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.

EzDent-i 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

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.

EzDent-i 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) but the EzDent-i itself does not view, transfer or process 3D radiographs.

EzDent-i 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

The provided text describes a 510(k) premarket notification for a dental imaging software named EzDent-i. The primary purpose of this submission is to demonstrate substantial equivalence to a previously cleared predicate device, not to showcase the performance of an AI algorithm based on comparative studies. Therefore, much of the requested information regarding acceptance criteria and performance studies (especially relating to AI, human readers, and ground truth establishment) is not detailed in this document because it is not typically required for a software device demonstrating substantial equivalence by adding convenience features.

However, based on the context of the document, we can infer some details and explicitly state what is not provided.

Here's an attempt to answer your questions based on the provided text, indicating where information is not present:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics. Instead, it relies on demonstrating that the modified device's performance aligns with its intended use and is comparable to the predicate device.

The "Performance Data" section states: "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 internal testing was performed, and the device met its internal "Pass/Fail criteria," but these specific criteria and results are not provided in this summary.

Given that this is a 510(k) for a medical image management and processing system (not an AI-driven diagnostic aid that independently identifies pathologies), the "performance" here refers to its ability to correctly acquire, view, save, load, and manipulate dental images, similar to its predicate.

Acceptance Criterion (Inferred)	Reported Device Performance
Functionality & Reliability (e.g., image acquisition, viewing, saving, loading, editing, display functions)	"The device passed all of the tests based on pre-determined Pass/Fail criteria." The device "provides various features to acquire, transfer, edit, display, store, and perform digital processing of medical images." "Supports general image formats such as JPG and BMP for 2D image viewing as well as DICOM format." "Supports the acquisition of dental images by interfacing with OpenCV library."
Measurement Accuracy (e.g., linear distance, angle)	"The device passed all of the tests based on pre-determined Pass/Fail criteria." (Specific accuracy metrics not provided).
Substantial Equivalence (to predicate device)	"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." "The device has been validated through system level test."
Safety and Effectiveness (no new safety/effectiveness questions)	"The modifications are PC system requirement information change, adding logout option, and 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."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify any sample size for a test set in terms of patient images. The "performance data" section refers to "SW verification/validation and the measurement accuracy test," implying software-level testing rather than clinical study data on a patient image test set. No information is available regarding data provenance (country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable and not provided. The device (EzDent-i) is described as "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." It is a viewer and manager, not an AI diagnostic tool that produces a finding requiring expert ground truth for performance evaluation in the described context. The performance verification likely focuses on technical accuracy of image display, manipulation, and data handling, not diagnostic accuracy against a ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable and not provided. As per point 3, there's no indication of a diagnostic test set requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No such study was mentioned or required for this 510(k) submission. This device is a general image management and processing system, not an AI-assisted diagnostic tool that would typically warrant an MRMC study to show human reader improvement with AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This device is not an algorithm performing a standalone diagnostic task. It is software that provides "diagnostic tools" for viewing and interpreting images by human professionals. Therefore, a standalone algorithm performance evaluation would not be applicable or described here.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable and not provided. As this is not an AI diagnostic device, the concept of ground truth for diagnostic accuracy (e.g., concerning a disease or finding) is not relevant to the described performance evaluations. The "performance" relates to the software's ability to achieve its technical specifications.

8. The sample size for the training set

Not applicable and not provided. This document describes a traditional software upgrade and substantial equivalence claim, not a machine learning or AI device that would have a training set.

9. How the ground truth for the training set was established

Not applicable and not provided. As per point 8, there is no mention of a training set for an AI model in this submission.

Summary

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October 4, 2021

Image /page/0/Picture/1 description: The image shows 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 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.

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

Re: K211795

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 Dated: August 10, 2021 Received: August 13, 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

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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 (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) K211795

Device Name EzDent-i / E2 / Prora View / Smart M Viewer

Indications for Use (Describe)

EzDent-i 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.

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 (K211795)

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

1. Date: 8/10/2021

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 v3.1
510k Number: K202116 ●
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:

EzDent-i 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	Unmodified Device
Device name	EzDent-i v3.2	EzDent-i v3.1
510K number	K211795	K202116
Manufacturer	Ewoosoft	Ewoosoft
Indications for use	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 imagesand are 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.	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 Database	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 imaging software, Ez3D-i. EzDent-i imaging software does not view, transfer or process 3D radiographs.	Includes interface to 3D imaging software, Ez3D-i. EzDent-i imaging software does not view, transfer or process 3D radiographs.
		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

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EzDent-i v3.2 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 logout option, and 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:

EzDent-i v3.2 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).