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 v3.4 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, K211791, K222069) but the EzDent-i itself does not view, transfer or process 3D radiographs. None of the changes to the predicate software are related to the 3D functions.

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.

The software level of concern is Moderate.

AI/ML Overview

The provided document is a 510(k) summary for the EzDent-i / E2 / Prora View / Smart M Viewer software. It describes the device, its intended use, and argues for its substantial equivalence to a predicate device.

However, the document does not contain the detailed information necessary to answer all parts of your request, specifically regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.

This 510(k) submission primarily focuses on demonstrating that the updated software version (v3.4) is substantially equivalent to a previous cleared version (v3.3) by highlighting that the changes are for "user convenience and do not affect the device safety or effectiveness". It therefore does not provide a comprehensive study report with quantified performance metrics against specific acceptance criteria for diagnostic accuracy, which would typically be found in direct performance studies for devices with diagnostic claims.

Here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not Specified	Not Specified
(The document states "The device passed all of the tests based on pre-determined Pass/Fail criteria." but does not elaborate on what these criteria or the test results were in terms of specific performance metrics.)

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not specified.
Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not specified.
Qualifications of Experts: Not specified.
- The Indications for Use state the device is "meant to be used by trained medical professionals such as radiologist and dentist." This implies the target users, but not the experts for ground truth.

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

Adjudication Method: Not specified.

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

MRMC Study: No, an MRMC comparative effectiveness study is not mentioned. The device is described as "dental imaging software that is intended to provide diagnostic tools" and its results are "dependent on the interpretation of trained and licensed radiologists, clinicians and referring physicians as an adjunctive to standard radiology practices for diagnosis." This suggests it is a viewing and processing tool, not a diagnostic AI that would typically undergo an MRMC study to show improvement in human reader performance.

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

Standalone Performance Study: No, a standalone performance study is not described. Given the device's function as an image management and processing system used "as an adjunctive to standard radiology practices for diagnosis," it is not presented as an AI algorithm providing standalone diagnoses.

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

Type of Ground Truth: Not specified, as specific performance tests against diagnostic ground truth are not detailed. The performance data section broadly mentions "SW verification/validation and the measurement accuracy test were conducted," implying functional and technical testing rather than a clinical performance study with established ground truth for diagnostic accuracy.

8. The sample size for the training set

Sample Size for Training Set: Not applicable/Not specified. The document describes software with various image processing and management features, rather than a machine learning or AI algorithm that would require a distinct "training set."

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

Ground Truth for Training Set: Not applicable/Not specified, as no training set for a machine learning model is mentioned.

Summary of what the document implies about performance testing:

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 Ewoosoft performed internal validation testing to ensure the software met its specified functional and technical requirements (e.g., correct image display, accurate measurements for linear distance and angle, proper functioning of new features like "Image Share" and "IO sensor image Preview"). However, these are not detailed clinical performance metrics for diagnostic efficacy or accuracy that would typically be associated with AI-driven diagnostic devices. Since the device is presented as substantially equivalent to a predicate device for managing and processing images, the focus of the 510(k) is on the safety and effectiveness of the software updates rather than demonstrating novel diagnostic performance.

Summary

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February 17, 2023

Image /page/0/Picture/1 description: The image contains 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 the FDA logo, which 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: K223820

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: November 15, 2022 Received: December 21, 2022

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,

Lu Jiang

Lu Jiang, 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)

K223820

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 (K223820)

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

1. Date: 1/10/2023

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. Subject Device:

Trade/Device Name: EzDent-i / E2 / Prora View / Smart M Viewer
Version #: v3.4 ●
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
Version #: v.3.3
510k Number: K222145 ●
Regulation Number: 21 CFR 892.2050 ●
Regulation Name: Medical Image Management and Processing System ●

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Regulatory Class: Class II
Product Code: LLZ ●

6. Device Description:

The software level of concern is Moderate.

