HeartFocus (V.1.1.1)

HeartFocus is AI-powered software that guides medical professionals in acquiring cardiac ultrasound images in real time. It operates as an accessory to compatible diagnostic ultrasound systems and assists users in obtaining ten standard two-dimensional transthoracic echocardiography views by providing live guidance on probe positioning, automatic quality detection, and automated or manual clip recording. It is indicated for use in adult patients requiring cardiac ultrasound examination.

HeartFocus uses deep learning and machine learning algorithms similar to its predicate Caption Guidance. Both employ AI to emulate sonographer expertise and provide real-time probe positioning guidance. The main differences are the compatible ultrasound systems (HeartFocus supports Clarius; predicate used uSmart 2300t) and minor variations in the user interface for displaying guidance, though the underlying functionality and type of guidance remain equivalent.

IEC 62366-1:2015 (human factors and usability engineering for medical devices) and FDA Guidance Document 'Applying Human Factors and Usability Engineering to Medical Devices.' Cohen's kappa score (>0.6) and positive predictive value (>0.8) were used as statistical success criteria for algorithm performance validation.

HeartFocus is substantially equivalent to Caption Guidance because both are AI-assisted acquisition guidance systems for the same clinical purpose (cardiac ultrasound imaging in adults), employ identical deep learning methodology to guide probe positioning, provide equivalent real-time feedback on image quality, include comparable automatic and manual recording features, and are installed on cleared third-party ultrasound devices. Although they connect to different ultrasound platforms and have minor UI differences, these variations do not raise new safety or effectiveness questions because the core technology and intended guidance function are equivalent.