AISight Dx
PathAI, Inc.AISight Dx is a software-only, web-based digital pathology image viewing and management system designed to aid pathologists in viewing, interpreting, and managing digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It supports images from scanners such as the Hamamatsu NanoZoomer S360MD and Leica Aperio GT 450 DX. The software allows pathologists to zoom, pan, measure, and annotate whole slide images to assist in primary diagnosis while ensuring image quality through built-in quality controls.
Intended Use
AISight Dx is a software only device intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review, interpret, and manage digital images of these slides for primary diagnosis. It is not intended for use with frozen sections, cytology, or non-FFPE hematopathology specimens.
Technology
AISight Dx is a web-based, software-only image viewing and management system that ingests whole slide images from compatible FDA-cleared scanners (Hamamatsu NanoZoomer S360MD and Leica Aperio GT 450 DX) in multiple digital file formats (NDPI, SVS, DICOM). It allows pathologists to view, pan, zoom, measure, annotate, and compare images in an integrated workflow within a compliant computer environment. The software leverages interoperable displays, scanners, file formats, and web browsers validated through a Predetermined Change Control Plan (PCCP).
Performance
Performance testing included pixel-wise image comparison to predicate devices demonstrating pixel-identical output; clinical studies showing non-inferiority of digital reads using AISight Dx vs. traditional glass slide microscopy for primary diagnosis, with major discordance rates below the pre-specified threshold; turnaround time testing for adequate image loading and interactions; measurement accuracy verified against calibrated slide; and human factors validation proving safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
10/31/2024
7 months - 2
FDA Approval
6/26/2025
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