The Network System is intended to provide electronic management of the acquisition, storage, distribution and review of Medical Images. Management activities include: Acquisition of the Network System from all medical modalities and digitized films. Storage archive is managed by a database. Distribution and wide area networks based on standard TCP protocols. Review Reading Station (MMRS), the primary diagnostic reading station. The reading station has all necessary functions to enable full Radiological interpretation Images.

Device Description

The Network System is a Picture Archiving and Communication System (PACS). The system is intended to computerize Medical Image handling in Medical institutions. The computerization of the Medical records improves the efficiency of Medical Record handling and thus has a positive effect on Medical practice. The Network System is intended to provide electronic management of the acquisition, storage, distribution and review of Medical Images.

AI/ML Overview

Here's the breakdown of the acceptance criteria and study information for "The Network System" based on the provided text:

Important Note: The provided text is a 510(k) summary for a Picture Archiving and Communication System (PACS). For such systems, the "acceptance criteria" and "device performance" are typically related to the functional capabilities of saving, retrieving, and displaying images, rather than accuracy metrics (like sensitivity/specificity) for a diagnostic AI. The document primarily focuses on demonstrating substantial equivalence to a predicate device for these functionalities. There is no mention of an AI algorithm or diagnostic performance criteria in the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the device (a PACS), the acceptance criteria and reported performance revolve around its ability to manage medical images.

Acceptance Criteria	Reported Device Performance
Acquisition: Ability to acquire images from all medical modalities and digitized films.	The Network System is intended to acquire images from all medical modalities and digitized films.
Storage: Ability to store images in a managed archive via a database.	The archive is managed by a database.
Distribution: Ability to distribute images via local and wide area networks based on standard TCP protocols.	Distribution is via local and wide area networks based on standard TCP protocols.
Review: The Medical Monitor Reading Station (MMRS) provides all necessary functions for full Radiological interpretation of images.	The reading station has all necessary functions to enable full Radiological interpretation of images.

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not mention a specific "test set" in the context of diagnostic performance or AI validation. The 510(k) submission focuses on the functional capabilities of the PACS and its substantial equivalence to a predicate device. Therefore, no information regarding sample size or data provenance for a "test set" (as typically understood for AI evaluation) is available.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable and not provided in the document as it pertains to a PACS system, not a diagnostic AI algorithm that requires expert-established ground truth for a test set.

4. Adjudication Method for the Test Set

This information is not applicable and not provided, as there is no diagnostic "test set" requiring adjudication mentioned in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC study is not mentioned in the document. The device is a PACS for image management, not an AI intended to assist human readers diagnostically. Therefore, there is no information about human reader improvement with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone study for an AI algorithm is not mentioned in the document. The device is a PACS system, and its performance is described in terms of its ability to acquire, store, distribute, and display images, not evaluate them diagnostically as a standalone algorithm.

7. Type of Ground Truth Used

The concept of "ground truth" (e.g., pathology, outcomes data) is not applicable and not mentioned in the context of this PACS device. The ground truth for this type of system would be its functional correctness (e.g., did the image save correctly, can it be retrieved, is it displayed properly).

8. Sample Size for the Training Set

The document does not mention a "training set" as it is describing a PACS system, not an AI algorithm that requires training data.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable and not provided, as there is no "training set" or AI algorithm mentioned that would require ground truth establishment.

Summary

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JUN 17 1998

SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807 92.

Submitter: Medical SNI Ltd. POB 25370 Haifa ISRAEL tel. +972.4.842.6192

Name of the Device: The Network System.

Description of the Device:

and Communication System (PACS). The system is intended to computerize Medical Image handling in Medical institutions. The computerization of the Medical records improves the efficiency of Medical Record handling and thus has a positive effect on Medical practice.

The Network System is intended to provide electronic management of the acquisition, storage, distribution and review of Medical Images.

Acquisition

the Network System from all medical modalities and digitized films.

Storage

archive is managed by a database.

Distribution

and wide area networks based on standard TCP protocols.

Review

Reading Station (MMRS), the primary diagnostic reading station. The reading station has all necessary functions to enable full Radiological interpretation Images.

The Network System is shown schematically in the figure below:

Image /page/0/Figure/20 description: The image shows a diagram with four boxes connected by arrows and a horizontal line. The top left box is labeled "Input Data Digital Modalities", and the top right box is labeled "Input Data Digital X - Ray". The bottom left box is labeled "Archive", and the bottom right box is labeled "MMRS". The arrows indicate the flow of data between the boxes.

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Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, resembling a bird-like shape.

ి ప్రాథమిక
శాశాల

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

す

JUN 1 7 1998

Eli M. Orbach, Ph.D. International Regulatory Consultants Medical SNI LTD POB 6718, ERFRAT 90435 ISRAEL Re:

K980234 The Network System (Picture archiving and communications system Dated: May 28, 1998 Received: June 1, 1998 Regulatory class: II 21 CFR 892.2050/Procode: 90 LLZ

Dear Dr. Orbach:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.

If your device is classified (see above) into either class II (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drue Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdr/dsmaldsmamain.html".

Sincerely vours

sincerely yours,

Lillian Yin, Ph.D.

Director, Division of Reproductive Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page_ of_

510(k) Number (if known) K980234

Device Name The Network System

Indications For Use:

The Network System is intended to provide electronic management of the acquisition, storage, distribution and review of Medical Images. Management activities include:

Acquisition

the Network System from all medical modalities and digitized films.

Storage

archive is managed by a database.

Distribution

and wide area networks based on standard TCP protocols.

Review

ਗਈ ਹੈ।
ਬਹੁਤੀ
ਸਾਰਨ

Reading Station (MMRS), the primary diagnostic reading station. The reading station has all necessary functions to enable full Radiological interpretation Images.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David C. Segerson
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT and Radiological Dey

510(k) Number KY80234

Prescription Use (Per 21 CFR 801.109)

Over The Counter Use

(Optional Format 1-2-96)

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).