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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Define Standard of Truth (SOT) by 3 experts | Other | Three experts A, B, and C independently define standard of truth (SOT) about 108 cases. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Define Standard of Truth (SOT) by Taihao Breast Cancer Diagnostic Software | Diagnostic Test | TaiHao Breast Cancer Diagnostic Software independently define standard of truth (SOT) about108 cases. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TaiHao Medical Inc | Taipei | 10663 | Taiwan |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 27, 2023 | Mar 28, 2023 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D001941 | Breast Diseases |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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