A Single-center, Retrospective Study to Evaluate the Clinical Performance of Artificial Intelligence Medical Assisted Diagnostic Software (VeriSee DR) for Screening of Diabetic Retinopathy in Patients With Diabetes Mellitus
Conditions: Diabetic Retinopathy
Sponsor: Acer Being Health Inc.

Acer Healthcare Inc. 
CONFIDENTIAL 
Clinical Study Protocol  
Protocol No.: QCR19002 
Protocol Version: 1.1 
Version Date: 30-Jul-2019 
 
I. 
Protocol Title:  
A Single-center, Retrospective Study to Evaluate the Clinical Performance of 
Artificial Intelligence Medical Assisted Diagnostic Software (VeriSee DR) for 
Screening of Diabetic Retinopathy (DR) in Patients with Diabetes Mellitus. 
II. 
Objectives:  
This study is to evaluate the clinical performance of VeriSee DR for Diabetic 
Retinopathy from color fundus photography images. The sensitivity and 
specificity of VeriSee DR’s automated image analysis for screening the DR will be 
determined. 
III. Investigational products: 
1. Name: VeriSee DR 
2. Method of analysis: VeriSee DR is a software as medical device that 
incorporates an artificial intelligence (AI)-based algorithm to evaluate the 
Diabetic Retinopathy (DR) from color fundus photography images screening. 
The screening result of DR will be determined as referable DR or non-
referable DR by VeriSee DR. 
3. Method of analysis: VeriSee DR is a software as medical device that 
incorporates an artificial intelligence (AI)-based algorithm to evaluate the 
diabetic retinopathy (DR) from color fundus photography images screening. 
The screening result of DR will be determined as referable DR or non-
referable DR by VeriSee DR.  
 
4. Intended use: VeriSee DR is intended to screen DR from the images taken by 
color fundus photography, which can assist the physicians to assess whether 
further examination for retinopathy by the ophthalmologist is needed. 
VeriSee DR only provides the screening results of DR for the physicians’ 
reference and VeriSee DR is not intended to diagnose of DR or treat DR.  
5. Device type: Software as a medical device (SaMD) 
IV. Endpoint: 
1. Primary endpoint:  
 
To evaluate the clinical performance of VeriSee DR by determining the 
sensitivity and specificity.  
2. Secondary endpoints: 

Acer Healthcare Inc. 
CONFIDENTIAL 
Clinical Study Protocol  
Protocol No.: QCR19002 
Protocol Version: 1.1 
Version Date: 30-Jul-2019 
 
 
To evaluate the clinical performance of VeriSee DR by determining the 
positive and negative predictive values (PPV and NPV)  
V. 
Selection criteria:  
The screening by inclusion and exclusion criteria for eligibility of subjects will be 
performed by the information technology office at the clinical site. A dedicated 
ophthalmologist will be responsible to confirm the eligibility of enrolled subjects’ 
color fundus photography images for inclusion criterion # 4 and exclusion 
criterion # 2. 
1. Main inclusion criteria:  
 
Subject with age ≥ 20 years old 
 
Subject with documented diagnosis of diabetes mellitus 
 
Subject with image taken by color fundus photography that meet the 
following requirement: 
- 
The resolution of image is 1024×1024 pixels or higher; 
- 
The angle view of image is 45 or 50 degree. 
 
Subject’s image includes macula and optic nerve as judged by the 
ophthalmologist. 
2. Main exclusion criteria: 
 
The color fundus photography image previously used by VeriSee DR 
during the development process and pre-clinical test 
 
The macula, optic nerve, or other part in the image of color fundus 
photography is unclear to determine the disease condition as judged by 
the ophthalmologist. 
VI. Study procedures: This is a single-center, retrospective study to evaluate the 
performance of VeriSee DR for screening of potential diabetic retinopathy (DR). 
The sensitivity and specificity of VeriSee DR will be determined in this study by 
comparing the results of gold standard, which is the judgment of DR by the 
ophthalmologists (evaluators). 
 
 

Acer Healthcare Inc. 
CONFIDENTIAL 
Clinical Study Protocol  
Protocol No.: QCR19002 
Protocol Version: 1.1 
Version Date: 30-Jul-2019 
 
 
International Clinical Diabetic Retinopathy Disease Severity Scale 
Stage Proposed Disease Severity Level 
Findings Observable upon Dilated 
Ophthalmoscopy 
0 
No apparent retinopathy 
No abnormalities 
1 
Mild non-proliferative diabetic 
retinopathy (NPDR) 
Microaneurysms only  
2 
Moderate NPDR 
More than just microaneurysms but less 
severe NPDR 
3 
Severe NPDR 
Any of the following and no signs of PDR 
 
More than 20 intraretinal hemorrhages 
in each of 4 quadrants 
 
Definite venous beading in 2 or more 
quadrants 
 
Prominent IRMA in 1 or more 
quadrants 
4 
Proliferative diabetic retinopathy 
(PDR) 
One of both of the following: 
 
Neovascularization  
 
Vitreous/preretinal hemorrhage