Medtech company Rivanna has received FDA 510(k) clearance for BoneEnhance, a machine learning software module for its Accuro XV diagnostic ultrasound system.
BoneEnhance identifies bone and surrounding tissue within volumetric ultrasound scans. It displays color-coded overlays on 2D B-mode images while leaving the original image data visible underneath and supports three-dimensional visualization of skeletal anatomy during image review, according to an Oct. 22 news release.
The module is the first machine learning tool cleared for Accuro XV, which the FDA cleared for musculoskeletal imaging in April.
Rivanna trained and validated BoneEnhance in a national eight-site clinical study. Three sites supplied training data, and five provided an independent test set of 233 volumetric datasets comprising 69,900 images from 173 subjects. Three board-certified radiologists set the reference labels. Per-volume labeling accuracy ranged from 95.1% to 100%.
“This clearance is the foundation,” said Will Mauldin, PhD, co-founder and CEO of Rivanna. Dr. Mauldin said the module anchors decision-support capabilities now in development.
The next of those capabilities is an investigational injury detection module designed to help clinicians evaluate potential extremity fractures.
Rivanna holds more than 100 issued and pending patents. It is positioning Accuro XV as a point-of-triage tool to speed emergency department evaluation of low-severity extremity injuries and reduce X-ray referrals.
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