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The SleepImage System is Software as a Medical Device (SaMD) that establishes sleep quality. The SleepImage System analyzes, displays and summarizes Electrocardiogram (ECG) or Plethysmogram (PLETH) data, typically collected during sleep, that is intended for use by or on the order of a Healthcare Professional to aid in the evaluation of sleep disorders, where it may inform or drive clinical management for children, adolescents and adults. The SleepImage Apnea Hypopnea Index (sAHI), presented when oximeter data is available, is intended to aid healthcare professionals in diagnosis and management of sleep disordered breathing. The SleepImage System output is not interpreted or clinical action taken without consultation of a qualified healthcare professional.

The SleepImage System 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. The Sleeplmage System automatically analyzes and displays Electrocardiogram (ECG) and Plethysmogram (PLETH) data. When provided in addition to the ECG or PLETH data, the SleepImage System can optionally analyze and display accelerometer and oximeter data. The results of the processed data are graphical and numerical presentations and reports of sleep latency, sleep duration, sleep quality and sleep pathology for the use by or on 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 children, adolescents and adults. When oximeter data is available, the Sleeplmage System will generate the Sleeplmage Apnea Hypopnea Index (sAHI) to aid healthcare professionals in diagnosis and management of sleep disordered breathing. The SleepImage System reports results of the automated data analysis, including expected values for sleep quality, sleep duration and sleep pathology based on published peer-reviewed publications, and guidelines for sleep duration (National Sleep Foundation) and sleep apnea (American Academy of Sleep Medicine). The clinician can view raw data for interpretation, adjust study duration, write clinical notes in the report and make recommendations to patients for further testing, recommend a referral to another clinician and/or recommendations for therapy. The SleepImage System output is not intended to be interpreted or clinical action taken without consultation of a qualified healthcare professional. Due to the intra-night variability of sleep, it is recommended that patients track their sleep over time. The SleepImage System is a sleep health evaluation application that is indicated for use on a general-purpose computing platform. Like the predicate device, it processes data typically recorded during sleep, using a cloud-based web application.

The SleepImage System is medical software that establishes sleep quality. The SleepImage system analyzes, displays and summarizes ECG data, typically collected during sleep that is intended for use by or on the order of a Health Care Professional to aid in the evaluation of sleep disorders, where it may inform or drive clinical management.

The SleepImage System consists of an operator-independent process that automatically analyzes Electrocardiography data using a general purpose computing platform. When provided in addition to the ECG data, the SleepImage System can optionally display accelerometer and oximeter data. The results of the processed data are graphical and numerical presentations and reports of sleep latency, sleep duration, sleep quality and sleep pathology for the use by or on the order of physicians, trained technicians, or other healthcare professionals. The data output establishes sleep quality and allows the healthcare professional 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. The clinician can create unique patient reports for the patient being evaluated, and configure parameters in the software. The SleepImage System is a standalone, sleep health evaluation application that provides automated analysis of cardiovascular and respiratory waveforms. Like the predicate device, it processes information recorded during sleep. The SleepImage System is considered to be medical software. The SleepImage System is being updated from the predicate device, the M1 Sleep Data Recorder and CPC Application Software to operate independent of the dedicated M1 Sleep Data Recorder cleared under K092003.