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510(k) Data Aggregation

    K Number
    K243218
    Device Name
    TBS iNsight (V4)
    Manufacturer
    Medimaps Group SA
    Date Cleared
    2025-01-17

    (105 days)

    Product Code
    KGI
    Regulation Number
    892.1170
    Why did this record match?
    Applicant Name (Manufacturer) :

    Medimaps Group SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TBS iNsight is a software provided for use as a complement to both DXA analysis and clinical examination. It computes the antero-posterior spine DXA examination file and calculates a score (Trabecular Bone Score - TBS) that is compared to those of the age matched controls. The TBS is derived from the texture of the DXA image and has been shown to be related to bone microarchitecture. TBS iNsight provides as an option an assessment of 10-year fracture risk. It provides an estimate of 10-year probability of hip fracture and 10-year probability of a major osteoporotic fracture (clinical spine, forearm, hip or shoulder fracture). This estimate is based on the WHO's FRAX® Fracture Risk Assessment Tool, after adjustment for the TBS. The tool has been validated for Caucasian and Asian men and post-menopausal women between 40 and 90 years old. TBS provides information independent of BMD value: it is used as a complement to the data obtained from the DXA analysis and the clinical examination (questioning by the clinician about patient history, bioassay of bone resorption markers...). The results can be used by a physician in conjunction with other clinical risk factors as an aid in the diagnosis of osteoporosis and other medical conditions leading to altered trabecular bone microarchitecture, and ultimately in the assessment of fracture risk. The TBS score can assist the health care professional in monitoring the effect of treatments on patients across time. Overall fracture risk will depend on many additional factors that should be considered before making diagnostic or therapeutic recommendations. The software does not disease or recommend treatment regimens. Only the health care professional can make these judgments.
    Device Description
    TBS iNsight is a software application provided for use as a complement to bone mineral density (BMD) acquired from dual energy X-ray absorptiometry (DXA) and other clinical risk factors for osteoporosis and fragility fracture. It calculates a score (Trabecular Bone Score - TBS) derived from the texture of the DXA image of the anterior-posterior (AP) lumbar spine and has been shown to be related to bone microarchitecture. The method analyzes X-ray based images acquired by DXA imaging systems and produces the TBS based on the computation of an Adapted Experimental Variogram (modified fractal-like approach). This variogram is used to measure the degree of spatial variation between pairs of data points in a spatial dimension of a region of a digital image. The absolute TBS values for the same equivalent tissue thickness vary slightly between GE and Hologic systems. Additionally, within each system, variability in TBS values can be observed across different scan modes. To address these differences, corrections are applied that are both device-specific and mode-specific. For instance, TBS is corrected differently for GE and Hologic systems to account for inherent differences in tissue thickness assessment. Furthermore, corrections are also tailored separately for each scan mode within the same system, ensuring that TBS measurements remain consistent and reliable regardless of the scan mode used. These device-specific and mode-specific corrections are necessitated by differences in the dynamic range of tissue thickness measurements between GE and Hologic devices. The variations arise due to differences in the methodologies used to assess tissue thickness. To harmonize these discrepancies and ensure measurement accuracy, correction fits derived from ex-vivo data are applied individually to each device and scan mode. This approach ensures the accuracy and consistency of TBS measurements across all configurations. The device is intended to be used for bone health assessment in medical facilities employing one or more DXA system(s) to which the subject device is connected. These facilities are usually hospitals, clinics, healthcare centers, radiology practices and medical imaging centers. The software is designed to be used by qualified clinical professionals (including physicians, radiologists and DXA technicians) and the physicians are solely responsible for making all final patient management decisions.
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    K Number
    K152299
    Device Name
    TBS iNsight
    Manufacturer
    MEDIMAPS GROUP SA
    Date Cleared
    2016-04-29

    (260 days)

    Product Code
    KGI
    Regulation Number
    892.1170
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDIMAPS GROUP SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TBS iNsight is a software provided for use as a complement to both DXA analysis and clinical examination. It computes the antero-posterior spine DXA examination file and calculates a score (Trabecular Bone Score - TBS) that is compared to those of the age-matched controls. The TBS is derived from the texture of the DXA image and has been shown to be related to bone microarchitecture. TBS iNsight provides as an option an assessment of 10-year fracture risk. It provides an estimate of 10-year probability of hip fracture and 10-year probability of a major osteoporotic fracture (clinical spine, forearm, hip or shoulder fracture). This estimate is based on the WHO's FRAX® Fracture Risk Assessment Tool, after adjustment for the TBS. The tool has been validated for Caucasian and Asian men and post-menopausal women between 40 and 90 years old. TBS provides information independent of BMD value: it is used as a complement to the data obtained from the DXA analysis and the clinical examination (questioning by the clinician about patient history, bioassay of bone resorption markers . . . ). The results can be used by a physician in conjunction with other clinical risk factors as an aid in the diagnosis of osteoporosis and other medical conditions leading to altered trabecular bone microarchitecture, and ultimately in the assessment of fracture risk. The TBS score can assist the health care professional in monitoring the effect of treatments on patients across time. Overall fracture risk will depend on many additional factors that should be considered before making diagnostic or therapeutic recommendations. The software does not disease, or recommend treatment regimens. Only the health care professional can make these judgments.
    Device Description
    TBS iNsight is a software provided for use as a complement to to both DXA analysis and clinical examination. It computes the AP spine DXA examination file and calculates the Trabecular Bone Score (TBS) that is compared to those of the age-matched controls. The TBS is derived from the texture of the DXA image and has been shown to be related to bone microarchitecture. It provides as an option an assessment of 10-year fracture risk, based on the WHO's FRAX® Tool, after adjustment for the TBS. The results can be used by a physician in conjunction with other clinical risk factors as an aid in the diagnosis of osteoporosis and other medical conditions leading to altered trabecular bone microarchitecture, and ultimately in the assessment of fracture risk. The TBS score can assist the health care professional in monitoring the effect of treatments on patients across time.
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    K Number
    K121716
    Device Name
    TBS INSIGHT
    Manufacturer
    MEDIMAPS GROUP SA
    Date Cleared
    2012-10-05

    (116 days)

    Product Code
    KGI, TBS
    Regulation Number
    892.1170
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDIMAPS GROUP SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Med-Imaps TBS iNsight is a software provided for use as a complement to a DEXA analysis. It computes the antero-posterior spine DEXA examination file and calculates a score (Trabecular Bone Score - TBS) that is compared to those of the age-matched controls. The TBS is derived from the texture of the DEXA image and has been shown to be related to bone microarchitecture and fracture risk. This data provides information independent of BMD value; it is used as a complement to the data obtained from the DEXA analysis and the clinical examination (questioning by the clinician about patient history, bioassay of bone resorption markers ... ). The TBS score can assist the health care professional in assessment of fracture risk and in monitoring the effect of treatments on patients across time. Overall fracture risk will depend on many additional factors that should be considered before making diagnostic or therapeutic recommendations. The software does not diagnose disease, or recommend treatment regimens. Only the health care professional can make these judgments.
    Device Description
    TBS iNsight is a software package that provides an estimate of the trabecular bone quality based on analysis of data derived from DEXA examination. The program utilizes a quantitative bone structural algorithm that analyzes the texture of AP spine projection scans from which the Trabecular Bone Score (TBS) is mathematically derived. The results (TBS) can be used for comparison to a reference database of age-matched controls.
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