Ez3D-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.

Ez3D-i is intended for use as software to load, view and save DICOM images from CT, panorama, cephalometric and intraoral imaging equipment and to provide 3D visualization, 2D analysis, in various MPR (Multi-Planar Reconstruction) functions.

Device Description

Ez3D-i v5.5 is 3D viewing software for dental CT images in DICOM format with a host of useful functions including MPR, 2-dimensional analysis and 3-dimensional image reformation. It provides advanced simulation functions such as Implant Simulation, Drawing Canal, and Implant Environ Bone Density, etc. for the benefit of effective doctor and patient communication and precise treatment planning.

AI/ML Overview

Here's an analysis based on the provided FDA 510(k) summary for the Ez3D-i /E3 device, specifically version 5.5:

This document is a 510(k) summary for the Ez3D-i /E3 (v5.5) device, asserting its substantial equivalence to a previously cleared device (Ez3D-i /E3 v5.4, K222069). It does not present a standalone clinical study to prove the device meets specific acceptance criteria based on diagnostic accuracy or clinical outcomes. Instead, it relies on demonstrating that the new version is substantially equivalent to a previously cleared version and that software verification and validation tests were performed.

Here's a breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not contain a table of specific quantitative acceptance criteria related to diagnostic performance or clinical effectiveness, nor does it report such performance metrics. The approval is based on substantial equivalence and software verification/validation.

Instead, the summary implies the "acceptance criteria" are related to successful software verification and validation, ensuring the new features function as intended and the overall device maintains the same functionality and safety profile as its predicate.

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Software functionality as per specifications	Passed all tests based on pre-determined Pass/Fail criteria.
Consistency with predicate device's intended use and technical characteristics	Demonstrated substantial equivalence in intended use, functionalities (operation software, computer platform, etc.), and image processing features. Differences (e.g., UI adjustments, specific tool functions) did not raise new safety concerns.
Safety and Effectiveness maintained	Modifications were not significant and did not raise any new or potential safety risks or questions of safety/effectiveness.

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

Test Set Sample Size: Not explicitly stated for any clinical performance or diagnostic accuracy test. The document refers to "SW verification/validation and the measurement accuracy test," implying internal testing rather than a clinical study with a patient dataset.
Data Provenance: Not specified, as no clinical study with patient data is detailed. The tests mentioned are likely internal software tests.

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

Not applicable / Not specified. Since no clinical study or diagnostic performance assessment is detailed, there's no mention of experts establishing a ground truth for a test set. The device is a viewing and analysis tool, and its outputs are for interpretation by trained medical professionals.

4. Adjudication Method for the Test Set

Not applicable / Not specified. No clinical test set requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not reported in this 510(k) summary. The submission focuses on substantial equivalence based on technical characteristics and software changes, not on comparing human reader performance with and without the AI (or specific features) of the device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No. The device, Ez3D-i /E3, is described as "dental imaging software that is intended to provide diagnostic tools" and "meant to be used by trained medical professionals such as radiologist and dentist." It is explicitly stated that "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." This confirms it is not intended for standalone, algorithm-only performance.

7. The Type of Ground Truth Used

Not applicable / Not specified for any diagnostic performance. The ground truth for the software's functionality would be its design specifications, against which its operational performance was verified.

8. The Sample Size for the Training Set

Not applicable / Not specified. This device is described as "dental imaging software" with "diagnostic tools" and "advanced simulation functions" primarily for viewing, analysis, and processing. There is no mention of machine learning or AI that would require a "training set" in the context of deep learning algorithms. It appears to be a rule-based or conventional image processing software.

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

Not applicable / Not specified, as there is no mention of a training set for machine learning.

Summary

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September 11, 2023

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

Re: K231757

Trade/Device Name: Ez3D-i /E3 Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: QIH

Dear Priscilla Chung:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated July 14th, 2023. Specifically, FDA is updating this SE Letter's incorrect product code as an administrative correction.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Lu Jiang, OHT8: Office of Radiological Health, 240-402-5779, lu.jiang@fda.hhs.gov.

