(229 days)
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.
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.
Here's an analysis of the acceptance criteria and study proving the device meets them, based on the provided text:
Device Name: EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document does not explicitly present a formal "acceptance criteria" table with thresholds. Instead, it describes performance metrics that were achieved and deemed "met" or "greater than" a certain level. For clarity, I've inferenced the acceptance criteria based on these reported performance numbers.
| Feature / Metric | Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Accuracy - Identification of Imaging Mode | > 95% | 0.99 (99%) |
| Accuracy - Identification of View | > 95% | 0.99 (99%) |
| Quality Control Model: Filter non-CXR images | Sensitivity > X, Accuracy > Y (e.g., deemed sufficient by FDA) | Sensitivity: 0.99, Accuracy: 0.99 |
| Quality Control Model: Filter non-PA view CXR | Sensitivity > X, Accuracy > Y (e.g., deemed sufficient by FDA) | Sensitivity: 0.99, Accuracy: 0.97 |
| Boundary Clarity Threshold Message | Present message for unclear images whose threshold < 0.5 | Presents message for images with unclear boundary whose threshold < 0.5 |
| Annotation Model: Max Transverse Diameter of Heart (RMSE) | Lower RMSE deemed better (e.g., < 10mm) | 8.81mm |
| Annotation Model: Max Inner Diameter of Thoracic Cavity (RMSE) | Lower RMSE deemed better (e.g., < 15mm) | 14.3mm |
| CTR Accuracy (System vs. Physician-derived) | Defined as 0.95 or higher | 0.95 |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: At least a total of 840 eligible PA CXR images.
- Data Provenance: The images were from three participating sites, with 280 PA CXR images from each site. The document does not specify the country of origin, but given the submitter is from Taiwan, it is plausible the data originated from Taiwan or other undisclosed locations. The study refers to "patients," implying real-world data, but does not explicitly state if it was retrospective or prospective. Typically, K-submissions rely on retrospective data for such clinical performance studies.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: The ground truth for the test set was established by a "panel of expert readers." The exact number of experts is not specified.
- Qualifications of Experts: The document explicitly states "expert readers" but does not provide their specific qualifications (e.g., board certification, years of experience, specialty).
4. Adjudication Method for the Test Set
- The document states that results of the EFAI iCTR were "compared to evaluation by a panel of expert readers." It does not specify the adjudication method used by the expert panel to establish the ground truth (e.g., 2+1, 3+1 consensus, individual reads averaged/aggregated, etc.).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a MRMC comparative effectiveness study was not explicitly done to evaluate how much human readers improve with AI vs. without AI assistance. The study described focuses on the standalone performance of the AI model and its agreement with aggregated physician-derived CTR measurements. The "Indications for Use" explicitly state: "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," which suggests it's an assistive tool, but the clinical study did not assess its assistive benefit.
6. Standalone (Algorithm Only) Performance
- Yes, a standalone performance study was done. The described clinical performance testing directly evaluated the EFAI iCTR system's ability to assess CTR independently and compared its outputs (iCTR-derived CTR) to physician-derived CTR, yielding an accuracy of 0.95. The various quality control models and annotation model RMSE values also represent standalone performance metrics.
7. Type of Ground Truth Used
- The ground truth for the clinical performance testing (CTR accuracy) was expert consensus / physician-derived CTR. The document states, "We used accuracy to evaluate the agreement between EFAI iCTR-derived and physician derived CTR." For other quality control aspects (e.g., filtering non-CXR images), the ground truth would likely be established by a human review or a pre-defined dataset with known labels.
8. Sample Size for the Training Set
- The document states: "Images and cases used for verification testing were carefully separated from training algorithms." However, the sample size for the training set is not provided in the supplied text.
9. How the Ground Truth for the Training Set Was Established
- The document states that "Extensive algorithm development and software verification testing assessed the performance characteristics of the algorithm". It also mentions that "Images and cases used for verification testing were carefully separated from training algorithms." However, the method for establishing ground truth for the training set is not described in the provided text. It is typically assumed that for AI models, the training data is meticulously annotated, often by human experts or through other trusted sources, but this document does not detail that process.
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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
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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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
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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) | ||
|---|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D)☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ||
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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: (886)-4-2322-6363 | |
| Fax: (886)-4-2322-9797 | |
| ra99@everfortuneai.com.tw | |
| Contact: | MING-FONG, CHEN (Chairman) |
| ra99@everfortuneai.com.tw | |
| 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 |
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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.
