EzDent Web is a dental imaging software that is intended to provide viewer and image processing tools for maxillofacial radiographic images. 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.

EzDent Web is intended for use as software to acquire, view, and save 2D and 3D image files, to load DICOM project files from panorama, cephalometric, and intra-oral imaging equipment, and to provide 3D visualization and 2D analysis. EzDent Web is not for use for diagnostic purposes.

Device Description

EzDent Web is a dental imaging software that enables you to save, manage, view and process patients' images. EzDent Web is equipped with management and processing system for various 2D and 3D images. In addition. EzDent Web provides media contents for patient consultation and user friendly instruction to assist your use of the software.

EzDent Web provides you with the following functions using patient images in 2D and 3D.

Manage patient information
View patient images in 2D/3D using tools for image processing and view function.
Use high resolution 3D VR to view 3D images in the optimized view for user intent.
Consult patients using media contents provided for patient consultation.

EzDent Web can be used in a networked environment. If EzDent Web is installed in several computers, the patient and image database can be shared among them and used on different workstations.

AI/ML Overview

The provided text describes EzDent Web, a dental imaging software, and its substantial equivalence to predicate devices (EzDent-i and Ez3D-i v5.2). However, it does not contain specific acceptance criteria, detailed study designs, or performance metrics that would allow for a comprehensive answer to all parts of the request.

Here's a breakdown of what can be extracted and what is missing based on the provided document:

Description of Acceptance Criteria and Proving Device Adherence

The document 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."

However, the specific "pre-determined Pass/Fail criteria" (acceptance criteria) and the "reported device performance" are not detailed in the provided text. Therefore, a table explicitly outlining these cannot be generated from this document.

Detailed Information about the Study:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Not explicitly stated in document)	Reported Device Performance (Not explicitly stated in document)
Specific criteria for image management, viewing, processing, accuracy of measurements, and system reliability are not provided.	The document only states that the device "passed all of the tests based on pre-determined Pass/Fail criteria." No quantitative results or specific performance metrics are given.

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

Sample Size: Not specified in the document.
Data Provenance: Not specified in the document (e.g., country of origin, retrospective or prospective).

3. Number of Experts and their Qualifications for Ground Truth Establishment:

Not specified in the document. The document mentions the software is "meant to be used by trained medical professionals such as radiologist and dentist," but it does not describe their involvement in establishing ground truth for testing.

4. Adjudication Method for the Test Set:

Not specified in the document.

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

Was it done? No, the document does not mention an MRMC study or any comparison of human readers with or without AI assistance.
Effect Size: Not applicable, as no MRMC study is reported.

6. Standalone (Algorithm Only) Performance Study:

Was it done? The document describes "SW verification/validation and the measurement accuracy test" and that the "device passed all of the tests." This suggests a standalone performance evaluation of the software's functionalities. However, specific details of this standalone performance (e.g., accuracy, precision for specific tasks) are not provided. The device is purely software, so its "performance" would inherently be standalone in its function.

7. Type of Ground Truth Used:

Not specified in the document. Given the context of dental imaging software for viewing and processing, potential ground truths could include expert consensus on image quality, accurate measurement validation, or comparison to established benchmarks for image processing functions. However, the document does not elaborate.

8. Sample Size for the Training Set:

The document describes a "verification/validation" study for the modified device and states its similarity to predicate devices. It does not mention a "training set" in the context of an AI/machine learning model, which this device, as described, does not appear to be. It's a medical image management and processing system.

9. How Ground Truth for the Training Set was Established:

Not applicable, as a "training set" in the context of machine learning is not mentioned or implied for this device. The document describes a software system for viewing and processing images, not an AI diagnostic tool that requires a training phase.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".

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

September 28, 2021

Re: K211700

Trade/Device Name: EzDent Web Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: August 24, 2021 Received: August 30, 2021

Dear Priscilla 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 and Part 809; medical device reporting of medical device-related adverse events) (21 CFR

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for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about 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) K211700

Device Name EzDent Web

Indications for Use (Describe)

EzDent Web is intended for use as software to acquire, view, and save 2D image files, to load DICOM project files from panorama, cephalometric, and intra-oral imaging equipment, and to provide 3D visualization and 2D analysis. EzDent Web is not for use for diagnostic purposes.

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 (K211700)

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

1. Date: 8/24/2021

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: EzDent Web
Regulation Number: 21 CFR 892.2050
Regulation Name: Medical Image Management and Processing System ●
Regulatory Class: Class II
o Product Code: LLZ

5. Predicate Device:

Manufacturer: Ewoosoft Co., Ltd.
Trade/Device name: EzDent-i(E2/ProraView/Smart M viewer) / Ez3D-i v5.2(E3)
510(k) number: K202116 / K200178
Regulation number 21 CFR 892.2050 ●
o Regulation name: Picture Archiving and Communications System
Regulatory Class: Class II ●
Classification Product Code: LLZ

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6. Device Description:

EzDent Web provides you with the following functions using patient images in 2D and 3D.

