EzOrtho is a software indicated for use by dentists who provide orthodontic treatment for image analysis, simulation, profilogram, VTO/STO and patient consultation. Results produced by the software's diagnostic, treatment planning and simulation tools are dependent on the interpretation of trained and licensed practitioners or dentists.

Device Description

EzOrtho is a 2D orthodontic analysis program developed by Ewoosoft. EzOrtho manages patient information and images for orthodontic analysis. This software also assists in orthodontic treatment by providing accurate image analysis, profilograms, superimpositions, and VTO (visualised treatment objective) and STO (surgical treatment objective). The analyzed results are saved in chart format so that you can easily store and track the treatment and records of each patient.

EzOrtho is designed to provide a simple and straightforward user interface.

Managing Patients and Registering Images EzOrtho offers powerful features related to making schedules and managing patient appointments. In addition, EzOrtho enables you to import images from EzDenti(K190087, K172364, K163533, K161117, K150747), Explorer, or a scanner and easily calibrate the size of the image or arrange multiple film/photo images.
. Analyzing and Tracing Images The Landmark Voice Guide and the improved Landmark Input Interface support more accurate and easier tracing.
. Establishing Treatment Plans The Morphing feature enables you to predict how the treatment plan established may affect the face of a patient. In addition, the Compare feature enables you to establish a treatment plan by comparing photos before and after the treatment.
. Assisting with Patient Consultation EzOrtho provides features to facilitate understanding and communication between doctors and patients during consultation. For example, the Superimposition feature displays the changes visually due to the treatment and the Gallery feature plays a slide show with multiple images of patients.

AI/ML Overview

The EzOrtho device's acceptance criteria and the study proving it meets them are described below:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document focuses on establishing substantial equivalence to a predicate device (OrthoVision v2.1) rather than defining granular acceptance criteria for specific performance metrics of the new features. However, for the newly added "automatic cephalometric tracing feature," a validation test was performed to evaluate its accuracy.

Acceptance Criteria (Implied for Automatic Cephalometric Tracing):

Feature	Acceptance Criteria (Implied)	Reported Device Performance
Automatic Cephalometric Tracing	The automatic cephalometric tracing feature should demonstrate acceptable accuracy.	The validation test concluded that the auto feature demonstrates accuracy. (Specific performance metrics like mean absolute error or agreement rates are not provided in this summary.)
Overall Software Performance	The device passed all tests based on pre-determined Pass/Fail criteria for software verification/validation and measurement accuracy.	The device passed all of the tests.

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

Test Set Sample Size: The document does not specify the exact sample size (number of images or cases) used for the "validation test to evaluate the accuracy of this auto feature."
Data Provenance: Not specified in the document.

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

Not specified in the document.

4. Adjudication Method for the Test Set

Not specified in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not explicitly mentioned or described for the EzOrtho device. The focus of the performance data section is on the device's own accuracy and software validation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance evaluation of the "automatic cephalometric tracing feature" was done. The document states: "We performed the validation test to evaluate the accuracy of this auto feature." This implies an assessment of the algorithm's performance on its own. It also states that "The users can still adjust the points manually when necessary," indicating that while standalone performance was evaluated, the device is ultimately intended for human-in-the-loop use.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the "automatic cephalometric tracing feature," the type of ground truth used is not explicitly stated. However, given the context of cephalometric analysis, it is highly probable that the ground truth would have been established by:

Expert Tracings/Measurements: Manual tracings and measurements performed by one or more qualified orthodontic experts.

8. The Sample Size for the Training Set

Not specified in the document. The document details a 510(k) submission for a software device, and while it mentions an "auto feature," it does not provide details about model training or the size of any training sets.

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

Not specified in the document. As no information on a training set is provided, the method for establishing its ground truth is also not mentioned.

Summary

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March 13, 2020

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 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.

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

Re: K192888

Trade/Device Name: EzOrtho Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: February 5, 2020 Received: February 11, 2020

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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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) K192888

Device Name EzOrtho

Indications for Use (Describe)

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) Summarv

(K192888)

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

1. Date: 2/5/2020

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:

EzOrtho

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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and records of each patient.

EzOrtho is designed to provide a simple and straightforward user interface.

