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510(k) Data Aggregation

    K Number
    K213944
    Device Name
    HealthOST
    Manufacturer
    Date Cleared
    2022-04-22

    (126 days)

    Product Code
    Regulation Number
    892.1750
    Why did this record match?
    Applicant Name (Manufacturer) :

    NanoxAI Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    HealthOST is an image processing software that provides qualitative and quantitative analysis of the spine from CT images to support clinicians in the evaluation and assessment of musculoskeletal disease of the spine. The HealthOST software provides the following functionality: -Labelling of T1-L4 vertebrae -Measurement of height loss in each vertebra (T1-L4) -Measurement of the mean Hounsfield Units (HU) in volume of interest within vertebra (T11-L4) HealthOST is indicated for use in patients aged 50 and over undergoing CT scan for any clinical indication, that includes at least four vertebrae in the T1-L4 portion of the spine (for vertebral height loss) and T11-L4 (for bone attenuation) portions of the spine. The device is indicated for FBP-reconstructed images only.
    Device Description
    HealthOST is an image processing software that provides qualitative and quantitative analysis of the spine from CT images to support clinicians in the evaluation and assessment of musculoskeletal disease of the spine. HealthOST does this by analyzing CT scans of patients aged 50 and above being performed for any clinical indication and providing the following outputs for each analyzed vertebra - 1. The vertebral name, e.g. "L3" - 2. The percentage of vertebral height loss, calculated as: Height loss = 1 - (minimum(anterior or middle) vertebral height measurement / posterior vertebral height measurement) from three vertebral height measurements placed at the anterior, middle and posterior aspects of the vertebral body, at the point nearest to the center of the vertebral body. The height loss measurement is provided for every complete vertebra in the range of T1-L4. Height loss above the height loss display threshold will be indicated to the user. The height loss display threshold is configurable per installation from a predefined list, with the default set at >20% height loss. In addition, vertebrae without height loss but with significant height deviation from neighboring vertebrae will be displayed to the user. - 3. The mean hounsfield unit vertebral bone attenuation, calculated by taking the mean HU from a volume of interest of the trabecular bone. This measurement is provided for every complete vertebrae in the range of T11-L4. HU bone attenuation below a set bone attenuation display threshold will be indicated to the user. The bone attenuation display threshold is configurable per installation from a predefined list. The following modules compose the HealthOST software: Data input and validation: Following retrieval of a study, the validation feature assessed the input data (i.e. age, modality, view, etc.) to ensure compatibility for processing by the algorithm. HealthOST algorithm: Once a study has been validated, the algorithm analyzes the CT for analysis and quantification. IMA Integration feature: The study analysis and the results of a successful study analysis is provided to IMA. Error codes feature: In the case of a study failure during data validation or the analysis by the algorithm, an error is provided to the system. Use of axial scans for analysis is only intended as a "back up" in cases that a sagittal scan is not available in the study.
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