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 & K163533 & K173863) 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 images by interfacing with X-ray capture software.

EzDent-i makes it easier to diagnose and analyze 2D dental images with simple and convenient user interface. EzDent-i's main functions are;

· Easy and convenient data search function for patient information and clinical images
· Various image viewing format for 2D dental images
· Various image processing functions including adjustment of brightness and contrast for images
· Measurement function of length and angle for 2D images
· Dental implant simulation for treatment planning and effective patient consultation
· Crown simulation for more effective patient consultation
· Print function supporting various viewing output format

AI/ML Overview

The provided text is a 510(k) summary for the EzDent-i / E2 / Prora View dental imaging software. Based on the information given, here's an analysis addressing your questions:

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

The document states:

"Verification, validation and testing activities 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."
"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 differences are that the subject device has changes in PC System Requirement Information Change, Settings upgrade (Annotation, Privacy Policy, adding Help Document, VIEWER tab upgrade (Export Image with Overlay, Saving as IO Sensor Image) and adding SERVICE tab. These differences are not significant since they are additional features for user convenience and do not raise the questions of safety or effectiveness."

Crucially, this 510(k) summary does not provide a specific table of quantitative acceptance criteria or detailed performance metrics. The core of this submission is to demonstrate substantial equivalence to a previously cleared device (EzDent-i / E2 / ProraView, K172364). The "performance data" section only states that testing was done and passed pre-determined criteria, but it does not specify what those criteria were (e.g., minimum accuracy, sensitivity, specificity for a diagnostic task). The changes appear to be primarily related to software features, user interface, and system compatibility, rather than fundamental diagnostic algorithm performance.

Therefore, a table of acceptance criteria and reported device performance specific to diagnostic accuracy (e.g., AUC, sensitivity, specificity) cannot be extracted from this document because it's not a de novo submission or a significant change that would necessitate such detailed performance validation for diagnostic claims.

2. Sample size 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 the sample size used for any test set or the provenance of the data (country of origin, retrospective/prospective). Given that the submission focuses on substantial equivalence based on feature updates rather than new diagnostic claims, it's unlikely a large-scale diagnostic performance study with specific sample sizes was conducted. The testing likely focused on functional verification and validation of the new software features.

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)

This information is not provided in the document. Since the submission is not focused on validating a new diagnostic algorithm's performance against ground truth, there's no mention of expert-established ground truth or expert qualifications used for such a test.

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

This information is not provided in the document.

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 (MRMC or otherwise demonstrating human reader improvement with AI assistance) is mentioned or implied in this 510(k) summary. The device's purpose is "to provide diagnostic tools" and is "meant to be used by trained medical professionals such as radiologist and dentist" for viewing and interpreting images. It is not described as an AI-powered diagnostic aid that assists human readers.

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

This document does not indicate that a standalone algorithm performance study was conducted. The device is described as software that provides tools for human interpretation, not an autonomous diagnostic algorithm.

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

Since the document does not detail a diagnostic performance study, the type of ground truth used is not specified.

8. The sample size for the training set

This information is not provided. The device is described as "dental imaging software," and it's unclear if it even employs machine learning/AI models that would require a "training set" in the conventional sense for diagnostic tasks. The changes described are primarily software features and compatibility updates.

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

Not applicable, as no information about a training set or its ground truth establishment is provided.

Summary of what's provided for acceptance criteria and proof of meeting them:

The 510(k) submission for EzDent-i / E2 / Prora View (K190087) focuses on demonstrating substantial equivalence to its predicate device (K172364) following software updates. The acceptance criteria described are primarily functional:

The device retains the same indications for use.
The device maintains the same functionalities as the predicate, including image acquisition, viewing, saving, loading DICOM files, image processing features (brightness, contrast, measurement), and simulation tools.
New features (PC system requirement changes, settings upgrades, viewer tab upgrades, service tab) are deemed "additional features for user convenience" and do not raise new questions of safety or effectiveness.
"Verification, validation and testing activities 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."

The proof of meeting those criteria is presented as the statement that "the device passed all of the tests based on pre-determined Pass/Fail criteria" and the FDA's ultimate determination of substantial equivalence. The document does not disclose the specific quantitative criteria or the detailed results of those tests (e.g., specific error rates, precision, or recall for any diagnostic task). This is typical for a 510(k) submission based on substantial equivalence for software updates, where the primary concern is that the changes do not adversely affect existing validated functionality and safety.

Summary

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February 27, 2019

Ewoosoft Co., Ltd. % Ms. Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 1150 Roosevelt. STE 200 IRVINE, CA 92620

Re: K190087

Trade/Device Name: EzDent-i / E2 / Prora View Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: January 9, 2019 Received: January 17, 2019

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice

(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jeff Badges

for Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K190087

Device Name EzDent-i / E2 / ProraView

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

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

1. Date: 1/09/2019

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. 1150 Roosevelt STE 200, Irvine, CA 92620 Tel: 714.202.5789 Fax: 714.409.3357 Email: juhee.c@LKconsultingGroup.com

4. Trade/Proprietary Name:

EzDent-i / E2 / Prora View

5. Common Name:

Dental Imaging Software

6. Classification:

System, image processing, radiological (21CFR 892.2050, Product code LLZ, Class 2, Radiology)

7. Device Description:

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EzDent-i makes it easier to diagnose and analyze 2D dental images with simple and convenient user interface. EzDent-i's main functions are;

· Easy and convenient data search function for patient information and clinical images
· Various image viewing format for 2D dental images
· Various image processing functions including adjustment of brightness and contrast for images
· Measurement function of length and angle for 2D images
· Dental implant simulation for treatment planning and effective patient consultation
· Crown simulation for more effective patient consultation
· Print function supporting various viewing output format

8. 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.

9. Predicate Device:

Manufacturer: Ewoosoft Co., Ltd.
Device: EzDent-i / E2 / ProraView
510(k) Number: K172364 ●

10. Substantial Equivalence:

EzDent-i v3.0 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

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

The differences are that the subject device has changes in PC System Requirement Information Change, Settings upgrade (Annotation, Privacy Policy, adding Help Document, VIEWER tab upgrade (Export Image with Overlay, Saving as IO Sensor Image) and adding SERVICE 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.

11. Technological Characteristics:

EzDent-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.

12. Performance Data:

Verification, validation and testing activities 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.

13. Conclusion:

The new device and predicate device are substantially equivalent in the areas of technical characteristics, general function, application, and intended use. The new device does not introduce a fundamentally new scientific technology, and the modifications are validated through system level test. Therefore, it is our opinion that the EzDent-i 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).

Indications for Use

Indications for Use (Describe)

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510(k) Summary

1. Date: 1/09/2019

2. Applicant / Submitter

3. U.S. Designated Agent

4. Trade/Proprietary Name:

5. Common Name:

6. Classification:

7. Device Description:

8. Indication for use:

9. Predicate Device:

10. Substantial Equivalence:

11. Technological Characteristics:

12. Performance Data:

13. Conclusion:

§ 892.2050 Medical image management and processing system.

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