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.

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.

AI/ML Overview

Based on the provided text, the document is a 510(k) Premarket Notification from EverFortune.AI Co., Ltd. for their device, EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows. The primary purpose of this document is to demonstrate "substantial equivalence" to a legally marketed predicate device (AutoQUANT® Plus) rather than providing detailed performance data from a clinical study for specific acceptance criteria.

The document explicitly states: "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."

Therefore, much of the requested information regarding "acceptance criteria" based on a study proving the device meets the criteria, particularly clinical performance data, is not present in this 510(k) summary because a clinical study was not conducted or deemed necessary for this submission. The tests performed were non-clinical, focusing on software verification and validation, and usability engineering.

Here's a breakdown of the information that can be extracted or inferred, and what is explicitly not available:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: No specific numerical acceptance criteria (e.g., minimum sensitivity, specificity, or image quality scores) from a performance study are provided in this document. The "criteria" for this 510(k) submission appear to be demonstrating substantial equivalence through non-clinical testing and comparison of technological characteristics with the predicate device.
Reported Device Performance:
- Non-Clinical Tests: "Results confirm that the design inputs and performance specifications for the device are met." (General statement, no specific metrics provided).
- Standards Met:
  - 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

Table (based on inferred "acceptance" for substantial equivalence and reported non-clinical performance):

Acceptance Criteria Category (Inferred)	Reported Device Performance
Equivalence in Principle of Operation	Found to be substantially equivalent to predicate device
Equivalence in Indications for Use	Found to be substantially equivalent to predicate device
Equivalence in Fundamental Scientific Technology	Found to be substantially equivalent to predicate device
Non-Clinical Performance: Software Validation	Passed testing in accordance with IEC 62304/FDA Guidance
Non-Clinical Performance: Usability Engineering	Passed testing in accordance with IEC 62366-1 and IEC 62366-2
Safety and Effectiveness	Supported by non-clinical testing; no new questions of safety/effectiveness

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not specified. Since no clinical study was performed, there isn't a "test set" of patient data in the sense of a clinical trial. The non-clinical testing would have used various test cases and scenarios, but the number of these is not disclosed.
Data Provenance: Not specified for the non-clinical tests. For the intended use of the device, it processes DICOM images acquired from GE Medical Systems Nuclear Quantitative Perfusion SPECT software. The origin of the training data is not mentioned.

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

This information is not available as no clinical study with expert-established ground truth on a test set was conducted for this 510(k) submission.

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

This information is not available as no clinical study with a test set requiring adjudication was conducted.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC study was done. The document explicitly states: "EFAI SPECT Workflows did not require clinical study". Therefore, no effect size of human reader improvement with AI assistance is provided.

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

The document describes the device as "image processing software that provides analysis on DICOM images... to support appropriately trained healthcare professionals in the evaluation and assessment of myocardial perfusions." It's stated as an "adjunct tool." While software verification and validation were done, indicating standalone technical performance testing, no specific "algorithm only" performance metrics comparable to a clinical study (e.g., sensitivity/specificity for a clinical outcome) are reported. The focus was on software functionality and compliance with standards.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

This information is not available as no clinical study with established ground truth was conducted. For the non-clinical software tests, the "ground truth" would be determined by the software's specified design outputs and expected behavior, not clinical expert consensus or pathology.

8. The sample size for the training set

The sample size for the training set is not specified in this document. The document focuses on demonstrating substantial equivalence, not detailing the development or training of the AI components.

9. How the ground truth for the training set was established

How the ground truth for the training set was established is not specified in this document. Similar to point 8, the focus of this 510(k) summary is on equivalence and non-clinical validation, not on the specifics of algorithm development and training data curation.

Summary

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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

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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.

