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1717SGC Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. Not to be used for mammography.

1717SGC is a digital solid state X-ray detector that is based on flat-panel technology. This radiographic image detector and processing unit consists of a scintillator coupled to an a-Si TFT sensor. This device needs to be integrated with a radiographic imaging system. It can be utilized to capture and digitalize X-ray images for radiographic diagnosis The RAW files can be further processed as DICOM compatible image files by separate console SW (not part of this 510k submission) for a radiographic diagnosis and analysis.

The provided text is a 510(k) summary for the 1717SGC Digital Flat Panel X-ray Detector. It focuses on demonstrating substantial equivalence to a predicate device and adherence to electrical, mechanical, and safety standards. It does not contain information related to acceptance criteria for algorithm performance or a study proving such criteria are met for an AI/CAD/software device.

Therefore, I cannot populate the table or answer the questions based on the provided text. The document describes a hardware device (X-ray detector), not a software or AI device that would have performance metrics like sensitivity, specificity, or reader improvement.

If you have a document specific to an AI/CAD software device, please provide that, and I would be happy to analyze it.

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