The EzDent-i /E2 /ProraView/ Smart M Viewer 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.

The EzDent-i F2 /ProraView/ Smart M Viewer is intended for use as software to acquire, view, save 2D image files, and load DICOM project files from panorama, cephalometric, and intra-oral imaging equipment.

Device Description

The EzDent-i / E2 / Prora View / Smart M Viewer v.3.3 is a device that provides various features to acquire, transfer, edit, display, store, and perform digital processing of medical images. The subject device 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.

It also supports general image formats such as JPG and BMP for 2D image viewing as well as DICOM format. For 3D image management, it provides uploading and downloading support for dental CT Images in DICOM format. It interfaces with a 3D imaging software made by our company, the Ez3D-i (K131616, K150761, K161246, K163539, K173863, K190791, K200178, K211791) but does not view, transfer or process 3D radiographs.

The subject device supports the acquisition of dental images by interfacing with OpenCV library to import the intra-oral camera images. It also supports the acquisition of CT/Panoramic/Cephalo/Intra-Oral Sensor /Intra-Oral Scanner images by interfacing with Xray capture software.

AI/ML Overview

This document describes a 510(k) premarket notification for the EzDent-i / E2 / ProraView/ Smart M Viewer, a dental imaging software. The submission aims to demonstrate substantial equivalence to a previously cleared version of the same software (EzDent-i / E2 / Prora View / Smart M Viewer v.3.2, K211795).

Based on the provided information, the following can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or detailed device performance metrics in a pass/fail format. Instead, it relies on a statement that "The device passed all of the tests based on pre-determined Pass/Fail criteria." The study's focus was on demonstrating that modifications made to the software "do not raise the questions of safety or effectiveness" and that the newer version is substantially equivalent to the predicate device.

The reported device performance, in terms of meeting criteria, is implicitly described as:

Acceptance Criteria Category	Reported Device Performance
Software Functionality	The device passed all SW verification/validation tests.
Measurement Accuracy	The device passed all measurement accuracy tests.
Safety & Effectiveness	Modifications (PC system requirements, video tutorial, setting/viewer/report tab upgrades) do not raise questions of safety or effectiveness.
Substantial Equivalence	Demonstrated substantial equivalence to the predicate device in technical characteristics, general function, application, and indications for use.

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

The document states that "SW verification/validation and the measurement accuracy test were conducted." However, it does not provide any details regarding:

The specific sample size (e.g., number of images, number of cases) used for the test set.
The data provenance (e.g., country of origin, retrospective or prospective nature of the data).

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

This information is not provided in the document. The document mentions that the software's diagnostic tools are "meant to be used by trained medical professionals such as radiologist and dentist" and that "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." However, it does not specify how ground truth was established for the performance testing.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) used for establishing ground truth for the test set.

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

An MRMC comparative effectiveness study was not performed or reported in this submission. The study focuses on demonstrating substantial equivalence of the modified software version to its predicate through software verification/validation and measurement accuracy testing, rather than evaluating human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study focused on the algorithm's performance without human-in-the-loop interaction was performed implicitly through the "SW verification/validation and the measurement accuracy test." These tests are typically designed to assess the software's intrinsic functionalities and accuracy parameters independently. The submission indicates that these tests were conducted and passed. However, specific metrics (e.g., sensitivity, specificity, AUC) for diagnostic capabilities are not provided, as the device is characterized as a "medical image management and processing system" with "diagnostic tools," meaning it is an adjunctive tool for image interpretation by clinicians.

7. Type of Ground Truth Used

The type of ground truth used for the "SW verification/validation and the measurement accuracy test" is not explicitly stated. Given the nature of a "medical image management and processing system" and its function of enabling trained professionals to "view and interpret" images and provide "diagnostic tools," the ground truth for measurement accuracy tests would likely involve precisely measured objects or features within reference images. For software functionality, it would involve confirming that features operate as intended based on predefined specifications. Pathology or outcomes data are not mentioned as being used for ground truth.

8. Sample Size for the Training Set

The document does not provide any information about a training set or its sample size. This submission describes an updated version of existing software, and the evaluation focuses on comparing it to a predicate device rather than on the development and training of a new AI algorithm.

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

As no training set is mentioned, information on how its ground truth was established is not applicable/not provided in this document.

Summary

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August 12, 2022

Image /page/0/Picture/1 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 a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

Re: K222145

Trade/Device Name: EzDent-i / E2 / ProraView/ Smart M Viewer Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: July 11, 2022 Received: July 20, 2022

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

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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 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 (OS) 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,

Laurel Burk, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of 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) K222145

Device Name EzDent-i /E2 /ProraView/ Smart M Viewer

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 (K222145)

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

1. Date: 8/5/2022

2. Applicant / Submitter

Ewoosoft Co., Ltd. 801-ho, Vatechnetworks Bldg., 13, Samsung 1-ro 2-gil, Hwaseong-si. Gyeonggido . Republic of Korea Fax: +82 31 8015 6196 Tel: +82 31 8015 6172 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. Subject Device:

Trade/Device Name: EzDent-i / E2 / Prora View / Smart M Viewer
. 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: EzDent-i / E2 / Prora View / Smart M Viewer v.3.2
510k Number: K211795 ●
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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6. Device Description:

7. Indication for use:

The EzDent-i /E2 /ProraView/ Smart M Viewer is intended for use as software to acquire. view, save 2D image files, and load DICOM project files from panorama, cephalometric, and intra-oral imaging equipment.

