UltraSight Guidance

UltraSight Guidance is a software application that uses machine learning and artificial intelligence to provide real-time guidance on transducer positioning and orientation during cardiac ultrasound imaging. It assists non-expert medical professionals in acquiring diagnostic-quality echocardiography images by displaying visual cues for probe manipulation and an image quality score.

The device uses machine learning-based algorithms identical to its predicate to provide real-time guidance on transducer position and orientation. Both systems are software accessories coupled with third-party ultrasound systems and deliver guidance during 2D echocardiography acquisition. The main modification introduces a preprocessing step prior to image input to enable future compatibility with additional ultrasound probes.

The submission references FDA guidance documents on premarket submissions for device software functions and cybersecurity in medical devices. Performance testing employed receiver operating characteristic (ROC) curve analysis and mean area under the curve (AUC) metrics, with acceptance criteria of AUC > 0.8 and false positive rate < 0.2 at specified quality thresholds.

UltraSight Guidance has identical intended use, indications for use, technological characteristics, and principles of operation as the predicate device UltraSight AI Guidance (K223347). The modifications implemented do not raise different questions of safety or effectiveness, and bench performance data demonstrates equivalent performance to the predicate device, therefore the devices are substantially equivalent.