Ez3D-i is dental imaging software that is intended to provide diagnostic tools for maxillofacial radiographic imaging. These tools are available to view and interpret a series of DICOM compliant dental radiology images and are meant to be used by trained medical professionals such as radiologist and dentist.

Ez3D-i is intended for use as software to load, view and save DICOM images from CT, panorama, cephalometric and intraoral imaging equipment and to provide 3D visualization, 2D analysis, in various MPR (Multi-Planar Reconstruction) functions.

Device Description

Ez3D-i is 3D viewing software for dental CT images in DICOM format with a host of useful functions including MPR, 2-dimensional analysis and 3-dimensional image reformation. It provides advanced simulation functions such as Implant Simulation, Drawing Canal, and Implant Environ Bone Density, etc. for the benefit of effective doctor and patient communication and precise treatment planning.

AI/ML Overview

This FDA 510(k) summary for Ewoosoft Co., Ltd.'s Ez3D-i/E3 device (K211791) focuses on demonstrating substantial equivalence to a previous version of the same device (K200178). As such, it does not provide detailed acceptance criteria and a study proving the device meets those criteria in the way one might expect for a novel device or a significantly modified one. Instead, the performance data section states that "SW verification/validation and the measurement accuracy test were conducted to establish the performance, functionality and reliability characteristics of the modified devices. The device passed all of the tests based on pre-determined Pass/Fail criteria." This indicates that the study performed was primarily a verification and validation study to ensure the new version performed as expected and was equivalent to the predicate.

Given the information provided, I will extract and present the available details while noting where specific information, such as detailed acceptance criteria and comprehensive study results, is not present in this type of submission.

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) submission does not provide specific quantitative acceptance criteria or detailed reported device performance metrics for a clinical study comparing the device to ground truth. Instead, it relies on demonstrating substantial equivalence to a predicate device (Ez3D-i/E3, K200178) through software verification and validation, and measurement accuracy tests. The performance is reported in terms of passing pre-determined Pass/Fail criteria.

Note: For this type of submission, detailed performance metrics like sensitivity, specificity, or AUC are not typically required if substantial equivalence is being claimed for minor software updates where the core diagnostic functionality remains unchanged and validated.

Metric/Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
Software Functionality	All specified functions (e.g., MPR, 3D visualization, 2D analysis, implant simulation) performed as intended.	Passed all tests based on pre-determined Pass/Fail criteria.
Measurement Accuracy	Measurements (e.g., length, angle, volume) performed accurately.	Passed all tests based on pre-determined Pass/Fail criteria.
Reliability	Software operated reliably without critical errors or crashes.	Passed all tests based on pre-determined Pass/Fail criteria.
Equivalence to Predicate	Overall performance and safety equivalent to predicate device (K200178).	Deemed substantially equivalent; differences do not raise new safety or effectiveness questions.

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

The document does not specify a "test set" in the context of a clinical performance study with human subjects. The performance data refers to "SW verification/validation and the measurement accuracy test." These typically involve testing the software against pre-defined test cases, simulated data, or existing (potentially de-identified) DICOM images, rather than a prospective clinical dataset.

Sample Size (Test Set): Not specified.
Data Provenance: Not specified. Given it's a software verification/validation, the data would likely be a mix of internal test datasets, and potentially de-identified DICOM images used for functionality testing. The country of origin and retrospective/prospective nature are not mentioned.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided because the submission does not detail a clinical study where ground truth was established by experts for a specific test set. The validation performed was software-centric. The "Indications for Use" statement does, however, mention the intended users: "trained medical professionals such as radiologist and dentist."

4. Adjudication Method for the Test Set

This information is not provided as the submission does not describe a clinical study with expert adjudication of a test set.

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

Was an MRMC study done? No. The document does not mention any MRMC study. The submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data (software verification/validation).
Effect size of human reader improvement with AI vs. without AI assistance: Not applicable, as no MRMC study was conducted or reported.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Was a standalone study done? No, not in the typical sense of evaluating diagnostic accuracy of an AI algorithm against ground truth. The device is a "Medical image management and processing system" that provides tools for human interpretation, not an AI diagnostic algorithm meant to operate standalone. The performance data describes "SW verification/validation and the measurement accuracy test" for the software's functionality and reliability, which is a standalone evaluation of the software components but not in the context of diagnostic accuracy.

7. Type of Ground Truth Used

For the "SW verification/validation and the measurement accuracy test," the "ground truth" would likely be:

Pre-defined expected outputs/behaviors for various software functions.
Known measurements or anatomical landmarks in test images used for accuracy checks.
Industry standards for DICOM compliance and image processing.

This is distinct from clinical ground truth such as pathology or outcomes data, which would be expected for a diagnostic AI system.

8. Sample Size for the Training Set

Not applicable. The Ez3D-i/E3 device is described as "3D viewing software for dental CT images" that provides diagnostic tools and image manipulation functions. It is not explicitly stated to be an AI/machine learning device that requires a "training set" in the context of supervised learning for a specific diagnostic task. The software's functionality is based on image processing algorithms and user interface design.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no "training set" for AI/machine learning is described.

Summary

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August 20, 2021

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Ewoosoft Co., Ltd. % Ms. Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 18881 Von Karman Ave., STE 160 IRVINE CA 92612

Re: K211791

Trade/Device Name: Ez3D-i/E3 Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: June 4, 2021 Received: June 10, 2021

Dear Ms. Chung:

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)

K211791

Device Name Ez3D-i /E3

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summarv

(K211791)

This summary of 510(k) information is being submitted in accordance with requirements of 21 CFR Part 807.92.

