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Abstract:
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Radiological imaging devices such as ultrasound, CT, MRI, etc. can serve as screening, diagnostic and monitoring tool in providing visual assistance and guidance to the radiologists/physicians in identifying abnormalities in breast, lung, colon and so on. Evaluation of the clinical performance of such devices often involves the reader's interpretation. In this talk, a typical study called multi-reader multi-case (MRMC) study is discussed from a regulatory reviewer's perspective. Several issues in study design and statistical analysis encountered when reviewing such devices will be summarized and presented.
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