that can be used by medically trained professionals forthe purpose of visualizing gray value images.It is intended for use as pre-operative planning software for theplacement of dental implant(s) based on imported CT image data,optionally aligned to an optical 3D surface scan. Virtual Crownscan be used for optimized implant positioning under theprosthetic aspect. The digital three dimensional model of asurgical guide for a guided surgery can be designed based on theapproved implant position. This 3D data can be exported tomanufacture a separate physical product.Indications of the dental implants do not change with guidedsurgery compared to conventional surgery.Use of the software requires that the user has the necessarymedical training in implantology and surgical dentistry. | application to support the treatment planning for dentalimplantation. It is designed for qualified dental practitioners,including dentists and lab technicians. The software imports themedical image dataset of the patient in DICOM format frommedical CT or dental CBCT scanners for pre-operative planningand simulation of dental placement. It is intended for use as pre-operative planning software for the placement of dentalimplant(s) based on imported CT image data, optionally alignedto an optical 3D surface scan. Virtual Crowns can be used foroptimized implant positioning under the prosthetic aspect. Thedigital three dimensional model of a surgical guide for a guidedsurgery can be designed based on the approved implant position.This 3D data can be exported to manufacture a separate physicalproduct. Indications of the dental implants do not change withguided surgery compared to conventional surgery. Use of thesoftware requires that the user has the necessary medicaltraining in implantology and surgical dentistry.Dentiq Guide Software is a stand-alone Windows-based softwareapplication to support the treatment planning for dentalimplantation. It is designed for qualified dental practitioners,including dentists and lab technicians. The software imports themedical image dataset of the patient in DICOM format frommedical CT or dental CBCT scanners for pre-operative planningand simulation of dental placement. It is intended for use as pre-operative planning software for the placement of dentalimplant(s) based on imported CT image data, optionally alignedto an optical 3D surface scan. Virtual Crowns can be used foroptimized implant positioning under the prosthetic aspect. Thedigital three dimensional model of a surgical guide for a guidedsurgery can be designed based on the approved implant position.This 3D data can be exported to manufacture a separate physicalproduct.Implant Studio™ is indicated for use as medical front-endsoftware that can be used by medically trained professionals forthe purpose of visualizing gray value images.It is intended for use as pre-operative planning software for theplacement of dental implant(s) based on imported CT image data,optionally aligned to an optical 3D surface scan. Virtual Crownscan be used for optimized implant positioning under theprosthetic aspect. The digital three dimensional model of asurgical guide for a guided surgery can be designed based on theapproved implant position. This 3D data can be exported tomanufacture a separate physical product.Indications of the dental implants do not change with guidedsurgery compared to conventional surgery.Use of the software requires that the user has the necessarymedical training in implantology and surgical dentistry. | |
| Platform | IBM-compatible PCor PC network | IBM-compatible PCor PC network | IBM-compatible PCor PC network | Equivalent |
| Computer | OS: Microsoft | OS: Microsoft | OS: Windows 7 or | Equivalent |
| SystemRequirement | Window 7, 8 or 1064-bitCPU: Inter i-3 coreor higherRAM: 2 GBMonitorResolution:1600 x900 or HigherVideo Card:compatible withDirectX 10.1 orHigherHDD: 2 GB freehard disk spaceNetwork: NetworkInternet connectionMouse: With thewheel button | Window 7, 8 or 1064-bitCPU: Inter i-3 coreor higherRAM: 2 GBMonitorResolution:1600 x900 or HigherVideo Card:compatible withDirectX 10.1 orHigherHDD: 2 GB freehard disk spaceNetwork: NetworkInternet connectionMouse: With thewheel button | 8 64-bitCPU: IntelCore i7or higherRAM: 16GB orbetterMonitor Resolution:1920x1200 orhigherVideo CardMemory: 2GBGeForce or betterAvailable HDDSpace: 500GBNetwork: NetworkInternet connectionMouse: With thewheel button | |
| UserInterface | Monitor, Mouse,Keyboard | Monitor, Mouse,Keyboard | Monitor, Mouse,Keyboard | Equivalent |
| Image InputSources | Images can bescanned, loadedfrom card readers,or imported from aradiographicimaging device. | Images can bescanned, loadedfrom card readers,or imported from aradiographicimaging device. | Images can bescanned, loadedfrom card readers,or imported from aradiographicimaging device. | Equivalent |
| Data Format | DICOM, STL | DICOM, STL | DICOM, STL, DCM | DifferentThe ImplantStudioTMsupports itsown format aswell which isDCM format. |
| SoftwareFunction | MPR (multi-planarreconstruction),panoramic, and, 3Dimagereconstruction foranalyzinganatomicalcondition | MPR (multi-planarreconstruction),panoramic, and, 3Dimagereconstruction foranalyzinganatomicalcondition | Axial, cross-sectional,tangential,panoramic, 3Dviews for displayingthe 3D volumetricdata for analyzinganatomicalcondition | Equivalent |
