A Single-center, Retrospective Study to Evaluate the Clinical Performance of Artificial Intelligence Medical Assisted Diagnostic Software (VeriSee AMD) for Screening of Age-Related Macular Degeneration
Conditions: Macular Degeneration, Age Related, Maculopathy, Age Related
Sponsor: Acer Medical Inc.

Acer Medical Inc. 
CONFIDENTIAL 
Clinical Study Protocol  
Protocol No.: AHCI21001 
Protocol Version : 1.2 
Version Date : 16-Jul-2021 
 
 
 
Page 1  
 
CLINICAL STUDY PROTOCOL 
 
TITLE: 
A Single-center, Retrospective Study to Evaluate the Clinical Performance of 
Artificial Intelligence Medical Assisted Diagnostic Software (VeriSee AMD) 
for Screening of Age-Related Macular Degeneration 
 
Protocol Number: AHCI21001 
 
Phase of Study: Pivotal study 
 
Version No: 1.2 
 
Version Date: 16-Jul-2021 
 
Sponsor: Acer Medical Inc. 
 
Sponsor Address: 24F., No. 110, Sec.1, Xintai 5th Rd., Xizhi Dist., New Taipei City 221, Taiwan 
 
Confidentiality Statement 
The information in this document contains trade secrets and commercial information that are 
privileged or confidential and may not be disclosed unless such disclosure is required by applicable 
laws and regulations. In any event, persons for whom this information is disclosed must be informed 
that the information is privileged or confidential and may not be further disclosed by them. These 
restrictions on disclosure will apply equally to all future information supplied to you that is indicated 
as privileged or confidential. 

Acer Medical Inc. 
CONFIDENTIAL 
Clinical Study Protocol  
Protocol No.: AHCI21001 
Protocol Version : 1.2 
Version Date : 16-Jul-2021 
 
 
 
Page 2  
Title: 
A Single-center, Retrospective Study to Evaluate the Clinical Performance of Artificial Intelligence 
Medical Assisted Diagnostic Software (VeriSee AMD) for Screening of Age-Related Macular 
Degeneration. 
Objectives: 
This study is to evaluate the clinical performance of VeriSee AMD for AMD screening from color 
fundus photography images. The sensitivity and specificity of VeriSee AMD’s automated image 
analysis for screening the age-related macular degeneration will be determined. 
Investigational product: 
1. 
Name: VeriSee AMD 
2. 
Model: AMD-01 
3. 
Manufacturer: Acer Medical Inc.  
4. 
Method of analysis: VeriSee AMD is a software as medical device that incorporates an 
artificial intelligence (AI)-based algorithm to evaluate the age-related macular degeneration 
(AMD) from color fundus photography images screening. The screening result of AMD will 
be determined as non-more than level 3 AMD (non-mtl3AMD) or more than level 3 AMD 
(mtl3AMD). 
5. 
Intended use: VeriSee AMD is intended to screen AMD 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. The screening result of AMD will be determined 
as non-mtl3AMD or mtl3AMD. VeriSee AMD only provides the screening results of AMD 
for the physicians’ reference and VeriSee AMD is not intended to diagnose of AMD, detect 
concomitant diseases, or treat AMD.  
6. 
Device type: Software as a medical device (SaMD) 
 
 

Acer Medical Inc. 
CONFIDENTIAL 
Clinical Study Protocol  
Protocol No.: AHCI21001 
Protocol Version : 1.2 
Version Date : 16-Jul-2021 
 
 
 
Page 3  
Endpoints:  
1. Primary endpoint: 
 
To evaluate the clinical performance of VeriSee AMD by determining the sensitivity and 
specificity.  
2. Secondary endpoints: 
 
To evaluate the clinical performance of VeriSee AMD by determining the positive and 
negative predictive values (PPV and NPV)  
 
To determine the percentage of subjects’ images with insufficient quality as judged by 
VeriSee AMD 
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 # 3 and exclusion criterion # 2. 
1. 
Main inclusion criteria: 
(1) Subject with age ≥ 50 years old 
(2) Subject with image taken by Canon CR-2 that meet the following requirement: 
• The resolution of image is 271×271 pixels or higher. 
• The angle view of image is 45 or 50 degrees. 
(3) Subject’s image includes macula as judged by the ophthalmologist. 
2. Main exclusion criteria: 
(1) The color fundus photography image previously used by VeriSee AMD during the 
development process and pre-clinical test 
(2) The macula or other part in the image of color fundus photography is unclear to determine 
the disease condition as judged by the ophthalmologist. 

Acer Medical Inc. 
CONFIDENTIAL 
Clinical Study Protocol  
Protocol No.: AHCI21001 
Protocol Version : 1.2 
Version Date : 16-Jul-2021 
 
 
 
Page 4  
Study procedures: 
This is a single-center, retrospective study to evaluate the performance of VeriSee AMD for 
screening of potential age-related macular degeneration (AMD). The sensitivity and specificity of 
VeriSee AMD will be determined in this study by comparing the results of gold standard, which is 
the judgment of AMD by the ophthalmologists (evaluators). 
Age-Related Macular Degeneration Severity Scale (AMD Severity Scale) 
AMD Level 
Criteria 
1 
Drusen maximum size < circle C-0 (63 μm diameter) and total area < circle C-1 (125 μm 
diameter) 
2 
Presence of one or more of the following: 
(a) Drusen maximum size ≥ circle C-0 but < circle C-1 
(b) Drusen total area ≥ circle C-1 
(c) Retinal pigment epithelial pigment abnormalities consistent with AMD, defined as 
one or more of the following in the central or inner subfields: 
(1) Depigmentation present 
(2) Increased pigment ≥ circle C-1 
(3) Increased pigment present and depigmentation at least questionable 
3 
Presence of one or more of the following: 
(a) Drusen maximum size ≥ circle C-1 
(b) Drusen maximum size ≥ circle C-0 and total area > circle I-2 and type is soft 
indistinct 
(c) Drusen maximum size ≥ circle C-0 and total area > circle O-2 and type is soft distinct 
(d) Geographic atrophy within grid but none at center of macula 
4  
(Advanced) 
Presence of one or more of the following: 
(a) Geographic atrophy in central subfield with at least questionable involvement of 
center of macula 
(b) Evidence of neovascular AMD 
(1) Fibrovascular/serous pigment epithelial detachment 
(2) Serous (or hemorrhagic) sensory retinal detachment 
(3) Subretinal/subretinal pigment epithelial hemorrhage 
(4) Subretinal fibrous tissue (or fibrin) 
(5) Photocoagulation for AMD