ANKYRAS

ANKYRAS is medical device software that enables visualization of cerebral blood vessels and computational modeling of neurointerventional braided endovascular devices (flow diverters) for preoperational planning and sizing. It provides segmentation of neurovascular structures, centerline generation, X-ray image visualization, and tools for placing and sizing braided endovascular devices. The software is available on Windows, Android, and iOS platforms.

The subject device (v4.0) expands platform availability to include WebGL and Mobile App in addition to Standalone mode, and adds Android and iOS compatibility beyond Windows. It maintains the same DICOM image interface, 3D rotational angiography support, and measurement outputs (length, expansion, porosity, vessel diameter metrics). The flow diverter database remains identical with five FDA-cleared devices. Key difference is the addition of download and share simulation features on WebGL and Mobile platforms.

Not stated in this summary.

The subject device has identical indications for use, regulatory classification, and intended use as the predicate. Both devices perform the same core functions: segmentation, centerline generation, visualization, and flow diverter simulation with identical measurement outputs. The technological differences—expanded platform support and additional sharing/download capabilities—do not alter the fundamental mode of action or introduce new safety concerns. Verification and validation testing (including phantom studies and retrospective clinical image comparisons) demonstrated the device's computational accuracy meets or exceeds manufacturer specifications for length, expansion, and porosity predictions, matching the predicate's performance standards.