Diagnostic accuracy for sleep stages and sleep parameters was high, suggesting comparable outcomes to in-lab PSG. The average time (minutes:seconds) needed by sleep technicians to apply the Onera STS on a patient was 6:17 ± 2:34, compared to 28:15 ± 8:39 necessary to apply traditional PSG, resulting in reduced average set-up time of more than 20 min for all patients. Overall epochby- epoch analysis found substantial agreement between the Onera STS and in-lab PSG (kappa = 0.69).
FDA 510k cleared and CE-marked refers to the Onera Sleep Test System, which is a Class IIa medical device. Onera STS includes the Onera STS I System, which is CE marked in Europe, and the Onera STS System, which was cleared the the Food and Drug Administration for use in the United States.