Accuro 3S
Rivanna Medical, Inc.Accuro 3S is a portable diagnostic ultrasound imaging system designed for use by trained healthcare professionals in hospitals or clinics. It provides B-mode ultrasound imaging with an advanced AI-based software called SpineNav-AI that assists with musculoskeletal imaging of the lumbar spine, especially guiding neuraxial anesthesia procedures. This system enhances clinicians' ability to accurately visualize anatomical structures and guide needle placements safely and efficiently.
Intended Use
The Accuro 3S is a diagnostic ultrasound imaging system for use by qualified and trained healthcare professionals. Accuro 3S is intended to be used in a hospital or medical clinic environment at the point of care. It supports B-mode imaging and a SpineNav-AI™ image processing software for musculoskeletal conventional and superficial imaging, and guidance for needle or catheter placement, typically for neuraxial anesthesia.
Technology
Accuro 3S is a portable ultrasound system featuring a Dual-Array™ convex probe with two side-by-side convex arrays that compound images into a single sector scan. It has a touchscreen interface, integrated battery for portability, and interfaces with healthcare IT networks using DICOM. SpineNav-AI employs a deep convolutional neural network for automated segmentation of lumbar spine anatomy to assist musculoskeletal imaging and procedural guidance.
Performance
Performance testing included validation of acoustic output and safety standards compliance, image accuracy, and AI segmentation accuracy across diverse demographics. SpineNav-AI was validated using a dataset from multiple geographic sites with ground truth annotations by radiologists. The AI achieved per-frame accuracy between 82.1% and 99.3%, per-sequence detection success rate from 91.7% to 100%, and Dice scores of 0.64–0.87 for anatomical structures. The epidural region indicator had an average accuracy within ~1.61 mm lateral and 2.42 mm depth compared to radiologist ground truth.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/20/2024
5 months - 2
FDA Approval
5/23/2025
Other devices from Rivanna Medical, Inc.
- Accuro® 3S Needle Guide Kit2025 • 510K
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