The Samsung RAYPAX™ Display Workstation is a device that receives digital images and data from various image sources, (including but not limited to CT Scanners, MR Scanners, Ultrasound Systems, R/F Units, Computed & Direct Radiographic devices, secondary capture devices, film scanners, imaging gateways, or other imaging sources). Images and data can be stored, communicated, processed, and displayed within the workstation or across computer networks at distributed locations.

The typical users of this system are trained professionals, including but not limited to physicians, nurses, and medical technicians.

Device Description

The Display Workstation is one of the components of the RAYPAX, a PACS solution by Samsung or can be a separate device for other manufacturer's PACS. The Display Workstation provides image-processing functions and workflow for the radiology department for medical images that are acquired and stored in the RAYPAX image server in DICOM 3.0 format.

Furthermore, the Display Workstation can transfer medical images stored in RAYPAX system to other PACS through a DICOM compatible network and can export images to other applications in bitmap format.

AI/ML Overview

This 510(k) submission (K992306) describes the Samsung RAYPAX™ Display Workstation System. However, it does not contain a study or data proving the device meets specific acceptance criteria in the manner you've requested for a modern AI/CADe device.

This submission is from 1999 for a "Digital Imaging Workstation" which is essentially a specialized computer for viewing medical images. It predates the widespread use of AI/Machine Learning in medical devices and the rigorous performance testing and reporting requirements we see today for such algorithms.

Here's a breakdown based on the information provided, highlighting why most of your requested points cannot be answered from this document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not specified in this document. The submission focuses on substantial equivalence to a predicate device, primarily through technological characteristics and intended use.	No performance metrics (e.g., sensitivity, specificity, AUC) are reported. The document confirms the device functions as a display workstation for medical images.

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

Not applicable / Not specified. This type of device (a display workstation) does not typically undergo performance testing with a "test set" of medical images in the way an AI algorithm would. Its function is to display images, not to autonomously interpret them or produce diagnostic outputs.
The document mentions receiving digital images from various sources (CT, MR, Ultrasound, etc.), but this refers to its functionality, not a test dataset for performance evaluation.

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

Not applicable / Not specified. No ground truth establishment is mentioned because no performance study is detailed.

4. Adjudication method for the test set

Not applicable / Not specified. No test set performance study is 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

No, an MRMC comparative effectiveness study was not done. This device is a display workstation, not an AI-powered diagnostic tool intended to assist human readers diagnostically.

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

No, a standalone performance study was not done. The device's purpose is to display images for human interpretation, not to provide standalone diagnostic outputs. The document explicitly states: "A physician, providing ample opportunity for competent human intervention interprets images and information being printed."

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

Not applicable / Not specified. No performance study with ground truth is mentioned.

8. The sample size for the training set

Not applicable / Not specified. This device is not an AI algorithm that requires a training set.

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

Not applicable / Not specified. No training set or ground truth establishment for a training set is mentioned.

Summary of the Study (as described in the 510(k) submission):

The "study" or justification for this device's acceptance is based on demonstrating substantial equivalence to a predicate device (Olicon Imaging Systems, Inc 02-Workstation & PACS View Software, K973959). The submission outlines:

Device Description: What the device is and what it does (receives, stores, communicates, processes, and displays medical images in DICOM format).
Indications for Use: The specific medical purposes for which the device is intended.
Technological Characteristics: How it operates, noting it does not contact the patient, control life-sustaining devices, and that a physician interprets the images.
Conclusion: The claim that the device is substantially equivalent to the predicate device, implying similar safety and effectiveness based on its technical features and intended use. The submission also mentions compliance with voluntary standards and a hazard analysis classifying potential hazards as "Minor."

In essence, this 510(k) application demonstrates that the Samsung RAYPAX™ Display Workstation performs the same functions, has similar technological characteristics, and is therefore as safe and effective as a previously cleared workstation. It does not involve the type of clinical performance study with specific acceptance criteria typically associated with AI/CADe devices.

Summary

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K99 2306

SEP 22 1999

510(k) Summary of Safety and Effectiveness

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

Date Prepared:

June 30, 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™ Display Workstation System
Common Name:	Digital Imaging Workstation
Classification Name:	System, Digital Image Communication accessory
Device Classification:	21 CFR 892.2020

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

Manufacturer:	Olicon Imaging Systems, Inc
Device:	02-Workstation & PACS View Software
510(k) Number:	K973959
Date Received:	10/16/97
Decision Date:	12/22/97
Decision:	Substantially Equivalent
Panel Code device reviewed by:	Radiology
Panel Code device classified by:	Radiology
Product Code:	90 LMD
Classification:	Class II

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

Furthermore, the Display Workstation can transfer medical images stored in RAYPAX system to other PACS through a DICOM compatible network and can export images to other applications in bitmap format.

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

The typical users of this system are trained professionals, including but not limited to physicians, nurses, and medical technicians.

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 intervention interprets images and information being printed.

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

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

The RAYPAX™ Display Workstation system has been and will be manufactured in 1. accordance with the voluntary standards listed in the enclosed voluntary standard survey.
The submission contains the results of a hazard analysis and all potential hazards 2. have been classified as Minor.

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Public Health Service

Rockville MD 20850

Food and Drug Administration 9200 Corporate Boulevard

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

SEP 2 2 1999

Samsung SDS Co., LTD. C/O Mr. Carl Aletto OTECH. Inc. 2001 East Oakshores Drive Aubrey, TX 76227

Re:

K992306 Samsung RAYPAX™ Display Workstation Dated: June 30, 1999 Received: July 9, 1999 Regulatory Class: II (TWO) Product Code: 90 LLZ 21 CFR 892.2050

Dear Mr. Aletto:

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 (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 (Special Controls) or 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 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 531 through 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/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:

Device Name:

Samsung SDS Co. Ltd. RAYPAX™ Display Workstation System

Indications for Use:

The typical users of this system are trained professionals, including but not limited to physicians, nurses, and medical technicians.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

ministen CircOfficial	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Annual design of the consideration-------

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

510(k) Number K992346

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).