R2GATE is intended for use as a software interface and image segmentation system for the transfer of imaging information from a CBCT scanner. It is also intended as pre-planning software for dental implant placement and surgical treatment.

Device Description

R2GATE is a web application and is intended for pre-operative planning to create and review plans for dental implant placement and surgical treatment, using MEGAGEN Implants. A dental implant plan can be edited with R2GATE Editor, a desktop software application, by a licensed dentist with clinical experience in implant surgery and medical image review.

The implant surgery plan can be used for manufacturing a surgical guide or for evaluation of treatment options by a licensed dentist.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the R2GATE device based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a direct, quantified table of acceptance criteria with specific numerical targets and the reported performance against those targets. Instead, it describes general categories of validation and verification performed and states that the "test results met the acceptance criteria and demonstrated equivalence."

However, based on the non-clinical performance data section, we can infer some criteria:

Acceptance Criteria Category (Inferred)	Reported Device Performance
Validation of CBCT data (Distance & Angle)	- Distance and angle values between R2GATE Windows and Blue Sky Plan were measured within the acceptable range.
Validation of CBCT data (Hounsfield Unit, HU)	- HU values between R2GATE Windows and Blue Sky Plan were measured within the acceptable range.
Verification of integrity of CBCT data (DICOM Image Data)	- No modification or conversion of the DICOM file between Blue Sky Plan and R2GATE Windows.
Verification of surgical guide model (Bonding/Precision)	- Differences in bonding or precision measurement between the design file (STL) and the actual structure were within the acceptable range.

2. Sample Size for Test Set and Data Provenance:

The document does not explicitly state the sample size used for the non-clinical tests. It also does not specify the provenance (e.g., country of origin, retrospective/prospective) of the CBCT data used in the validation studies. It only mentions "Physical measurement values and numerical values (Hounsfield unit, HU) of distance and angle between specific points of CBCT data."

3. Number of Experts and Qualifications:

The document does not specify the number or qualifications of experts used to establish ground truth for the test set. It mentions that the R2GATE Editor is used by "a licensed dentist with clinical experience in implant surgery and medical image review," but this refers to the intended user, not necessarily the ground truth determiners for the validation study.

4. Adjudication Method:

The document does not describe any adjudication method (e.g., 2+1, 3+1) for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study evaluating the effect size of human readers improving with AI vs. without AI assistance. The study focuses on comparing the subject device (R2GATE) to a predicate device (Blue Sky Bio Plan) based on technical performance and equivalence, not human-in-the-loop effectiveness.

6. Standalone (Algorithm Only) Performance:

The described "Non-Clinical Performance Data" and "Software testing" sections primarily relate to the standalone performance of the software in terms of data handling, measurement accuracy, and integrity. While the device is intended to be used by a dentist, the validation tests presented are focused on the software's inherent capabilities without explicitly detailing human-in-the-loop performance. Therefore, a standalone performance assessment akin to algorithm-only evaluation was performed for the features tested.

7. Type of Ground Truth Used:

The ground truth used appears to be a combination of physical measurements and comparative analysis with a legally marketed predicate device (Blue Sky Bio Plan).

For CBCT data validation (distance, angle, HU), the ground truth seems to be derived from the inherent properties of the CBCT data and the measurements taken by both the subject and predicate devices, comparing their consistency.
For surgical guide model verification, the ground truth would likely be the actual physical structure or a highly accurate reference model, against which the design file (STL) and actual manufactured structure are compared.

8. Sample Size for Training Set:

The document does not mention a training set sample size. This submission focuses on a Picture Archiving and Communication System (PACS) and pre-planning software, which typically relies on established algorithms for image processing and measurement rather than a machine learning model that requires a dedicated training set.

9. How Ground Truth for Training Set Was Established:

Since there is no mention of a machine learning component requiring a training set, the document does not provide information on how ground truth for a training set was established.

Summary

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Image /page/0/Picture/0 description: The image contains 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.

