Clinical Validation of TetraGraph EMG System

This technical report presents the clinical validation findings of the TetraGraph® electromyography (EMG) system in comparison to the traditional mechanomyography (MMG) for neuromuscular monitoring. The objective of the study was to assess the accuracy and precision of the TetraGraph system across various phases of neuromuscular block, including train-of-four (TOF) ratios, TOF counts, and post-tetanic count (PTC) measurements. The study involved 26 patients undergoing elective surgery, with over 685 paired recordings analyzed. Key findings indicate that the TetraGraph achieved a mean difference of -2.1% compared to MMG, showcasing high accuracy and reliability. The results demonstrate that 95% of PTC measurements were within two counts of MMG, and the TetraGraph was validated as the new clinical standard for quantitative TOF monitoring. The report concludes that the TetraGraph EMG system is a portable, user-friendly tool that enhances patient safety and aligns with guidelines from the American and European societies.