(268 days)
Yes
The device description explicitly states that the algorithm used for sleep staging is implemented with an artificial neural network, including recurrent and attention layers, which are components of machine learning.
No
The device is described as measuring, recording, displaying, transmitting, and analyzing electrical activity of the brain to assess sleep and wake in the home or healthcare environment. It generates a sleep report and provides automatic sleep staging based on EEG and accelerometer data. The intended use is for assessment of sleep, which is diagnostic, not therapeutic.
Yes
The Dreem 3S is intended for prescription use to measure, record, display, transmit and analyze the electrical activity of the brain to assess sleep and awake. It outputs a hypnogram of sleep scoring and a summary of sleep metrics, which are used to assess sleep. This fits the definition of a diagnostic device as it measures and analyzes physiological data to assess a health condition (sleep).
No
The device description explicitly states that the Dreem 3S includes a headband containing microelectronics, EEG electrodes, and a 3D accelerometer sensor, which are hardware components.
Based on the provided information, the Dreem 3S is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Dreem 3S Function: The Dreem 3S measures and analyzes electrical activity of the brain (EEG) and head movement (accelerometer) directly from the patient's body. It does not analyze samples taken from the body.
- Intended Use: The intended use is to "measure, record, display, transmit and analyze the electrical activity of the brain to assess sleep and awake". This is a physiological measurement and analysis, not an in vitro test.
Therefore, the Dreem 3S falls under the category of a physiological monitoring and analysis device, not an IVD.
No
The document contains no mention of the FDA reviewing, approving, or clearing a PCCP for this specific device.
Intended Use / Indications for Use
The Dreem 3S is intended for prescription use to measure, record, display, transmit and analyze the electrical activity of the brain to assess sleep and awake in the home or healthcare environment.
The Dreem 3S can also output a hypnogram of sleep scoring by 30-second epoch and summary of sleep metrics derived from this hypnogram.
The Dreem 3S is used for the assessment of sleep on adult individuals (22 to 65 years old). The Dreem 3S allows for the generation of user/predefined reports based on the subject's data.
Product codes (comma separated list FDA assigned to the subject device)
OLZ, OLV
Device Description
The Dreem 3S headband contains microelectronics, within a flexible case made of plastic, foam, and fabric. It includes 6 EEG electrodes and a 3D accelerometer sensor.
The EEG signal is measured by two electrodes in the frontal position) and two at the back of the head (occipital position), along with one reference electrode and one ground electrode.
The 3D accelerometer is embedded in the top of the headband to ensure accurate measurements of the wearer's head movement during the night. The raw EEG and accelerometer data are transferred to Dreem's servers for further analysis after the night is over.
The device includes a bone-conduction speaker with volume control to provide notifications to the wearer, and a power button circled by a multicolor LED light
The device generates a sleep report that includes a sleep staging for each 30-second epoch during the night. This output is produced using an algorithm that analyzes data from the headband EEG and accelerometer sensors. A raw data file is also available in EDF format.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
The algorithm is implemented with an artificial neural network. Frequency spectrums are computed from raw data and then passed to several neural network layers including recurrent layers and attention layers. The algorithm outputs prediction for several epochs of 30 seconds at the same time, every 30 seconds. The various outputs for a single epoch of 30 seconds are combined to provide robust sleep scoring.
Input Imaging Modality
Not Found
Anatomical Site
Brain (electrical activity), Head (movement)
Indicated Patient Age Range
22 to 65 years old
Intended User / Care Setting
Home or healthcare environment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance compared to lab PSG:
- Study type: Clinical investigation comparing Dreem 3S sleep staging output with a 510(k)-cleared PSG system.
- Sample size: 38 subjects (23 to 66 years old, mean age 35.8 ± 11.6 years).
- Data source: Sleep lab setting.
- Key results: Agreement between Dreem 3S automated analysis and consensus expert-scored PSG for sleep stages (confusion matrix and positive agreement per stage provided). A total of 36447 epochs, corresponding to about 303 hours and 43 minutes of sleep were included the study.
EEG data quality:
- Study type: Study to establish EEG data quality from Dreem 3S for manual review and scoring.
- Key results: 96.6% epochs per night of recording were determined to be acceptable for manual scoring and sleep staging by at least two out of three reviewers. All data recordings reviewed had ≥4 hours of data considered to be scoreable by at least two out three reviewers.
Usability Study:
- Study type: Investigation to assess usability in the home setting.