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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(K212624) | Imbio RV/LVSoftware(K203256) | Difference | |
| Manufacturer | Ever Fortune.AI Co.,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 | |
| RegulationName | Medical imagemanagement andprocessing system | Medical imagemanagement andprocessing 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 softwarefor 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 isdesigned to measure the maximal transverse diameterof heart and maximal inner transverse diameter of thoracic cavity and calculatethe CTR of a chest X-ray image in posterior-anterior (PA) chest view using anartificial intelligence algorithm.Intended users of the software are aimed to the physicians or other licensedpractitioners in the healthcare institutions, such as clinics, hospitals, healthcarefacilities, residential care facilities and long-term care services. The system issuitable for adults between 20 - 80 years of age.Its results are not intended to be used on a stand-alone basis for clinical-decisionmaking or otherwise preclude clinical assessment of cardiothoracic ratio (CTR)cases. | |||
| Technical Characteristics | EFAI iCTR(K212624) | Imbio RV/LVSoftware(K203256) | Difference | |
| Input | Post-anterior (PA) viewchest X-ray image | Non-gated, CTPulmonaryangiography images | Yes, there is difference.The proposed device usedchest x-ray images in PAview as input to identifythe maximal diameters ofthe maximal transversediameter of heart andmaximal inner transversediameter of thoracic cavity.The primary device usedCTPA images as input toidentify the maximaldiameters of the right andleft ventricles of the heart.The verification report canverify the difference doesnot raise the impact of thesafety and effectiveness.Both of the devices are inDICOM images as input. | |
| Output | Reports, DICOMSecondary Captureseries | Reports, DICOMSecondary Captureseries | Same | |
| Report Structure | Report will be output inthe DICOM and JSONfile format which isstructured with | Report will be outputin DICOM file formatwhich is structuredwith following | Similar.The subject device isintended to output themaximal inner borderdiameter of thoracic cavity | |
| following informationand function tool:1) CTR2) adjustableannotation line(maximal innerborder diameter ofthoracic cavity andmaximal diameterof heart)3) the trajectory ofCTR (includingchest X-ray) | information andfunction tool:1) the RV/LVAnnotated ImageSeries (the sliceswith the maximumventriculardiameters, theRV/LV Ratio, andthe individualventricularmeasurements ifavailable.)2) the RV/LVSummary Report | and heart. The predicatedevice is intended to outputthe maximum ventriculardiameters.The report structure bothcan demonstrate theannotation line and subjectimage in DICOM format. | ||
| Intended Users | Physicians or otherlicensed practitioners inthe healthcareinstitutions | Thoracic Radiologists,General Radiologists,Pulmonologists,Cardiologists, imagingtechnologists under thesupervision of aphysician, orresearchers | Yes, there is difference.The proposed device isintended to provide thetrained clinicians to usebut no limited in the doctorspecialists. The predicatedevice is intended toprovide the radiologistsand cardiologist andimaging technologists touse. The difference doesnot raise no impact of thesafety and effectiveness. | |
| Target Population | Adults of 20-80 years old | No restrictions | Yes, there is a difference.Proposed device onlyintended use for the patientin the adults of 20-80 yearsold. The validation reportcan verify the differencedoes raise no impact of thesafety and effectiveness. | |
| Imaging Modality | Chest X-ray in DigitalRadiography (DR) | ComputedTomographyPulmonaryAngiography (CTPA)images | Yes, there is a difference.Despite two compareddevices is present with thedifferent imaging modality.The verification &validation result has shownno impact raise in thesafety and effectiveness. | |
| Intended UseEnvironment | Healthcare institutions(Clinics, hospitals,healthcare facilities,residential care facilitiesand long-term careservices) | No restrictions | Yes, there is a difference.The usability report canverify the differentenvironment does not raisethe impact of safety andeffectiveness. | |
| Software device thatoperates on off-the-shelfhardware | Yes | Yes | Same | |
| Software devices usessoftware algorithms forimage | Yes | Yes | Same | |
| Diameter Measurement | Yes - Automated | Yes - Automated | Same | |
| Storage | Saved in JSON andDICOM file format textfor DICOM andDICOM file format | Saved in PDF andDICOM compatibleformat | They have same DICOMformat storage. Thestorage of subject device inJSON format has beenvalidated through thesystem test. There is noimpact on safety oreffectiveness of the subjectdevice. |
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
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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.
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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.
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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.
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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.
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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.
§ 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).