ArmSure Fluoroscopic Positioning System

The ArmSure Fluoroscopic Positioning System is a software-enabled manual assist arm designed for use with fluoroscopic systems to help visualize and maintain the spatial position of attached surgical instruments and accessories on X-ray images. It is intended for use by trained healthcare professionals during fluoroscopically-guided procedures involving the spine and long bones.

The device uses a mechanical tracking method via a manual Assist Arm rather than optical or electromagnetic tracking like the predicates. It runs on a standalone computer with specific hardware requirements (Intel i7-9700E CPU, NVIDIA T1000 GPU, Windows 11). The system achieves 99.7% confidence interval accuracy of less than 1.5mm, which exceeds predicate specifications. Like the predicates, it is passive, does not control the fluoroscope, and requires a sterile tracker attached to surgical instruments.

ISO 10993 for biocompatibility; ISO 11135 for sterilization via ethylene oxide; IEC 60601-1 for electrical safety; IEC 60601-1-2 for electromagnetic compatibility; ISO 9283 and ASTM F2554 for positional accuracy; IEC 62366-1:2015/AMD 1:2020 for usability validation; FDA guidance on software cybersecurity and human factors engineering.

The ArmSure system shares the same intended use and similar technological characteristics as predicate devices TrackX (K173736) and TrackX v.2.0 (K200360), both classified as Image-Intensified Fluoroscopic X-Ray Systems. Although ArmSure uses mechanical rather than optical/electromagnetic tracking, this difference does not raise new safety or effectiveness questions. Non-clinical performance testing demonstrates superior accuracy, and usability validation showed 100% success rate with no use errors, confirming the device performs as safely and effectively as the predicates.