MINDWAYS SOFTWARE, INC. DI_CTXAHIP CTXA Hip Bone Mineral Densitometer

The CTXA Hip Bone Mineral Densitometer (CTXA Hip) is a software package intended for estimation of bone mineral content (BMC), in grams, and bone mineral density (BMD), in g/cm2, of the proximal femur. The CTXA Hip uses quantitative computed tomography (QCT) methods to derive bone mass and bone density estimates from 3D CT image data sets obtained from compatible, whole-body CT scanners and with compatible CT calibration phantoms. BMD estimates are derived in units of g/cm2 equivalent K2HPO4 density. The BMD estimates can be compared with CTCA Hip-derived reference data. T-scores are calculated with respect to CTXA Hip young normal female reference data, and the T-scores ca be used by the physician an an aid in determining fracture risk.CTXA Hip uses the same technical procedures to acquire and calibrate CT image data as are used for the predicate device K894854: QCT Bone Mineral Density Analysis Software. CTXA Hip reference data for young normal US Caucasian females were acquired in a clinical study, so that patient results obtained using CTXA Hip can be compared to this normal reference population. The CTXA Hip BMD estimates compared to the CTXA Hip reference population are sued as an aid to the physician in identifying patients with low bone mineral density. Additionally, normal data comparisons provide a basis for estimating fracture risk.BMC and BMD estimates are returned by the CTXA Hip for the following proximal femur regions of interest (ROIs): (1) femoral neck, (2) trochanter, (3) intertrochanter, (4) Ward’s triangle, and (5) total hip (i.e., superposition of ROIs 1-3).