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 is 3D viewing software for dental CT images from CT, panorama, cephalometric and intraoral image equipment 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.

Ez3D-i's main functions are:

Image adaptation through various rendering methods such as Teeth/Bone/Soft tissue/MIP
Versatile 3D image viewing via MPR Rotating, Curve mode
"Sculpt" for deleting unnecessary parts to view only the region of interest.
Implant Simulation for efficient treatment planning and effective patient consultation
Canal Draw to trace alveolar canal and its geometrical orientation relative to teeth.
"Bone Density" test to measure bone density around the site of an implant(s) .
Various utilities such as Measurement, Annotation, Gallery, and Report
3D Volume function to transform the image into 3D Panorama and the Tab has been optimized for Implant Simulation.
Provides the Axial View of TMJ, the Condyle/Fossa images in 3D and the Section images, and supports functions to separate the Condyle/Fossa and display the bone density
STO/VTO Simulation to predict orthodontic treatment/ surgery results with 3D Photo image.
Segmentation function to get tooth segmentation data from CT, label each segmented tooth data as an object and utilize them in simulation such as tooth extraction, implant simulation, etc.

AI/ML Overview

The provided text describes a 510(k) summary for the Ez3D-i/E3 device, primarily focusing on proving its substantial equivalence to a predicate device (K211791) rather than detailing specific acceptance criteria and a comprehensive study proving the device meets them.

The filing states: "The 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." However, it does not provide the specific acceptance criteria, the detailed results of these tests, or the methodology of the study.

Therefore, many of the requested details cannot be extracted from the given text.

Based on the information provided, here's what can be extracted and what is missing:

Acceptance Criteria and Device Performance

The document does not explicitly state specific acceptance criteria in a quantitative manner or provide a table of reported device performance against such criteria. It generally states that the device "passed all of the tests based on pre-determined Pass/Fail criteria," but these criteria are not detailed.

Study Details

Given the context of a 510(k) for a software update (Ez3D-i v5.4 to Ez3D-i v5.3), the studies conducted appear to be software verification and validation (V&V) and measurement accuracy tests. These are typically internal tests to ensure the new version functions as intended and maintains the performance of the previous version, rather than large-scale clinical trials.

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

Not explicitly stated for the "measurement accuracy test" or "SW verification/validation." The document mentions the device processes DICOM images from CT, panorama, cephalometric, and intraoral imaging equipment. The data provenance (country of origin, retrospective/prospective) is also not stated.

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

Not stated. For a software update focusing on functionality and measurement accuracy of an image viewer, ground truth might be established through technical specifications or comparison to known accurate measurements rather than expert consensus on diagnostic interpretations. The document mentions the software is "meant to be used by trained medical professionals such as radiologist and dentist," but it doesn't specify if these professionals were involved in establishing ground truth for testing.

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

Not stated. This method is typically relevant for human-in-the-loop studies where multiple readers interpret images to establish consensus. For software V&V and measurement accuracy, it's unlikely to be applicable in the traditional sense.

4. 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, an MRMC study was not done or reported. The device is described as "dental imaging software that is intended to provide diagnostic tools" and is used by professionals as "an adjunctive to standard radiology practices for diagnosis." It is not presented as an AI-assisted diagnostic tool that directly improves human reader performance in the way an AI algorithm for disease detection might be. The focus of the submission is on software functionality and substantial equivalence.

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

Not explicitly detailed as a "standalone performance study" in terms of diagnostic accuracy. The "measurement accuracy test" could be considered a form of standalone testing for specific functions, but no specific metrics (e.g., sensitivity, specificity for diagnostic tasks) are provided. The device is not an AI algorithm making diagnostic predictions in the absence of a human.

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

Not explicitly stated. For "measurement accuracy," ground truth would likely be established by known physical dimensions or validated measurements. For general software verification/validation, ground truth often relates to the expected output from a given input based on design specifications.

7. The sample size for the training set:

Not applicable/Not stated. This device is described as a medical image management and processing system, not an AI/ML device that requires a training set. While it performs "3D visualization, 2D analysis, in various MPR (Multi-Planar Reconstruction) functions," these are standard image processing techniques, not algorithms that learn from data.

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

Not applicable/Not stated. As it's not described as an AI/ML device, there's no "training set."

Summary of what is known from the document:

Device Name: Ez3D-i /E3 (K222069)
Intended Use: Dental imaging software for maxillofacial radiographic imaging, providing diagnostic tools to view and interpret DICOM images from various dental imaging equipment, offering 3D visualization, 2D analysis, and MPR functions. Used by trained medical professionals (radiologists and dentists).
Predicate Device: Ez3D-i /E3 v.5.3 (K211791)
Studies Conducted: Software verification/validation and measurement accuracy tests.
Conclusion: The device passed all tests based on pre-determined Pass/Fail criteria, leading to a conclusion of substantial equivalence to the predicate device.