- Key results: Device could be successfully used and was tolerated by study subjects.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Confusion Matrix (Percentages):
| Consensus from manual staging | |||||
|---|---|---|---|---|---|
| W | N1 | N2 | N3 | REM | |
| Dreem 3S | |||||
| (Automated analysis) | |||||
| W | 90.7% | 14.1% | 0.6% | 0.1% | 1.4% |
| N1 | 4.4% | 55.2% | 1.8% | 0.0% | 1.0% |
| N2 | 0.8% | 21.8% | 83.7% | 2.1% | 2.2% |
| N3 | 0.2% | 0.2% | 11.7% | 97.8% | 0.0% |
| REM | 3.8% | 8.7% | 2.2% | 0.0% | 90.7% |
| Unassigned | 0.01% | 0.0% | 0.0% | 0.0% | 0.0% |
Average Subject-level Positive Agreement (PA) with Bootstrapped CI estimates (2.5%, 97.5%):
| Stage | Dreem 3S
Positive Agreement with
Bootstrapped CI estimates (2.5%, 97.5%) |
|-------|--------------------------------------------------------------------------------|
| Wake | 88.5% (85.1%, 91.3%) |
| N1 | 58.0% (52.7%, 63.0%) |
| N2 | 83.4% (80.7%, 85.7%) |
| N3 | 98.2% (96.73%, 99.3%) |
| REM | 91.57% (86.63%, 95.72%) |
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).
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August 18, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below.
Beacon Biosignals, Inc. % Delphine Lemoine Regulatory Affairs Project Manager 17-21 rue Saint-Fiacre Paris, 75002, France
Re: K223539
Trade/Device Name: Dreem 3S Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLZ, OLV Dated: July 19, 2023 Received: July 20, 2023
Dear Delphine Lemoine:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Patrick Antkowiak -S
for Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K223539
Device Name Dreem 3S
Indications for Use (Describe)
The Dreem 3S is intended for prescription use to measure, record, display, transmit and analyze the electrical activity of the brain to assess sleep and awake in the home or healthcare environment.
The Dreem 3S can also output a hypnogram of sleep scoring by 30-second epoch and summary of sleep metrics derived from this hypnogram.
The Dreem 3S is used for the assessment of sleep on adult individuals (22 to 65 years old). The Dreem 3S allows for the generation of user/predefined reports based on the subject's data.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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dreem
510(k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92.
General Information
- Submitter: Beacon Biosignals, Inc. 22 Boston Wharf Rd., 7th Floor, unit 41, Boston, MA 02210 USA
Contact Person: Delphine Lemoine Regulatory Affairs project manager 17-21 rue Saint-Fiacre Paris France
Date Prepared: 19 July 2023
Device Information
Trade name: Dreem 3S Common Name: Sleep Assessment System Regulation: 21 CFR 882.1400, Electroencephalograph Product code: OLZ, OLV Device Class: 2 Review Panel: Neurology
Predicate Device
Nox Medical, Nox Sleep System - K192469. Device Description
The Dreem 3S headband contains microelectronics, within a flexible case made of plastic, foam, and fabric. It includes 6 EEG electrodes and a 3D accelerometer sensor.
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The EEG signal is measured by two electrodes in the frontal position) and two at the back of the head (occipital position), along with one reference electrode and one ground electrode.
The 3D accelerometer is embedded in the top of the headband to ensure accurate measurements of the wearer's head movement during the night. The raw EEG and accelerometer data are transferred to Dreem's servers for further analysis after the night is over.
The device includes a bone-conduction speaker with volume control to provide notifications to the wearer, and a power button circled by a multicolor LED light
The device generates a sleep report that includes a sleep staging for each 30-second epoch during the night. This output is produced using an algorithm that analyzes data from the headband EEG and accelerometer sensors. A raw data file is also available in EDF format.
The algorithm uses raw EEG data and accelerometer data to provide automatic sleep staging according to the AASM classification. The algorithm is implemented with an artificial neural network. Frequency spectrums are computed from raw data and then passed to several neural network layers including recurrent layers and attention layers. The algorithm outputs prediction for several epochs of 30 seconds at the same time, every 30 seconds. The various outputs for a single epoch of 30 seconds are combined to provide robust sleep scoring.
Indication for use
The Dreem 3S is intended for prescription use to measure, record, display, transmit and analyze the electrical activity of the brain to assess sleep in the home or healthcare environment.
The Dreem 3S can also output a hypnogram of sleep scoring by 30-second epoch and summary of sleep metrics derived from this hypnogram.
The Dreem 3S is used for the assessment of sleep on adult individuals (22 to 65 years old). The Dreem 3S allows for the generation of user/predefined reports based on the subject's data.
Technological Characteristics and Comparison
The Dreem 3S is substantially equivalent to the Nox Sleep System (K192469) from Nox Medical based on the technological and performance characteristics as described in the summary table below.
The subject device Dreem 3S and the predicate Nox Sleep System are both for the assessment of sleep and are both used to measure, record, display, transmit and analyze physiological parameters during sleep and wake in the home and healthcare facility. Both subject and predicate devices are used to aid diagnosis of adult patients with disturbed sleep. Both devices allow for the generation of user/predefined reports based on the subject's data. Both the subject and predicate devices may be used in home and healthcare facilities. Both devices are for prescription use only.
