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510(k) Data Aggregation

    K Number
    DEN230023
    Device Name
    Rho
    Manufacturer
    Date Cleared
    2024-04-09

    (372 days)

    Product Code
    Regulation Number
    892.1171
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    Product Code :

    SAO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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. Rho provides a notification in the form of a report to aid radiologists and/or physician interpreters in identifying patients with possible low bone mineral density (BMD) at L1-L4 or the femoral neck to prompt a clinical assessment of bone health. Rho should not be used to rule out low BMD. Radiologists and referring clinicians should follow recommended practices for screening and assessment, regardless of the absence of Rho report.
    Device Description
    Rho is a machine learning-based software-as-a-medical device that interfaces with institutional Picture Archiving and Communications Systems (PACS) to identify patients 50 years and older undergoing x-ray with possible low bone mineral density (BMD). Eligible x-rays are frontal projections of the lumbar spine, thoracic spine, chest, pelvis, knee or hand/wrist. Rho uses the xray DICOM and DICOM tags of age and sex as inputs into a locked machine learning algorithm. The locked machine learning algorithm is trained on a patient-based dataset (True North Imaging. TNI13). The algorithm presents a binary output to indicate whether or not the patient likely has low BMD at either the femoral neck or L1-L4. A Rho Report is generated for positive cases that can be sent back to the PACS for physician interpretation or viewed through a browser-based interface. Radiologists can choose to include this finding in their report to the referring physician. Inclusion may trigger a referring physician to conduct a clinical fracture risk assessment related to bone health. For cases where Rho algorithm outputs a negative result, no Rho Report will be sent, and neither the radiologist nor the referring physician will receive any device output.
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