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3D-SHAPER uses data from conventional Dual Energy X-Ray Absorptiometry (DXA) scans to measure the distribution of bone mineral mass at the hip and allows the physician to estimate structural properties of the hip, such as cortical sBMD, trabecular vBMD and integral vBMD.

These values can then be compared to an adult reference population at the sole discretion of the physician. The results can assist the physician in the assessment of relative fracture risk.

3D-SHAPER is indicated to be used by qualified medical professionals to assist healthcare professionals in the bone health evaluation & changes, and cannot fully substitute their clinical judgement.

3D-SHAPER is a software reconstructing in 3D, the shape and bone mineral density from 2D DXA images. The software incorporates a DXA-based 3D reconstruction algorithm and measures the distribution of bone mineral mass at the hip. It provides physicians with estimates of the structural properties of the hip, such as cortical sBMD, trabecular vBMD and integral vBMD. The software is not suitable for use with pediatric patients or for subjects with hip prosthesis such as total hip replacement prosthesis, hip resurfacing prosthesis or an osteosynthesis system, since the software has not been tested against these conditions. 3D-SHAPER is indicated to be used by qualified medical professionals to assist healthcare professionals in the bone health evaluation & changes, and cannot fully substitute their clinical judgement.

The 3D-SHAPER measurements include the following parameters calculated at the total femur:

• Cortical surface Bone Mineral Density (Cortical sBMD, mg/cm²)
• Trabecular volumetric Bone Mineral Density (Trabecular vBMD, mg/cm³)
• Integral volumetric Bone Mineral Density (Integral vBMD, mg/cm³), the integral compartment being the union of the cortical and trabecular compartments.

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