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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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