Development and Application of a Standardized Testset for an Artificial Intelligence Medical Device Intended for the Computer-Aided Diagnosis of Diabetic Retinopathy

Table 2

Definition of DR phases.

DR phases and findings observable on fundus photos [33]	Classes in ICO guidelines [32]
0: no abnormalities	No apparent DR
I: microaneurysms only	Mild NPDR
II: microaneurysms and other signs (e.g., dot and blot hemorrhages, hard exudates, and cotton wool spots), but less than severe nonproliferative DR	Moderate NPDR
III: moderate nonproliferative DR with any of the following:	Severe NPDR
(1) Intraretinal hemorrhages (≥20 in each quadrant)
(2) De nite venous beading (in 2 quadrants)
(3) Intraretinal microvascular abnormalities (in 1 quadrant)
(4) No signs of proliferative retinopathy
IV: neovascularization of the optic disc or elsewhere. When accompanied by vitreous/preretinal hemorrhage, it is defined as high risk PDR	Proliferative DR (PDR)
V: fibrous membrane could be accompanied by preretinal hemorrhage or vitreous hemorrhage
VI: traction retinal detachment, combined with fibrous membrane, combined with/without vitreous hemorrhage, and neovascularization of the iris and the anterior chamber angle