What is demonstrably missing from the provided text:

Specific, quantitative acceptance criteria.
Detailed reported performance data against those criteria.
Specific sample sizes for the test set.
Data provenance (country of origin, retrospective/prospective).
Details on experts and ground truth establishment methodologies for the test set.
Adjudication methods for the test set.
Any MRMC study details or effect sizes related to AI assistance.
Detailed standalone performance metrics (e.g., diagnostic accuracy metrics).
Ground truth type beyond general "measurement accuracy."
Training set information (as it's not an AI/ML device).

Summary

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September 6, 2022

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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.

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

Re: K222069

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 27, 2022 Received: July 14, 2022

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/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,

Laurel Burk, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Imaging Devices and Electronic Products OHT8: Office of 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) K222069

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

(K222069)

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

1. Date: 8/1/2022

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: Ez3D-i /E3
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 v.5.3
510(k) number: K211791
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:

Ez3D-i's main functions are:

Image adaptation through various rendering methods such as Teeth/Bone/Soft ● tissue/MIP
Versatile 3D image viewing via MPR Rotating, Curve mode ●
"Sculpt" for deleting unnecessary parts to view only the region of interest.
Implant Simulation for efficient treatment planning and effective patient consultation ●
Canal Draw to trace alveolar canal and its geometrical orientation relative to teeth.
"Bone Density" test to measure bone density around the site of an implant(s) .
Various utilities such as Measurement, Annotation, Gallery, and Report ●
3D Volume function to transform the image into 3D Panorama and the Tab has been ● optimized for Implant Simulation.
. Provides the Axial View of TMJ, the Condyle/Fossa images in 3D and the Section images, and supports functions to separate the Condyle/Fossa and display the bone density
. STO/VTO Simulation to predict orthodontic treatment/ surgery results with 3D Photo image.
Segmentation function to get tooth segmentation data from CT, label each segmented tooth data as an object and utilize them in simulation such as tooth extraction, implant simulation, etc.

7. Indication for use:

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8. Substantial Equivalence:

	Subject Device	Predicate Device
Device Name	Ez3D-i v5.4(E3)	Ez3D-i v5.3(E3)
510K number	K222069	K211791
Manufacturer	Ewoosoft	Ewoosoft
Indications for use	Ez3D-i is dental imaging software that isintended to provide diagnostic tools formaxillofacial radiographic imaging.These tools are available to view andinterpret a series of DICOM compliantdental radiology images and are meantto be used by trained medicalprofessionals such as radiologist anddentist.Ez3D-i is intended for use as software toload, view and save DICOM imagesfrom CT, panorama, cephalometric andintraoral imaging equipment and toprovide 3D visualization, 2D analysis, invarious MPR (Multi-PlanarReconstruction.) functions	Ez3D-i is dental imaging software thatis intended to provide diagnostic toolsfor maxillofacial radiographic imaging.These tools are available to view andinterpret a series of DICOM compliantdental radiology images and are meantto be used by trained medicalprofessionals such as radiologist anddentist.Ez3D-i is intended for use as softwareto load, view and save DICOM imagesfrom CT, panorama, cephalometric andintraoral imaging equipment and toprovide 3D visualization, 2D analysis, invarious MPR (Multi-PlanarReconstruction.) functions
Platform	IBM-compatible PC or PC network	IBM-compatible PC or PC network
Operating System	Microsoft Window 10 or higher	Microsoft Window 10
User Interface	Mouse, Keyboard	Mouse, Keyboard
Image InputSources	Images can be scanned, loaded fromdigital cameras or card readers, orimported from a radiographic imagingdevice	Images can be scanned, loaded fromdigital cameras or card readers, orimported from a radiographic imagingdevice
32 bit / 64 bit	32 / 64 bit	32 / 64 bit
Image format	DICOM	DICOM
ImageMeasurementTools	Length, Multi Length, Angle, MultiAngle, 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
Imagemanipulation	Grayscale, invert, emboss, brightness,contrast, gamma, sharpen, median,despeckle, hue, saturation, equalize, flip,mirror, masking, rotate, magnify,annotation, cephalometric tracing, cephgrowth projections, 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 process3D radiographs. Furthermore, it supportsSmart Click, Smart Clipping, ImplantSimulation and Canal Draw.	Ez3D-i can view, transfer and process3D radiographs. Furthermore, itsupports Smart Click, Smart Clipping,Implant Simulation and Canal Draw.
Image annotation	Text, paint, ellipse, pointer, select, draw,magnify, line, rectangle, polygon, ruler,protractor, smile library, smudge, brush,	Text, paint, ellipse, pointer, select,draw, magnify, line, rectangle, polygon,ruler, protractor, smile library, smudge,
redeye reduction, select region, copy /paste	brush, redeye reduction, select region,copy / paste

8.1. Comparison chart of features and specifications

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8.2. Substantial Equivalence Discussion

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

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, upgrading Main Button (Exporting Recon Ceph Image to the Server), upgrading the Settings tab (windowing filter, curvature, curve), upgrading the MPR Tab (Region Capture), upgrading the SECTION Tab (Switching L/B direction), upgrading the ENDO Tab (Sculpting Selected Region).

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 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:

Ez3D-i has been tested according to IEC 62304 and ISO 14971. The 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).