(186 days)
Not Found
No
The description focuses on image processing, segmentation, and quantitative analysis based on user-defined color scales and settings, without mentioning AI or ML algorithms.
No
The device is described as image processing software that provides analysis and aids in evaluating and assessing myocardial perfusions, but it does not directly treat or prevent a disease or condition.
Yes
This device is designed to provide analysis on medical images to support healthcare professionals in evaluating and assessing myocardial perfusions, which is a diagnostic purpose. It helps clinicians in diagnosing the patient's condition by providing numerical analysis and generating reports.
Yes
The device is described as "image processing software" and its functionality is entirely based on processing existing DICOM images and generating reports. There is no mention of any hardware component being part of the device itself; it relies on images acquired from a separate GE Medical Systems hardware system.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples: IVDs are designed to examine specimens taken from the human body, such as blood, urine, tissue, etc., to provide information about a person's health.
- This device analyzes medical images: The EFAI CARDIOSUITE SPECT MYOCARDIAL PERFUSION AGILE WORKFLOWS software processes DICOM images acquired from a SPECT scanner. It analyzes the visual data within these images, not biological samples.
- The intended use is image processing and analysis: The description clearly states it's "image processing software" and provides "analysis on DICOM images."
While the software aids in the evaluation of myocardial perfusion, which is a physiological process, it does so by analyzing the output of an imaging modality (SPECT), not by directly testing a biological sample.
N/A
Intended Use / Indications for Use
EFAI CARDIOSUITE SPECT MYOCARDIAL PERFUSION AGILE WORKFLOWS is an image processing software that provides analysis on DICOM images acquired from GE Medical Systems Nuclear Quantitative Perfusion SPECT software to support appropriately trained healthcare professionals in the evaluation and assessment of myocardial perfusions.
It provides the following functionality:
- Segmentation of the Bull's Eye images from the original DICOM
- Analysis of the Bull's Eye images to help assess perfusion
- Custom settings to generate text reports
The results of this processing may be used to aid in evaluating and assessing myocardial perfusions.
The system is an adjunct tool for GE Medical Systems Nuclear Quantitative Perfusion SPECT software.
Product codes (comma separated list FDA assigned to the subject device)
KPS, LLZ
Device Description
The device allows users to interact with the software application via a web interface to upload, inspect, assess myocardial perfusion from Bull's Eye images. The user can change the quantitative settings to correct for numerical calculations and clinical adjustments.
The device is designed to take images produced by GE Medical Systems Nuclear Quantitative Perfusion SPECT software and process the data to provide both numerical analysis of the Bull's Eye images to help assess for myocardial perfusions, and generate a report based on the users report settings and preference.
The algorithm segments bull's eye images from SPECT images generated by GE's workstation and conducts quantitative analysis based on the color settings set by the user. The color scale is designed to follow GE's design convention, where the color red is indicative of a normal condition and blue representing severe perfusion. Each of the 17 segments would produce a quantitative evaluation under rest and stress conditions based on the color scale. The clinician would then design and fill in diagnosis terminologies that is best suited for each associated numerical results of each segment and generate a template report documenting the patient's condition.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Nuclear Medicine Cardiology SPECT Perfusion Image (specifically, GE SPECT Scanning (Bull's eye image in DICOM file))
Anatomical Site
Left Ventricle
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The intended users of the device are trained nuclear radiologists.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
To demonstrate safety and effectiveness of EFAI SPECT Workflows 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 SPECT Workflows passed the testing in accordance with internal requirements, national standards, and international standards shown below, supporting its safety and effectiveness, 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
EFAI SPECT Workflows did not require clinical study since substantial equivalence to the currently market and predicate device was demonstrated with the following attribute:
- Principle of Operation;
- Indications for Use;
- Fundamental scientific technology;
- Non-clinical performance testing:
- Safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1200 Emission computed tomography system.
(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.
