KBA3D (v2.4.0) is a cloud-based software tool that helps doctors plan spine surgeries using X-ray images. It enables users to measure and analyze spinal alignment, simulate potential surgical corrections, and design customized implants. This supports accurate planning for spinal procedures, aiming to improve patient outcomes.
Intended Use
The KBA3D v2.4.0 is intended for assisting healthcare professionals in viewing X-ray images, identifying spinal anatomical structures, simulating surgical correction strategies, and defining the geometry of patient-specific implants (such as rods) based on the surgeon's validated surgical plan.
Technology
KBA3D v2.4.0 is a cloud-based standalone software that allows manual identification of anatomical structures on X-ray images, performs spine-related measurements, enables simulation of surgical corrections, and designs customized implant geometry. Recent upgrades include a module for quick measurements, automatic report generation, expanded 3D visualization (now including cervical vertebrae), and adaptation to mobile devices for image viewing.
Performance
Non-clinical performance testing (verification and validation) including unit testing, integration, usability testing, and accuracy validation was conducted. The software demonstrated high accuracy for key spinal measurements (e.g., pelvic incidence ±0.69°, Cobb angle ±0.65°) and usability testing confirmed safe operation by target users.
Predicate Devices
No predicate devices specified
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