Table 3.

Concordance Between Device and Reference Standard: Diagnosis

 Reference: biopsy1or panel consensus2
Device DecisionBenignMalignantAll
Benign88/145 (60.7%)1/10 (10.0%)89/155 (57.4%)
Malignant57/145 (39.3%)9/10 (90.0%)66/155 (42.6%)
Specificity (95% CI)0.61 (0.53 - 0.68)  
Sensitivity (95% CI)*0.90 (0.71 - 1.00)  
NPV (95% CI)0.99 (0.93 - 0.99)  
PPV (95% CI)0.14 (0.07 - 0.25)  
 Reference: panel consensus2 alone
Benign85/136 (62.5%)1/12 (8.3%)86/148 (58.1%)
Malignant51/136 (37.5%)11/12 (91.7%)62/148 (41.9%)
Specificity (95% CI)0.63 (0.54 - 0.70)  
Sensitivity (95% CI)*0.92 (0.76 - 1.000)  
NPV (95% CI)0.99 (0.93 - 0.99)  
PPV (95% CI)0.18 (0.09 - 0.30)  
  • Notes: 1Biopsy results are used as reference standard in lieu of consensus dermatologist panel assessment when biopsy results are available. Biopsy results are available for 22 lesions. 2Panel consensus: only includes diagnosis where all panel members agreed, regardless of the number of members in the panel. Panel consensus was available for 148 lesions. 95% Confidence interval (CI) calculated accounting for the within-subject correlation using the Wilson method *Wilson method not estimable, Wald method used.