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Activity Number:
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160
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Type:
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Topic Contributed
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Date/Time:
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Monday, August 3, 2009 : 10:30 AM to 12:20 PM
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Sponsor:
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Section on Statistics in Epidemiology
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| Abstract - #304889 |
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Title:
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Design Issues for Studies of Diagnostic Devices Involving Readers
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Author(s):
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Thomas E. Gwise*+
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Companies:
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FDA
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Address:
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, , ,
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Keywords:
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Diagnostic Devices ; Study Designs
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Abstract:
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Medical devices reaching a certain risk threshold must be evaluated as to their safety and efficacy before they can be legally marketed in the United States. Evaluation of radiological imaging devices poses certain complications because some level of subjective reader interpretation is necessary to utilize the devices. For example, a thorough study of an imaging system, such as a mammography system or a computer aided detection system for chest x-rays will include reader interpretations. This presentation will discuss biases and other complications in studies of diagnostic devices involving multiple readers as well as suggest steps that can mitigate those complications.
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- The address information is for the authors that have a + after their name.
- Authors who are presenting talks have a * after their name.
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