The EC-WEB FS-PACS is intended for the manipulation, management, and display of medical images. It can manage and display images from different modalities and interfaces and can distribute those images to various workstation, image storage and printing devices using, DICOM or similar standards. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using cleared monitors intended for mammography display. Typical users of this system are trained medical professionals, including physicians, nurses, technicians and computer system professionals.

Device Description

The EC-WEB FS-PACS system is based on DICOM standard application. The main function of FS-PACS is about medical image management within a PACS environment. It's including image archival, retrieval and distribution of medical images.

FS-PACS can support the following modality: CR, ES, NM, RF, US, CT, MG, OT, RT, XA, DX, MR, PT, SC, VR, IO, SR. There is no 3D image manipulation functions. FS-PACS provides the following measurement tools: 2-point distance, 3-point angles, ellipse area, and square area. FS-PACS can support the iOS device (i.e., iPad and iPhone). Images reviewed on the mobile device are not intended for diagnostic use. FS-PACS does not include any type of imaging hardware. It does not provide any masking or image filtering functions.

AI/ML Overview

The provided text is a 510(k) summary for the EC-WEB FS-PACS, a Picture Archiving and Communications System (PACS). This document primarily focuses on establishing substantial equivalence to a predicate device (DATACOM DC-PACS K083182) rather than providing detailed acceptance criteria and a study demonstrating performance against those criteria.

Therefore, many of the requested details about acceptance criteria, device performance metrics, and study specifics are not available in the provided text. The document states that "Non-clinical data are employed upon submission of this 510(k) premarket notification according to the FDA guidance document," and that "This submission contains the results of software validation that the risks analysis and the potential hazards have been classified as Moderate Level of Concern." However, it does not explicitly describe the test methods, acceptance criteria, or performance results in detail.

Here's a breakdown of the available information:

1. Table of acceptance criteria and the reported device performance:

This information is not explicitly provided in the document. The submission focuses on functional equivalence to a predicate device. It states that "The conclusions drawn from the non-clinical tests demonstrate that the device is as safe, as effective, and performs as well as the legally marketed device identified in the submission." However, specific numerical acceptance criteria or performance metrics are not presented.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

This information is not available in the provided text. The document mentions "non-clinical data" and "software validation" but does not specify details about test sets, sample sizes, or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not available. The document focuses on the technical characteristics and functional equivalence of the PACS system. It is a device for managing and displaying medical images, not an AI diagnostic tool that requires ground truth established by experts for performance evaluation. The "typical users" are described as "trained medical professionals, including physicians, nurses, technicians and computer system professionals."

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

This information is not available. As noted above, the provided document does not detail specific performance studies that would involve adjudication for a test set.

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:

An MRMC comparative effectiveness study was not done or at least not reported in this 510(k) summary. This device is a PACS system for image management and display, not an AI-powered diagnostic aide. Therefore, the concept of human readers improving with AI assistance is not applicable in this context.

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

A standalone performance study of an algorithm is not described. The device is a PACS system that supports human review and interpretation of images. The document explicitly states that "A physician, providing ample opportunity for competent human intervention, interprets images and information being displayed and printed."

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

This information is not applicable or available. As a PACS system, it handles and displays medical images but does not generate diagnoses or interpretations that would require a "ground truth" in the diagnostic performance sense. The validation would likely be against functional requirements and DICOM compliance.

8. The sample size for the training set:

This information is not available. The FS-PACS is a software system for image management, not a machine learning model that requires a training set.

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

This information is not available and not applicable. As stated above, this device is not a machine learning model requiring a training set and associated ground truth.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around the perimeter. In the center is a stylized graphic of what appears to be a human figure.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 23, 2016

EC-WEB CO., LTD. % Dr. Ke-Min Jen Official Correspondent 4F., NO. 89, Taiyuan Road, Datong Dist. Taipei City, 103 Taiwan REPUBLIC OF CHINA

Re: K152034

Trade/Device Name: FS-PACS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 14, 2016 Received: January 20, 2016

Dear Dr. Jen:

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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael D'Hara

For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K152034

Device Name

FS-PACS

Indications for Use (Describe)

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

ا Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Image /page/3/Picture/0 description: The image shows a blue circular icon with a stylized "E" in a lighter blue color. The "E" appears to be three-dimensional, with a blocky design. The icon has a glossy effect, suggesting it might be a software or application icon. The background is a gradient of light blue to white.

