Method comparison studies: Assessing Agreement for Medical Devices
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*Shanti V Gomatam, FDA/CDRH 

Keywords: Agreement, Bland Altman, Measurement error regression, diagnostic devices

A method comparison study is often a supporting study for diagnostic medical devices cleared via the 510K regulatory pathway. In such studies the investigative devices is compared to either the clinical reference standard or a predicate device. We discuss, compare and contrast various statistical approaches that are used, or can be used, in method comparison studies.