Evaluation of TaiHao Breast Ultrasound Diagnosis Software RN-CES Descartes

TaiHao Medical Inc.3 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Breast Cancer Breast Diseases

Interventions

Define Standard of Truth (SOT) by Taihao Breast Cancer Diagnostic SoftwareDIAGNOSTIC_TEST

TaiHao Breast Cancer Diagnostic Software independently define standard of truth (SOT) about108 cases.

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 69 Years

Medical Language ↔ Plain English

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.

Locations (1)

TaiHao Medical Inc

Taipei, Taiwan

Outcomes

Primary Outcomes

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.

Time frame: 1 week

Secondary Outcomes

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.

Time frame: 1 week

Data from ClinicalTrials.gov

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