ENSOSLEEP

DEVICE PROFILE
Reference Document

EnsoSleep 6.25+ / REF0007-B-ENG Page 1 of 10

EnsoSleep Device Profile Introduction

Introduction
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. This includes calculation of total sleep time.

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 in EnsoViewer 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

Please read the instructions for use carefully before using the EnsoSleep device.

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EnsoSleep Device Profile Indications for Use

Indications for Use

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 and adult patients as follows:
• Pediatric patients ages 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 sleep,
detection 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 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.

Contraindications
There are no known contraindications.

Product Requirements
Computer Requirements:
• Operating System – Microsoft Windows Operating System version 10+
• Minimum 4 GB RAM, 16 GB RAM recommended
• Web Browser – Google Chrome (Mac or Windows) or Microsoft Edge (Windows)
• High Speed Internet connection - 12 Mbps or more recommended
• Patient Data File Formats – EDF or EDF+, HL7

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EnsoSleep Device Profile Study Scoring

AASM Required Signals - minimum AASM Recommended Signals - minimum

sampling rate; anatomical derivation sampling rate; anatomical derivation
Event Type Event Subtypes Default system settings Optional system settings
Arousal Arousals 3 channel EEG (200 Hz; Frontal, Central, and EOG (200 Hz; Outer Canthus) and/or EMG
Events Occipital) (200 Hz; Submental)
Cardiac Bradycardia, ECG (200 Hz; Lead II) N/A
Events Tachycardia
Movement LM, PLMS EMG (200 Hz; Anterior tibialis) Actigraphy (1 Hz; Wrist)
Events
Respiratory OSA, CSA, MSA, Airflow (25 Hz; Oronasal Thermal Sensor RIP (25 Hz; Thoracic and Abdominal), PVDF
Events Hypopnea, Cheyne- and/or Nasal Pressure Transducer) and (25 Hz; Thoracic and Abdominal), ECG (200
Stokes respiration, Oximetry (10 Hz; Finger or Earlobe pulse Hz; Lead II), Snoring Microphone (200 Hz),
Periodic breathing oximeter) Peripheral Arterial Tonometry (200 Hz;
Finger), and/or Esophageal Manometry (25 Hz)
Sleep Staging Wake, N1, N2, N3, 3 channel EEG (200 Hz; Frontal, Central, and EOG (200 Hz; Outer Canthus) and/or EMG
Events REM Occipital) (200 Hz; Submental)
Sleep-Wake, Wake, Sleep Photoplethysmogram (100 Hz), Airflow (25 N/A
Staging Light, Deep, REM Hz; Nasal pressure transducer) and RIP (25
Events* Hz; Thoracic)
*Only intended to be used in the absence of EEG signals.

Study Scoring
The EnsoSleep autoscoring software is based directly on the recommendations of the American
Academy of Sleep Medicine (AASM) Manual for the Scoring of Sleep and Associated Events designed
to guide sleep study professionals through the technical aspects of polysomnography (PSG) testing.

Input signals used to derive outputs include:

• Electroencephalogram (EEG)
• Electrocardiogram (ECG)
• Electro-oculogram (EOG)
• Electromyogram (EMG)
• Peripheral arterial tone (PAT)*
• Actigraphy
• Airflow
• Oximetry
• Saturation of Peripheral Oxygen (SpO2)
• Respiratory Inductance Plethysmogram (RIP)
• Polyvinylidene Fluoride (PVDF)
• Photoplethysmogram (PPG)
• Pulse Rate
• Snoring Microphone
• Esophageal Manometry

*Display and manual scoring only.

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EnsoSleep Device Profile Study Scoring

The EnsoSleep autoscoring algorithm identifies the following physiological events and indices.
Scoring results may be reviewed and edited as necessary.

