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Thursday, January 11
Thu, Jan 11, 7:30 AM - 9:00 AM
Crystal Ballroom Prefunction
Continental Breakfast & Poster Session II

Precision studies for In Vivo diagnostic devices (304006)

Bipasa Biswas, FDA/CDRH/OSB/DBS 
*Arianna Simonetti, FDA/CDRH/OSB/DBS 

Keywords: Repeatability, reproducibility, variance components, experimental design, analysis of variance

The In Vivo diagnostic devices often involve measurements of anatomical or physiological features on subjects with a quantitative output. These measurements may be used for monitoring patients over time to evaluate the patient’s status or for diagnosing a condition of interest. To assess that these measurements are reliable and precise, one component of assessment is evaluation of variability of the measurements due to factors like device, operator, and time of the day among others. Examples are the Ophthalmic Coherence Tomography (OCT) devices which measure various anatomical features of the eye. This poster will discuss the study design issues and statistical analysis involved in assessing repeatability and reproducibility of in vivo diagnostic devices with quantitative output.