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Aurora is a Software as a Medical Device (SaMD) that establishes sleep quality. Aurora automatically analyzes, displays, and summarizes Photoplethysmogram (PPG) data collected during sleep using compatible devices. Aurora is intended for use by and by order of a healthcare professional to aid in the diagnosis of sleep disorders including sleep apnea in adults. The Aurora output, including automatically detected respiratory events and parameters, may be displayed and edited by a qualified healthcare professional. The Aurora output is not intended to be interpreted or clinical action taken without consultation of a qualified healthcare professional. Aurora is not intended for use with polysomnography devices.

Aurora is a Class II Software as a Medical Device (SaMD), intended to aid in the evaluation of sleep disorders, where it may inform or drive clinical management. Aurora is a software application that is indicated for use on a general-purpose computing platform. It is a cloud-based software-as-a-medicaldevice (SaMD) with a user interface that runs in a web browser. Aurora automatically analyzes and displays photoplethsmography (PPG) signal data including SPO2 and pulse/heart rate only from compatible FDA-cleared medical purpose pulse oximeters that meet Aurora's data acquisition requirements for sampling rate, digital resolution, measurement range, and accuracy range. Following upload of a compatible PPG study to the cloud software, the algorithm functions by verifying minimum signal quality, study length, and technical adequacy requirements, preprocessing the data including normalization, digital filtration, and artifact detection/rejection procedures, applying machine learning algorithms including multiple deep neural network machine learning models, statistical signal processing analyses including time-domain and time-frequency domain analyses over multiple time and resolution scales, and other analyses output a detected set of events and derived signals for the PPG study that are post-processed and logically filtered according to algorithm rules based on the American Academy of Sleep Medicine (AASM) recommended scoring event, desaturation, and association rules. Aurora algorithm outputs, including scored respiratory events, sleep stages, Aurora Apnea-Hypopnea Index (eAHI), Total Sleep Time (TST), Sleep Efficiency (SE), Sleep Latency (SL), Wake After Sleep Onset (WASO), and Oxygen Desaturation Events Index (ODI) measures, are stored and made available for display, editing, and review in Aurora by qualified healthcare professionals. Aurora reports results of the automated data analysis based on AASM guidelines, including the Aurora output Apnea-Hypopnea Index (eAHI) and total sleep time (TST). The algorithm outputs are graphical and numerical displays and reports of sleep latency, sleep quality, and sleep pathologies including sleep disordered breathing. The Aurora displays and reports are for the order of physicians, trained technicians, or other healthcare professionals to evaluate sleep disorders where it may inform or drive clinical management taking into consideration other factors that normally are considered for clinical management of sleep disorders for adults. The clinician can view raw data for interpretation, edit events, write clinical notes, and customize sleep reports for the patient. Aurora output is not intended to be interpreted or clinical action taken without consultation of a qualified healthcare professional.

EnsoSleep is intended for use in the diagnostic evaluation by a physician to assess sleep quality and as an aid for physicians in the diagnosis of sleep disorders and respiratory related sleep disorders in pediatric as follows: - · Pediatric patients 13 years and older with polysomnography (PSG) tests obtained in a Hospital or Sleep Clinic - · Adult patients with PSGs obtained in a Hospital or Sleep Clinic - · Adult patients with Home Sleep Tests EnsoSleep is a software-only medical device to be used under the supervision of a clinician to analyze physiological signals and automatically score sleep study results, including the staging of arousals, leg movements, and sleep disordered breathing events including obstructive apneas (OSA), central sleep apneas (CSA), and hypopneas. All automatically scored events and physiological signals which are retrieved, analyzed, displayed, and summarized are subject to verification by a qualified clinician. Central sleep apneas (CSA) should be manually reviewed and modified as appropriate by a clinician. All events can be manually marked or edited within records during review. Photoplethysmography (PPG) total sleep time is not intended for use when electroencephalograph (EEG) data is recorded. PPG total sleep time is not intended to be used as the sole or primary basis for diagnosing any sleep related breathing disorder, prescribing treatment, or determining whether additional diagnostic assessment is warranted.

EnsoSleep is a software-only medical device that analyzes previously recorded physiological signals obtained during sleep. Users of EnsoSleep are consistent with the roles required to run a sleep clinic: sleep physicians, sleep technicians, clinic operations managers, and IT administrators. EnsoSleep can analyze at-home and in-lab sleep studies for both adult and pediatric patients who are at least 13 years old. Automated algorithms are applied to the raw signals in order to derive additional signals and interpret the raw and derived signal information. The software automates recognition of the following: respiratory events, sleep staging events, arousal events, movement events, cardiac events, derived signals, and calculated indices. EnsoSleep does not interpret the results, nor does it suggest a diagnosis. The device only marks events of interest for review by a physician who is responsible for diagnoses. The device does not analyze data that are different from those analyzed by human scorers. The signals and automated analyses can be visually inspected and edited prior to the results being integrated into a sleep study report. The software consists of 4 major components: - The Application Platform runs on local clinic workstations and manages the detection, upload, and download of study records and scoring to and from the Storage Platform - The Processing Platform accepts raw physiological signals as inputs in order to recognize events, derive signals, and calculate indices - . The Storage Platform facilitates file and database storage in the EnsoSleep cloud through an API - The Dashboard is a web-based user interface to support configuration, clinic management, and sleep study scoring

EnsoSleep is intended for use for the diagnostic evaluation by a physician to assess sleep quality and as an aid for the diagnosis of sleep and respiratory related sleep disorders in adults only. EnsoSleep is a software-only medical device to be used under the supervision of a clinician to analyze physiological signals and automatically score sleep study results, including the staging of sleep, detection of arousals, leg movements, and sleep disordered breathing events including obstructive apneas. All automatically scored events are subject to verification by a qualified clinician. Central apneas, mixed apneas, and hypopneas must be manually marked within records.

EnsoSleep is a software application that analyzes previously recorded physiological signals obtained during sleep. The EnsoSleep software can analyze any EDF or EDF+ files. Automated algorithms are applied to the raw signals in order to derive additional signals and interpret the raw and derived signal information. The software automates recognition of: Sleep Stage Events - Wake - Stage N1 - Stage N2 - Stage N3 - Stage REM Respiratory Events - Sleep disordered breathing (apneas and hypopneas) - Apneas detected with airflow signal are classified as obstructive apnea (OSA), and can be edited to be central or mixed appeas - Sleep disordered breathing events not detected to be apneas are marked as hypopnea - Central apneas, mixed apneas, and hypopneas must be manually marked within records Arousal Events - Arousals Movement Events - Periodic Leg Movements during Sleep (PLMS) The EnsoSleep software can be used as a stand-alone application for use on Microsoft Windows 7 & 8 operating system platforms. All processing, scoring, and analysis of signal data occurs on the EnsoSleep cloud servers.