Medical News Observer

Key Points

• BoneView supports limbs, pelvis, rib cage, and dorsolumbar vertebra radiographs across different computing and X-ray imaging platforms.
• Serves as a concurrent reading aid to enhance fracture detection in adult and pediatric patients without replacing professional judgment.
• Showed high sensitivity and specificity in fracture detection for both demographic groups, reinforcing its utility in radiographic diagnostics.

Overview

BoneView 1.1-US is a software designed to assist clinicians in interpreting radiographs using machine learning techniques to identify and highlight fractures.You can deploy it on-premise or in the cloud, and it is intended only for prescription use. GLEAMER developed this software

Device Information

The software analyzes limbs, pelvis, rib cage, and dorsolumbar vertebra radiographs for both children/adolescents and adults. It supports various computing and X-ray imaging platforms, ensuring compatibility across different medical infrastructures.

Indication

BoneView 1.1-US is intended as a concurrent reading aid by clinicians with authority to diagnose fractures in various settings while reviewing radiographs to enhance the detection of fractures, with indications covering a wide range of anatomical areas for adult and pediatric patients.

Limitations

The device’s effectiveness is subject to its intended use environment and user competence. It is a diagnostic aid and not a replacement for professional judgment. Its performance may vary based on the quality of radiographs and the specific clinical context.

Study Results

Performance testing demonstrated high sensitivity and specificity in fracture detection across various anatomical areas for children/adolescents and adults. It showed that the software could reliably assist in the diagnosis process without significant differences in performance between the two demographic groups.

Conclusion

BoneView 1.1-US is substantially equivalent to its predicate device, BoneView 1.0-US, with the addition of pediatric applications. The software’s ability to support a broader patient demographic without compromising performance underscores its potential as a valuable tool in radiographic diagnostics.

Reference

“Boneview K222176 510(k) Premarket Notification.” Accessed February 23, 2024. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K222176.