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 and simulation 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) simulations. The analyzed results are saved in chart format so that the user 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 features for making schedules and managing patient appointments. In addition. EzOrtho enables the users to import images from EzDent-i made by our company, 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 features support easier tracing.
Establishing Treatment Plans ● The Morphing feature enables the user to predict how the treatment plan established may affect the face of a patient. In addition, the Compare feature enables the user 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 after surgery changes visually, and the Gallery feature plays a slide show with multiple images of patients.

AI/ML Overview

The provided text is a 510(k) summary for the medical device EzOrtho. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any performance data from a specific study that demonstrates the device meets particular acceptance criteria. The "Performance Data" section only states that "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." This is a general statement and does not provide the specific details required to answer your questions about acceptance criteria and a study proving their fulfillment.

Therefore, I cannot populate the table or provide the detailed information requested regarding sample size, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the provided document.

To answer your questions, I would need a section detailing a specific clinical or performance study, including:

Specific performance metrics and their acceptance thresholds.
The actual results of the device against those metrics.
Details about the dataset used (size, type, origin).
Information about the ground truth establishment process (number/qualifications of experts, adjudication).

Without this specific performance study data, I can only provide general information based on the document's structure, which states that performance, functionality, and reliability characteristics were verified and validated, and all tests passed their pre-determined criteria.

Summary

{0}------------------------------------------------

October 22, 2020

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 includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below.

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

Re: K202948

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: September 22, 2020 Received: September 30, 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

{1}------------------------------------------------

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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known)

K202948

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary

(K202948)

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

1. Date: 10/12/2020

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 Fax: 714.409.3357 Tel: 714.202.5789 Email: juhee.c@LKconsultingGroup.com

4. Trade/Proprietary Name:

EzOrtho

5. Common Name:

Dental Imaging Software

6. Classification:

Device: System, image processing, radiological
Regulation Name: Picture Archiving and Communication Systems
Review Panel: Radiology
Device Class: Class 2
Product Code: LLZ,
Regulation Number: 21CFR 892.2050 ●

{4}------------------------------------------------

7. Device Description:

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

Managing Patients and Registering Images ● EzOrtho offers features for making schedules and managing patient appointments. In addition. EzOrtho enables the users to import images from EzDent-i made by our company, 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 features support easier tracing.
Establishing Treatment Plans ● The Morphing feature enables the user to predict how the treatment plan established may affect the face of a patient. In addition, the Compare feature enables the user 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 after surgery changes visually, and the Gallery feature plays a slide show with multiple images of patients.

8. Indication for use:

9. Predicate Device:

EzOrtho (K192888) by Ewoosoft Co., Ltd.

Device: System, image processing, radiological
Regulation Name: Picture Archiving and Communication Systems ●

{5}------------------------------------------------

Review Panel: Radiology
Device Class: Class 2 ●
Product Code: LLZ,
Regulation Number: 21CFR 892.2050 ●

10. Substantial Equivalence:

EzOrtho v1.1 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 adding Help Document, upgrading the Patient Tab(quick search(recently added), exporting patient information, export to 3rd party SW, hide the displayed patient information), upgrading the Viewer Tab(adding reference line, adding image information), upgrading the Analysis Tab(Print Chart) and upgrading the Consult Tab(removing from favorites). 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:

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 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 EzOrtho 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).