AISight Dx

AISight Dx is a web-based software-only device that enables pathologists to view, interpret, and manage digital whole slide images of surgical pathology slides prepared from formalin-fixed paraffin-embedded (FFPE) tissue. It aids in primary diagnosis by allowing zooming, panning, annotation, and measurement of scanned slides acquired from compatible WSI scanners.

Unlike the predicate devices which are Windows-based systems that include hardware scanners and displays, AISight Dx is an internet browser-based image management software only. It accepts multiple image file formats (NDPI, SVS, DICOM) from either Hamamatsu or Leica scanners and displays them on compatible FDA-cleared monitors via Google Chrome or Microsoft Edge browsers.

Not stated in this summary. The document references NIST calibration for measurement validation but does not cite specific consensus standards such as ISO, IEC, or ASTM.

AISight Dx is substantially equivalent because it performs the same intended function—digital pathology image viewing and diagnosis support for FFPE tissue—with equivalent image viewing and measurement features (zoom, pan, annotation, distance/area measurements) as the predicate devices. Clinical studies demonstrated non-inferior diagnostic performance compared to glass slide microscopy, with major discordance rates meeting the prespecified non-inferiority threshold of 4%. Pixel-wise comparison testing confirmed identical image reproduction across supported file formats.