Validating Whole Slide Imaging Systems for Diagnostic Purposes in Pathology

The validation process should include a sample set of at least 60 cases for one application, or use case (eg, hematoxylin-eosin–stained sections of fixed tissue, frozen sections, hematology), that reflect the spectrum and complexity of specimen types and diagnoses likely to be encountered during routine practice. The validation should include another 20 cases to cover additional applications such as immunohistochemistry or other special stains if these applications are relevant to an intended use and were not included in the 60 cases mentioned above. (Strong)