SafeOp 3: Neural Informatix System

The SafeOp 3: Neural Informatix System is an intraoperative neuromonitoring device used by trained healthcare professionals to record motor evoked potentials (MEP), somatosensory evoked potentials (SSEP), electromyography (EMG), and assess neuromuscular junction function during various surgical procedures including spinal, orthopedic, and neurological surgeries.

The device comprises a patient interface with power supply, an Alpha Informatix tablet running Windows 11 (upgraded from Windows 10), docking station, and disposable accessories including electrode harnesses and stimulating probes. It maintains identical specifications to the predicate in power supply (100-240 VAC input; 12 VDC 2.5A output), amplifier channels (up to 16), stimulation parameters, frequency range (0.1-50 Hz), and impedance measurements, with minor hardware updates that do not alter intended use or clinical performance.

The document cites 60601-1 (electrical safety standard for medical devices). Performance verification includes testing for accuracy, positive predictive value (PPV ≥90%), and F1-score (≥85%) criteria, with non-inferiority demonstrations at 95% confidence levels for planned algorithm modifications.

Substantial equivalence is established because the subject device has identical indications for use, intended use, device classification (Class II), product codes, and monitoring modalities to the predicate SafeOp 3 System (K234092). The Windows 11 operating system upgrade and minor hardware refinements do not alter technological characteristics or clinical performance, as confirmed by nonclinical testing and usability analysis.