Manage patient information
View patient images in 2D/3D using tools for image processing and view function.
Use high resolution 3D VR to view 3D images in the optimized view for user intent.
Consult patients using media contents provided for patient consultation.

EzDent Web can be used in a networked environment. If EzDent Web is installed in several computers, the patient and image database can be shared among them and used on different workstations.

7. Indication for use:

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Substantial Equivalence ප්‍

Device name	Subject Device	Predicate Device
510K number	EzDent Web	EzDent-i(E2/ProraView/Smart M viewer)	Ez3D-i v5.2(E3)
Manufacturer	K211700Ewoosoft Co., Ltd	K202116Ewoosoft Co., Ltd.	K200178Ewoosoft Co., Ltd.
Indications for use	EzDent Web is a dental imaging software that is intended to provide viewer and image processing tools for maxillofacial radiographic images. 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.	EzDent-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 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.
	EzDent Web is intended for use as software to acquire, view, and save 2D and 3D image files, to load DICOM project files from panorama, cephalometric, and intra-oral imaging equipment, and to provide 3D visualization and 2D analysis.	EzDent-i is intended for use as software to acquire, view and save 2D image files, load DICOM project files from panorama, cephalometric, and intra-oral imaging equipment.	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
Technology/Principle of Operation	EzDent Web is a device that provides various features to acquire, transfer, edit, display, store, and perform digital processing of medical images. EzDent Web is a patient & image management software specifically for digital dental radiography. It also provides server/client model so that the users upload and download clinical diagnostic images and patient information from any workstations in the network environment.	EzDent-i is a device that provides various features to acquire, transfer, edit, display, store, and perform digital processing of medical images. EzDent-i is a patient & image management software specifically for digital dental radiography. It also provides server/client model so that the users upload and download clinical diagnostic images and patient information from any workstations in the network environment.	Ez3D-i can view, transfer and process 3D radiographs. Furthermore, it supports Smart Click, Smart Clipping, Implant Simulation and Canal Draw.
Platform	EzDent-i supports general image formats such as JPG and BMP for 2D,3D image viewing as well as DICOM format.IBM-compatible PC or PC network	EzDent-i supports general image formats such as JPG and BMP for 2D image viewing as well as DICOM format.IBM-compatible PC or PC network	IBM-compatible PC or PC network

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Operating System	User Interface	Image Input Sources	32 bit / 64 bit	Image format	Patient Database	Compatibility	Includes Image	Measurement tools	Image viewing	Image manipulation
Microsoft Windows 10	Mouse, Keyboard	Images can be scanned, loaded from digital cameras or card readers, or imported from a radiographic imaging device	32 / 64 bit	DICOM, JPG, BMP	SQL	Linear distance, Angle, Profile	Full, side by side, gallery, thumbnail	Brightness, contrast, sharpness, inverse, film view, rotate, zooming, draw canal, memo, implant simulations	Generic implant libraries	Text, paint, ellipse, pointer, select, draw, magnify, line, rectangle, polygon, ruler, protractor, reduction, select region, copy / paste
Microsoft Windows 7, 8,10	Mouse, Keyboard	Images can be scanned, loaded from digital cameras or card readers, or imported from a radiographic imaging device	32/64 bit	DICOM, JPG, BMP	SQL	Linear distance, Angle, Profile	Full, side by side, gallery, thumbnail	Brightness, contrast, sharpness, inverse, film view, rotate, zooming, whitening, nerve canal tracing, memo	Generic implant libraries	Text, paint, ellipse, pointer, select, draw, magnify, line, rectangle, polygon, ruler, protractor, smile library, smudge, brush, redeye reduction, select region.copy/paste
Microsoft Window 7, 8, 10	Mouse, Keyboard	Images can be scanned, loaded from digital cameras or card readers, or imported from a radiographic imaging device	32/64 bit	DICOM	SQL	Length, Multi Length, Angle, ROI/Area, Volume, Profile	Full, side by side, gallery, thumbnail	Grayscale, invert, emboss, brightness, contrast, gamma, sharpen, median, despeckle, hue, saturation, equalize, flip, mirror, masking, rotate, magnify, annotation, cephalometric tracing, ceph growth projections, implant simulations	Generic implant libraries	Text, paint, ellipse, pointer, select, draw, magnify, line, rectangle, polygon, ruler, protractor, smile library, smudge, brush, redeye reduction, select region, copy / paste

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9. Technological Characteristics:

EzDent Web 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).