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Bldg.138, Rm.413, Seoul National University,
1 Gwanak-ro, Gwanak-gu, Seoul, Republic of Korea (08826)
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Bldg.138, Rm.413, Seoul National University,
1 Gwanak-ro, Gwanak-gu, Seoul, Republic of Korea (08826)
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Bldg.138, Rm.413, Seoul National University,
1 Gwanak-ro, Gwanak-gu, Seoul, Republic of Korea (08826)
| Graphicvisualizationinterface for placingthe implant inmandible or maxillaimages, | Graphicvisualizationinterface for placingthe implant inmandible or maxillaimages, | Various imageviews, such asaxial, cross-sectional,tangential, andpanoramic,provided for placingthe implant |
|---|---|---|
| Nerve module forassisting users indistinguishinginferior alveolarnerve (passingthrough mandibularcanal) | Nerve module forassisting users indistinguishinginferior alveolarnerve (passingthrough mandibularcanal) | Nerve module toassist indistinguishing thenerve mandibularchannel |
| Simulation ofdifferent sizedimplants | Simulation ofdifferent sizedimplants | Different implantsselected fromimplant database.Change thediameter andlength of theimplant selected. |
| Adjustment ofimplant location,including positionand direction | Adjustment ofimplant location,including positionand direction | Aligning implant bymoving androtating the implantwith the mouse |
| Alignment functionfor multipleimplants, | Alignment functionfor multipleimplants, | Alignment functionfor multipleimplants, |
| Simulation of crown | Simulation of crown | Abutment andvirtual teeth toolsprovided |
| Measurement toolsfor measuringlength and angle | Measurement toolsfor measuringlength and angle | Activemeasurementtools, length andangle, for individualmeasuring ofimplant position |
| Bone quality(indicated by CTnumber) displayedin the point aroundthe implant | Bone quality(indicated by CTnumber) displayedin the point aroundthe implant | Bone densitometrywith a densitystatistic for densitymeasuring in thepoint around thepositioned implant |
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Bldg.138, Rm.413, Seoul National University,
1 Gwanak-ro, Gwanak-qu, Seoul, Republic of Korea (08826)
| The treatment planof the patient canbe saved in thecomputer storagemedia. The plancan be retrievedlater on forrevision. | The treatment planof the patient canbe saved in thecomputer storagemedia. The plancan be retrievedlater on forrevision. | All working stepsare savedautomatically to thepatient file, calledthe plan. | ||
|---|---|---|---|---|
| Compatible withdental 3D printers,milling machinesand CAMequipment thatsupport the STL fileformat. | Compatible withdental 3D printers,milling machinesand CAMequipment thatsupport the STL fileformat. | Compatible withdental 3D printers,milling machinesand CAMequipment thatsupport the STL fileformat. | ||
| - | - | Gingiva supportedsurgicalguide designpossible | DifferentVARO PlanSoftware doesnot provideedentuloustreatment andsubsequentdesign ofgingivasupportedguides. | |
| AnatomicArea | Maxilla, Mandible | Maxilla, Mandible | Maxilla, Mandible | Equivalent |
Comparing to as Implant Studio™ (K152078), the differences are such that the predicate device supports its own format additionally and the subject device does not have the feature for edentulous treatment and subsequent design of gingiva supported quides. However, these differences do not raise questions of safety or effectiveness since the two features of the predicate devices are additional options.
Based on the results of software validation and performance tests and the information provided herein, we conclude that the proposed device is substantially equivalent to the predicate devices.
09. Non clinical Testing
SW verification and validation testing activities such as code review, module review, and dynamic tests were conducted to establish the performance, functionality and reliability characteristics of the subject device.
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 and Surgical
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Bldg.138, Rm.413, Seoul National University,
1 Gwanak-ro, Gwanak-qu, Seoul, Republic of Korea (08826)
guide model) in the subject device. The P/F criteria was less than 2% average and maximum absolute difference. Accuracy test of Surgical guide model demonstrate that the generated output surgical guide by the subject device matches the user input requirements (Guide thickness, Offset from teeth to quide, Offset from sleeve to quide).
- Accuracy test to verify the size of the implants (Diameter and Length) which the implant library of the subject device provides by comparing them to the real size values of the implant. The P/F criteria was less than 2% average and maximum absolute difference.
The testing results support that the subject device is substantially equivalence to the predicate device.
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, and intended use. The new device does not introduce a fundamentally new scientific technology. Therefore, it is our opinion that the VARO Plan described in this submission is substantially equivalent to the predicate device.
§ 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).