3D-SHAPER

3D-SHAPER is software that reconstructs 3D bone shape and mineral density from 2D DXA (dual-energy X-ray absorptiometry) scans of the hip. It measures cortical and trabecular bone mineral density and allows physicians to estimate structural hip properties and assess relative fracture risk as an aid to clinical judgment.

The device uses a DXA-based 3D reconstruction algorithm operating on Windows with mouse/keyboard input. It provides numerical results, graphs with age-related reference data and density categories (normal, low, very low), 2D/3D visualization, and exports as PNG snapshots, CSV data, and proprietary file formats with DICOM connectivity. Performance characteristics including computing time, convergence, accuracy, precision, scanner compatibility, and inter-scanner variability were equivalent to the prior 2.11 version.

Design and development followed ISO 14971 for risk management, IEC 62304 for software life-cycle processes, and IEC 82304 for health software safety. Testing also aligned with multiple FDA guidance documents including software validation, off-the-shelf software use, cybersecurity, and interoperability recommendations.

The subject device shares identical regulatory classification, product code, and intended anatomical site (hip) with the primary predicate (3D-SHAPER v2.11). Although the indications for use differ by excluding certain parameters (CSA, CSMI, Z, Buckling Ratio) that were never included in clinical reports or used for clinical decisions, the core measurements (cortical sBMD, trabecular vBMD, integral vBMD) and fracture risk assessment remain the same. Performance bench testing confirmed v2.14 is equivalent to v2.11, and six clinical studies demonstrate that 3D-SHAPER measurements associate with fracture risk similarly to BMD from the secondary predicate, establishing comparable safety and effectiveness.