UNiD™ Spine Analyzer

The UNiD™ Spine Analyzer is a web-based software application that assists healthcare professionals in viewing, measuring, and analyzing medical images for preoperative and postoperative spine surgery planning. It provides generic measurement tools (lines, circles, angles), spine-specific measurement tools (various spinal parameters and classifications), surgical simulation capabilities, and implant selection/placement tools to help surgeons plan surgical procedures and design patient-specific implants.

The subject device (v5.0.0) maintains the same fundamental architecture as the predicate (v4.0.0): standalone cloud-based software running on Windows/Mac with PC-compatible systems. Key differences include upgraded backend code (.NET 8.0 vs 4.8), updated frontend framework (Angular 14 & Angular JS 1.7 vs Angular JS 1.7 only), and migration from MySQL to SQL Server database. Most measurement and surgical tools remain functionally similar; removed features (intermodal calibration, Guide Spline tool) are bug fixes; reworked features (Sagittal Wizard, SA Analysis, Cervical tool, Lenke tool, export options) maintain similar operating modes with improvements. A new version of the Degenerative AI predictive model adds support for Lower Instrumented level on L5.

Software verification and validation conducted per IEC 62304 and IEC 82304-1. Cybersecurity testing performed in accordance with ANSI AAMI SW96 and IEC 81001-5-1. Usability evaluation conducted per IEC 62366-1. Performance validation for the Degenerative predictive model used one-tailed paired T-tests for non-inferiority (alpha 0.025, 90% power) on preoperative and postoperative images from 1,050 patient surgery cases.

The subject device demonstrates substantial equivalence because it maintains the same intended use, regulatory classification (Class II, 21 CFR 892.2050), and fundamental design as the predicate: both are standalone software applications for assisting with spine surgery planning and image analysis. Although the subject device incorporates technological upgrades (backend code, database), these represent modernization rather than functional change. The predicate model performance testing demonstrated non-inferiority using rigorous statistical methods (paired T-tests at defined acceptance criteria). Reworked features maintain similar operating modes with bug fixes and improvements but no change in output data. Removed features (intermodal calibration, Guide Spline tool) are bug fixes, not functional reductions. The new Degenerative AI model, while enhanced, serves the same purpose (predicting compensatory mechanisms post-surgery) as the predicate and met non-inferiority acceptance criteria.