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.

AI/ML Overview

The provided text is a 510(k) summary for the EzOrtho device. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a study proving the device meets them.

Specifically, the document 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." (Page 6)

This confirms that tests were done and acceptance criteria existed, but the document does not provide the specific "predetermined Pass/Fail criteria" (acceptance criteria) nor the detailed "measurement accuracy test" results (reported device performance). It also does not elaborate on the specific study details such as sample size, data provenance, expert involvement, or ground truth establishment.

Based on the available information, here's what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance:

This information is not explicitly detailed in the provided 510(k) summary. The document states that a "measurement accuracy test" was conducted and "The device passed all of the tests based on pre-determined Pass/Fail criteria." However, the specific criteria (e.g., tolerance for linear distance measurements, angular measurements) and the numerical results are not included.

Acceptance Criteria (Example - Not provided in doc)	Reported Device Performance (Example - Not provided in doc)
Linear Measurement Accuracy: within X % of ground truth	Achieved: Y %
Angular Measurement Accuracy: within Z degrees	Achieved: A degrees
... (other functional tests)	Passed all defined functional tests

2. Sample sized used for the test set and the data provenance:

This information is not provided in the document.

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

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

This information is not provided in the document for the "measurement accuracy test." The document mentions that the software's results are "dependent on the interpretation of trained and licensed practitioners or dentists" (page 4, Indications for Use), but this refers to the clinical use of the device, not the ground truth establishment for the validation study itself.

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:

A MRMC comparative effectiveness study is not mentioned in the document. The EzOrtho device is described as a "Medical Image Management and Processing System" that assists in orthodontic treatment by providing analysis and simulation tools, and its results are "dependent on the interpretation of trained and licensed practitioners or dentists." It does not describe an AI assistance feature for human readers within a diagnostic workflow in the context of improving reader performance, but rather a tool for analysis and simulation.

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

The document describes "SW verification/validation and the measurement accuracy test" as being conducted. While these tests evaluate the algorithm's performance, the context does not explicitly state if this was a "standalone" performance evaluation in the sense of a diagnostic performance claim without human interpretation. Given the device's description and indications for use ("Results produced by the software's diagnostic, treatment planning and simulation tools are dependent on the interpretation of trained and licensed practitioners or dentists."), it suggests the device is an assistive tool, not a standalone diagnostic device. The "measurement accuracy test" would evaluate the accuracy of the measurements generated by the software itself, which is a form of standalone evaluation of that specific function.

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

This information is not explicitly detailed in the document for the "measurement accuracy test." For a "measurement accuracy test" in imaging, ground truth is typically established by highly accurate manual measurements (e.g., by experts) or by phantoms with known dimensions. The document does not specify how the ground truth was established for the measurements.

8. The sample size for the training set:

The document makes no mention of a "training set," implying that the device's functionality (measurement and simulation) is likely based on defined algorithms and parameters rather than a machine learning model that requires a training set. If there were a machine learning component, information about training data would typically be included.

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

Since no training set is mentioned (see point 8), this information is not applicable/provided.

In summary: The provided 510(k) letter confirms that the EzOrtho device underwent "measurement accuracy tests" and passed "pre-determined Pass/Fail criteria" for its performance, functionality, and reliability. However, this regulatory summary does not contain the detailed clinical study report or technical specifications that would provide the specific quantitative acceptance criteria, the actual numerical performance results, sample sizes for testing or training, details on ground truth establishment, or any information about comparative effectiveness studies with human readers. This level of detail is typically found in the full submission, not necessarily in the publicly available 510(k) summary letter.

Summary

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August 23, 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 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 % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 18881 Von Karman Ave. STE 160 IRVINE CA 92612

Re: K211793

Trade/Device Name: EzOrtho Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management and Processing System Regulatory Class: Class II Product Code: LLZ Dated: June 2, 2021 Received: June 10, 2021

Dear Priscilla 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

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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 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 (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 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) K211793

Device Name EzOrtho

Indications for Use (Describe)

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

(K211793)

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

1. Date: 8/9/2021

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. Device Information:

Trade/Device Name: EzOrtho
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: EzOrtho
510(k) number: K202948
Regulation number 21 CFR 892.2050 ●
. Regulation name: Picture Archiving and Communications System
Regulatory Class: Class II ●
. Classification Product Code: LLZ

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6. Device Description:

7. Indication for use:

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8. Substantial Equivalence:

	Modified Device	Unmodified Device
Device name	EzOrtho v1.2	EzOrtho v1.1
510K number	K211793	K202948
Manufacturer	Ewoosoft	Ewoosoft
Indications foruse	EzOrtho is a software indicated for use bydentists who provide orthodontic treatmentfor image analysis, simulation, profilogram,VTO/STO and patient consultation. Resultsproduced by the software's diagnostic,treatment planning and simulation tools aredependent on the interpretation of trainedand licensed practitioners or dentists.	EzOrtho is a software indicated for use bydentists who provide orthodontic treatmentfor image analysis, simulation, profilogram,VTO/STO and patient consultation. Resultsproduced by the software's diagnostic,treatment planning and simulation tools aredependent on the interpretation of trainedand licensed practitioners or dentists.
Platform	IBM-compatible PC or PC network	IBM-compatible PC or PC network
Operating System	Microsoft Window 10	Microsoft Window 7, 8, 10
User Interface	Mouse, Keyboard	Mouse, Keyboard
Image InputSources	Images can be scanned, loaded from digitalcameras or card readers, or imported from aradiographic imaging device	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 DatabaseCompatibility	SQL	SQL
Includes ImageMeasurementtools	Linear distance, angle	Linear distance, angle
Image viewing	Full, side by side, thumbnail	Full, side by side, thumbnail
Imagemanipulation	Grayscale, invert, emboss, brightness,contrast, gamma, sharpen, median,despeckle, hue, saturation, equalize flip,mirror, masking, rotate, annotation,cephalometric tracing, implant simulations	Grayscale, invert, emboss, brightness,contrast, gamma, sharpen, median,despeckle, hue, saturation, equalize flip,mirror, masking, rotate, annotation,cephalometric tracing, implant simulations
Cephalometrictracing	In addition to the user-configured analysis,standard orthodontic tracing analysisinclude: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, ruler, protractor,brush, select region, copy / paste

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EzOrtho v1.2 described in this 510(k) has the same intended use and the same technical chara cteristics 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 changes in PC System Requirement Information Change, Settings upgrade (EzServer Web Console), adding logout. 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:

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.

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.

The subject device user the following FDA guidance documents used in the development of the device.

. Guidance for the Content of Premarket Submissions for Software Contained in Medical (https://www.fda.gov/regulatory-information/search-fda-guidancedocuments/guidance-content-premarket-submissions-software-contained-medicaldevices)
. Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (https://www.fda.gov/regulatory-information/search-fda-guidancedocuments/content-premarket-submissions-management-cybersecurity-medicaldevices)

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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).