EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System

K212624 · Ever Fortune.Ai, Co., Ltd. · QIH · Apr 4, 2022 · Radiology

Device Facts

• Record ID: K212624
• Device Name: EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System
• Applicant: Ever Fortune.Ai, Co., Ltd.
• Product Code: QIH · Radiology
• Decision Date: Apr 4, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: AI/ML, Software as a Medical Device

Intended Use

EFAI Intelligent Cardiothoracic Ratio Assessment System (or iCTR) is a software for use by hospital and clinics to automatically assess the cardiothoracic ratio (CTR) of a chest X-ray image from the X-ray imager subject. The iCTR is designed to measure the maximal transverse diameter of heart and maximal inner transverse diameter of thoracic cavity and calculate the CTR of a chest X-ray image in posterior (PA) chest view using an artificial intelligence algorithm. Intended users of the software are aimed to the physicians or other licensed practitioners in the healthcare institutions, such as clinics, hospitals, healthcare facilities, residential care facilities and long-term care services. The system is suitable for adults between 20 - 80 years of age. Its results are not intended to be used on a stand-alone basis for clinical-decision making or otherwise preclude clinical assessment of cardiothoracic ratio (CTR) cases.

Device Story

Software-based radiological tool; analyzes DICOM chest X-ray images (PA view). Uses AI algorithm to identify maximal transverse heart diameter and maximal inner thoracic cavity diameter; calculates cardiothoracic ratio (CTR). Outputs structured report in DICOM/JSON format containing CTR, annotated images, and historical trajectory. Used in hospitals/clinics by physicians/licensed practitioners. Assists clinicians by providing automated measurements; does not replace clinical assessment or provide diagnostic/prognostic predictions. Benefits include standardized, automated CTR calculation to support clinical workflow.

Clinical Evidence

Clinical performance evaluated using 840 PA CXR images from three sites (adults 20-80 years). Accuracy of EFAI iCTR-derived CTR compared to physician-derived CTR was 0.95. Algorithm performance: quality control models (sensitivity 0.99, accuracy 0.99 for non-CXR filtering; sensitivity 0.99, accuracy 0.97 for non-PA view filtering); annotation models (RMSE 8.81mm for heart diameter, 14.3mm for thoracic cavity diameter).

Technological Characteristics

SaMD; operates on off-the-shelf hardware. Inputs: DICOM PA chest X-rays. Outputs: DICOM/JSON reports with CTR and annotations. AI-based algorithm for automated measurement. Standards: IEC 62304 (software lifecycle), IEC 62366-1/2 (usability).

Indications for Use

Indicated for use by physicians and licensed practitioners in healthcare institutions to automatically assess the cardiothoracic ratio (CTR) in posterior-anterior (PA) chest X-ray images for adults aged 20-80 years. Not for stand-alone clinical decision-making.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• Imbio RV/LV Software (K203256)

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image contains 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.

Ever Fortune. AI Co., Ltd. Chen Ming-Fong Chairman Rm. D, 8F , NO. 573, Sec. 2, Taiwan Blvd., West Dist. TAICHUNG, 403020 TAIWAN

April 4, 2022

#### Re: K212624

Trade/Device Name: EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: QIH Dated: March 9, 2022 Received: March 14, 2022

#### Dear Chen Ming-Fong:

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

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

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 medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For

Thalia T. Mills Division 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) K212624

Device Name

EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System

Indications for Use (Describe)

EFAI Intelligent Cardiothoracic Ratio Assessment System (or use by hospital and clinics to automatically assess the cardiothoracic ratio (CTR) of a chest X-ray image from the X-ray imager subject.

The iCTR is designed to measure the maximal transverse diameter of heart and maximal inner transverse diameter of thoracic cavity and calculate the CTR of a chest X-ray image in posterior (PA) chest view using an artificial intelligence algorithm.

Intended users of the software are aimed to the physicians or other licensed practitioners in the healthcare institutions, such as clinics, hospitals, healthcare facilities, residential care facilities and long-term care services.