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Ever Fortune.AI Co., Ltd. % Cheng Ming-Fong Chairman 8F., No. 573, Sec. 2, Taiwan Blvd., West Dist. Taichung City, 403020 TAIWAN
Re: K213731
Trade/Device Name: EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: Class II Product Code: KPS, LLZ Dated: March 18, 2022 Received: April 4, 2022
Dear Cheng 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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
Michael D. O'Hara, Ph.D. Deputy Director DHT 8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K213731
Device Name
EFAI CARDIOSUITE SPECT MYOCARDIAL PERFUSION AGILE WORKFLOWS
Indications for Use (Describe)
EFAI CARDIOSUITE SPECT MYOCARDIAL PERFUSION AGILE WORKFLOWS is an image processing software that
provides analysis on DICOM images acquired from GE Medical Systems Nuclear Quantitative Perfusion SPECT software to
support appropriately trained healthcare professionals in the evaluation and assessment of myocardial perfusions.
It provides the following functionality:
- Segmentation of the Bull's Eye images from the original DICOM
- Analysis of the Bull's Eye images to help assess perfusion
- Custom settings to generate text reports
The results of this processing may be used to aid in evaluating and assessing myocardial perfusions.
The system is an adjunct tool for GE Medical Systems Nuclear Quantitative Perfusion SPECT software.
| Type of Use ( Select one or both, as applicable ) | ||
|---|---|---|
| [X] Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) | [X] Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| [X] 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 contains a logo for a company called "EVER FORTUNE.AI". The logo consists of a stylized human figure with a circular head and outstretched arms, colored in a gradient of light blue and green. Above the figure's head is a green sphere with a network pattern on it. To the right of the figure is the company name, "EVER FORTUNE.AI", also in light blue and green.
510(k) Summary
K213731
The following information is provided in accordance with 21 CFR 807.92 for the Premarket 510(k) Summary:
I. Submitter
| Company: | EverFortune.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 | ||
| Correspondence Person: | Ming-Fong, Chen (Chairman) | |
| ra99@everfortuneai.com.tw | ||
| Applicant Person: | Jenna Hsiao (RA) | |
| ra05@everfortuneai.com.tw | ||
| Date Prepared: | May 18th, 2022 | |
| II. | ||
| Name of the Device | ||
| Name of Device: | EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflow | |
| Common Name: | EFAI SPECT Workflows | |
| Classification Name: | Emission Computed Tomography System | |
| Review Panel | Radiology | |
| Proposed Classification: | Device Class: II |
Predicate Device III.
AutoQUANT® Plus manufactured by ADAC LABORATORIES under K040326 This predicate has not been subject to a design-related recall. No reference devices were used in this submission. Predicate Classification: Class II / KPS / 21 CFR §892.1200
Product Code: KPS, LLZ
Regulation Number: 21 CFR §892.1200
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Image /page/4/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 on top, followed by the company name in a sans-serif font. The color scheme is a light teal or cyan, giving the logo a modern and tech-oriented feel.
Device Description IV.
The device allows users to interact with the software application via a web interface to upload, inspect, assess myocardial perfusion from Bull's Eye images. The user can change the quantitative settings to correct for numerical calculations and clinical adjustments.
The device is designed to take images produced by GE Medical Systems Nuclear Quantitative Perfusion SPECT software and process the data to provide both numerical analysis of the Bull's Eye images to help assess for myocardial perfusions, and generate a report based on the users report settings and preference.
The algorithm segments bull's eye images from SPECT images generated by GE's workstation and conducts quantitative analysis based on the color settings set by the user. The color scale is designed to follow GE's design convention, where the color red is indicative of a normal condition and blue representing severe perfusion. Each of the 17 segments would produce a quantitative evaluation under rest and stress conditions based on the color scale. The clinician would then design and fill in diagnosis terminologies that is best suited for each associated numerical results of each segment and generate a template report documenting the patient's condition.
Intended User Population
The intended users of the device are trained nuclear radiologists.
Intended Patient Population
The target population of the device are patients who receive cardiac SPECT imaging.
Description of user interface and outputs
The device displays Bull's Eye images of the heart along with myocardial segments overlaid on top to allow end users to assess myocardial perfusions. The device interacts with DICOM files generated from GE Medical Systems software workstation. The results and settings are displayed via a web interface where the end user uploads files, inspect quantitative results, adjust settings and generate a report.