It is thus concluded that the intended use of the Dreem 3S is substantially equivalent to the Nox Sleep System.
The comparison table below is provided as a summary of the most relevant characteristics of the Dreem 3S relative to the primary predicate Nox Sleep System.
| Technological | Subject Device | Predicate Device | Comparison to |
|---|---|---|---|
| Characteristic | Predicate Device | ||
| Device Name | Dreem 3S | Nox Sleep System | N/A |
| Manufacturer | Beacon Biosignals, Inc. | NOX MEDICAL | N/A |
| 510(k) # | K223539 | K192469 | N/A |
| Regulation Number | 21 CFR 882.1400 | 21 CFR 882.1400 | Same |
| Class | 2 | 2 | Same |
| Device | |||
| Classification Name | Automatic Event Detection | ||
| Software for PSG with EEG | Automatic Event Detection | ||
| Software For PSG With EEG | Same | ||
| Like the Predicate Device, | |||
| the Dreem 3S is composed | |||
| of a software for automatic | |||
| analysis and staging of the | |||
| EEG measurements. | |||
| Product Codes | OLZ, OLV | OLZ, KZM | Same regulation and |
| primary product code | |||
| 882.1400 | |||
| Portable Design | Yes | Yes | same |
| Patient Worn Device | Yes | Yes | same |
| Physical dimensions | Head perimeter 540mm to | ||
| 620mm. | |||
| One size fits all. Adjustable | |||
| with XS, S, M, L spacers. | Nox A1 Recorder: 82x63x21 | ||
| mm | |||
| Nox C1 Access Point: | |||
| 135x149x26 mm | same | ||
| Weight | 130g | Nox A1 Recorder: | |
| 92 g (120 g with battery) | |||
| Nox C1 Access Point: 264 g | No significant difference | ||
| Materials | ABS Soft polyester fabric | Plastic, | |
| ABS/Polycarbonate blend | Similar materials of | ||
| construction. | |||
| Method of Connection to | |||
| Patient | 6 dry electrodes for EEG | ||
| assessment on the | |||
| headband. | |||
| 3D-accelerometer for | |||
| movement/body position | |||
| assessment. | |||
| Bone conduction audio | |||
| system. | Respiratory bands/belts for | ||
| respiratory effort. | |||
| Respiratory bands/belts for | |||
| attaching the device and clip | |||
| straps to secure the position | |||
| of the device Plastic tubing | |||
| and cannula for pressure | |||
| sensing. | |||
| Snap-on electrode cables | |||
| with snap-on disposable | |||
| electrodes for EMG/EOG. | |||
| Thermal flow | |||
| sensors/thermocouple for | |||
| measuring nasal/oral | |||
| airflow. | |||
| Nox A1 EEG 5 Lead Gold | |||
| Electrode Cable and Nox A1 | The Dreem 3S only utilizes | ||
| EEG electrodes unlike the | |||
| predicate, which has | |||
| additional inputs which can | |||
| be selected by the user if | |||
| needed. | |||
| The use of only EEG | |||
| electrodes does not impact | |||
| the subject device's | |||
| performance for the | |||
| intended use in automatic | |||
| sleep scoring. | |||
| EEG Head Cable for EEG/EOG. | |||
| Surface electrode leads for EEG/EOG/EMG. | |||
| Surface Electrodes for measuring of leg movements. | |||
| Wrist-worn oximeter and probes for oximetry worn on the finger. | |||
| Data Analysis | Automatic scoring and derived sleep metrics are provided to the health care provider through a specific report, in a pdf file. Manual analysis and marking are available on raw data. | Yes, by use of Noxturnal PSG SW (PC). | |
| Automatic results may be manipulated (manual review/verification must be performed prior to diagnosis). | |||
| Manual analysis. | |||
| Event marking (scoring). | |||
| Technician Notes. | Both devices allow the generation of reports with accurate data analysis and provide access to the patient's raw data. | ||
| #Channels of data recorded | 5 EEG channels from 5 electrodes: | ||
| Frontal - Occipital | |||
| Frontal - Occipital | |||
| Frontal - Frontal | Nox A1 recorder: up to 26 | ||
| Nox C1 Access Point: up to 16 | The subject device has fewer EEG channels than the predicate device. | ||
| Operating Time | Up to 24 hours | Up to 8 hours | Subject device has longer battery life. |
| Sensors | - EEG dry electrodes x6 |
- Accelerometer | - Nox A1 EEG 5 Lead Gold Electrode Cable
- Disposable electrodes for EMG/EOG
- Thermal flow sensors / thermocouple
- Surface Electrodes for measuring leg movements
- Oximeter and probes for oximetry | The Subject Device's sensors are a subset of the Predicate Device's sensors.
