R2GATE Lite ™ allows for surgical guides to be export to a validated manufacturing center or to the point of care. Manufacturing at the point of care requires FDA cleared or legally marketed 3D printing fabrication method and compatible material (biocompatible and sterilizable ).

Device Description

The proposed device, R2GATE Lite ™ software is an image viewer compatible for Windows PC. MacOS and Apple iOS tablet platform to view and approve preoperative planning for dental implant placement and surgery provided by R2GATE Window (K190096).

The software R2GATE Lite TM is used by dental professionals with clinical experience in implant surgery and in medical image review.

R2GATE Lite TM let the user view, measure, zoom and rotate 2D and 3D images of dental implant plans generated by R2GATE Window (K190096). R2GATE Lite TM can be used by dental professionals as a patient consultation tool for planning dental implant surgery and treatment.

R2GATE Lite TM let the user review, revise and approve the implant surgical plan on Windows PC. MacOS and Apple iOS tablet platform before manufacturing a surgical guide.

AI/ML Overview

The provided text is a 510(k) summary for the R2GATE Lite™ device and does not contain the specific details about acceptance criteria, device performance, and the study methodologies typically found in a comprehensive clinical or performance evaluation report. The document primarily focuses on establishing substantial equivalence to a predicate device (R2GATE Windows).

However, I can extract and infer some information related to software testing and general claims.

Here's an analysis based on the provided text, with a clear indication of what is not present in the document.

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary does not explicitly state specific quantitative acceptance criteria or detailed performance metrics for the R2GATE Lite™ device. It mentions "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." and "Verification and validation tests confirm that all user needs and SW performance requirements are fulfilled according to the design input."

This implies that the device met its functional and performance requirements as defined internally by the manufacturer, but these specific requirements and their numerical outcomes are not detailed in this summary.

General Software Functionalities (Implied Performance):

Acceptance Criteria (Implied from Functional Description)	Reported Device Performance (Implied from V&V Statement)
Ability to view, measure, zoom, and rotate 2D and 3D images of dental implant plans.	Fulfilled (as per V&V statement)
Ability to review, revise, and approve implant surgical plans.	Fulfilled (as per V&V statement)
Compatibility with Windows PC, macOS, and Apple iOS tablet platforms.	Fulfilled (as per V&V statement)
Accurate creation of 3D nerve canal models from R2GATE Windows data.	Fulfilled (as per V&V statement)
Accurate import and use of scanned 3D models (STL files) for implant planning.	Fulfilled (as per V&V statement)
Ability to manipulate images on 2D or 3D screens.	Fulfilled (as per V&V statement)
Accurate measurement of angles and lengths on a 2D screen.	Fulfilled (as per V&V statement)
Functionality for adding, deleting, moving, and rotating implant models.	Fulfilled (as per V&V statement)
Functionality for adding, deleting, moving, and rotating anchor-pins.	Fulfilled (as per V&V statement)
Ability to view CT data from R2GATE Windows in axial, coronal, and sagittal images.	Fulfilled (as per V&V statement)
Functionality for enlarging/reducing, moving, and rotating 2D/3D views.	Fulfilled (as per V&V statement)
Ability to proceed with, save, or load existing projects created in R2GATE Windows.	Fulfilled (as per V&V statement)

2. Sample Size Used for the Test Set and Data Provenance

The 510(k) summary does not specify the sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective) for either training or testing data. The testing mentioned is "Software verification and validation," which includes unit tests, integration tests, system tests, and acceptance tests. These typically involve synthetic data, simulated scenarios, and potentially real patient data for validation, but the details are not provided.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

The document does not provide any information about the number or qualifications of experts used to establish ground truth for a test set.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method used for a 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. The device is a "pre-planning software" for dental implant placement and surgical treatment, and its primary function described is viewing, measuring, and approving plans generated by the predicate device (R2GATE Windows), suggesting a focus on functional equivalency rather than comparative clinical performance with human readers.

6. Standalone Performance Study

While the "Software verification and validation" (V&V) activities listed (Unit test, Peer Code Review, Integration test, Internal release test, Formal system test, Acceptance test) can be considered forms of standalone testing for the algorithm's functionality, the document does not detail a specific standalone performance study in terms of diagnostic accuracy metrics (e.g., sensitivity, specificity, AUC) for any AI or algorithmic component, as the device is presented as an "image viewer" and "pre-planning software" that primarily interfaces with another cleared device (R2GATE Windows).