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Image /page/5/Picture/0 description: The image shows the logo for Ever Fortune AI. The logo consists of a stylized human figure with a green sphere on top, representing the head. The sphere is made up of interconnected dots, suggesting a network or connection. To the right of the figure, the text "EVER FORTUNE.AI" is displayed in a light blue color, with the "O" in "FORTUNE" replaced by a similar sphere as the one on top of the human figure.
V. Intended Use / Indications For Use
EFAI CARDIOSUITE SPECT MYOCARDIAL PERFUSION AGILE WORKFLOWS is an image processing software that provides analysis on DICOM images acquired from GE Medical Systems Nuclear Quantitative Perfusion SPECT software to support appropriately trained healthcare professionals in the evaluation and assessment of myocardial perfusions.
It provides the following functionality:
- · Segmentation of the Bull's Eye images from the original DICOM
- Analysis of the Bull's Eye images to help assess perfusion
- · Custom settings to generate text reports
The results of this processing may be used to aid in evaluating and assessing myocardial perfusions.
The system is an adjunct tool for GE Medical Systems Nuclear Quantitative Perfusion SPECT software.
Comparison of Technological Characteristics with Predicate Device VI.
The following table compares the EFAI SPECT Workflows to the predicate device with respect to intended use, indications for use, principles of operation, technological characteristics, device modalities and forms the basis for 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.
The subject device and predicate devices share the same technological characteristics:
- ◆ Interface is able to review, transfer, process, storage and report of myocardial perfusion SPECT images;
- � Used to receive the SPECT image data;
- � Generation of display and report the Nuclear Medicine Cardiology medical images
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Image /page/6/Picture/1 description: The image shows a logo for a company called "EVER FORTUNE.AI". The logo consists of a stylized human figure with a globe on top of 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.
| Table - Comparison Table | ||||
|---|---|---|---|---|
| Proposed Device | Predicate Device | |||
| Attribute | EFAI SPECT Workflows | |||
| (K213731) | AutoQUANT® Plus | |||
| (K040326) | Difference | |||
| Manufacturer | Ever Fortune.AI Co., Ltd. | ADAC LABORATORIES | NA | |
| Regulation | ||||
| Number | 21 CFR §890.1200 | 21 CFR §890.1200 | Same | |
| Regulatory Class | Class II | Class II | Same | |
| Product Code | KPS | KPS | Same | |
| Device Property | Software (SaMD) | Software applications | ||
| (Module) | Same | |||
| Intended Use / Indications for Use | ||||
| EFAI SPECT | ||||
| Workflows | ||||
| (K213731) | EFAI CARDIOSUITE SPECT MYOCARDIAL PERFUSION AGILE WORKFLOWS is an | |||
| image processing software that provides analysis on DICOM images acquired from GE Medical | ||||
| Systems Nuclear Quantitative Perfusion SPECT software to support appropriately trained | ||||
| healthcare professionals in the evaluation and assessment of myocardial perfusions. | ||||
| It provides the following functionality: | ||||
| • Segmentation of the Bull's Eye images from the original DICOM | ||||
| • Analysis of the Bull's Eye images to help assess perfusion | ||||
| • Custom settings to generate text reports | ||||
| The results of this processing may be used to aid in evaluating and assessing myocardial | ||||
| perfusions. | ||||
| The system is an adjunct tool for GE Medical Systems Nuclear Quantitative Perfusion SPECT | ||||
| software. | ||||
| AutoQUANT® | ||||
| Plus (K040326) | AutoQUANT® Plus applications are intended to enable an automated display, review, and | |||
| quantification of Nuclear Medicine Cardiology medical images and datasets. | ||||
| AutoQUAINT® Plus may be used in multiple settings including the hospital, clinic, doctors | ||||
| office, or remotely via dial up. The results provided should be reviewed by qualified healthcare | ||||
| professionals (e.g., radiologists, cardiologists, or general nuclear medicine physicians) trained in | ||||
| the use of medical imaging devices. | ||||
| Data Type / | ||||
| Device Source | EFAI SPECT Workflows | |||
| (K213731) | AutoQUANT® Plus | |||
| (K040326) | Difference | |||
| Applied Body | ||||
| Parts | Left Ventricle | Left Ventricle | Same | |
| Data File Type | Nuclear Medicine | |||
| Cardiology SPECT | ||||
| Perfusion Image | Nuclear Medicine | |||
| Cardiology SPECT | ||||
| Perfusion Image | Same | |||
| Data Device Source | GE Medical System Israel, | |||
