EFAI PACS PICTURE ARCHIVING AND COMMUNICATION SYSTEM is intended to be used as a Digital Imaging and Communications in Medicine (DICOM) and non-DICOM information and data management system. The EFAI PACS PICTURE ARCHIVING AND COMMUNICATION SYSTEM displays, processes, stores, and ransfers medical data from original equipment manufacturers (OEMs) that support the DICOM standard, with the exception of mammography. It provides the capability to store images and patient information from OEM equipment, and perform filtering, digital manipulation and quantitative measurements. The client software is designed to run on standard personal and business computers. The product is intended to be used by trained medical professionals, including but not limited to radiologists. oncologists, and physicians. It is intended to provide image and related information that is interpreted by a trained professional to render findings and/or diagnosis, but it does not diagnosis or potential findings.

Device Description

The software is a stand-alone software as medical device (Stand-alone SaMD) which provide to instant services for clinician can able to use web browser at client stations to search and view medical data of desired patient which is stored in the software also provides the following visualization, annotation and quantification functionalities which can be applied to the images on the web browser at client stations:

Visualization Functionalities:

a). 2D image view
b). Zoom ratio adjust
c). Pan
d). Window Level and Window Width adjust
e). Positive & Negative film effect
f). Mirror Flip
g). Multi-screen display
h). Cine Loop Play

Annotation Functionality:

Point Annotation

Quantification Functionalities:

a). Distance measurement
b). Area measurements
c). Angle measurement
d). Single Point measurement

AI/ML Overview

The provided document, a 510(k) Premarket Notification for the EFAI PACS Picture Archiving and Communication System, primarily focuses on demonstrating substantial equivalence to a predicate device (Arterys Viewer K171544) rather than presenting a detailed study proving the device meets specific acceptance criteria through extensive empirical performance testing.

The document explicitly states on page 7, Section 5.8 "Performance Date - Clinical": "EFAI PACS did not require clinical study since substantial equivalence to the currently market and predicate device was demonstrated with the following attribute: Design features; Indications for Use; Fundamental scientific technology; Non-clinical performance testing; Safety and effectiveness."

Therefore, a table of acceptance criteria and reported device performance based on a dedicated clinical study cannot be extracted from this document, as such a study was not performed for this 510(k) submission.

Instead, the submission relies on the successful completion of non-clinical tests (software verification and validation, usability engineering) and a clinical evaluation based on existing literature and adverse event data to support substantial equivalence.

Here's an analysis of the provided information concerning the device's acceptance, focusing on what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance (as inferred from Non-Clinical Testing and Equivalence Claim):

Since no specific "performance criteria" for a clinical study are provided, the acceptance criteria are implicitly those of demonstrating substantial equivalence to the predicate device and meeting software/usability standards.

Acceptance Criteria (Implied)	Reported Device Performance (as stated in document)
Non-Clinical Performance:
Software Verification & Validation (IEC 62304/FDA Guidance)	"Results confirm that the design inputs and performance specifications for the device are met. The EFAI PACS 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." (Page 7, Section 5.7) "In Compliance with." (Page 7, Section 5.7)
Usability Engineering (IEC 62366-1 & 62366-2)	"In Compliance with." (Page 7, Section 5.7)
Clinical Performance (via Equivalence and Evaluation):
Substantial Equivalence to Predicate Device (Arterys Viewer K171544) for indicated uses and technological characteristics, without raising new safety/effectiveness questions.	"EFAI PACS did not require clinical study since substantial equivalence to the currently market and predicate device was demonstrated with the following attribute: Design features; Indications for Use; Fundamental scientific technology; Non-clinical performance testing; Safety and effectiveness." (Page 7, Section 5.8) "The EFAI PACS has the same intended use as the Arterys Viewer, and the same or similar technological characteristics. The differences in technological characteristics do not raise new or different questions of safety and effectiveness. Performance testing has demonstrated the EFAI PACS is as safe and effective as the predicate device. Therefore, the EFAI PACS is substantially equivalent to the predicate device." (Page 8, Section 5.9)

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

Sample Size: Not applicable in the context of a prospective clinical performance study. The document refers to "non-clinical tests" and a "clinical evaluation" which relied on existing data.
Data Provenance: Not explicitly stated as a sampled test set. The clinical evaluation involved reviewing "adverse event data base search results" and "three clinical articles mentioned in the CEP and CER" (Page 8, Section 5.8). The country of origin for these databases or articles is not specified. It's retrospective analysis of existing information.

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

Not applicable. No new test set requiring expert ground truth establishment was used for performance validation in a clinical study. The clinical evaluation relied on existing literature and adverse event data.

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

Not applicable. No test set requiring adjudication of findings was used for a clinical study.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The device is a PACS system for image management, display, and basic manipulation, not an AI-assisted diagnostic tool. Its functionality explicitly states it "does not directly generate any diagnosis or potential findings" (Page 4, Section 5.4).

