Question: The FDA will approve the new test if the lower bound of a 90% CI for the mean score is +5. Should the FDA approve

The FDA will approve the new test if the lower bound of a 90% CI for the mean score is ≥+5. Should the FDA approve the test? A yes/no answer is not sufficient.

Suppose a quality score is constructed for the test. A true positive identified by the test is given a score of +20. A true negative identified by the test is given a score of +10. A false positive identified by the test is given a score of -5. A false negative identified by the test is given a score of -20.

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