The Web Clinical System is intended for the management and displaying of x-ray images, other radiological objects, and information. It can manage images from different modalities, single and multiple file servers, and interfaces to various Radiological Information Systems (RIS), image storage and printing devices using DICOM or similar interface standards within the system or across computer networks at distributed locations.

Device Description

The Web-Clinical System (WCS) is a component of the RAYPAX System, a PACS solution by Samsung or can be a separate device for other manufacturer's PACS. The WCS is a system for managing radiological images and data by retrieving and browsing medical images through the World Wide Web, (Internet), a clients Intranet or over computer networks.

AI/ML Overview

This document is a 510(k) summary for the 삼성 SDS Co. Ltd. RAYPAX™ Web Clinical System (WCS). It establishes substantial equivalence to a predicate device for marketing approval. However, it does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

Specifically, the following information is not present in the provided text:

A table of acceptance criteria and the reported device performance: This document describes the device's intended use and technological characteristics but does not define specific performance metrics or acceptance criteria for those metrics.
Sample size used for the test set and the data provenance: No information about a test set, its size, or its origin (country, retrospective/prospective) is provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: As there's no test set described, there's no mention of experts or ground truth establishment.
Adjudication method for the test set: No test set means no adjudication method.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: This is a system for managing and displaying images, not an AI or diagnostic aid that would typically undergo MRMC studies with human readers for improved performance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The device description emphasizes human interpretation ("A physician, providing ample opportunity for competent human interprets images and information being printed."), indicating it's not a standalone diagnostic algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No ground truth is mentioned.
The sample size for the training set: No training set is mentioned as this is not an AI/ML device that requires training.
How the ground truth for the training set was established: Not applicable without a training set.

Summary of available information related to device evaluation:

The document primarily focuses on demonstrating substantial equivalence to a predicate device (SECTRA IMTEC AB Wise II Image Management System) based on indications for use and technological characteristics. It mentions:

Hazard Analysis: All potential hazards have been classified as "Minor."
The system has been designed and will be manufactured in accordance with voluntary standards.
The FDA's letter (K992426) confirms the device's substantial equivalence to legally marketed predicate devices.

This 510(k) process for this type of device (a digital imaging workstation/image communication accessory) in 1999 typically would not involve the kind of clinical performance studies and AI-specific metrics you've asked for. It's a system to manage and display images, meaning its efficacy is largely tied to its functionality, reliability, and security, rather than diagnostic accuracy as a standalone AI model.

Summary

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510(k) Summary of Safety and Effectiveness OCT 1 3 1999

K992426

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

Date Prepared:

July 16, 1999

Submitter's Information: 21 CFR 807.92(a){1)

SAMSUNG SDS CO., LTD 707-19, Yoksam-Dong, Kangnam-Gu, Seoul, South Korea, 135-080

Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2)

Trade Name:	Samsung RAYPAX™ Web Clinical System
Common Name:	Digital Imaging Workstation
Classification Name:	System, Digital Image Communication Accessory
Device Classification:	21 CFR 892.2010

Predicate Device: 21 CFR 807. 92(a)(3)

The Samsung SDS Co. Ltd. RAYPAX™ WCS is substantially equivalent to the: Manufacturer: SECTRA IMTEC AB Device Name: Wise II Image Management System 510(k) Number: K983447 9/30/98 Date Received: Decision Date: 10/29/98 Decision: Substantially Equivalent Panel Code device reviewed by: Radiology Panel Code device classified by: Radiology Product Code: 90 LMB Classification: Class I

Device Description: 21 CFR 807 92(a)(4)

Indications for Use: 21 CFR 807 92(a)(5)

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Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants.

Technological Characteristics: 21 CFR 807 92(a)(6)

The device does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human interprets images and information being printed.

Conclusion: 21 CFR 807 92(b)(1)

The 510(k) Pre-Market Notification for the WCS contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.

The RAYPAX™ WCS system has been designed and will be manufactured in accordance 1. with the voluntary standards listed in the enclosed voluntary standard survey.
1. The submission contains the results of a hazard analysis and all potential hazards have been classified as Minor.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 3 1999

Carl Alletto Samsung SDS Co. Ltd. C/O Otech, Inc. 2001 East Oakshores Drive Aubrey, Texas 76227

Re:

K992426

RAYPAX™ Web Clinical System (WCS) Dated: July 16, 1999 Received: July 21, 1999 Regulatory class: I 21 CFR 892.2020/Procode: 90 LMD

Dear Mr. Alletto:

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 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). 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 III (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 QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation 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 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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 notfication"(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/cdrh/dsma/dsmamain.html".

Sincerely yours,

Capt. Daniel G. Schultz, M.D. Acting 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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(Indications for Use Form)

510(k) Number: K992426

Device Name:

Samsung SDS Co. Ltd. RAYPAX™ Web Clinical System

Indications for Use:

The Web Clinical System is intended for the management and displaying of xray images, other radiological objects, and information. It can manage images from different modalities, single and multiple file servers, and interfaces to various Radiological Information Systems (RIS), image storage and printing devices using DICOM or similar interface standards within the system or across computer networks at distributed locations.
Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants.

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

David G. Hanson

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices

510(k) Number K992426

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 892.2020 Medical image communications device.

(a)
Identification. A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, and interfaces. It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions. This does not include electronic transfer of medical image software functions.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.