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Proceedings Paper

Quantitative risk analysis of medical devices: an endoscopic imaging example
Author(s): Ronald W. Waynant
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Paper Abstract

The performance of trained human observers in diagnosing a medical situation through an endoscope can be represented by a receiver operating characteristic (ROC) curve. When the ROC plot is related to a plot of signal to noise ratio (SNR) of the endoscope system display versus system resolution, the operator performance for a given size target object can be determined from the ROC. The ROC curve gives probability statistics associated with detection. When the costs of errors are assigned, this method would quantify the risks associated with the use of the device. It is proposed as a method which would allow a regulatory agency to judge imaging devices based on quantified cost/benefits.

Paper Details

Date Published: 27 October 1995
PDF: 9 pages
Proc. SPIE 2499, Health Care Technology Policy II: The Role of Technology in the Cost of Health Care: Providing the Solutions, (27 October 1995); doi: 10.1117/12.225336
Show Author Affiliations
Ronald W. Waynant, U.S. Food and Drug Administration (United States)


Published in SPIE Proceedings Vol. 2499:
Health Care Technology Policy II: The Role of Technology in the Cost of Health Care: Providing the Solutions
Warren S. Grundfest, Editor(s)

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