Onera SleepMap (SLEEPMAP)

“SleepMap is a software- only medical device to be used under the supervision of a clinician to analyze physiological signals and automatically score sleep study recordings, including the staging of sleep, detection of arousals, leg movements, desaturations, obstructive apneas and obstructive hypopneas.”

“The Onera SleepMap contains the following algorithms: - Sleep staging algorithm, a deep learning model (Al-model) which classifies sleep stages, based on EEG, EOG and EMG inputs. - Arousals algorithm, a Convolutional Neural Network (Al-model) which predicts arousals, based on sleep stages, EEG, EOG, EMG, ECG and nasal pressure inputs. - Desaturation algorithm, a rule-based algorithm which detects events of minimum 3% or 4% oxygenation drop based on sleep stages and SpO2 signal inputs. - Apnea (obstructive) detection, a rule-based algorithm which detects ≥90% nasal pressure drops, based on sleep stages and nasal pressure signal inputs. - Hypopneas (obstructive) detection, a rule-based algorithm which detects ≥30% nasal pressure drops based on sleep stages, nasal pressure signal, arousal events, and desaturation event inputs. - Leg Movement algorithm, a rule-based algorithm which detects (repetitive) EMG amplitude increasements, based on sleep stages, EMG signal and respiratory event inputs. - Artifact algorithms, rule-based algorithms which detect artifacts, based on SpO2, EEG, EOG, EMG and heart rate inputs.”

“Authentication controls, authorization controls, cryptographic controls, access controls, integrity controls, intrusion & availability monitoring controls, and database controls.”