O.,LTD.

Taiyuan Rd., Datong Dist., Taipei City 103, Taiwan (R.O.C.) +886-2-2550-4790 Fax:+886-2-2559-8682 Web Site:www.e-web.com.tw

B. Administrative Information

B.1 510(K) Summary of Safety and Effectiveness

(Per 21 CFR 807.92)

Type of 510(k) Submission	Traditional
Basis for the submission	A New Device (There is no prior submission for the subject derive.)
510(k) Submitter	EC-WEB CO., LTD.
	4F., No.89, Taiyuan Rd., Datong Dist., Taipei City
	103, Taiwan (R.O.C.)
	Telephone: +886-2-2550-4790
	Fax:+886-2-2559-8682
	Web: www.e-web.com.tw
Official Correspondent	Dr. Jen, Ke-Min
	TEL: +886-3-5208829 FAX: +886-3-5209783
	Email: ceirs.jen@msa.hinet.net
Preference for ContinuedConfidentiality (21 CFR 807.95)	510(k) Summary

Date Prepared

January 14, 2016

FS-PACS Proprietary (Trade) Name Common Name of the Proposed Picture Archiving and Communications System Device

Classification Name Regulation Number Class Panel Product Code

Predicate Device

Picture Archiving and Communications System 21 CFR 892.2050 II Radiology LLZ

DATACOM TECHNOLOGY CORP DATACOM DC-PACS K083182

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C-WEB CO.,LTD.

No.89, Taiyuan Rd., Datong Dist., Taipei City 103, Taiwan (R.O.C.) : +886-2-2550-4790 Fax: +886-2-2559-8682 Web Site: www.e-web.com.tw

● Indications For Use::

The EC-WEB FS-PACS is intended for the manipulation, management, and display of medical images. It can manage and display images from different modalities and interfaces and can distribute those images to various workstations, image storage and printing devices using. DICOM or similar standards. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using cleared monitors intended for mammography display. Typical users of this system are trained medical professionals, including physicians, nurses, technicians and computer system professionals.

● Device Description:

● Technological Characteristics:

FS-PACS has multiple software components and has no imaging hardware. The FS-PACS is a software server application and does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human intervention, interprets images and information being displayed and printed.

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Image /page/5/Picture/0 description: The image shows a blue circular icon with a stylized "E" in the center. The "E" is rendered in a three-dimensional, isometric style, giving it a blocky appearance. The icon has a glossy, reflective surface, suggesting a digital or web-based context.

EC-WEB CO.,LTD.

4F., No.89, Taiyuan Rd., Datong Dist., Taipei City 103, Taiwan (R.O.C.) Tel:+886-2-2550-4790 Fax:+886-2-2559-8682 Web Site:www.e-web.com.tw