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

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July 14, 2023

Image /page/1/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "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: K231757

Trade/Device Name: Ez3D-i /E3 Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: June 12, 2023 Received: June 16, 2023

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,

Lu Jiang

Enclosure

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Indications for Use

510(k) Number (if known) K231757

Device Name Ez3D-i /E3

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

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

1. Date: 6/12/2023

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

4. Subject Device:

. Trade/Device Name: Ez3D-i /E3
Version #: v5.5 ●
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: Ez3D-i /E3 ●
Version #: v5.4
510(k) number: K222069
Regulation number 21 CFR 892.2050 ●
Regulation name: Picture Archiving and Communications System
Regulatory Class: Class II

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Classification Product Code: LLZ .

6. Device Description:

7. Indication for use:

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8. Substantial Equivalence:

	Subject Device	Predicate Device
Device Name	Ez3D-i v5.5(E3)	Ez3D-i v5.4(E3)
510K number	-	K222069
Manufacturer	Ewoosoft	Ewoosoft
Indications for use	Ez3D-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 dental radiologyimages and are meant to be used by trainedmedical professionals such as radiologistand dentist.Ez3D-i is intended for use as software toload, view and save DICOM images fromCT, panorama, cephalometric and intraoralimaging equipment and to provide 3Dvisualization, 2D analysis, in various MPR(Multi-Planar Reconstruction.) functions	Ez3D-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.Ez3D-i is intended for use as software toload, view and save DICOM images fromCT, panorama, cephalometric and intraoralimaging equipment and to provide 3Dvisualization, 2D analysis, in various MPR(Multi-Planar Reconstruction.) functions
Platform	IBM-compatible PC or PC network	IBM-compatible PC or PC network
Operating System	Microsoft Window 10 or higher	Microsoft Window 10 or higher
User Interface	Mouse, Keyboard	Mouse, Keyboard
Image Input Sources	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 / 64 bit	64 bit	64 bit
Image format	DICOM	DICOM
Image MeasurementTools	Length, Multi Length, Angle, Multi Angle,Circle, ROI/Area, Volume, Profile	Length, Multi Length, Angle, ROI/Area,Volume, Profile
Image viewing	Full, side by side, gallery, 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, magnify, annotation,cephalometric tracing, ceph growthprojections, implant simulations	Grayscale, invert, emboss, brightness,contrast, gamma, sharpen, median,despeckle, hue, saturation, equalize, flip,mirror, masking, rotate, magnify,annotation, cephalometric tracing, cephgrowth projections, implant simulations
3D imagingcapability	Ez3D-i can view, transfer and process 3Dradiographs. Furthermore, it supports SmartClick, Smart Clipping, Implant Simulationand Canal Draw.	Ez3D-i can view, transfer and process 3Dradiographs. Furthermore, it supports SmartClick, Smart Clipping, Implant Simulationand Canal Draw.
Image annotation	Text, paint, ellipse, pointer, select, draw,magnify, line, rectangle, polygon, ruler,protractor, smile library, smudge, brush,redeye reduction, select region, copy / paste	Text, paint, ellipse, pointer, select, draw,magnify, line, rectangle, polygon, ruler,protractor, smile library, smudge, brush,redeye reduction, select region, copy / paste

8.2. Substantial Equivalence Discussion

Ez3D-i v5.5 described in this 510(k) has the same intended use and the same technical characteristics as the unmodified device (K211791, Ez3D-i /E3).

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The subject device and the predicate devices 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, 3D image construction, image edit, measurements and manipulation.

The modifications are changes in PC system requirement information, upgrades on Main Menu (size adjustment for 3D photo and reorientation function), Settings Dialog (server control panel button, DICOM tag customization, and acquisition information display option), Open function (search function, additional side panel, and Patient tab in the environment settings), MPR tab (Switch to Focus CT function), TMJ tab (Draw Curve function), and CONSULT tab and Report (inserting server images).

These differences are not significant since they do not raise any new or potential safety risks to the user or patient and 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 devices.

9. Technological Characteristics:

Ez3D-i v5.5 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).