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

Multi-Reader Multi-Case, Cross-Over, Retrospective Study to Evaluate the Effectiveness of CadAI-B Dx for Decision Support in Breast Ultrasound

This is a retrospective, fully-crossed, multi-reader, multi-case (MRMC) study to evaluate the effectiveness of 'CadAI-B Dx' (CadAI-B) for decision support in breast ultrasound. The study compares the diagnostic performance of readers interpreting breast ultrasound images with and without the aid of CadAI-B. A total of 797 patient cases will be included, comprising 350 cases with a confirmed diagnosis of malignancy and 447 cases with a confirmed benign diagnosis. Sixteen readers will participate in the study to evaluate the device.

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:

1. Women aged 22 years or older at the time of the breast ultrasound examination.
2. Standard B-mode breast ultrasound images available for analysis.
3. 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:

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