Breast Cancer, Breast Diseases
Conditions
Brief summary
A standard of truth SOT is determined based on the interpretation results of the case data by interpretation experts, and the SOT is compared with the detection results of this program's function for detecting suspected breast cancer (CADe function). Estimate the detectability of the CADe function by comparing.
Interventions
DIAGNOSTIC_TESTDefine Standard of Truth (SOT) by Taihao Breast Cancer Diagnostic Software
TaiHao Breast Cancer Diagnostic Software independently define standard of truth (SOT) about108 cases.
Sponsors
TaiHao Medical Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 69 Years
Healthy volunteers
No
Inclusion criteria
* Female patients aged 20 to 69, including those with and without breast lesions.
Exclusion criteria
* Have a pacemaker or prosthetic valve. * A post-surgery follow-up patient.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The average performance of the 4 machines, in terms of sensitivity for detecting suspicious breast cancer, is not inferior to Siemens performance. | 1 week | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The performance of each of the 4 machines, in terms of sensitivity for detecting suspicious breast cancer, is not inferior to Siemens' performance. | 1 week | 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. |
Countries
Taiwan
Outcome results
None listed