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

The device itself is a "Stand-alone Software as Medical Device (SaMD)" (Page 4, Section 5.5). However, a standalone performance test in the sense of an algorithm producing diagnostic output was not done because the device's function is as an image management system, not a diagnostic AI. The non-clinical testing verified its functional performance (e.g., display, measurement accuracy, DICOM compliance).

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

For functional non-clinical tests: The "ground truth" would be against design specifications and expected outputs for image display, processing, storage, and measurement tools. This would be established through internal verification and validation procedures.
For the clinical evaluation: It relied on available "adverse event data base search results" and data from "three clinical articles," which represent existing clinical information rather than a newly established ground truth for device performance.

8. The sample size for the training set:

Not applicable. This is a PACS system, not a machine learning algorithm that learns from training data for diagnostic or predictive tasks.

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

Not applicable, as there is no training set for this type of device.

In summary, the EFAI PACS 510(k) submission primarily demonstrates safety and effectiveness through substantial equivalence to an existing predicate device and compliance with relevant software and usability engineering standards, rather than through a dedicated clinical performance study with defined acceptance criteria and a test set.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font below.

September 10 , 2021

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

Re: K211257

Trade/Device Name: EFAI PACS Picture Archiving and Communication System Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: July 29, 2021 Received: August 2, 2021

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 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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

For

Thalia T. Mills, Ph.D. 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)

K211257

Device Name

EFAI PACS PICTURE ARCHIVING AND COMMUNICATION SYSTEM

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------

× Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for Ever Fortune.AI at the top. Below the logo is the text "5. 510(k) Summary". The text is in a large, bold font and is likely a section heading within a document. The number 5 suggests that this is the fifth section of the document.

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

5.1 Submitter Information
Company:	CHEN MING-FONG
	Chairman
	EVER FORTUNE.AI Co., Ltd.
	Rm. D, 8 F., No. 573, Sec. 2, Taiwan Blvd., West Dist.,
	Taichung City 403020, Taiwan
	Telephone: (886)-4-2321-3838
	Fax: (886)-4-2322-9797
	ra05@everfortuneai.com.tw
Contact:	CHEN MING-FONG
	Chairman
	EVER FORTUNE.AI Co., Ltd.
	Rm. D, 8 F., No. 573, Sec. 2, Taiwan Blvd. West Dist.,
	Taichung City 403020, Taiwan
	Telephone: (886)-4-2321-3838
	Fax:(886)-4-2322-9797
	ra05@everfortuneai.com.tw
Date Summary Prepared:	April 20, 2021

5.2 Name of the Device

The product name "EFAI PACS Picture Archiving and Communication System" will be replaced by "EFAI PACS" abbreviation in the whole document.

Trade Name:	EFAI PACS Picture Archiving and Communication System (orEFAI PACS)
Common Name:	EFAI PACS Picture Archiving and Communication System (orEFAI PACS)

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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 circular head made of interconnected nodes, suggesting a network or global connection. The text "EVER FORTUNE.AI" is written in a sans-serif font, with "EVER" positioned above "FORTUNE.AI", indicating the company's name and its focus on artificial intelligence.

Classification Name:	Radiology
Review Panel:	Radiology
Regulation:	892.2050 - Medical image management and processing system
Class:	Class II
Product Code:	LLZ

5.3 Equivalence Claimed to Predicate Device

The EFAI PACS is equivalent to the Arterys Viewer (K171544), manufactured by Arterys Inc. is provided as primary predicate device.

5.4 Indication for Use

EFAI PACS Picture Archiving and Communication System is intended to be used as a Digital Imaging and Communications in Medicine (DICOM) and non-DICOM information and data management system. The EFAI PACS Picture Archiving and Communication System displays, processes, stores, and transfers medical data from original equipment manufacturers (OEMs) that support the DICOM standard, with the exception of mammography. It provides the capability to store images and patient information from OEM equipment, and perform filtering, digital manipulation and quantitative measurements. The client software is designed to run on standard personal and business computers. The product is intended to be used by trained medical professionals, including but not limited to radiologists, oncologists, and physicians. It is intended to provide image and related information that is interpreted by a trained professional to render findings and/or diagnosis, but it does not directly generate any diagnosis or potential findings.

5.5 Device Description

Visualization Functionalities:

a). 2D image view
b). Zoom ratio adjust
c). Pan
d). Window Level and Window Width adjust
e). Positive & Negative film effect
f). Mirror Flip

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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 in teal, with a green globe-like structure above its head. The text "EVER" is positioned above "FORTUNE.AI" in a sans-serif font, also in teal. The overall design is clean and modern.

g). Multi-screen display
h). Cine Loop Play

Annotation Functionality:

Point Annotation
Quantification Functionalities:
a). Distance measurement
b). Area measurements
c). Angle measurement
d). Single Point measurement

5.6 Substantial Equivalence

The following table compares the EFAI PACS to the predicate device with respect to indications for use, principles of operation, technological characteristics, materials, and performance, and forms the basis for the determination of substantial equivalence. The subject device does not raise any new questions of safety or effectiveness as compared to the predicate device.

