Rho
16 Bit IncRho is a machine learning software that analyzes standard frontal x-rays of various body parts in patients aged 50 and older to identify possible low bone mineral density. It helps radiologists by generating reports suggesting patients who may benefit from further clinical bone health assessment, thereby assisting in early detection and management of bone health issues.
Intended Use
Rho is a software application intended for use opportunistically with standard frontal radiographs of the lumbar spine, thoracic spine, chest, pelvis, knee, or hand/wrist performed in patients aged 50 years and older to aid in identifying possible low bone mineral density (BMD) at L1-L4 or the femoral neck to prompt a clinical assessment of bone health.
Technology
Rho is a machine learning-based software integrated with PACS that uses patient age, sex, and frontal X-ray DICOM images to estimate BMD at femoral neck or lumbar vertebrae with a locked algorithm trained on patient data. It outputs a binary classification and generates a report for clinical use.
Performance
Clinical performance was evaluated retrospectively using multiple datasets with paired DXA (gold standard) comparison showing high specificity (~0.90+) but moderate to low sensitivity. The device met performance goals for specificity and AUC but had lower sensitivity in some subgroups and datasets. Postmarket monitoring is planned to assess real-world generalizability.
Device Timeline
- 1
Submission
4/3/2023
1 year - 2
FDA Approval
4/9/2024
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