The system is suitable for adults between 20 - 80 years of age.

Its results are not intended to be used on a stand-alone basis for clinical-decision making or otherwise preclude clinical assessment of cardiothoracic ratio (CTR) cases.

| Type of Use (Select one or both, as applicable) | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|--------------------------------------------------------------|
| <table><tr><td><label><span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</label></td></tr><tr><td><label>☐ Over-The-Counter Use (21 CFR 801 Subpart C)</label></td></tr></table> | <label><span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label>☐ Over-The-Counter Use (21 CFR 801 Subpart C)</label> |
| <label><span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</label> | | |
| <label>☐ Over-The-Counter Use (21 CFR 801 Subpart C)</label> | | |

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}------------------------------------------------

Image /page/3/Picture/0 description: The image displays the logo and name of the "EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System". The logo features a stylized teal-colored graphic with the text "EVER FORTUNE. AI" next to it. The text below the logo indicates that it is an intelligent system for assessing the cardiothoracic ratio.

# 510(k) Summary

# K212624

The following information is provided in accordance with 21 CFR 807.92 for the Premarket 510(k) Summary:

## I. Submitter

| Company: | EVER FORTUNE.AI Co., Ltd. |
|----------------|------------------------------------------|
| | 8 F., No. 573, Sec. 2, Taiwan Blvd., |
| | West Dist., Taichung City 403020, Taiwan |
| | Phone: [phone] |
| | Fax: [phone] |
| | [e-mail] |
| Contact: | MING-FONG, CHEN (Chairman) |
| | [e-mail] |
| Date Prepared: | March 09, 2022 |

# II. Name of the Device

| Name of Device: | EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System |
|----------------------|----------------------------------------------------------------|
| Common Name: | EFAI iCTR |
| Classification Name: | Medical image management and processing system |
| Review Panel: | Radiology |
| Regulation: | 21 CFR 892.2050 |
| Device Class: | Class II |
| Product Code: | QIH |

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

Image /page/4/Picture/0 description: The image shows the logo for Ever Fortune AI. The logo consists of a stylized human figure in teal with a green globe above its head. To the right of the figure is the text "EVER FORTUNE.AI" also in teal. The logo is simple and modern, and the colors are bright and eye-catching.

#### III. Predicate Device

| Name | Manufacturer | 510(K)# |
|----------------------|--------------|---------|
| Imbio RV/LV Software | Imbio, LLC | K203256 |

The EFAI iCTR is equivalent to the Imbio RV/LV Software (K203256), manufactured by Imbio, LLC is provided as primary predicate device. The predicate has not been subject to a design-related recall. No references device was used in this submission.

#### IV. Device Description

The iCTR is a non-invasive software medical device designed to be installed on the computer with specific system requirements. It is a radiological computer-assisted software system that automatically analyzes DICOM chest X-ray images in PA view and outputs the CTR through an artificial intelligence algorithm. The structure report includes a preview of the compressed chest X-ray image with the automatically-derived CTR result and annotation line, indicating the maximal transverse diameter of heart and maximal inner transverse diameter of thoracic cavity, and the trajectory of CTR records. The trajectory of CTR does not implement a predictive or prognostic feature.

#### V. Indications for Use

EFAI Intelligent Cardiothoracic Ratio Assessment System (or iCTR) is a software for use by hospital and clinics to automatically assess the cardiothoracic ratio (CTR) of a chest X-ray image from the X-ray imager subject. The iCTR is designed to measure the maximal transverse diameter of heart and maximal inner transverse diameter of thoracic cavity and calculate the CTR of a chest X-ray image in posterior (PA) chest view using an artificial intelligence algorithm.

Intended users of the software are aimed to the physicians or other licensed practitioners in the healthcare institutions, such as clinics, hospitals, healthcare facilities, residential care facilities and long-term care services. The system is suitable for adults between 20 - 80 years of age.

Its results are not intended to be used on a stand-alone basis for clinical-decision making or otherwise preclude clinical assessment of cardiothoracic ratio (CTR) cases.