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

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
RegulationNumber	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 SPECTWorkflows(K213731)	EFAI CARDIOSUITE SPECT MYOCARDIAL PERFUSION AGILE WORKFLOWS is animage processing software that provides analysis on DICOM images acquired from GE MedicalSystems Nuclear Quantitative Perfusion SPECT software to support appropriately trainedhealthcare 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 reportsThe results of this processing may be used to aid in evaluating and assessing myocardialperfusions.The system is an adjunct tool for GE Medical Systems Nuclear Quantitative Perfusion SPECTsoftware.
AutoQUANT®Plus (K040326)	AutoQUANT® Plus applications are intended to enable an automated display, review, andquantification of Nuclear Medicine Cardiology medical images and datasets.AutoQUAINT® Plus may be used in multiple settings including the hospital, clinic, doctorsoffice, or remotely via dial up. The results provided should be reviewed by qualified healthcareprofessionals (e.g., radiologists, cardiologists, or general nuclear medicine physicians) trained inthe use of medical imaging devices.
Data Type /Device Source	EFAI SPECT Workflows(K213731)	AutoQUANT® Plus(K040326)	Difference
Applied BodyParts	Left Ventricle	Left Ventricle	Same
Data File Type	Nuclear MedicineCardiology SPECTPerfusion Image	Nuclear MedicineCardiology SPECTPerfusion Image	Same
Data Device Source	GE Medical System Israel,Functional Imaging :Myovation Software,K201103	All types of cardiac SPECTdataset; Nuclear MedicineCardiology medical images	Similar.The data sources bothcame from similar typeof SPECT device.
Input Data(Image Modality)	GE SPECT Scanning (Bull'seye image in DICOM file)	All type Cardiac SPECTraw data (Nuclear MedicineCardiology medical imagesin DICOM SC file)	No SignificantDifference.The proposed deviceacquires the GE SPECTscanning images;The predicate deviceacquires the cardiacSPECT raw data.Both devices can receiveSPECT scanning & data.
Output Format(Report Modality)	Texts and Pictures;Web page, HTML;Structured Text File.	DICOM SC for snapshotssaved to the database; TIFFor PNG for screen capturessaved to a folder on a localdrive; Output files are forPowerPoint use only. Anyother usage of output files(outside of PowerPoint) isnot supported.	Similar type outputformat in picturesformat;The proposed device hasconducted the softwaretest report to ensure thefunctionalities is safe andeffective.
Data Storage	Report format can be store(PDF, word, TXT) inDatabase Unit.	Storage of all generatedresults in a separate reviewfile.Available formats are:	Similar.The proposed device isused the texts andpictures file format
		TIFF, JPEG, PNG, BMP,DICOM SC.	stored in Database Unit;The predicate device isused the snapshot filesaved in the local patientdatabase.Both devices can storethe SPECT images.
	Features/Functions	EFAI SPECT Workflows(K213731)	AutoQUANT® Plus(K040326)	Difference
SegmentationAlgorithm		YESHough Transform(Segmentation of the Bull'sEye Image)	YES(Ventricular Segmentation)	Both devices includesegmentation algorithm.
OrientationMethod		NO	YES	No orientation methodwas used in proposeddevice.The difference does notraise any new questionsof safety or effectiveness.
SegmentalPerfusion Scores(Stress, Rest)		YES(Based on 17- Segment)	YES(Based on 17- or 20- Segment)	Same in 17- segmentperfusion scores.
ProcessingFunctions		Segmentation of the Bull'sEye images from theoriginal DICOM :- Stress/Rest Score- Percentage extent of thedefect in the polar mapAnalysis of the Bull's Eyeimages to help assessperfusion :- Color bar react in each of	Quantitative PerfusionSPECT (QPS) &Quantitative Gated SPECT(QGS) :- Determine the location,orientation, and anatomicalextent of the left ventricleof the heart- Construct 3D contourmaps of the heart- Calculate the heart volume	The processing functionshares the same clinicaluse including:- 17-Segment mapperCalculation anddisplay of polar map- Stress/ Rest ScoreThe target of region onthe Visual Score on twodevices are not same,
	into 4 categories(Max/Min/Mean/Median)- Color Bar for user toadjust threshold of scoring,number of split (3/4/5)- Area diagnosis of theevaluation for coronaryheart disease	- Calculate TransientIschemic Dilation (TID)Quantitative Blood PoolSPECT (QBS) :- Generation left and rightvalve plans and ventricularendocardial surfaces- Calculation left and rightvalve ventricular volumes- Calculate left and rightventricular ejectionfractions- Calculation and display ofpolar mapsQuantitative PerfusionChange (QPC)	devices are aimed toscore the region ofperfusion polar maps.
Interface	Custom settings to generate	- ARG (automatic report	Similar.
Functions	text reports :- Modify and approve thereport- Download the report- Report filter setting- Select and edit theclinical findings	generation)- QARG (for reportingpurposes	Two devices can generateand edit the report forthe 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.

Regulation Number and Section

§ 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.