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8. Substantial Equivalence:

	Modified Device	Predicate Device
Device name	EzDent-i v3.3	EzDent-i v3.2
510K number	K222145	K211795
Manufacturer	Ewoosoft	Ewoosoft
Indications for use	The EzDent-i /E2 /ProraView/ SmartM Viewer is dental imaging softwarethat is intended to provide diagnostictools for maxillofacial radiographicimaging. These tools are available toview and interpret a series of DICOMcompliant dental radiology imagesand are meant to be used by trainedmedical professionals such asradiologist and dentist.The EzDent-i /E2 /ProraView/ SmartM Viewer is intended for use assoftware to acquire, view, save 2Dimage files, and load DICOM projectfiles from panorama, cephalometric,and intra-oral imaging equipment.	EzDent-i is dental imaging softwarethat is intended to provide diagnostictools for maxillofacial radiographicimaging. These tools are available toview and interpret a series of DICOMcompliant dental radiology images andare meant to be used by trainedmedical professionals such asradiologist and dentist.EzDent-i is intended for use assoftware to acquire, view and save 2Dimage files, load DICOM project filesfrom panorama, cephalometric, andintra-oral imaging equipment.
Technology/Principleof Operation	EzDent-i is a device that providesvarious features to acquire, transfer,edit, display, store, and performdigital processing of medical images.EzDent-i is a patient & imagemanagement software specifically fordigital dental radiography. It alsoprovides server/client model so thatthe users upload and downloadclinical diagnostic images and patientinformation from any workstations inthe network environment.EzDent-i supports general imageformats such as JPG and BMP for 2Dimage viewing as well as DICOMformat.EzDent-i supports the acquisition ofdental images by interfacing withOpenCV library to import the intra-oral camera images. It also supportsthe acquisition ofCT/Panoramic/Cephalo/Intra-OralSensor images by interfacing with X-ray capture software.	EzDent-i is a device that providesvarious features to acquire, transfer,edit, display, store, and perform digitalprocessing of medical images. EzDent-i is a patient & image managementsoftware specifically for digital dentalradiography. It also providesserver/client model so that the usersupload and download clinicaldiagnostic images and patientinformation from any workstations inthe network environment.EzDent-i supports general imageformats such as JPG and BMP for 2Dimage viewing as well as DICOMformat.EzDent-i supports the acquisition ofdental images by interfacing withOpenCV library to import the intra-oral camera images. It also supportsthe acquisition ofCT/Panoramic/Cephalo/Intra-OralSensor images by interfacing with X-ray capture software.
Platform	IBM-compatible PC or PC network	IBM-compatible PC or PC network
Operating System	Microsoft Windows XP, Vista, 7, 8,10	Microsoft Windows XP, Vista, 7, 8,10
User Interface	Mouse, Keyboard	Mouse, Keyboard
Image Input Sources	Images can be scanned, loaded fromdigital cameras or card readers, orimported from a radiographic imagingdevice	Images can be scanned, loaded fromdigital cameras or card readers, orimported from a radiographic imagingdevice
32 bit / 64 bit	32 / 64 bit	32 / 64 bit
Image format	DICOM	DICOM
Patient DatabaseCompatibility	SQL	SQL
Includes ImageMeasurement tools	Linear distance, angle	Linear distance, angle
Image viewing	Full, side by side, gallery, thumbnail	Full, side by side, gallery, thumbnail
Image manipulation	Brightness, contrast, sharpness,inverse, film view, rotate, zooming,whitening, nerve canal tracing, memo	Brightness, contrast, sharpness,inverse, film view, rotate, zooming,whitening, nerve canal tracing, memo
Implant module	Generic implant libraries	Generic implant libraries
3D imagingcapability	Includes interface to 3D imagingsoftware, Ez3D-i. EzDent-i imagingsoftware does not view, transfer orprocess 3D radiographs.	Includes interface to 3D imagingsoftware, Ez3D-i. EzDent-i imagingsoftware does not view, transfer orprocess 3D radiographs.
Image annotation	Text, paint, ellipse, pointer, select,draw, magnify, line, rectangle,polygon, ruler, protractor, smilelibrary, smudge, brush, redeyereduction, select region, copy / paste	Text, paint, ellipse, pointer, select,draw, magnify, line, rectangle,polygon, ruler, protractor, smilelibrary, smudge, brush, redeyereduction, select region, copy / paste

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The EzDent-i / E2 / Prora View / Smart M Viewer v.3.3 described in this 510(k) has the same intended use and the same technical characteristics as the unmodified device.

The subject device and the unmodified device are substantially equivalent, having the same indications for use and functionalities like operation software, computer platform, picture archiving and communication format, image format, image processing features, windowing, image edit, measurements and manipulation.

The modifications are PC system requirement information change, adding Video Tutorial, upgrades to Setting tab, Viewer tab, and Report tab. These differences are not significant since they are additional features for user convenience and do not raise the 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 device.

9. Technological Characteristics:

The EzDent-i / E2 / Prora View / Smart M Viewer v.3.3 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.

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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).