1. Date: 8/9/2021

2. Applicant / Submitter

Ewoosoft Co., Ltd. 801-ho, Vatechnetworks Bldg., 13, Samsung 1-ro 2-gil, Hwaseong-si, Gyeonggido , Republic of Korea Tel: +82 31 8015 6172 Fax: +82 31 8015 6196 Contact person: Young Seok Kim Email: eddie.kim@ewoosoft.com

3. U.S. Designated Agent

Priscilla Chung LK Consulting Group USA, Inc. 18881 Von Karman Ave. STE 160 Irvine, CA 92612 Fax: 714.409.3357 Tel: 714.202.5789 Email: juhee.c@LKconsultingGroup.com

4. Device Information:

Trade/Device Name: Ez3D-i /E3
Regulation Number: 21 CFR 892.2050
Regulation Name: Medical Image Management and Processing System ●
Regulatory Class: Class II
Product Code: LLZ

5. Predicate Device:

Manufacturer: Ewoosoft Co., Ltd. ●
Trade/Device name: Ez3D-i /E3
510(k) number: K200178
Regulation number 21 CFR 892.2050 ●
. Regulation name: Picture Archiving and Communications System
Regulatory Class: Class II ●
. Classification Product Code: LLZ

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6. Device Description:

7. Indication for use:

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8. Substantial Equivalence:

	Subject Device	Predicate Device
Device Name	Ez3D-i v5.3(E3)	Ez3D-i v5.2(E3)
510K number	K211791	K200178
Manufacturer	Ewoosoft	Ewoosoft
Indications for use	Ez3D-i is dental imaging software that isintended to provide diagnostic tools formaxillofacial radiographic imaging. Thesetools are available to view and interpret aseries of DICOM compliant dental radiologyimages and are meant to be used by trainedmedical professionals such as radiologistand dentist.Ez3D-i is intended for use as software toload, view and save DICOM images fromCT, panorama, cephalometric and intraoralimaging equipment and to provide 3Dvisualization, 2D analysis, in various MPR(Multi-Planar Reconstruction.) functions	Ez3D-i is dental imaging software that isintended to provide diagnostic tools formaxillofacial radiographic imaging. Thesetools are available to view and interpret aseries of DICOM compliant dentalradiology images and are meant to be usedby trained medical professionals such asradiologist and dentist.Ez3D-i is intended for use as software toload, view and save DICOM images fromCT, panorama, cephalometric and intraoralimaging equipment and to provide 3Dvisualization, 2D analysis, in various MPR(Multi-Planar Reconstruction.) functions
Platform	IBM-compatible PC or PC network	IBM-compatible PC or PC network
Operating System	Microsoft Window 8, 10	Microsoft Window 7, 8, 10
User Interface	Mouse, Keyboard	Mouse, Keyboard
Image Input Sources	Images can be scanned, loaded from digitalcameras or card readers, or imported from aradiographic imaging device	Images can be scanned, loaded from digitalcameras or card readers, or imported from aradiographic imaging device
32 bit / 64 bit	32 / 64 bit	32 / 64 bit
Image format	DICOM	DICOM
Image MeasurementTools	Length, Multi Length, Angle, Multi Angle,Circle, ROI/Area, Volume, Profile	Length, Multi Length, Angle, ROI/Area,Volume, Profile
Image viewing	Full, side by side, gallery, thumbnail	Full, side by side, gallery, thumbnail
Image manipulation	Grayscale, invert, emboss, brightness,contrast, gamma, sharpen, median,despeckle, hue, saturation, equalize, flip,mirror, masking, rotate, magnify, annotation,cephalometric tracing, ceph growthprojections, implant simulations	Grayscale, invert, emboss, brightness,contrast, gamma, sharpen, median,despeckle, hue, saturation, equalize, flip,mirror, masking, rotate, magnify,annotation, cephalometric tracing, cephgrowth projections, implant simulations
3D imagingcapability	Ez3D-i can view, transfer and process 3Dradiographs. Furthermore, it supports SmartClick, Smart Clipping, Implant Simulationand Canal Draw.	Ez3D-i can view, transfer and process 3Dradiographs. Furthermore, it supports SmartClick, Smart Clipping, Implant Simulationand Canal Draw.
Image annotation	Text, paint, ellipse, pointer, select, draw,magnify, line, rectangle, polygon, ruler,protractor, smile library, smudge, brush,redeye reduction, select region, copy / paste	Text, paint, ellipse, pointer, select, draw,magnify, line, rectangle, polygon, ruler,protractor, smile library, smudge, brush,redeye reduction select region copy/paste

Ez3D-i described in this 510(k) has the same intended use and the same technical characteristics as the unmodified device (K200178, Ez3D-i /E3).

The subject device and the predicate devices are substantially equivalent, having the same indications for use and functionalities like operation software, computer platform, picture

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archiving and communication format, image format, image processing features, windowing, 3D image construction, image edit, measurements and manipulation.

The differences are that the subject device has additional features such as changes in PC system requirement information, login/logout function, the location of the User Account Management to Server Web Console EzServer, license plan options setting, export icon function, show/hide patient information icon function, adding and deleting VR coloring graph function, MPR interval function, and export to DICOM function. These differences are not significant since they do not raise any new or potential safety risks to the user or patient and questions of safety or effectiveness. Based on the test results submitted in this 510K, we conclude that the subject device is substantially equivalent to the predicate devices.

9. Technological Characteristics:

Ez3D-i 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.

10. Performance Data:

SW verification/validation and the measurement accuracy test were conducted to establish the performance, functionality and reliability characteristics of the modified devices. The device passed all of the tests based on pre-determined Pass/Fail criteria.

11. Conclusion:

The subject device is substantially equivalent in the areas of technical characteristics, general function, application, and indications for use. The new device does not introduce a fundamentally new scientific technology, and the device has been validated through system level test. Therefore, we conclude that the subject device described in this submission is substantially equivalent to the predicate device.

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).