| Functional Imaging : | ||||
| Myovation Software, | ||||
| K201103 | All types of cardiac SPECT | |||
| dataset; Nuclear Medicine | ||||
| Cardiology medical images | Similar. | |||
| The data sources both | ||||
| came from similar type | ||||
| of SPECT device. | ||||
| Input Data | ||||
| (Image Modality) | GE SPECT Scanning (Bull's | |||
| eye image in DICOM file) | All type Cardiac SPECT | |||
| raw data (Nuclear Medicine | ||||
| Cardiology medical images | ||||
| in DICOM SC file) | No Significant | |||
| Difference. | ||||
| The proposed device | ||||
| acquires the GE SPECT | ||||
| scanning images; | ||||
| The predicate device | ||||
| acquires the cardiac | ||||
| SPECT raw data. | ||||
| Both devices can receive | ||||
| SPECT scanning & data. | ||||
| Output Format | ||||
| (Report Modality) | Texts and Pictures; | |||
| Web page, HTML; | ||||
| Structured Text File. | DICOM SC for snapshots | |||
| saved to the database; TIFF | ||||
| or PNG for screen captures | ||||
| saved to a folder on a local | ||||
| drive; Output files are for | ||||
| PowerPoint use only. Any | ||||
| other usage of output files | ||||
| (outside of PowerPoint) is | ||||
| not supported. | Similar type output | |||
| format in pictures | ||||
| format; | ||||
| The proposed device has | ||||
| conducted the software | ||||
| test report to ensure the | ||||
| functionalities is safe and | ||||
| effective. | ||||
| Data Storage | Report format can be store | |||
| (PDF, word, TXT) in | ||||
| Database Unit. | Storage of all generated | |||
| results in a separate review | ||||
| file. | ||||
| Available formats are: | Similar. | |||
| The proposed device is | ||||
| used the texts and | ||||
| pictures file format | ||||
| TIFF, JPEG, PNG, BMP, | ||||
| DICOM SC. | stored in Database Unit; | |||
| The predicate device is | ||||
| used the snapshot file | ||||
| saved in the local patient | ||||
| database. | ||||
| Both devices can store | ||||
| the SPECT images. | ||||
| Features/Functions | EFAI SPECT Workflows | |||
| (K213731) | AutoQUANT® Plus | |||
| (K040326) | Difference | |||
| Segmentation | ||||
| Algorithm | YES | |||
| Hough Transform | ||||
| (Segmentation of the Bull's | ||||
| Eye Image) | YES | |||
| (Ventricular Segmentation) | Both devices include | |||
| segmentation algorithm. | ||||
| Orientation | ||||
| Method | NO | YES | No orientation method | |
| was used in proposed | ||||
| device. | ||||
| The difference does not | ||||
| raise any new questions | ||||
| of safety or effectiveness. | ||||
| Segmental | ||||
| Perfusion Scores | ||||
| (Stress, Rest) | YES | |||
| (Based on 17- Segment) | YES | |||
| (Based on 17- or 20- Segment) | Same in 17- segment | |||
| perfusion scores. | ||||
| Processing | ||||
| Functions | Segmentation of the Bull's | |||
| Eye images from the | ||||
| original DICOM : |
- Stress/Rest Score
- Percentage extent of the
defect in the polar map
Analysis of the Bull's Eye
images to help assess
perfusion :
- Color bar react in each of | Quantitative Perfusion
SPECT (QPS) &
Quantitative Gated SPECT
(QGS) : - Determine the location,
orientation, and anatomical
extent of the left ventricle
of the heart - Construct 3D contour
maps of the heart - Calculate the heart volume | The processing function
shares the same clinical
use including: - 17-Segment mapper
Calculation and
display of polar map - Stress/ Rest Score
The target of region on
the Visual Score on two
devices are not same, |
| | into 4 categories
(Max/Min/Mean/Median)
- Color Bar for user to
adjust threshold of scoring,
number of split (3/4/5) - Area diagnosis of the
evaluation for coronary
heart disease | - Calculate Transient
Ischemic Dilation (TID)
Quantitative Blood Pool
SPECT (QBS) : - Generation left and right
valve plans and ventricular
endocardial surfaces - Calculation left and right
valve ventricular volumes - Calculate left and right
ventricular ejection
fractions - Calculation and display of
polar maps
Quantitative Perfusion
Change (QPC) | devices are aimed to
score the region of
perfusion polar maps. | |
| Interface | Custom settings to generate | - ARG (automatic report | Similar. | |
| Functions | text reports : - Modify and approve the
report - Download the report
- Report filter setting
- Select and edit the
clinical findings | generation) - QARG (for reporting
purposes | Two devices can generate
and edit the report for
the users. | |
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Image /page/7/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 green network-like structure as its head. The company name is written in a sans-serif font, with "EVER" on top of "FORTUNE.AI". The color scheme is primarily teal and green.
