Effectiveness of CadAI-B Dx for Decision Support in Breast Ultrasound

The study utilizes a crossover design where all readers independently review all cases. The control arm consists of a reading session where participating readers independently review cases without the assistance of the CadAI-B device (unaided reading). The experimental arm involves reading with CadAI-B assistance (AI-aided reading). To minimize potential bias, a washout period of four weeks will be maintained between the unassisted and assisted reading sessions for each reader. The primary hypothesis is that CadAI-B assistance significantly improves overall reader performance in breast ultrasound interpretation, as measured by the area under the Localization Receiver Operating Characteristic (LROC) curve (AULROC).

Inclusion criteria

• Women aged 22 years or older at the time of the breast ultrasound examination.
• Standard B-mode breast ultrasound images available for analysis.
• Lesions must have a confirmed diagnosis based on one of the following reference standards:

3-1. Malignant Cases: Diagnosis of breast cancer confirmed through biopsy or surgery.

3-2. Benign Cases: Confirmed as benign through biopsy or surgical excision, or confirmed as having no evidence of malignancy for at least 2 years of follow-up.

Exclusion criteria

• mages containing modes other than standard B-mode ultrasound, such as Doppler, elastography, or other annotations/overlays.
• Patients who have breast implant(s).
• Patients suffering from significant breast trauma or mastitis at the time of the breast ultrasound examination.
• Images of post-surgical resection sites.
• Images where multiple lesions are present within a single 2D ultrasound image