MegaGen Implant Co., Ltd. % Mr. Dave Kim President Mtech Group 8310 Buffalo Speedway HOUSTON TX 77025

June 26, 2019

Re: K190096

Trade/Device Name: R2GATE Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: June 4, 2019 Received: June 4, 2019

Dear Mr. Kim:

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, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K190096

Device Name R2GATE

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)

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		510(k) SUMMARY
		K190096
		R2GATE Picture Archiving and Communication
		System
1.	Submitter Information:	MEGAGEN IMPLANT CO., LTD
		41940, 10F, 12 Gong Pyeong Ro
		Jung Gu Daegu, 41940
		Republic of Korea
	Contact Person:	HyeJin Jung
	Telephone Number:	+82-70-4352-1120
	Fax Number:	+82-70-7469-1120
	Date Prepared:	1/13/2019
2.	Device Name:
	Proprietary Name:	R2GATE
	Classification Name:	Picture Archiving and Communication System
	CFR Number:	21 CFR §892.2050
	Device Class:	Class II
	Product Code:	LLZ
3.	Predicate Device:
	Trade/Device Name:	Blue Sky Bio Plan
	510k Number:	K090607
	Regulation Number:	21 CFR 892.2050
	Regulation Name:	Picture archiving and communications system
	Regulatory Class:	Class II
	Product Code:	LLZ.

4. Description of Device:

The implant surgery plan can be used for manufacturing a surgical guide or for evaluation of treatment options by a licensed dentist.

Indications for Use:

Substantial Equivalence:

Table 6-1 Substantial equivalence comparison table

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Criteria	Predicate Devices	Device underConsideration	K190096Equivalency
Element ofComparison	Blue Sky Bio, LLC (K090607)	MegaGen Implant Co., Ltd,	Equivalency
Device Name	Blue Sky Bio Plan	R2GATE Windows
Intended Use	Review and approve implant plan, Edit implantplan for approval in online case review.	Create, edit and approve implantplan. For approval in online casereview.	Same
Indications for Use	Blue Sky Plan is intended to be used asconversion software for ComputedTomography (CT) generated DICOM imagesinto a format that allows a dentist to assess theanatomic topography of the maxilla andmandible as well as location of importantstructures. It allows the information to be usedfor pre- surgical treatment planning of dentalimplant procedures. The Blue Sky Plansoftware is deployed on standard personalcomputer hardware using a Windows operatingsystem.	R2GATE is intended for use as a softwareinterface and image segmentation systemfor the transfer of imaging informationfrom a CBCT scanner. It is also intendedas pre-planning software for dental implantplacement and surgical treatment.	Same
Media for Delivery	- Software-File for download	- Software-File for download	Same
Principles ofoperation	Online software applicationDesktop software application	Online software applicationDesktop software application	Same
Program language	C# C++	C# C++	Same
Operating System	Windows	Windows	Same
	software functionalities
Reorientation	Reorientation function to change thedirection of the CT image on display.	Reorientation function to change thedirection of the CT image on display.	Same
Nerve canal	Create a nerve carnal tracing model using thetools provided on the 2D image. The crosssection of the model is displayed as a 3D imageon the volumetric rendering view.	Create a nerve carnal tracing model usingthe tools provided on the 2D image. Thecross section of the model is displayed as a3D image on the volumetric renderingview.	Same
3D model scanimplant planning	The scanned 3D model (STL file) can bereconstructed and used for implant planning.	The scanned 3D model (STL file) can bereconstructed and used for implant	Same
Image processing	Change the image displayed on the 2D or 3Dscreen using a tool provided by the program.	Change the image displayed on the 2D or3D screen using a tool provided by theprogram.	Same
Printing output	Output data that can be used for implant surgicalguide fabrication.	Output data that can be used for implantsurgical guide fabrication.	Same
Output compatibility	The STL file generated can be loaded formother software in conformity with thestandard.	The STL file generated can be loadedform other software in conformity withthe standard.	Same
Screenshot	A screen view on a program can be stored asan image file.	A screen view on a program can bestored as an image file	Same
			K190096
Measurement Tools	Measure the angle and length on a 2Dscreen using the tool available in theprogram. Measure the length using 2 pointsand measure the angle between the two linesegments using 3 points.	Measure the angle and length on a 2Dscreen using the tool available in theprogram. Measure the length using 2points and measure the angle between thetwo line segments using 3 points.	Same
Implant Control	Implant model can be added, deleted, movedand rotated on the screen. Only the implantmodels in the implant library can be used.	Implant model can be added, deleted,moved and rotated on the screen. Onlythe implant models in the implantlibrary can be used.	Same
Anchor pin Control	Anchor-pins can be added, deleted, moved androtated on the screen. The user may use theproduct provided by the program or enter thediameter and length setting.	Anchor-pins can be added, deleted,moved and rotated on the screen. Theuser may use the product provided bythe program only.	Same
Cephalo analysis	The user can set points of the analysisusing the cephalon analysis methodprovided by the program.	The user can set points of the analysisusing the cephalon analysis methodprovided by the program.	Same
2D Image View	The CT image data can be loaded for axial,coronal, sagittal, cross section andpanorama view mode.	The CT image data can be loaded foraxial, coronal, sagittal, cross section andpanorama view mode.	Same
STL fileManagement	Load a STL file or save a 3D modelcreated in the program as an STL file.	Load a STL file or save a 3D modelcreated in the program as an STL file.	Same
View Management	2D/3D view can be zoomed, moved,rotated.	2D/3D view can be zoomed, moved,rotated.	Same
Project Management	Proceed to a new project. Save the currentproject or recall the previous project.	Proceed to a new project. Save thecurrent project or recall the previousproject.	Same
Wax Up Fabrication	Create the desired model by adjusting theposition, size, and direction of the basic waxup model provided by the program.	No function to make a wax up model	Difference
Surgical GuideFabrication	Using the virtual STL model and implantmodel, the surgical guide is constructed as apoint-set area on the surface of the STL model.	This SW does not provide the surgicalguide fabrication function.	Difference
Report Template	Includes a report template via PDF export andprint setting. A screen shot can be saved fordisplay.	No report document template. A screenshot can be saved for display.	Partiallyequivalent
Printing Output	Dental Surgical Guide	Dental Surgical Guide	Same
OutputCompatibility	Compatible with dental 3D printers,milling machines and CAM equipmentthat support the STL file format.	Compatible with dental 3D printers,milling machines and CAM equipmentthat support the STL file format.	Same

