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K Number
K970628
Device Name
GE ADVANTAGE DIGITIZER WORKSTATION
Manufacturer
GE MEDICAL SYSTEMS, INC.
Date Cleared
1997-05-12

(82 days)

Product Code
LMD
Regulation Number
892.2020
Type
Traditional
Panel
Radiology
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The GE Advantage Digitizer Workstation is a film digitizing and DICOM converting quality assurance (QA) workstation that permits viewing and annotation changes of digitized images prior to lossless storage to a hard drive or transmission to another DICOM device on a local or wide area network.

Device Description

The GE Advantage Digitizer Workstation consists of a PC Pentium computer running Windows NT with a keyboard, mouse and SVGA color monitor, application software and a film digitizer.

AI/ML Overview

I am sorry, but the provided text is a 510(k) summary for the GE Advantage Digitizer Workstation and does not contain the specific information requested about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment relevant to the performance of an AI-powered medical device.

The document describes a film digitizing and DICOM converting quality assurance (QA) workstation. It focuses on:

  • Device Description: A PC Pentium computer running Windows NT with specific hardware and software, including a film digitizer.
  • Indications for Use: Viewing and annotating digitized images, lossless storage, and transmission to other DICOM devices.
  • Comparison with Predicate Device: States it is comparable to other existing film digitizer acquisition gateways and medical imaging software.
  • Summary of Studies: Mentions "system design verification tests to assure conformance with the design specifications" and validation for "overall user satisfaction."

There is no mention of an AI algorithm, acceptance criteria for an AI's performance (e.g., sensitivity, specificity), data from a clinical study proving such performance, or details about ground truth, expert opinions, or sample sizes related to evaluating an AI's diagnostic accuracy.

Therefore, I cannot populate the table or answer the specific questions based on the provided text.

§ 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.