Concordance Between Omnyx System With Omnyx .RTS Images and the Omnyx Dynamyx Software With Hamamatsu .NDPI Images

The overall study design was to compare the diagnosis obtained by .rts WSI from the Omnyx system (Omnyx scanner and Omnyx Software) and diagnosis obtained by .ndpi WSI of the Hamamatsu S360 or similar scanner with the Omnyx Software. Pathologists read cases in the Omnyx Dynamyx software with .rts images from an Omnyx scanner and complete a Preliminary Surgical Pathology Consultant Report that includes a preliminary diagnosis. After a two-week washout period, the pathologists read the same cases in the Omnyx Dynamyx software with .ndpi images from a Hamamatsu scanner. The diagnosis from the Omnyx scanners are provided in the Final Surgical Pathology Consultant Report. Pathologists then complete an Inspirata Whole Slide Imaging Case Worksheet to determine confirmation of diagnosis - that is, agreement/concordance between the WSI from the two scanners.

The study is designed to prove that the diagnosis of a case will be the same when using the Omnyx .rts file type as the Hamamatsu .ndpi file type regardless of tissue or procedure type.

All discrepancies between the two "systems" will be documented and reconciled. Discrepancies categorized as Major or Minor. The Principal Investigator Discordance Review Form will be utilized to document the Principal Investigator's review of those cases where discrepancies were attributed to technical/technological aspects of WSI, such as sub-optimal image quality.

This is a deidentified, retrospective study to evaluate surgical pathology cases, excluding frozen sections and cytology. Formalin-fixed paraffin embedded tissue from sixty (60) cases across a range of three (3) subspecialist categories will be used.

Materials for each case include the original pathology report and the complete set of physical slides from each case at the time of diagnosis. Cases will be no more than two (2) years older than the Date of Protocol.