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Analysis of differences

The proposed device has similar indications for use and mostly same basic functionalities in comparison with the predicate device. The functions, view, and module for both the subject and predicate device are used for review of radiographic images, creation of a dental treatment plan and implant surgical guide. The differences include the proposed implant devices that each program depends on. For an implant surgical guide and treatment simulation, R2GATE utilizes a pre-loaded implant device library featuring MEGAGEN IMPLANT family whereas Blue Sky Bio may have different implant library other than MEGAGEN Implant.

7. Software testing

Software verification and validation was conducted to ensure the functionality and compatibility of all system components and to support the safety and effectiveness of the proposed devices.

The verification and validation tests consist of the following activities:

Unit test
. Peer Code Review
Integration test ●
Internal release test
Formal system test
. Acceptance test

Verification and validation tests confirm that all user needs and SW performance requirements are fulfilled according to the design input.

Also the following comparison tests confirm the functionality, safety and efficacy of the proposed devices.

8. Non-Clinical Performance Data

Non-clinical tests have been developed in-house including acceptance criteria. The test results demonstrated substantial equivalence between the subject device and the predicate device. (Document No: R2W-D34-PER-001)

(i) Validation of CBCT data (DICOM Image Data): Physical measurement values and numerical values (Hounsfield unit, HU) of distance and angle between specific points of CBCT data of R2GATE Windows and Blue Sky Plan Software. The distance and angle value between the Blue Sky Plan and R2GATE Windows were measured within the acceptable range

(ii) Verification of integrity of CBCT data (DICOM Image Data): Experiments on modification of CBCT data of R2GATE Windows and Blue Sky Plan Software. There is no modification or conversion of the DICOM file between the Blue Sky Plan and R2GATE Windows.

(iii) Verification of the surgical guide model of the dental implant procedure using the STL file. The degree of bonding or precision measurement between the design file and the actual structure were reviewed and compared., The differences were within the acceptable range.

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The test results met the acceptance criteria and demonstrated equivalence between the subject and predicate device.

9. Conclusion Regarding Substantial Equivalence

The R2GATE has similar indications for use and incorporate the same fundamental functions, views and module as the predicate device Blue Sky Bio Plan cleared under premarket notification K090607. The performance test for both the subject and the predicate device has been conducted and the test outcome support substantial equivalence between R2GATE and Blue Sky Bio Plan without raising any new issues of safety or effectiveness.

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).