Table 5.1: Comparison Table
Attribute	EFAI PACS	Arterys Viewer (K171544)	Comparison
Device Name/510(k) #	EFAI PACS PictureArchiving andCommunication System(Ever Fortune.AI Co., Ltd.) /K#TBD	Arterys Viewer (ArterysInc.) / K171544	--
Support Mammography	No	No	Same
Device Property	Stand-alone Software	Stand-alone Software	Same
Classification	- Class II- Picture archiving andcommunications system- LLZ (21 CFR 892.2050)	- Class II- Picture archiving andcommunications system- LLZ (21 CFR 892.2050)	Same
Operating System(Web accessible)	Client server architectureusing Linux server and web	Client server architectureusing Linux server and web	Same
	browser client (Web-basedonly)	browser client (Web-basedonly)
Image Source	Medical data from originalequipment manufacturers(OEMs) that support theDICOM standard	Medical data from originalequipment manufacturers(OEMs) that support theDICOM standard	Same
Transfer/Storage/Displayof Medical Images	Yes	Yes	Same
Network Access	Web browser connects toexisting PACS	Web browser connects toexisting PACS	Same
Imagestorage/Compression(Image DataCompression)	Support JPEG2000 andcompression	Support JPEG2000 andcompression	Same
Mammography Use	No support for theexamination modality files ofmammography	No support for theexamination modality filesof mammography	Same
DICOM Compliant(Images file format)	Yes	Yes	Same
Worklists	Yes	Yes	Same
Filter and Searchcapabilities	Yes	Yes	Same
Ability to search studies	Yes	Yes	Same
Image analysis andreview capability	Yes	Yes	Same
Zoom in/Out	Yes	Yes. Default settings canzoom interactively	Same
View DICOM data	Yes	Yes. You can view theDICOM information aboutthe patient and study, andthe pixel information	Same
Window/leveldetermination	Yes. Window width/length inmenu	Yes. Let the user adjust W/L	Same
Window/level presets	Yes	Yes	Same
Adjust window/level	Yes	Yes	Same
Measuring tools(General imagemeasurements)	Yes	Yes. Linear, area, and pixelintensity and location of apoint	Same
Custom filters	Yes	Yes. Can set filters to affectthe studies listed	Same
Set reading state	Yes. Study description inmenu icon	Yes	Same

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Image /page/6/Picture/0 description: The image contains a logo for a company called EVER. The logo consists of a stylized teal-colored symbol resembling a person with a network of connected dots above their head, followed by the word "EVER" in a sans-serif font. Below "EVER" is the text "FORTUNE.AI" in a smaller font size.

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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 circular head made of interconnected dots, suggesting a network or connection. The figure and the text are in a teal color, creating a clean and modern look. The text "EVER" is in a larger, bolder font, while "FORTUNE.AI" is in a smaller font below it.

5.7 Performance Data - Non-Clinical

To demonstrate safety and effectiveness of EFAI PACS and to show substantial equivalence to the predicate device, Ever Fortune completed the non-clinical tests. Results confirm that the design inputs and performance specifications for the device are met. The EFAI PACS 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 In Compliance with. o
Application of usability engineering to medical devices Part 1 per IEC 62366-1 In . Compliance with.
Guidance on the application of usability engineering to medical devices per IEC 62366-2 In . Compliance with.

5.8 Performance Date - Clinical

EFAI PACS did not require clinical study since substantial equivalence to the currently market and predicate device was demonstrated with the following attribute:

Design features;
Indications for Use;
0 Fundamental scientific technology:
Non-clinical performance testing;
0 Safety and effectiveness.

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

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Image /page/8/Picture/0 description: The image shows the logo for Ever Fortune AI. The logo consists of a green icon that looks like a person with a network of dots above their head. To the right of the icon is the text "EVER" in a larger font and "FORTUNE.AI" in a smaller font. The text is also green.

Based on the requirements recommended by FDA regarding the Clinical Evaluation, Ever Fortune has conducted the Clinical Evaluation for the EFAI PACS, the Clinical Evaluation Plan, Report and the adverse event data base search results are provided as Attachment 31 (EFAI PACS P-CKEVIEWER001), Attachment 32 (EFAI PACS R-CKE-VIEWER001), Attachment 15 – 18 CER Annex I-FDA Recall LLZ 2011-2021). The three clinical articles mentioned in the CEP and CER are uploaded to the Reference section.

5.9 Statement of Substantial Equivalence

The EFAI PACS has the same intended use as the Arterys Viewer, and the same or similar technological characteristics. The differences in technological characteristics do not raise new or different questions of safety and effectiveness. Performance testing has demonstrated the EFAI PACS is as safe and effective as the predicate device. Therefore, the EFAI PACS is substantially equivalent to the predicate device.

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).