#### VI. Comparison of Technical Characteristics with Predicate Device

The following table compares the EFAI iCTR to the predicate device with respect to intended use, indications for use, technological characteristics, device modalities and forms the determination of substantial equivalence. The comparison table shows that the subject device does not raise any new questions of safety or effectiveness as compared to the predicate device.

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

Image /page/5/Picture/0 description: The image contains a logo for a company called EVER FORTUNE.AI. The logo consists of a stylized human figure with a globe-like structure above its head, both rendered in a teal color. To the right of the figure, the word "EVER" is written in a larger font, with "FORTUNE.AI" below it in a smaller font, also in teal. The overall design is clean and modern, suggesting a technology or innovation-focused company.

| Table - Comparison Table | | | | |
|---------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Feature | EFAI iCTR<br>(K212624) | Imbio RV/LV<br>Software<br>(K203256) | Difference | |
| Manufacturer | Ever Fortune.AI Co.,<br>Ltd. | Imbio LLC | NA | |
| Regulation Number | 21 CFR §890.2050 | 21 CFR §890.2050 | Same | |
| Regulatory Class | Class II | Class II | Same | |
| Product Code | OIH | OIH | Same | |
| Regulation<br>Name | Medical image<br>management and<br>processing system | Medical image<br>management and<br>processing system | Same | |
| Device Property | SaMD | SaMD | Same | |
| | | Intended Use / Indications For Use | | |
| EFAI iCTR (K212624) | EFAI Intelligent Cardiothoracic Ratio Assessment System (or iCTR) is a software<br>for use by hospital and clinics to automatically assess the cardiothoracic ratio<br>(CTR) of a chest X-ray image from the X-ray imager subject. The iCTR is<br>designed to measure the maximal transverse diameter<br>of heart and maximal inner transverse diameter of thoracic cavity and calculate<br>the CTR of a chest X-ray image in posterior-anterior (PA) chest view using an<br>artificial intelligence algorithm.<br>Intended users of the software are aimed to the physicians or other licensed<br>practitioners in the healthcare institutions, such as clinics, hospitals, healthcare<br>facilities, residential care facilities and long-term care services. The system is<br>suitable for adults between 20 - 80 years of age.<br>Its results are not intended to be used on a stand-alone basis for clinical-decision<br>making or otherwise preclude clinical assessment of cardiothoracic ratio (CTR)<br>cases. | | | |
| | | | | |
| Technical Characteristics | EFAI iCTR<br>(K212624) | Imbio RV/LV<br>Software<br>(K203256) | Difference | |
| Input | Post-anterior (PA) view<br>chest X-ray image | Non-gated, CT<br>Pulmonary<br>angiography images | Yes, there is difference.<br>The proposed device used<br>chest x-ray images in PA<br>view as input to identify<br>the maximal diameters of<br>the maximal transverse<br>diameter of heart and<br>maximal inner transverse<br>diameter of thoracic cavity.<br>The primary device used<br>CTPA images as input to<br>identify the maximal<br>diameters of the right and<br>left ventricles of the heart.<br>The verification report can<br>verify the difference does<br>not raise the impact of the<br>safety and effectiveness.<br>Both of the devices are in<br>DICOM images as input. | |
