OvAi Focus: AI-based Multi-class Segmentation of Functional Ovaries and Adnexal Masses in Gynecological Ultrasound

Ovarian cancer is the deadliest gynecological malignancy; accurate and objective segmentation of adnexal masses and functional ovaries in ultrasound (US) remains challenging due to operator variability and morphological complexity. We present OvAi Focus (SynDiag s.r.l., Italy), a stand-alone AI software medical device that performs multi-class semantic segmentation of functional ovaries and adnexal masses, distinguishing cystic from solid components. The system was trained and independently validated on a multicenter dataset of 1,081 adult women from 6 centers across Italy and Israel. Segmentation achieved DICE scores of 0.87 (complete lesion), 0.85 (cystic), 0.68 (solid), and 0.62 (functional ovary), in line with or superior to state-of-the-art approaches across heterogeneous acquisition settings.