● Comparison Table

Devices	Predicate device	Subject device
Proprietary Name	DATACOM DC PACS	FS-PACS
510(k) No.	K083182	TBA
Manufacturer	DATACOM Technology Corp.	EC-WEB CO., LTD.
Same Characteristics
ClassificationName	Picture Archiving andCommunications System	Same
Regulation Number	21 CFR 892.2050	Same
Product Code	LLZ	Same
Indications for Use	The DATACOMTM DC-PACS isintended for the manipulation,management, and display of medicalimages. It can manage and displayimages from different modalities andinterfaces and can distribute thoseimages to various workstation, imagestorage and printing devices using.DICOM or similar standards. Typicalusers of this system are trainedmedical professionals, includingphysicians, nurses, technicians andcomputer system professionals.	The EC-WEB FS-PACS isintended for themanipulation, management,and display of medicalimages. It can manage anddisplay images fromdifferent modalities andinterfaces and can distributethose images to variousworkstation, image storageand printing devices using.DICOM or similarstandards. Lossycompressedmammographic imagesand digitized film screenimages must not bereviewed for primaryimage interpretations.Mammographic imagesmay only be interpretedusing cleared monitorsintended for
		mammography display.Typical users of this systemare trained medicalprofessionals, includingphysicians, nurses,technicians and computersystem professionals.
NetworkingCommunicationsProtocol	DICOM 3.0	Same
DICOMC-Store Service	DICOM Workstation can use thisfunction to send the DICOM file toPACS	Same
DICOMC-Echo Service	DICOM Workstation can use thisfunction to verify theDICOM service of PACS	Same
DICOMQuery/RetrieveService	PACS Viewer can use this functionto search with PACS, and view theDICOM image from PACS.	Same
DICOMC-Find Service	DICOM Workstation can use thisfunction to get patient informationfrom PACS.	Same
DICOM Imagebackup system	Backup DICOM images anddatabase	Same
Different Characteristics
DICOMMulti-portC-Store Service	None	PACS can set multi-port toretrieve DICOM imagesfrom DICOM Workstationsin hospital.
Customize PaperPrint	None	PACS Viewer can use thisfunction to customize theprint layout.
Dental Template	None	PACS has dental template toview the intraoral DICOMimage.This dental template can becustomized by user.
Client ViewerLogin UserPermission	None	PACS has permission tocontrol every accounts andlimit their functions for user
Capture DICOMimage duringrecording	None	Capture workstationcan capture image duringrecording
Convert documentfile to DICOMimage	None	Gateway can convertdocument file or send toPACS.
Convert digitalimage to DICOMimage	None	Gateway can convert digitalimage to DICOM image andsend to PACS with mobiledevice.
Access DICOMimagefrom Internet	PACS provides Web-Viewer toaccess DICOM image from Internet	Web-Viewer can invite andsynchronize exam imageswith other online user.
Parse the DICOMSR (StructureReport) file	None	FS-Workstation can parsethe DICOM SR (StructureReport) file and insert themeasurement value tocustomize report by user.
MonitoringFS-PACS program	None	A monitor program to getstatus from all of FS-PACSprogram, when one ofFS-PACS program getserror, it will restart thatprogram automatically.

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Image /page/6/Picture/0 description: The image is a glossy, circular icon with a blue color scheme. Inside the circle, there is a stylized, three-dimensional shape that resembles a series of interconnected blocks or the letter 'W' repeated and layered. The shape is also in varying shades of blue, creating a sense of depth and dimension within the icon.

EC-WEB CO.,LTD.

4F., No.89, Taiyuan Rd., Datong Dist., Taipei City 103, Taiwan (R.O.C.) Tel:+886-2-2550-4790 Fax:+886-2-2559-8682 Web Site:www.e-web.com.tw

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Image /page/7/Picture/0 description: The image shows a blue, circular logo with a stylized, three-dimensional "W" in the center. The "W" is also blue and appears to be made of stacked blocks, giving it a geometric and modern look. The logo has a glossy, reflective effect, suggesting a digital or web-based context. The background is a gradient of light blue, fading from a lighter shade at the top to a slightly darker shade at the bottom.

EC-WEB CO.,LTD.

4F., No.89, Taiyuan Rd., Datong Dist., Taipei City 103, Taiwan (R.O.C.) Tel:+886-2-2550-4790 Fax:+886-2-2559-8682 Web Site:www.e-web.com.tw

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No.89, Taiyuan Rd., Datong Dist., Taipei City 103, Taiwan (R.O.C.) Tel: +886-2-2550-4790 Fax: +886-2-2559-8682 Web Site: www.e-web.com.tw

● Substantial Equivalence (SE) Discussion

A claim of substantial equivalence is made to DATACOM DC-PACS (K083182). Both of them have the similar indications for use, the same working principle and technologies. The extra statement about the mammographic images for the subject device provides more safety consideration than the predicate device. The other differences are due to the feature design aspects, not related to the safety and effectiveness aspects. This submission contains the results of software validation that the risks analysis and the potential hazards have been classified as Moderate Level of Concern. Thus they are substantially equivalent.

● Synopsis of Test Methods and Results

Non-clinical data are employed upon submission of this 510(k) premarket notification according to the FDA guidance document. Guidance for Industry: Guidance for the Submission of Premarket Notifications for Medical Image Management Devices. Document issued on: July 27, 2000.

● Conclusion

The conclusions drawn from the non-clinical tests demonstrate that the device is as safe, as effective, and performs as well as the legally marketed device identified in the submission. Thus the subject device is substantially equivalent to the predicate devices.

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).