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AI system diagnostic accuracy
| Point estimate | 95% CI | Superiority endpoint | |
|---|---|---|---|
| Sensitivity | 87.2% | 81.8%–91.2% | 85.0% |
| Specificity | 90.7% | 88.3%–92.7% | 82.5% |
Point estimates for sensitivity and specificity were calculated on the 819 participants that were analyzable, using the prespecified logistic regression. The superiority endpoints were previously discussed with FDA.