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for any performance evaluation. Given the device's function as a pre-planning and viewing tool for dental implants, ground truth would likely relate to the accuracy of measurements, correct rendering of 2D/3D images, proper display of generated nerve canal and implant models, and accurate application of revision/approval functions. This type of ground truth is often established through technical specifications and verification against expected outputs.

8. Sample Size for the Training Set

The document does not provide any information about a training set sample size.

9. How Ground Truth for the Training Set Was Established

The document does not provide any information about how ground truth for a training set was established.

In summary, the provided FDA 510(k) summary for R2GATE Lite™ focuses on demonstrating substantial equivalence through a comparison of intended use, indications for use, and functional descriptions with a predicate device. It indicates that software verification and validation activities were performed to confirm performance requirements were met, but it does not provide detailed quantitative performance metrics, study designs, sample sizes, or ground truth methodologies that would typically be found in a comprehensive clinical or performance study report. This level of detail is often not required or included in the public 510(k) summary for certain device types, especially those classified as image management and processing systems.

Summary

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October 20, 2023

MegaGen Implant Co. Ltd % Dave Kim President Mtech Group 7505 Fannin St. Suite 610 HOUSTON, TX 77054

Re: K223909

Trade/Device Name: R2GATE Lite TM Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: October 4, 2023 Received: October 4, 2023

Dear Dave 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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Lu Jiang

Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT 8B: Division of Radiological Imaging Devices and Electronic Products OHT 8: Office of Radiological Health Office of Product Evaluation and Quality

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Indications for Use

510(k) Number (if known) K223909

Device Name R2GATE Lite TM

Indications for Use (Describe)

R2GATE Lite ™ is intended for use as a pre-planning software for dental implant placement and surgical treatment for adult only.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY

K223909

1.	Submitter Information:	MegaGen Implant Co., Ltd45, Secheon-ro 7-gil, Dasa-eup, Dalseong-gunDaegu, 42921Republic of Korea
	Contact Person:	Tae Gyoun Lee / Manager
	Telephone Number:	+82-53-222-3878
	Date Prepared:	10/11/2023
2.	Device Name:Proprietary Name:	R2GATE Lite TM
	Regulation Number	21 CFR §892.2050
	Regulation Name:	Medical image management and processing system
	Device Class:	Class II
	Product Code:	LLZ
3.	Predicate Device:Trade/Device Name:	R2GATE
	510k Number:	K190096
	Regulation Number:	21 CFR 892.2050
	Regulation Name:	Medical image management and processing system
	Regulatory Class:	Class II
	Product Code:	LLZ

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1. Description of Device:
  The proposed device, R2GATE Lite ™ software is an image viewer compatible for Windows PC. MacOS and Apple iOS tablet platform to view and approve preoperative planning for dental implant placement and surgery provided by R2GATE Window (K190096).

The software R2GATE Lite TM is used by dental professionals with clinical experience in implant surgery and in medical image review.

R2GATE Lite TM let the user review, revise and approve the implant surgical plan on Windows PC. MacOS and Apple iOS tablet platform before manufacturing a surgical guide.

1. Indications for Use:
  R2GATE Lite ™ is intended for use as a pre-planning software for dental implant placement and surgical treatment for adult only.

R2GATE Lite TM allows for surgical guides to be export to a validated manufacturing center or to the point of care. Manufacturing at the point of care requires FDA cleared or legally marketed 3D printing fabrication method and compatible material (biocompatible and sterilizable ).

