Evaluation of TaiHao Breast Ultrasound Diagnosis Software (Plan for Partial Modification of Diagnostic Performance)
Phase: NA
Conditions: Breast Cancer, Breast Diseases
Sponsor: TaiHao Medical Inc.

 
 
 
 
 
 
 
 
 
 
 
 
Evaluation of TaiHao Breast Ultrasound Diagnosis Software RN-CES 
Descartes 
 
 
 
NCT number: n/a 
Document date: March 27, 2023 
 
 

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I. 
Objective 
The Evaluation of TaiHao Breast Ultrasound Diagnosis Software RN-CES 
Descartes is an AI-based software that received PMDA approval in November 
2020 (Approval number: 30200BZX00379000). While the software device 
currently requires input images captured using the 'Acuson S2000' imaging 
device (certification number: 220AIBZX00055000), we recognize the potential 
benefit of expanding compatibility with additional imaging devices from Canon, 
GE, and Fujifilm. As such, we have conducted an evaluation of the TaiHao 
Breast Ultrasound Diagnosis Software performance using input images obtained 
from ultrasound diagnostic equipment from the aforementioned manufacturers, 
with the aim of enhancing its contribution to the field of medical care. 
 
II. Purpose 
The Standard of Truth (SOT) is based on the image diagnostic results of case 
data reviewed by expert radiologists. This study will compare and verify the 
detection results of the detection function (CADe function) of this software 
device with SOT, in order to estimate the detection performance of the CADe 
function. 
 
III. Device Description 
BR-FHUS Navigation is a standalone software device installed on a Windows-
based computer for recording and storing electronic image. The device is an 
accessory to standard ultrasound systems and allows the digital recording images 
from those standard ultrasound devices, along with the spatial position 
coordinates of the recorded images. During breast ultrasound scanning, a series 
of images are continuously recorded, and the computer-assisted lesion detection 
function can be used to highlight the suspicious lesion for the current image. 
After finishing the scanning, the series of images are saved for further review. 
 
BR-FHUS Viewer is intended as a standalone software device installed on a 
Windows-based computer to assist physicians with manipulation and analysis 
tools in reviewing breast ultrasound images. Images and data are previously 
recorded from various imaging systems and other sources such as calibrated 
spatial positioning devices. BR-FHUS Viewer provides the capability to 
visualize two-dimensional ultrasound images along with the scanning paths and 
position information of probe that stored in the DICOM file in advance. During 
breast ultrasound reviewing, the computer-assisted lesion detection function can 
be used to highlight the suspicious lesions for the loaded image, assisting the 

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physicians to select images with lesions. 
 
IV. Case criteria 
i) 
Inclusion Criteria: Female patients aged 20 to 69, including those with and 
without breast lesions. 
ii) 
Exclusion Criteria: a pacemaker or prosthetic valve or a post-surgery 
follow-up patient. 
 
V. Study Design 
 
i) 
Three experts independently review the image and create ROIs (regions of 
interest) suspected of breast lesions. 
ii) 
The SOT is adopted by selecting the region where the ROIs of two experts 
overlap. 
iii) Using the CADe function, we detect regions suspected of breast lesions in 
108 cases of images. 
iv) We compare and verify the images detected by the CADe function with the 
SOT. 
v) 
The detection results of the CADe function are estimated in conjunction 
with the results of the CADe performance test for the BR-FHUS Smart 
System ultrasound imaging diagnostic. 
 
VI. Study endpoint 
i) 
Primary Outcome Measure: 
The average performance of the 4 machines, in terms of sensitivity for 
detecting suspicious breast cancer, is not inferior to Siemens performance. 
 
The average of 4 types of machines (Canon Aplio i800, GE Logiq E10, GE 
Invenia ABUS, Fuji ARIETTA 60) performance compared to Siemens 
performance which was submitted to PMDA last time. 

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ii) 
Secondary Outcome Measures: 
The performance of each of the 4 machines, in terms of sensitivity for 
detecting suspicious breast cancer, is not inferior to Siemens' performance. 
 
Each machine (Canon Aplio i800, GE Logiq E10, GE Invenia ABUS, Fuji 
ARIETTA 60) performance compared to Siemens performance which was 
submitted to PMDA last time.