(82 days)
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.
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.
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.
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GE Medical Systems
General Electric Company
P.O. Box 414, Mihenuhee. WI 53201
510(k) Summary of Safety and Effectiveness
This 510/k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h).
| Identification of Submitter: | GE Medical SystemsPO Box 414Milwaukee, WI 53201 |
|---|---|
| Contact: | Larry Kroger, Ph D |
ેવુસાં, Manager, Regulatory Programs 414-544-3894
Date Prepared: February 17, 1997
Product Identification: GE Advantage Digitizer Workstation. This is a new product release.
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.
Indications for 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.
Comparison with Predicate Device: The GE Advantage Digitizer Workstation is comparable in key safety and effectiveness features, components and hardware requirements and has the same intended uses as the Dejarnette Imageshare Film Digitizer Acquisition Gateway, the Lumisys DICOM Toolkit, and the RadWorks Medical Imaging Software.
Summary of Studies: In addition to system design verification tests to assure conformance with the design specifications, the design has or will undergo further validation to assure overall user satisfaction.
Conclusion: Intended uses and basic system design, including the hardware, are similar to products manufactured by other companies. The features of this product are the same as those available on other legally marketed products. Therefore, it is the opinion of GE Medical Systems that the GE Advantage Digitizer Workstation is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.
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