• Respiratory Events
• Obstructive Sleep Apneas (OSA)
• Central Sleep Apneas (CSA)
• Obstructive Hypopneas
• Central Hypopneas
• Cheyne-Stokes
• Periodic Breathing
• Sleep Staging Events
• Wake
• N1
• N2
• N3
• REM (rapid eye movement)
• Light (N1, N2)
• Deep (N3)
• Sleep (N1, N2, N3, REM)
• Arousal Events
• Arousals
• Respiratory Effort-Related Arousal (RERA)
• Movement Events
• Leg Movements (LM)
• Periodic Leg Movement Series (PLMS)
• Cardiac Events
• Bradycardia
• Tachycardia
• Apnea-Hypopnea Index (AHI)
• Sleep Architecture
• Sleep Efficiency (SE)
• Arousal Index (ArI)
• Sleep Latency (SL)
• REM Latency (RL)
• EnsoTST (total sleep time for home sleep studies)
• TST (total sleep time for in-clinic studies)
• Periodic Leg Movements (PLMS) Index

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EnsoSleep 6.25+ / REF0007-B-ENG Page 5 of 10
EnsoSleep Device Profile Study Scoring

The following events are supported for manual scoring.

• Lights
• Lights On
• Lights Off
• REM Behavior Disorder
• Respiratory Events
• Mixed Apneas
• Mixed Hypopneas
• Central Respiratory
• Obstructive Respiratory
• General (unclassified) Respiratory
• Hypoventilation
• Hypercapnia
• Respiratory Event
• Desaturation
• Snore
• Cardiac Events
• Sinus Tachycardia
• Narrow Complex Tachycardia
• Wide Complex Tachycardia
• Asystole
• Premature Atrial Contraction
• Premature Ventricular Contraction
• Movement Events
• Bruxism
• Alternating Leg Muscle Activiation
• Hypnagogic Foot Tremor
• Excessive Fragmentary Myoclonus
• Rhythmic Movement Disorder
• Treatment Events
• Continuous Positive Airway Pressure (CPAP)
• Bilevel Positive Airway Pressure (BiPAP)
• Automatic Positive Airway Pressure (APAP)
• Nasal Positive Airway Pressure (NPAP)
• Variable Positive Airway Pressure (VPAP)
• Adaptive Servo Ventilation

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EnsoSleep Device Profile Clinical Performance

• Auto Ventilation
• Oxygen
• Phrenic Nerve Stimulator
• Hypoglossal Nerve Stimulator
• Oral Appliance
• Position Events
• Upright
• Supine
• Prone
• Left
• Right
• General
• Unstaged
• Bad Data
• Inadequate
• Adequate
• Comment

Clinical Performance
Device performance in a clinical study compared automatically detected sleep staging events, sleep
disordered breathing events, apnea-hypopnea index, apnea events, obstructive apnea events, arousal
events, and leg movement events to polysomnography results obtained by a two-thirds majority of
three experienced sleep technologists. For more information about the clinical study, contact EnsoData
or view the study information in the most recent device clearance.

Adult Sample Pooled-Epochs EnsoSleep vs 2/3 Majority Sleep Staging Performance

Percent Agreement (%) with two-sided 95% bootstrap median percentile method confidence
(N=100, 84,408 PSG epochs)
intervals (R=2000)

Overall Total Positive Negative Overall

Wake 23,596 93.5% (93.1%, 93.8%) 97.2% (97.1%, 97.4%) 96.1% (96.0%, 96.3%)

N1 4,406 37.0% (35.6%, 38.5%) 98.3% (98.2%, 98.4%) 95.0% (94.8%, 95.1%)

N2 37,890 88.3% (87.9%, 88.6%) 89.3% (89.0%, 89.6%) 88.8% (88.6%, 89.0%)

N3 6,513 80.0% (79.0%, 81.0%) 96.3% (96.2%, 96.5%) 95.0% (94.9%, 95.2%)

REM 9,400 90.9% (90.4%, 91.5%) 99.3% (99.2%, 99.3%) 98.3% (98.2%, 98.4%)

Total 81,805 86.6% (86.4%, 86.9%)

None 2,603 -

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EnsoSleep Device Profile Clinical Performance

Pediatric Sample Pooled-Epochs EnsoSleep vs 2/3 Majority Sleep Staging Performance

Percent Agreement (%) with two-sided 95% bootstrap median percentile method confidence
(N=47, 38,568 PSG epochs)
intervals (R=2000)

Overall Total Positive Negative Overall

Wake 7,867 93.1% (92.5%, 93.6%) 99.2% (99.1%, 99.3%) 97.9% (97.8%, 98.1%)

N1 1,263 43.2% (40.4%, 45.9%) 98.8% (98.7%, 99.0%) 97.0% (96.8%, 97.1%)

N2 17,542 92.6% (92.3%, 93.0%) 89.4% (89.0%, 89.8%) 90.9% (90.6%, 91.2%)

