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A multi-site, randomized-read order, retrospective, paired-design evaluation of the Omnyxâ„¢ 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 Omnyxâ„¢ 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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omnyxâ„¢ IDP system | Active Comparator | Omnyxâ„¢ IDP system for Whole Slide Images (WSI) |
|
| Conventional light microscope | Placebo Comparator | conventional light microscope |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omnyxâ„¢ IDP system | Other | Omnyxâ„¢ IDP system for Whole Slide Images (WSI) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnosis of surgical pathology | Demonstrate the effectiveness of the Omnyxâ„¢ IDP system is non-inferior to the Diagnostic Reference Standard glass diagnosis in routine surgical pathology cases. | 1 Year |
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Inclusion Criteria:
• All surgical pathology samples from pre-identified list provided by FDA
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Montalto, PhD | Omnyx, LLC | Study Chair |
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| Label | URL |
|---|---|
| Company Website | View source |
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| Conventional light microscope |
| Other |
Conventional light microscope |
|