The PLATINUM Image Reading, Review & Analysis Workstation is an image display workstation that is intended for use by qualified physicians for reading, reviewing and analyzing computerized digital images and reports acquired from imaging devices such as CT, MRI or computed radiography systems. PLATINUM is used to view digital images which are obtained either from a GE PACS System or a DICOM device, i.e. Acquisition, Archive or Workstation.

Device Description

The PLATINUM Reading, Review & Analysis Workstation is a medical image display workstation intended to assist radiologists in making diagnoses.

AI/ML Overview

The provided text describes a medical device, the "PLATINUM Reading, Review & Analysis Workstation," which is a PACS workstation. However, it does not contain a study proving the device meets specific acceptance criteria.

Instead, the document is a 510(k) premarket notification summary submitted to the FDA in 1998, indicating the device's substantial equivalence to previously marketed devices. This type of submission generally does not require extensive clinical studies with specified acceptance criteria in the same way a novel high-risk device might. The focus is on demonstrating that the new device is as safe and effective as a legally marketed predicate device.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets them because that information is not present in the provided text.

Here is a breakdown of why each point cannot be addressed:

A table of acceptance criteria and the reported device performance: This information is not provided. The document states a general intent for the workstation to "assist radiologists in making diagnoses" and its similarity in "intended use and technological characteristics" to predicate devices, but no quantifiable performance metrics or acceptance criteria are given.
Sample size used for the test set and the data provenance: No test set is described. The document discusses regulatory compliance and substantial equivalence, not a performance study data set.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no test set or ground truth establishment is described.
Adjudication method: Not applicable as no test set or adjudication process is described.
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: Not applicable. This device is a PACS workstation, not an AI-assisted diagnostic tool. No MRMC study is mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a display workstation for human readers, not an algorithm performing a standalone diagnosis.
The type of ground truth used: Not applicable as no performance study requiring ground truth is described.
The sample size for the training set: Not applicable as training sets are associated with algorithms or AI, which this device is not.
How the ground truth for the training set was established: Not applicable.

Summary

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JUN 1 8 1998

SUMMARY OF SAFETY AND EFFECTIVENESS

I. General Information

Classification Name:

Common/Usual Name:

Device Trade Name:

Classification:

Anatomical Region: Intended Uses: Diagnostic Uses:

Establishment Name and Address:

Establishment Registration Number:

Performance Standards:

PACS (Picture. Archival and Communications System) Workstations

PLATINUM Reading, Review & Analysis Workstation

FDA has proposed a classification for PACS (Picture Archiving and Communication System) as Class II in 21CFR 892.2050.

All areas Image Review

GE Medical Systems 3000 N. Grandview Blvd. Waukesha, WI 53188

2126677

No applicable performance standards for this device have been issued under Section 514 of the Federal Food, Drug and Cosmetic Act. However, the video display monitors which are components of the system comply with applicable standards for television receivers and appropriate submissions have been filed with CDRH in accordance with the Radiation Control Health and Safety Act. The ROM components of the system comply with 21CFR, Subchapter J - Radiological Health. All workstation components are evaluated for compliance with Information Technology Equipment Standards (UL 1950/IEC 950) by a nationally recognized testing laboratory (NRTL) and so Listed. The device also complies with the standard for EMC -IEC 60601-1-2.

II. Safety and Effectiveness Information Supporting the Substantial Equivalence Determination

General Safety and Effectiveness Concerns:

The device labeling contains instructions for use. It includes indications for use and cautions. This information assures safe and effective use of the device.

Substantial Equivalence:

The PLATINUM Reading, Review & Analysis Workstation is a medical image display workstation intended to assist radiologists in making diagnoses. The intended use and technological characteristics are similar to the GE Medical Systems PACS Image Display Workstations, Image Acquisition Workstations, and Network Storage Products, GE Medical Systems PACS LiteBox, GE Medical Systems Advantage Windows Review Workstation, and ISG Technologies' ISG Viewing and Reading Stations (VRS), and ISG Silhouette Radiology Application products.

Page 199 of 201

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of 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, stacked on top of each other.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 8 1998

Larry A. Kroger, Ph.D. Regulatory Affairs Program Manager GE Medical Systems P.O. Box 414 Milwaukee, WI 53201

Re:

K981217 Platinum Reading, Review and Analysis Workstation Dated: April 2, 1998 Received: April 3, 1998 Regulatory class: II 21 CFR 892.2050/Procode: 90 LLZ

Dear Dr. Kroger:

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 revisions of the Rederal 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 Fecteral Regulations, Title 21, Parts 800 to 895. A substantially equivaliation assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) 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 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/odri/dsmaldsmam.html".

Sincerely yours,

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: PLATINUM Reading, Review & Analysis Workstation

Indications For Use:

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

	Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,and Radiological Devices

510(k) Number	K981217
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Prescription Use(Per 21 CFR 801.109)	OR	Over-The-Counter Use
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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).