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This study analyzes the Receiver Operating Characteristic (ROC) curve to evaluate the True Positive Fraction (TPF) and False Positive Fraction (FPF) in distinguishing between non-diseased and diseased cases. It highlights the relationship between sensitivity and 1-specificity for various thresholds. The findings are pertinent for clinical diagnostics, aiding in understanding the performance of health measurement tools. The analysis is based on data from Gallas at the FDA/CDRH/OSEL, emphasizing the importance of assessing diagnostic accuracy.
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Threshold Non-diseased cases Entire ROC curve TPF, sensitivity Diseased cases FPF, 1-specificity B. Gallas FDA/CDRH/OSEL