Accuro 3S

The Accuro 3S is a portable diagnostic ultrasound imaging system for use by qualified healthcare professionals in hospitals or medical clinics. It provides B-mode imaging and includes SpineNav-AI machine learning software to assist with musculoskeletal imaging and guidance for procedures like neuraxial anesthesia.

The Accuro 3S features a Dual-Array convex transducer probe with two side-by-side PZT-based arrays (64 elements each, 3.5–4.0 MHz center frequency) that compound images into a single sector-scan format, compared to the predicate's mechanically scanned single-element transducer. SpineNav-AI uses deep convolutional neural networks for anatomical segmentation, whereas the predicate's SpineNav3D uses analytical template-matching algorithms. The system includes an integrated battery, touchscreen interface, and DICOM-based archival workflows.

IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-37, IEC 62304, IEC 62366-1, IEC 62359, ISO 10993-1, ISO 14971, NEMA UD 2-2004, NEMA PS 3.1–3.20e (DICOM), and AAMI TIR69:2017.

Accuro 3S shares the same intended use, user population, and clinical applications (musculoskeletal imaging and neuraxial anesthesia guidance) as the predicate Accuro. Although the transducer geometry differs (Dual-Array versus mechanically scanned), non-clinical testing including acoustic output, safety compliance, and performance validation confirms no new risks. SpineNav-AI, while using machine learning instead of template matching, was validated on 120 test sequences from diverse demographics with per-frame accuracy of 82.1–99.3% and meets established success criteria; this methodology parallels the reference device Venue's cNerve feature. Together these findings support that the technological differences do not affect safety or effectiveness for the intended indications.