Also, we note that, while the predicate device does not use dry EEG electrodes, the. Neuronaute (K170138) is an example of a FDA cleared device that does use dry EEG electrodes. |
| Recording Time
Same as the operating time.
Up to 24 hours. | | Up to 8 hours | Subject device has longer recording time |
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Non-Clinical Performance
The Dreem 3S has been evaluated against the following electromagnetic compatibility and electrical safety standards:
- . IEC 60601-1:2005+A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2:2014 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests
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- IEC TR 60601-4-2:2016 Medical electrical equipment – Part 4-2: Guidance and interpretation =Electromagnetic immunity: performance of medical equipment and medical electrical systems
- . IEC 60601-2-26 Medical electrical equipment -- Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs
The Dreem 3S is intended to be used in the patient's home and has been evaluated against the following electrical safety and performance standard for home healthcare environment:
- . IEC 60601-1-11:2015 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
The Dreem 3S has undergone usability testing to comply with standards "IEC 60601-1-6:2010+A1:2013 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability" and "IEC 62366-1:2015/Amd1:2020 Medical devices — Part 1: Application of usability engineering to medical devices – Amendment 1".
All body contacting components (fabric inside the headband, front and back electrodes, bone conduction, pod) have gone through successful biocompatibility testing according to biocompatibility standards:
- ISO 10993-1 Fifth Edition 2018 Biological evaluation of medical devices Part 1: Evaluation . and testing within a risk management process
- ISO 10993-5 Third Edition 2009 Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10 Third Edition 2010 Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization
Clinical Performance
The Dreem 3S performance has been assessed through the following investigations:
Performance compared to lab PSG. A clinical investigation was completed that compared Dreem 3S sleep staging output with a 510(k)-cleared PSG system in a sleep lab setting on patients with disturbed sleep. This study included 38 subjects ranging from 23 to 66 years old with a mean ± standard deviation age of 35.8 ± 11.6 years. Subjects were equally split between male and female, and included individuals self-identified as White, Black African American, Asian, Hispanic and some not identified. A total of 36447 epochs, corresponding to about 303 hours and 43 minutes of sleep were included the study.
Data from this study is summarized in a confusion matrix below in table 2 comparing the performance of the Dreem device with expert-scored sleep stages from a cleared device. Table 3 provides subject-level positive agreement for each stage with bootstrapped confidence interval.
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Dreem 3S
| Consensus from manual staging | |||||
|---|---|---|---|---|---|
| W | N1 | N2 | N3 | REM | |
| Dreem 3S | |||||
| (Automated analysis) | |||||
| W | 90.7% | 14.1% | 0.6% | 0.1% | 1.4% |
| N1 | 4.4% | 55.2% | 1.8% | 0.0% | 1.0% |
| N2 | 0.8% | 21.8% | 83.7% | 2.1% | 2.2% |
| N3 | 0.2% | 0.2% | 11.7% | 97.8% | 0.0% |
| REM | 3.8% | 8.7% | 2.2% | 0.0% | 90.7% |
| Unassigned | 0.01% | 0.0% | 0.0% | 0.0% | 0.0% |
| Epoch | |||||
| count | 6719 | 2582 | 17534 | 3922 | 5690 |
Table 2: Confusion matrix comparing Dreem 3S and consensus of expert-scored PSG for all sleep epochs is summarized as percentages in the table below.
Table 3: Average subject-level positive agreement (PA) per sleep stage of the Dreem 3S compared to the expert-scored PSG with bootstrapped confidence intervals (CI).
| Stage | Dreem 3S
Positive Agreement with
Bootstrapped CI estimates (2.5%, 97.5%) |
|-------|--------------------------------------------------------------------------------|
| Wake | 88.5% (85.1%, 91.3%) |
| N1 | 58.0% (52.7%, 63.0%) |
| N2 | 83.4% (80.7%, 85.7%) |
| N3 | 98.2% (96.73%, 99.3%) |
| REM | 91.57% (86.63%, 95.72%) |
EEG data quality. A study was conducted to establish that EEG data quality from Dreem 3S is sufficient for manual review and scoring of data. 96.6% epochs per night of recording were determined to be acceptable for manual scoring and sleep staging by at least two out of three
9
reviewers qualified to read EEG and/or PSG data. All data recordings reviewed had ≥4 hours of data considered to be scoreable by at least two out three reviewers.
Usability Study. An investigation was completed to assess usability in the home setting and showed that the device could be successfully used and was tolerated by study subjects.
Conclusions
Based on the comparison to the predicate device and performance studies, the Dreem 3S is substantially equivalent to the currently U.S. legally marketed device Nox Sleep System (K192469) and presents no new concerns about safety or effectiveness.