| Output | Reports, DICOM<br>Secondary Capture<br>series | Reports, DICOM<br>Secondary Capture<br>series | Same | |
| Report Structure | Report will be output in<br>the DICOM and JSON<br>file format which is<br>structured with | Report will be output<br>in DICOM file format<br>which is structured<br>with following | Similar.<br>The subject device is<br>intended to output the<br>maximal inner border<br>diameter of thoracic cavity | |
| | following information<br>and function tool:<br>1) CTR<br>2) adjustable<br>annotation line<br>(maximal inner<br>border diameter of<br>thoracic cavity and<br>maximal diameter<br>of heart)<br>3) the trajectory of<br>CTR (including<br>chest X-ray) | information and<br>function tool:<br>1) the RV/LV<br>Annotated Image<br>Series (the slices<br>with the maximum<br>ventricular<br>diameters, the<br>RV/LV Ratio, and<br>the individual<br>ventricular<br>measurements if<br>available.)<br>2) the RV/LV<br>Summary Report | and heart. The predicate<br>device is intended to output<br>the maximum ventricular<br>diameters.<br>The report structure both<br>can demonstrate the<br>annotation line and subject<br>image in DICOM format. | |
| Intended Users | Physicians or other<br>licensed practitioners in<br>the healthcare<br>institutions | Thoracic Radiologists,<br>General Radiologists,<br>Pulmonologists,<br>Cardiologists, imaging<br>technologists under the<br>supervision of a<br>physician, or<br>researchers | Yes, there is difference.<br>The proposed device is<br>intended to provide the<br>trained clinicians to use<br>but no limited in the doctor<br>specialists. The predicate<br>device is intended to<br>provide the radiologists<br>and cardiologist and<br>imaging technologists to<br>use. The difference does<br>not raise no impact of the<br>safety and effectiveness. | |
| Target Population | Adults of 20-80 years old | No restrictions | Yes, there is a difference.<br>Proposed device only<br>intended use for the patient<br>in the adults of 20-80 years<br>old. The validation report<br>can verify the difference<br>does raise no impact of the<br>safety and effectiveness. | |
| Imaging Modality | Chest X-ray in Digital<br>Radiography (DR) | Computed<br>Tomography<br>Pulmonary<br>Angiography (CTPA)<br>images | Yes, there is a difference.<br>Despite two compared<br>devices is present with the<br>different imaging modality.<br>The verification &<br>validation result has shown<br>no impact raise in the<br>safety and effectiveness. | |
| Intended Use<br>Environment | Healthcare institutions<br>(Clinics, hospitals,<br>healthcare facilities,<br>residential care facilities<br>and long-term care<br>services) | No restrictions | Yes, there is a difference.<br>The usability report can<br>verify the different<br>environment does not raise<br>the impact of safety and<br>effectiveness. | |
| Software device that<br>operates on off-the-shelf<br>hardware | Yes | Yes | Same | |
| Software devices uses<br>software algorithms for<br>image | Yes | Yes | Same | |
| Diameter Measurement | Yes - Automated | Yes - Automated | Same | |
| Storage | Saved in JSON and<br>DICOM file format text<br>for DICOM and<br>DICOM file format | Saved in PDF and<br>DICOM compatible<br>format | They have same DICOM<br>format storage. The<br>storage of subject device in<br>JSON format has been<br>validated through the<br>system test. There is no<br>impact on safety or<br>effectiveness of the subject<br>device. | |

