EFAI PACS PRO 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 PRO 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.

Device Description

The software is a stand-alone software as medical device (Stand-alone SaMD) which provides instant services for clinicians able to use web browsers at client stations to search and view medical data of desired patients which is stored in the software. 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the EFAI PACS PRO device. However, it does not contain specific acceptance criteria, detailed performance data, or information regarding a study design (like sample sizes, ground truth establishment, expert qualifications, or MRMC studies) that would typically be associated with proving a device meets acceptance criteria.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (EFAI PACS K211257) based on its intended use, technological characteristics, and conformance to general software and usability standards.

Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly stated in the provided document in the form of a table with specific quantitative acceptance criteria or reported performance metrics (e.g., accuracy, sensitivity, specificity).

The "Performance Data - Non-Clinical" section states: "Results confirm that the design inputs and performance specifications for the device are met. The EFAI PACS PRO 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."

However, it does not detail:

What those "design inputs and performance specifications" are (i.e., the acceptance criteria).
The actual "results" or specific performance values achieved by the device against these criteria.

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

This information is not provided in the document. The document mentions "non-clinical tests" but does not detail the datasets used for these tests.

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

This information is not provided. The document does not describe the establishment of a ground truth for a test set, nor does it mention any experts involved in such a process.

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

This information is not provided. There is no description of an adjudication method, as no specific test set and ground truth establishment process are detailed.

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

This information is not provided. The document makes no mention of an MRMC study or any assessment of human reader performance improvement with AI assistance. The device is described as a PACS system for displaying, processing, storing, and transferring medical data, and does not directly generate diagnoses or findings, suggesting it may not involve an AI component that directly aids in human reader interpretation for diagnostic tasks in the way an AI-CAD device might.

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

This information is not provided. The device is described as a "stand-alone software as medical device" (SaMD) and offers functionalities like visualization, annotation, and quantification. However, it is a PACS system; it is not an algorithm designed to perform diagnostic tasks independently. Thus, a "standalone" performance evaluation in the context of an AI algorithm predicting an outcome is not applicable here. The "standalone" refers to the entire software system existing on its own, not an AI component's diagnostic performance.

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

This information is not provided. There is no mention of ground truth in the document, as no specific diagnostic performance study is detailed.

8. The sample size for the training set

This information is not provided. Since no AI/ML algorithm requiring a training set for diagnostic purposes is described, details about a training set are absent.

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

This information is not provided for the same reason as point 8.

Summary of what the document does provide regarding "performance":

The document indicates that adherence to the following standards supports its safety and effectiveness and substantial equivalence:

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

This implies that the "acceptance criteria" were met through compliance with these general software development, validation, and usability standards, rather than specific quantitative diagnostic performance metrics. The device is a "Medical Image Management And Processing System" (PACS), not a CAD (Computer-Aided Detection/Diagnosis) device, which would typically require extensive clinical performance studies with specific accuracy metrics.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Ever Fortune.AI Co., Ltd. Ti-Hao Wang Chief Technology Officer 8 F., No. 573, Sec. 2, Taiwan Blvd., West Dist. Taichung City, 403020 Taiwan

August 8, 2023

Re: K232100

Trade/Device Name: EFAI Pacs Picture Archiving and Communication System Pro Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: July 10, 2023 Received: July 14, 2023

Dear Ti-Hao Wang:

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.

Jessica Lamb

Jessica Lamb, PhD Assistant Director DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of 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) K232100

Device Name

EFAI PACS PICTURE ARCHIVING AND COMMUNICATION SYSTEM PRO

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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K232100 510(k) Summary

1. General Information

510(k) Sponsor	Ever Fortune.AI Co., Ltd.
Address	Rm. D, 8F. No. 573, Sec. 2 Taiwan Blvd.West Dist.Taichung City 403020TAIWAN
Applicant	Joseph Chang
Contact Information	886-04-23213838 #216joseph.chang@everfortune.ai
Correspondence Person	Ti-Hao Wang, CTO
Contact Information	886-04-23213838 #168tihao.wang@everfortune.ai
Date Prepared	July 10, 2023