N3 6,852 92.3% (91.6%, 92.9%) 97.5% (97.3%, 97.7%) 96.6% (96.4%, 96.7%)

REM 4,278 80.9% (79.6%, 82.0%) 99.1% (99.0%, 99.2%) 97.0% (96.8%, 97.2%)

Total 37,802 89.7% (89.4%, 90.0%)

None 766 -

EnsoSleep vs 2/3 Majority Sleep Apnea Diagnostic Agreement

- Adult Pediatric

AHI >= 5 AHI >= 15 AHI ≥ 1 AHI >= 5 AHI >= 10 AHI >= 15

Sample size (N) 100 100 47 47 47 47

Positive 94.4% 94.0% 94.4% 90.5% 78.6% 85.7%

Agreement (PA) (89.0%, 98.7%) (85.7%, 100.0%) (85.3%, 100.0%) (75.0%, 100.0%) (45.5%, 100.0%) (44.4%, 100.0%)

Negative 100.0% 100.0%

89.7% 96.3% 77.8% 94.9%
Agreement (NA) (100.0%, (100.0%,
(75.8%, 100.0%) (90.9%, 100.0%) (50.0%, 100.0%) (86.5%, 100.0%)
100.0%) 100.0%)

Overall 93.0% 95.0% 89.4% 95.7% 91.5% 97.9%

Agreement (OA) (88.0%, 97.0%) (90.0%, 100.0%) (80.9%, 97.9%) (89.4%, 100.0%) (83.0%, 97.9%) (93.6%, 100.0%)

Likelihood ratio (+) 9.146 25.458 4.190 ∞ 15.692 ∞

(3.879, ∞) (10.154, ∞) (1.892, ∞) (∞, ∞) (5.067, ∞) (∞,∞)

Likelihood ratio (-) 0.062 0.062 0.070 0.095 0.222 0.143

(0.014, 0.127) (0.000, 0.151) (0.000, 0.205) (0.000, 0.250) (0.000, 0.578) (0.000, 0.556)

Adult Sample Overall-Epochs EnsoSleep vs 2/3 Majority Event Detection Performance

Bootstrapped point-estimate of median Percent Agreement (%) with 95% percentile bootstrap
(N=100, 84,408 PSG epochs)
confidence interval (R=2000 resamples)
Positive Agreement (PA) Negative Agreement (NA) Overall Agreement (OA)
Events Total Epochs

Sleep Disordered
8108 75.4% (74.5%, 76.3%) 97.0% (96.9%, 97.2%) 94.9% (94.8%, 95.1%)
Breathing

Hypopnea 4420 66.3% (64.9%, 67.6%) 97.1% (97.0%, 97.2%) 95.5% (95.4%, 95.6%)

Obstructive Apnea 1659 74.1% (72.1%, 76.1%) 99.3% (99.2%, 99.3%) 98.8% (98.7%, 98.8%)

Central Apnea 1505 65.3% (63.1%, 67.6%) 99.5% (99.5%, 99.6%) 98.9% (98.8%, 99.0%)

Arousal 9047 73.6% (72.7%, 74.5%) 95.6% (95.5%, 95.7%) 93.2% (93.1%, 93.4%)

Leg Movement 6018 82.0% (81.0%, 83.0%) 92.4% (92.2%, 92.6%) 91.7% (91.5%, 91.8%)

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EnsoSleep 6.25+ / REF0007-B-ENG Page 8 of 10
EnsoSleep Device Profile Safety - Warnings and Cautions

Pediatric Sample Overall-Epochs EnsoSleep vs 2/3 Majority Event Detection Performance

Bootstrapped point-estimate of median Percent Agreement (%) with 95% percentile bootstrap
(N=47, 38,568 PSG epochs)
confidence interval (R=2000 resamples)
Positive Agreement (PA) Negative Agreement (NA) Overall Agreement (OA)
Events Total Epochs

Sleep Disordered
Breathing 1480 72.7% (70.4%, 74.9%) 98.6% (98.4%, 98.7%) 97.6% (97.4%, 97.7%)

Hypopnea 1046 68.8% (66.0%, 71.6%) 98.9% (98.8%, 99.0%) 98.0% (97.9%, 98.2%)