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Image /page/8/Picture/0 description: The image contains a logo for a company called "EVER FORTUNE.AI". The logo consists of a stylized figure with a circular head and a plus-shaped body, rendered in a gradient of light blue. Above the figure's head is a green sphere with a network of lines connecting points on its surface. To the right of the figure is the company name, with "EVER" in a larger font size and "FORTUNE.AI" in a smaller font size below it.
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Image /page/9/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 above its head, all in a teal color. The text "EVER" is positioned to the right of the figure, with "FORTUNE.AI" below it in a smaller font size.
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Image /page/10/Picture/0 description: The image shows the logo for Ever Fortune AI. The logo consists of a stylized person icon with a globe on top, followed by the text "EVER FORTUNE.AI". The person icon and text are in a light blue color, while the globe is in a light green color.
Performance Data - Non-Clinical VII.
The following performance data were provided in support of the substantial equivalence determination.
To demonstrate safety and effectiveness of EFAI SPECT Workflows 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 SPECT Workflows passed the testing in accordance with internal requirements, national standards, and international standards shown below, supporting its safety and effectiveness, 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
EFAI SPECT Workflows did not require clinical study since substantial equivalence to the currently market and predicate device was demonstrated with the following attribute:
- . Principle of Operation;
- . Indications for Use;
- . Fundamental scientific technology;
- . Non-clinical performance testing:
- . Safety and effectiveness.
Statement of Substantial Equivalence VII.
EverFortune.AI Co., Ltd. Choose the AutoQUANT® Plus (K040326) as a predicate device.
AutoQUANT® Plus is a suite of application are intended to enable an automated display, review, and quantification of Nuclear Medicine Cardiology medical images and datasets.
The proposed device is available to assess "bull's eye" images to show whether there are any potential areas of perfusion defects and automatically generates a report for clinicians; the predicate device integrates 2 functionalities, Quantitative Perfusion SPECT (QPS) and Quantitative Gated SPECT (QGS) into a single application for LV (Left Ventricle) extraction and analysis.
Both devices can assist clinicians in assessing bull's eye images and generating report, increasing the work efficiency.
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Image /page/11/Picture/0 description: The image shows the logo for Ever Fortune AI. The logo consists of a stylized figure in teal with a green globe above it. To the right of the figure is the text "EVER" in a larger font, with "FORTUNE.AI" below it in a smaller font. The logo has a modern and tech-oriented design.
EFAI SPECT Workflows is substantial equivalence to the function of storing, quantifying and report the nuclear medicine cardiology medical images with predicate device - AutoOUANT® Plus.
EFAI SPECT Workflows does not raise different questions of safety and effectiveness than associated with the predicate device.
IX. Conclusion
EFAI SPECT workflows is submitted the information in this premarket notification, including the performance testing and predicate device comparisons support the device; the verification and validation activities demonstrate that EFAI SPECT Workflows perform as intended in the specific use conditions. The difference between the proposed device and predicate devices do not affect the indication for use, safety and effectiveness. And no issues are raised regarding safety regarding safety and effectiveness.
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 AutoQUANT® Plus is substantial equivalent to and perform as well as the predicate device EFAI SPECT workflows.