#### The Imbio RV/LV Software device is designed to measure the maximal diameters Imbio RV/LV Software (K203256) of the right and left ventricles of the heart from a volumetric CTPA acquisition and report the ratio of those measurements. RV/LV analyzes cases using an artificial intelligence algorithm to identify the location and measurements of the

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image contains a logo with the text "EVER FORTUNE.AI". The word "EVER" is placed above "FORTUNE.AI". To the left of the text is a teal-colored graphic that resembles a person with a head made of a green network of connected dots. The logo appears to be for a company or organization related to artificial intelligence.

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image contains a logo for a company called EVERFORTUNE.AI. The logo consists of a stylized human figure with a globe as its head, and the company name is written in a sans-serif font to the right of the figure. The color scheme is a light teal or turquoise.

{8}------------------------------------------------

Image /page/8/Picture/0 description: The image shows the logo for Ever Fortune AI. The logo consists of a stylized figure with a globe as its head, followed by the text "EVER FORTUNE.AI". The figure and text are in a light blue color. The globe is green.

{9}------------------------------------------------

Image /page/9/Picture/0 description: The image contains a logo for Ever Fortune AI. The logo consists of a stylized human figure with a globe as its head on the left side. To the right of the figure, the text "EVER FORTUNE.AI" is displayed in a sans-serif font. The color scheme is primarily teal and light green.

| | EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System |
|--|----------------------------------------------------------------|

## VII. Performance Data – Clinical Testing

EFAI iCTR Software was developed and tested in accordance with EFAI's Design Control processes and has been subjected to extensive safety and performance testing. EFAI iCTR Software verification and validation test results established that the device meets its design requirements and intended use. Specifically, software verification was conducted at unit, module, and system integration levels. Extensive algorithm development and software verification testing assessed the performance characteristics of the algorithm including EFAI iCTR accuracy, risk management, and overall functional performance. Images and cases used for verification testing were carefully separated from training algorithms.

Results of the EFAI iCTR were compared to evaluation by a panel of expert readers. That study met the pre-defined acceptance criteria and found that the observed accuracy estimates for the software were greater than 95% for identification of the imaging mode and the view.

The EFAI iCTR encompasses three quality control models and two annotation models. The quality control models are capable of filtering out non-chest X-ray images (Sensitivity 0.99, Accuracy 0.99), filtering out the non-PA view chest X-ray images(Sensitivity 0.99, Accuracy 0.97), and presenting with message for images with unclear boundary whose threshold is <0.5; the annotation models are able to draw two annotation lines, one indicating maximal transverse diameter of the heart (root-mean-square-

error 8.81mm)and other indicating the maximal inner diameter of the thoracic cavity(root-meansquare-error 14.3mm).

For clinical performance testing, we included at least a total of 840 eligible PA CXR images of adults (20 to 80 years old) patients from three participating sites (280 per site). We used accuracy to evaluate the agreement between EFAI iCTR-derived and physician derived CTR. The accuracy of EFAI iCTR system is 0.95.

{10}------------------------------------------------

Image /page/10/Picture/0 description: The image contains a logo for a company called "EVER FORTUNE.AI". The logo consists of a stylized human figure in teal, with a green network-like structure above its head. The text "EVER FORTUNE.AI" is written in teal to the right of the figure. The word "EVER" is larger than the rest of the text.

As the result shown, the performance testing demonstrates that the EFAI Intelligent Cardiothoracic Ratio Assessment System performs as expected and in a manner that is substantially equivalent to the predicate device

### VIII. Performance Data - Non-Clinical

To demonstrate safety and effectiveness of EFAI iCTR and to show substantial equivalence to the predicate device, EFAI completed the non-clinical tests. Results confirm that the design inputs and performance specifications for the device are met. The EFAI iCTR passed the testing in accordance with internal requirements,

national standards, and international standards shown below, supporting its safety and its substantial equivalence to the predicate device:

- . Software verification and validation per IEC 62304/FDA Guidance
- . Application of usability engineering to medical devices - Part 1 per IEC 62366-1
- . Guidance on the application of usability engineering to medical devices per IEC 62366-2

The clinical evaluation is conducted on the device following FDA Guidance "Software as a Medical Device (SAMD): Clinical Evaluation" (IMDRF/SaMD WG/N41FINAL:2017).

#### IX. Statement of Substantial Equivalence

Ever Fortune.AI Co., Ltd. Choose the Imbio RV/LV Software (K203256) as a predicate device. Imbio RV/LV Software, a software device is designed to measure the maximal diameters of the right and left ventricles of the heart from a volumetric CTPA acquisition and report the ratio of those measurements. The R V/LV software provides the user with annotated images showing ventricular measurements.

EFAI iCTR is designed to measure the maximal transverse diameter of heart and maximal inner transverse diameter of thoracic cavity and calculate the CTR of a chest X-ray image in posterioranterior (PA) chest view using an artificial intelligence algorithm. is a software for use by hospital and clinics to automatically assess the cardiothoracic ratio (CTR) of a chest X-ray image from the X-ray imager subject.

The subject device shares the similar intended use and device functions to perform the physical measurement on the ratio of maximum horizontal diameter as the primary device.

## X. Conclusion

The result of the comparison of the design, intended use and testing results with the software release acceptance criteria, EverFortune.AI is the opinion, that Imbio RV/LV software is substantial equivalent to and perform as well as the predicate device EFAI iCTR.