Obstructive Apnea 105 45.5% (36.0%, 54.8%) 99.7% (99.6%, 99.7%) 99.5% (99.5%, 99.6%)

Central Apnea 277 68.9% (63.5%, 74.1%) 99.7% (99.7%, 99.8%) 99.5% (99.4%, 99.6%)

Arousal 3018 78.6% (77.1%, 80.0%) 97.0% (96.8%, 97.2%) 95.5% (95.3%, 95.7%)

Leg Movement 1247 66.0% (63.4%, 68.6%) 95.5% (95.3%, 95.7%) 94.5% (94.3%, 94.8%)

Per-Patient Adult, Pediatric and RR Sample Total Sleep Time vs 2/3 Majority Scoring
Sample
- Two-sided 95% bootstrapped median percentile confidence interval (R=2000 resamples)

EnsoSleep PPG-TST vs EnsoSleep EEG-TST vs EnsoSleep EEG-TST vs EnsoSleep EEG-TST vs

RR Sample RR Sample Adult Sample Pediatric Sample

Deming Regression
0.964 (0.860, 1.067) 0.984 (0.925, 1.023) 1.037 (0.974, 1.201) 1.006 (0.988, 1.018)
Slope ß1

Deming Regression
0.089 (-0.484, 0.663) 0.156 (-0.071, 0.504) -0.181 (-1.101, 0.182) 0.021 (-0.034, 0.134)
Intercept ß0 [hrs]

Bland-Altman mean 5.380 (2.372, 8.475) -4.785 (-6.131, -2.237) 0.515 (-4.173, 2.331) -3.255 (-4.411, -1.472)
difference (MD) [min]

Bland-Altman upper 73.463 (68.332, 78.743) 32.922 (30.625, 37.269) 57.750 (49.751, 60.849) 10.654 (9.310, 12.728)
limit (ULOA) 95% [min]

Bland-Altman lower -62.703 (-67.835, - -42.492 (-44.789, - -56.720 (-64.718, - -17.164 (-18.508, -
limit (LLOA) 95% [min] 57.423) 38.145) 53.621) 15.091)

Safety - Warnings and Cautions

• The EnsoSleep Automated Sleep Scoring is a prescription device used under supervision of a
physician in the United States.
• The device is intended for analysis of sleep data acquired from patients 13 years old and up.
• Capnography data is not supported or displayed.
• The tachycardia and bradycardia outputs are not for use for cardiovascular monitoring or diagnosis,
nor does the device detect arrhythmias.
• The device neither interprets results nor suggests a diagnosis or recommendations for treatment.
• The device aims to identify physiological events according to the latest sleep scoring rules,
procedures, and definitions under the current standards of care as recommended by the AASM
Manual for the Scoring of Sleep and Associated Events, industry-standard published papers, and
methods cleared for this device.

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EnsoSleep 6.25+ / REF0007-B-ENG Page 9 of 10
EnsoSleep Device Profile EnsoData

• Clinics using the API have the ability to send a link to view and edit a single study. The link can be
sent to and used by persons for whom the link was not intended. Follow your clinic guidelines and
your country regulations on privacy and access of patient data.
• The scoring provided by EnsoSleep must be reviewed, edited as necessary, and approved by a
qualified healthcare professional.
• Any preliminary or preexisting score reports should be regenerated after review and rescoring of
EnsoSleep studies to ensure any/all scoring changes are reflected in final reports.
• Notify EnsoData and the appropriate government agencies if an adverse event has occurred that is
related to use of this product.

EnsoData
EnsoData, Inc. reserves the right to make changes to both this document and to the product it describes.
Product specifications are subject to change without notice. Nothing contained within this document is
intended as any offer, warranty, promise or contractual condition, and must not be taken as such.

This product is approved for sale and distribution in the United States of America (USA), Canada, and
Colombia. Do not use, resell, or distribute this product outside of the USA, Canada, or Colombia.

EnsoSleep is a trademark of EnsoData in the United States and other countries.

Non-EnsoData product names may be trademarks of their respective owners.
Published in the United States of America.

Manufactured by: Part Number: REF0007-B-ENG

EnsoData, Inc. Publication Date: November 2023
10 E Doty Street, Suite 449 Software Version: EnsoSleep 6.25+
Madison, WI USA 53703

Phone: 608-889-3676 (ENSO)

Email: [email protected]

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