2. Proposed Device

Proprietary Name	EFAI PACS PICTURE ARCHIVING ANDCOMMUNICATION SYSTEM PRO (EFAI PACS PRO)
Common Name	EFAI PACS PRO
Classification Name	System, Image Processing, Radiological
Regulation Number	21 CFR 892.2050
Regulation Name	Medical Image Management and Processing System
Product Code	LLZ
Regulatory Class	II

3. Predicate Device

Proprietary Name	EFAI PACS PICTURE ARCHIVING AND COMMUNICATION SYSTEM (EFAI PACS)
Premarket Notification	K211257

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Classification Name	System, Image Processing, Radiological
Regulation Number	21 CFR 892.2050
Regulation Name	Medical Image Management and Processing System
Product Code	LLZ
Regulatory Class	II

4. Device Description

5. Intended Use

EFAI PACS PRO 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 PRO 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, 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.

6. Comparison of Technological Characteristics with Predicate Device

Table below provides a comparison of the intended use and key technological features of EFAI PACS PRO with that of the Primary Predicate, EFAI PACS (K211257).

Company	Ever Fortune.AI Co., Ltd. (EFAI)	Ever Fortune.AI Co., Ltd. (EFAI)
Device Name	EFAI PACS PRO	EFAI PACS
510k Number	Pending	K211257
Regulation No.	21CFR 892.2050	21CFR 892.2050
Classification	II	II

EFAI PACS PRO Special 510(k)

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Product Code	LLZ	LLZ
IntendedUse/Indicationfor Use	EFAI PACS PRO is intended to be used as a Digital Imaging andCommunications in Medicine (DICOM)and non-DICOM information and datamanagement system. The EFAI PACSPRO displays, processes, stores, andtransfers medical data from originalequipment manufacturers (OEMs) thatsupport the DICOM standard, with theexception of mammography. It providesthe capability to store images and patientinformation from OEM equipment, andperform filtering, digital manipulationand quantitative measurements. Theclient software is designed to run onstandard personal and businesscomputers. The product is intended to beused by trained medical professionals,including but not limited to radiologists,oncologists, and physicians. It isintended to provide image and relatedinformation that is interpreted by atrained professional to render findingsand/or diagnosis, but it does not directlygenerate any diagnosis or potentialfindings.	EFAI PACS is intended to be used as aDigital Imaging and Communications inMedicine (DICOM) and non-DICOMinformation and data management system.The EFAI PACS displays, processes,stores, and transfers medical data fromoriginal equipment manufacturers(OEMs) that support the DICOMstandard, with the exception ofmammography. It provides the capabilityto store images and patient informationfrom OEM equipment, and performfiltering, digital manipulation andquantitative measurements. The clientsoftware is designed to run on standardpersonal and business computers. Theproduct is intended to be used by trainedmedical professionals, including but notlimited to radiologists, oncologists, andphysicians. It is intended to provide imageand related information that is interpretedby a trained professional to renderfindings and/or diagnosis, but it does notdirectly generate any diagnosis orpotential findings.
Device Property	Stand-alone Software	Stand-alone Software
Image Source	Medical data from originalequipment manufacturers(OEMs) that support theDICOM standard	Medical data from originalequipment manufacturers(OEMs) that support theDICOM standard
Transfer/Storage/Displayof MedicalImages	Yes	Yes
DICOMCompliant(Images fileformat)	Yes	Yes
Worklists	Yes	Yes

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Filter and Searchcapabilities	Yes	Yes
Image analysisandreview capability	Yes	Yes.
View DICOMdata	Yes	Yes
Window/leveldetermination	Yes	Yes
Window/levelpresets	Yes	Yes
Adjustwindow/level	Yes	Yes
Measuring tools(General imagemeasurements)	Yes	Yes
Textandgraphicalannotationfunctionalities	Yes	Yes (Only provides Point Annotation:single point measurement)

7. Performance Data - Non-Clinical

To demonstrate safety and effectiveness of EFAI PACS PRO 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 PRO 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.

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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.

8. Conclusion

Based on the information submitted in this premarket notification, and based on the intended use, technological characteristics, and performance testing, the EFAI PACS PRO raises no new questions of safety and effectiveness and is substantially equivalent to the predicate device in terms of safety, effectiveness, and performance.

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).