Table 3.

Performance Characteristics (Sensitivity, Specificity, and Imageability/Gradability) for Subject Eyes with Dilated Ophthalmoscopy Examinations at Nonretina Sites (N = 778), Retina Sites (N = 221), and Total (N = 999)

Cohort (No. of Eyes with CRS)	Screening Methodology	Sensitivity (95% CI)	Specificity (95% CI)	Imageability/Gradability (95% CI)
Subjects with dilated ophthalmoscopy (n = 999 eyes)	Dilated ophthalmoscopy	27.7% [20.1%–35.2%]	99.6% [99.1%– 100.0%]	99.9% [99.7%–100.0%]
	EyeArt system (with dilation-if-needed) (147 eyes dilated)	96.4% [93.1%–99.8%]	88.4% [85.8%–91.1%]	97.4% [96.0%–98.8%]
Subjects enrolled at nonretina specialty centers (n = 778 eyes)	Dilated ophthalmoscopy	20.6% [13.1%–28.0%]	99.8% [99.5%–100.0%]	99.9% [99.6%–100.0%]
	EyeArt system (with dilation-if-needed) (109 eyes dilated)	96.5% [92.9%–100.0%]	86.3% [83.0%–89.7%]	97.6% [96.0%–99.1%]
Subjects enrolled at retina specialty centers (n = 221 eyes)	Dilated ophthalmoscopy	59.5% [40.2%–78.7%]	98.9% [97.1%– 100.0%]	100.0% [100.0%–100.0%]
	EyeArt system (with dilation-if-needed) (38 eyes dilated)	97.3% [90.3%–100.0%]	88.0% [82.5%–93.5%]	96.8% [93.6%–100.0%]

CI = confidence interval; CRS = clinical reference standard (as per reading center).