Evaluation of the Omnyx™ Integrated Digital Pathology System in the Primary Diagnosis of Surgical Pathology Specimens

Study Overview
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Brief Summary
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A multi-site, randomized-read order, retrospective, paired-design evaluation of the Omnyx™ Integrated Digital Pathology (IDP) system with de-identified and previously signed-out cases from all major organ systems. Pathologist will read and diagnose cases on a conventional light microscope and on the Omnyx™ IDP system for Whole Slide Images (WSI) with a randomized read order. College of American Pathologists (CAP) cancer protocol checklists will be used to capture diagnostic reporting. Diagnoses rendered by site Reading Pathologists will be captured on CAP checklists and compared directly to the Ground Truth (GT) diagnosis for both modalities.

Detailed Description
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Following the FDA issued guidance document, Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable- 2006, the specimens are surgical pathology samples from leftover human specimens from clinical cases, archived and previously signed-out across the majority of surgical pathology subspecialties

Official Title
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Evaluation of the Omnyx™ Integrated Digital Pathology System in the Primary Diagnosis of Surgical Pathology Specimens

Conditions
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Primary Diagnosis of Surgical Pathology Specimens

Intervention / Treatment
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* Other: Omnyx™ IDP system
* Other: Conventional light microscope


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • All surgical pathology samples from pre-identified list provided by FDA Exclusion Criteria: Gross evaluation only specimens (including hardware and specimens that do not require microscopic review for diagnosis) Immunofluorescence specimens Fluid-based specimens Intraoperative consultation specimens only (frozen preparation) Specimens from which a slide(s) fails quality control according to user manuals and training and issue(s) cannot be remediated at the time of procurement and over-labeling; this includes having too many labels such that slide damage or scanner failure is likely (as outlined in Omnyx user manuals). Specimens for which any slide (other than a blank) that should be in the case part cannot be located
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Omnyx™ IDP system<br>Omnyx™ IDP system for Whole Slide Images (WSI) | Other: Omnyx™ IDP system<br>* Omnyx™ IDP system for Whole Slide Images (WSI)<br>|
| Placebo Comparator: Conventional light microscope<br>conventional light microscope | Other: Conventional light microscope<br>* Conventional light microscope<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnosis of surgical pathology | Demonstrate the effectiveness of the Omnyx™ IDP system is non-inferior to the Diagnostic Reference Standard glass diagnosis in routine surgical pathology cases. | 1 Year |