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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	Modified Device	Unmodified Device
Device name	EzDent-i v3.4	EzDent-i v3.3
510K number	K223820	K222145
Manufacturer	Ewoosoft	Ewoosoft
Indications for use	EzDent-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.EzDent-i is intended for use as software toacquire, view and save 2D image files, loadDICOM project files from panorama,cephalometric, and intra-oral imagingequipment.	EzDent-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.EzDent-i is intended for use as software toacquire, view and save 2D image files,load DICOM project files from panorama,cephalometric, and intra-oral imagingequipment.
Technology/Principleof Operation	EzDent-i is a device that provides variousfeatures to acquire, transfer, edit, display,store, and perform digital processing ofmedical images. EzDent-i is a patient &image management software specificallyfor digital dental radiography. It alsoprovides server/client model so that theusers upload and download clinicaldiagnostic images and patient informationfrom any workstations in the networkenvironment.EzDent-i supports general image formatssuch as JPG and BMP for 2D imageviewing as well as DICOM format.EzDent-i supports the acquisition of dentalimages by interfacing with OpenCV libraryto import the intra-oral camera images. Italso supports the acquisition ofCT/Panoramic/Cephalo/Intra-Oral Sensorimages by interfacing with X-ray capturesoftware.	EzDent-i is a device that provides variousfeatures to acquire, transfer, edit, display,store, and perform digital processing ofmedical images. EzDent-i is a patient &image management software specificallyfor digital dental radiography. It alsoprovides server/client model so that theusers upload and download clinicaldiagnostic images and patient informationfrom any workstations in the networkenvironment.EzDent-i supports general image formatssuch as JPG and BMP for 2D imageviewing as well as DICOM format.EzDent-i supports the acquisition of dentalimages by interfacing with OpenCVlibrary to import the intra-oral cameraimages. It also supports the acquisition ofCT/Panoramic/Cephalo/Intra-Oral Sensorimages by interfacing with X-ray capturesoftware.
Platform	IBM-compatible PC or PC network	IBM-compatible PC or PC network
Operating System	Windows 10, 11	Windows 10, 11
User Interface	Mouse, Keyboard	Mouse, Keyboard
Image Input Sources	Images can be scanned, loaded from digitalcameras or card readers, or imported froma radiographic imaging device	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	Brightness, contrast, sharpness, inverse,film view, rotate, zooming, whitening
	nerve canal tracing, memo	nerve canal tracing, memo
Implant module	Generic implant libraries	Generic implant libraries
3D imaging	Includes interface to 3D imaging software,	Includes interface to 3D imaging software,
capability	Ez3D-i. EzDent-i imaging software does	Ez3D-i. EzDent-i imaging software does
	not view, transfer or process 3D	not view, transfer or process 3D
	radiographs.	radiographs.
Image annotation	Text, paint, ellipse, pointer, select, draw,	Text, paint, ellipse, pointer, select, draw,
	magnify, line, rectangle, polygon, ruler,	magnify, line, rectangle, polygon, ruler,
	protractor, smile library, smudge, brush,	protractor, smile library, smudge, brush,
	redeye reduction, select region, copy /	redeye reduction, select region, copy /
	paste	paste

8. Substantial Equivalence:

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EzDent-i v3.4 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 adding [Image Share] and [IO sensor image Preview] functions, upgrading the setting tab and the header & footer setting, also supporting image acquisition from PSP scanner. A brief description of the changes from the predicate are as below.

Setting tab upgrade .
- Dose unit setting can be set separately for extraoral and intraoral x-ray system. -
- Premium skin theme has been added. -
- [Server Control Panel] button has been added. -
- Crown color feature has been added. -
- DICOM tag add/edit/delete feature has been added. -
Acquisition tab upgrade ● Acquisition tab supports PSP scanner images.
Patient tab upgrade [Image Share] function has been added to patient tab.
. Report tab upgrade Additional Header/footer setting features
Viewer tab upgrade ● IO Sensor filtering preview function on the Viewer tab has been revised.

These differences are not significant since they are additional features for user convenience and do not affect the device 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.

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9. Technological Characteristics:

EzDent-i v3.4 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).