1. Substantial Equivalence:

Criteria	Predicate Devices	Device under Consideration	Equivalency
Element of Comparison	MegaGen Implant Co., Ltd,	MegaGen Implant Co., Ltd,
Device Name	R2GATE Windows	R2GATE LiteTM
510(k) Number	K190096	K223909
Intended Use	Create, edit and review onlineimplant plan case for approval.	Create, edit and review online implantplan case for approval.	Same
Indications for Use	R2GATE is intended for use as asoftware interface and imagesegmentation system for the transfer ofimaging information from a CBCTscanner. It is also intended as pre-planning software for dental implantplacement and surgical treatment.	R2GATE LiteTM is intended for use as a pre-planning software for dental implantplacement and surgical treatment for adultonly.R2GATE Lite TM allows for surgical guidesto be export to a validated manufacturingcenter or to the point of care.Manufacturing at the point of care requiresFDA cleared or legally marketed 3Dprinting fabrication method and compatiblematerial (biocompatible and sterilizable ).	reducedfunctionality
Media for Delivery	Download installation software file	Download installation software file	Same

Table 6-1 Substantial equivalence comparison table

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OperatingPlatform	Software application for onlineSoftware application for desktop	Software application for onlineSoftware application for desktopSoftware application for mobile device	Difference
Program language	C# C++	C#	Same
Operating System	Windows PC	Windows PC, macOS, iOS	Different
	software functionalities
Nerve canal	The user can create a nerve canal modelusing the tools provided on thepanoramic screen. The cross section ofthe model created is displayed in 2D and3D volumetric view.	A 3D model of the nerve canal can becreated using the information of the nervecanal model created in R2GATEWindows. The cross section of thecreated model is displayed in the 2D viewand 3D volumetric view.	Same
3D model scanimplant planning	A scanned 3D model (STL file) can beimported and used for implant treatmentplanning.	A 3D model (STL file) of mobile datacreated in R2GATE Window scan beimported and used for implant treatmentplanning.	Same
Image processing	The image displayed can bemanipulated on the 2D or 3D screenwith the tool provided by the program.	The image displayed can be manipulatedon the 2D or 3D screen with the toolprovided by the program.	Same
Measurement Tools	Angles and lengths can be measured ona 2D screen using tools provided by theprogram. Measure the length of twopoints and measure the angle using theslope of the two points.	Angles and lengths can be measured on a2D screen using tools provided by theprogram. Measure the length of twopoints and measure the angle using theslope of the two points.	Same

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Implant Control	Implant models can be added, deleted,moved and rotated on the screen.Different implant products are availableto choose. The implant products canonly be provided by the program.	Implant models can be added, deleted,moved and rotated on the screen.Different implant products are available tochoose. The implant products can only beprovided by the program.	Same
Anchor pin Control	Anchor-pin can be added, deleted,moved and rotated on the screen.Different Anchor-pin products that areonly provided by the program areavailable to choose.	Anchor-pin can be added, deleted, movedand rotated on the screen. DifferentAnchor-pin products that are onlyprovided by the program are available tochoose.	Same
2D Image View	The imported CT data can be viewed inthe form of axial, coronal, sagittal, crosssection, and panorama image.	CT data of mobile data created inR2GATE Windows can be viewed in theform of axial, coronal, and sagittal image.	reducedfunctionality
View Management	2D/3D view can be enlarged / reduced,moved and rotated.	2D/3D view can be enlarged / reduced,moved and rotated.	Same
Project Management	The user can create a new project, saveor load the existing project.	The user can proceed with the projectalready created in R2GATE Windows,save or load the existing project inR2GATE Windows.	reducedfunctionality

7. Analysis of differences

The proposed device has same indications for use and partly the same basic functionalities compared to the predicate device. The functions, view, and module for both the subject and predicate devices are used for review of radiographic images, creation of a dental treatment plan and implant surgical guide. The differences include that R2GATE Lite TM utilizes Windows PC, Apple MacOS, iOS tablet to review, revise and approve a pre-loaded implant image data generated by R2GATE Window (K190096) for an implant surgical simulation and treatment guide.

Both R2GATE Lite ™ and R2GATE Windows can be downloaded to a local computer from the website allowing the dental professional flexible and convenient way to plan and review implant surgical guide.

Software testing 8.

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 .

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Verification and validation tests confirm that all user needs and SW performance requirements are fulfilled according to the design input. The comparison tests confirm the functionality, safety and efficacy of the proposed devices.

Conclusion Regarding Substantial Equivalence 9.

The R2GATE Lite TM has similar indications for use and incorporate the same fundamental functions, views and module as the predicate device R2GATE Windows cleared under premarket notification K190096. The performance test for both the subject and the predicate device has been conducted and the test outcome support substantial equivalence between R2GATE Lite ™ and R2GATE Windows 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).