Managing Patients and Registering Images EzOrtho offers powerful features related to making schedules and managing patient appointments. In addition, EzOrtho enables you to import images from EzDenti(K190087, K172364, K163533, K161117, K150747), Explorer, or a scanner and easily calibrate the size of the image or arrange multiple film/photo images.
. Analyzing and Tracing Images The Landmark Voice Guide and the improved Landmark Input Interface support more accurate and easier tracing.
. Establishing Treatment Plans The Morphing feature enables you to predict how the treatment plan established may affect the face of a patient. In addition, the Compare feature enables you to establish a treatment plan by comparing photos before and after the treatment.
. Assisting with Patient Consultation EzOrtho provides features to facilitate understanding and communication between doctors and patients during consultation. For example, the Superimposition feature displays the changes visually due to the treatment and the Gallery feature plays a slide show with multiple images of patients.

8. Indication for use:

9. Predicate Device:

Manufacturer: Ewoosoft Co., Ltd. ●
Device: OrthoVision ●
510(k) Number: K173094

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10. Substantial Equivalence:

Device name	EzOrtho v1.0	OrthoVision v2.1
510K number	K192888	K173094
Manufacturer	Ewoosoft	Ewoosoft
Indications for use	EzOrtho is a software indicated for use bydentists who provide orthodontictreatment for image analysis, simulation,profilogram, VTO/STO and patientconsultation. Results produced by thesoftware's diagnostic, treatment planningand simulation tools are dependent on thepractitioners or dentists.	OtrhoVision software is indicated for use byorthodontists for image analysis, simulation,profilogram, growth forecast, VTO/STO andpatient consultation. Results produced by thesoftware's diagnostic, treatment planningand simulation tools are dependent on theinterpretation of trained and licensedpractitioners or dentists.
Platform	IBM-compatible PC or PC network	IBM-compatible PC or PC network
Operating System	Microsoft Window 7, 8, 10	Microsoft Window 7, Window 8
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 from digitalcameras or card readers, or imported from aradiographic imaging device
32 bit / 62 bit	32 bit / 62 bit	32 bit / 62 bit
Image format	DICOM, BMP, JPG, PNG, TIF	DICOM, BMP, JPG, PNG, TIF
Patient Database	SQL	SQL
Compatibility
Includes ImageMeasurement tools	Linear distance, angle	Linear distance, angle
Image viewing	Full, side by side, thumbnail	Full, side by side, gallery, thumbnail
Image manipulation	Grayscale, invert, emboss, brightness,contrast, gamma, sharpen, median,despeckle, hue, saturation, equalize flip,mirror, masking, rotate, annotation,cephalometric tracing, implantsimulations	Grayscale, invert, emboss, brightness,contrast, gamma, sharpen, median,despeckle, hue, saturation, equalize flip,mirror, masking, rotate, annotation,cephalometric tracing, ceph growthprojections, implant simulations
Cephalometrictracing	In addition to the user-configuredanalysis, standard orthodontic tracinganalysis include:DownsJarabekMcNamaraRickettsJefferson	In addition to the user-configured analysis,standard orthodontic tracing analysisinclude:DownsJarabekMcNamaraRickettsJefferson
Implant module	Generic	Generic
3D imagingcapability	None.	None.
Image annotation	Text, paint, ellipse, pointer, select, draw,magnify, line, rectangle, ruler, protractor,brush, select region, copy / paste	Text, paint, ellipse, pointer, select, draw,magnify, line, rectangle, polygon, ruler,protractor, smile library, smudge, brush,

The EzOrtho v1.0 described in this 510(k) has the same indications for use and the same technical characteristics as the OrthoVision v2.1(K173094).

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The EzOrtho v1.0 are substantially equivalent to the predicate device, 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 difference between the subject device and the predicate device is the UVUX design, and also some of the additional functions have been removed from the subject device such as gallery, ceph growth projections, and some of the annotation features. It has been found that these functions and features are not really used by users so we decided to remove them to improve usability for ease of use. We believe this difference does not raise a question in substantial equivalence, because these features are merely additional and does not affect the device to achieve the intended use. The other difference is that an automatic cephalometric tracing feature is added to the subject device. With this function, the SW automatically input the cephalometric landmarks for user convenience. The users can still adjust the points manually when necessary. We performed the validation test to evaluate the accuracy of this auto feature.

Based on the results of software validation and performance tests, we conclude that the subject device is substantially equivalent to the predicate device.

11. Technological Characteristics:

EzOrtho 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 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:

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.

13. 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).