SENYINT Remote Consultation System by Dalian Senyint Digital Medical System Co., Ltd.

It is a software system including several applications working together whose intended use is to provide completely scalable local and wide area PACS solutions for hospital, related Institutions and sites.

SENYINT Remote Consultation System provides several server applications that receive images from medical imaging modalities(including but not limited to CT, MRI, CR, DR, MG, US, RF, PET and other DICOM devices), store and archive them, and distribute them to DICOM devices, 3rd party Image View Workstation, SENYINT Remote Consultation System Web-Viewer, etc.

SENYINT Remote Consultation System provides a Client Image View Workstation. It allows the user to access patient records and retrieve images from the PACS server in a network. Senyint Image View Workstation has a simple GUI for viewing images in 2D and 3D mode. The functions in 2D mode including zoom, pan, windowing, basic measurements, image mosaic, cine, etc. It also display images from CT, MR and PET in the 3D mode including MPR, OPR, VR, VE, MIP, MinilP, AIP, tissue segmentation, Batch reconstruction, etc. In addition, using this Workstation, users can edit report and print film.

SENYINT Remote Consultation System provides a Web-Viewer that is a browser-based web application. It allows the user to access patient records and retrieve images from the PACS server in a wide area setup. The Web-Viewer has a simple GUI for viewing images including, basic measurements, cine, etc. It provides a diagnostic viewer of medical images for referral purposes. It is not intended to replace full workstations and should be used only when there is no access to a workstation. It is available as a supplement sub-system to SENYINT Remote Consultation System or as a stand-alone Web-based image and information distribution system. It is not intended to be used on mobile device platforms(e.g., iPAD, iPhone) .

SENYINT Remote Consultation System can manage the consultation and consultation process. The consultation information management realizes the input, verification of remote consultation information. The consultation process management realizes the quality control and review of consultation nodes and process. The video conference function can be used to build a real-time virtual conference between application and consultation physicians during remote consultation and diagnosis.

SENYINT Remote Consultation System Manager Workstation is used to set the basic information on the management of the system so that the system can work normally. The system management achieves the settings of such information as hospital, departments, physicians, user roles and video conference. Only authorized users to be able to visit our Workstation to operate.

Device Description

SENYINT Remote Consultation System is a Picture Archiving and Communication (PACS) software system. It is a software system including several applications working together whose intended use is to provide completely scalable local and wide area PACS solutions for hospital, related Institutions and sites. It provides server applications that receive, store, archive, and distribute images from medical imaging modalities. It also provides a Client Image View Workstation for accessing patient records and viewing images in 2D and 3D modes with various functions, and a Web-Viewer for accessing and viewing images for referral purposes. Additionally, it includes functions for managing consultation information and processes, video conferencing, and system management.

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA regarding the "SENYINT Remote Consultation System." This document primarily focuses on regulatory approval and declaring substantial equivalence to predicate devices. It describes the device's intended use and functionalities, but it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria, such as sensitivity, specificity, or any clinical accuracy metrics for an AI/CAD system.

The "SENYINT Remote Consultation System" is classified as a Picture Archiving and Communications System (PACS) software. Its functionalities include:

Receiving, storing, and archiving images from medical imaging modalities (CT, MRI, CR, DR, MG, US, RF, PET, and other DICOM devices).
Distributing images to DICOM devices and third-party viewers.
Providing a Client Image View Workstation with 2D and 3D viewing capabilities (zoom, pan, windowing, measurements, MPR, VR, MIP, etc.).
Offering a Web-Viewer for referral purposes (not intended to replace full workstations or for mobile devices).
Managing consultation information and processes, including quality control and video conferencing.

Since the device is a PACS system and not an AI/CAD system designed to automatically interpret medical images or assist human readers in diagnosis, the traditional performance metrics (sensitivity, specificity, AUROC) and study types (MRMC, standalone algorithm performance) commonly associated with AI/CAD devices are not applicable or described in this document. The FDA's review for such a device would typically focus on software validation, interoperability, data integrity, security, and usability, rather than diagnostic accuracy benchmarks.

Therefore, I cannot populate the requested table or answer most of the questions based on the provided text, as the information regarding specific acceptance criteria and a performance study for a diagnostic AI/CAD component is absent.

To directly answer your questions based only on the provided text:

A table of acceptance criteria and the reported device performance:
- Not Available. The document does not describe performance-based acceptance criteria for AI/CAD features (e.g., sensitivity, specificity) or report such performance data. The FDA letter is an approval letter based on substantial equivalence, not a detailed performance study report.
Sample sizes used for the test set and the data provenance:
- Not Applicable/Not Available. No test set for performance evaluation of AI/CAD is mentioned. The device is a PACS system.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable/Not Available. No test set or ground truth establishment process for AI/CAD performance is mentioned.
Adjudication method for the test set:
- Not Applicable/Not Available. No test set for AI/CAD performance is mentioned.
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, not mentioned. An MRMC study is not described, as this is a PACS system, not an AI-assisted diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, not mentioned. A standalone performance study for an AI algorithm is not described.
The type of ground truth used:
- Not Applicable/Not Available. No ground truth for AI/CAD performance evaluation is mentioned.
The sample size for the training set:
- Not Applicable/Not Available. No training set for an AI algorithm is mentioned, as this is a PACS system.
How the ground truth for the training set was established:
- Not Applicable/Not Available. No training set or ground truth establishment process for AI is mentioned.

Summary

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Dalian Senyint Digital Medical System Co., Ltd. % Di Wu Regulatory Affairs Consultant Di Wu Regulatory 3440 Indian Queen Lane, Rear PHILADELPHIA PA 19129

Re: K162727

Trade/Device Name: SENYINT Remote Consultation System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 18, 2018 Received: January 19, 2018

Dear Di Wu:

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

February 8, 2018

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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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn

(http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael D. O'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) K162727

Device Name SENYINT Remote Consultation System

Indications for Use (Describe)

SENYINT Remote Consultation System is a Picture Archiving and Communication (PACS) software system.

Typical users of SENYINT Remote Consultation System are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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).