(81 days)
For In Vitro Diagnostic Use
The PathPresenter Clinical Viewer is a software intended for viewing and managing whole slide images of scanned glass sides derived from formalin fixed paraffin embedded (FFPE) tissue. It is an aid to pathologists to review and render a diagnosis using the digital images for the purposes of primary diagnosis. PathPresenter Clinical is not intended for use with frozen sections, cytology specimens, or non-FFPE specimens. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using PathPresenter Clinical software. PathPresenter Clinical Viewer is intended for use with Hamamatsu NanoZoomer S360MD Slide scanner NDPI image formats viewed on the Barco NV MDPC-8127 display device.
The PathPresenter Clinical Viewer (version V1.0.1) is a web-based software application designed for viewing and managing whole slide images generated from scanned glass slides of formalin-fixed, paraffin-embedded (FFPE) surgical pathology tissue. It serves as a diagnostic aid, enabling pathologists to review digital images and render a primary pathology diagnosis. Functions of the viewer include zooming and panning the image, annotating the image, measuring distances and areas in the image and retrieving multiple images from the slide tray including prior cases and deprecated slides.
Here's a breakdown of the acceptance criteria and study information for the PathPresenter Clinical Viewer based on the provided FDA 510(k) clearance letter:
Acceptance Criteria and Device Performance for PathPresenter Clinical Viewer
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Pixelwise Comparison | The 95th percentile of the pixel-wise color difference in any image pair is less than 3 CIEDE2000 ( |
N/A