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.

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.

AI/ML Overview

The provided text is a 510(k) summary for the Dreem 3S device. It does not contain a comprehensive study detailing acceptance criteria and device performance. Instead, it states that no new testing was performed because the current submission is primarily for the inclusion of a Predetermined Change Control Plan (PCCP). It relies on the performance characteristics previously reported for the predicate device (K223539).

Therefore, I cannot provide a table of acceptance criteria with reported performance, or details about the sample sizes and ground truth for a new study, as none was conducted or reported in this document.

However, based on the information for the predicate device, and the intent behind the PCCP, I can infer and summarize what would typically be expected for such a device and what the PCCP aims to maintain:

Inferred Acceptance Criteria based on Predicate Device (K223539) and PCCP:
The document states, "clinical performance validation will also be repeated, and will require that the performance of any modification to Dreem 3S to be non-inferior to the all previously released versions of the Dreem 3S device." This indicates that the primary acceptance criterion for any future algorithmic updates under the PCCP is non-inferiority to the performance established in the original clearance (K223539). While the specific metrics are not detailed in this current summary, for a sleep staging device, these would typically include accuracy metrics like Cohen's Kappa, Sensitivity, Specificity, and overall accuracy for differentiating sleep stages (Wake, NREM1, NREM2, NREM3, REM).

Regarding Study Information (based on the original clearance of K223539, not detailed here):

Since the provided document explicitly states, "No bench testing, animal testing, or clinical testing was performed to support this submission," I cannot fill in the details for a new study. The performance information relates to the predicate device (K223539).

However, based on the Predetermined Change Control Plan (PCCP) section, which outlines how future algorithmic modifications will be validated, I can describe the methodology for future performance validation under that plan:

Inferred Acceptance Criteria and Future Performance Validation Methodology (based on PCCP)

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criterion (Inferred from PCCP)	Reported Device Performance (From K223539 - Not detailed in this document)
Non-inferiority of sleep staging performance to previously cleared versions	Specific performance metrics (e.g., Kappa, Accuracy, Sensitivity, Specificity for sleep stages) measured in K223539.
Maintain performance across specific sleep stages (Wake, N1, N2, N3, REM)	Specific performance metrics for each stage from K223539.
Robustness to signal preprocessing, ML model, and postprocessing updates	Performance maintained within non-inferiority margins after updates.

Note: The actual numerical performance metrics for the predicate device (K223539) are not provided in this document. They would have been part of the original K223539 submission. The PCCP ensures that future algorithmic changes meet these same (or non-inferior) performance levels.

2. Sample Size Used for the Test Set and Data Provenance:

For future updates under PCCP: The PCCP states, "Recordings that are used for any purpose (e.g., training, tuning, failure analysis, etc.) that might lead to direct or indirect insight regarding the performance of a modified sleep staging algorithm on this recording, other than execution of the clinical performance validation per the methods specified in the PCCP, are excluded from the test dataset." This implies that a new, independent test set will be used for each validation under the PCCP.
Sample Size: Not specified for future PCCP validations, but it is stated that "Quality checks will ensure that the test data are sufficiently high quality and representative of the intended use population."
Data Provenance: Not explicitly stated, but for sleep studies, typically involves polysomnography (PSG) data. The "human variability estimated from comparison of expert scoring from 284 American Academy of Sleep Medicine (AASM) compliant polysomnography recordings" suggests a U.S. or internationally recognized standard for data interpretation. The fact that the device assesses adult individuals (22 to 65 years old) means the test set would be composed of data from this age demographic. Retrospective or prospective is not specified, but typically retrospective datasets are used for initial clearances.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

For future updates under PCCP: "Non-inferiority margins were selected based on the level of human variability estimated from comparison of expert scoring from 284 American Academy of Sleep Medicine (AASM) compliant polysomnography recordings." This strongly implies that the ground truth for validation (both for K223539 and subsequent PCCP validations) is expert consensus scoring based on AASM guidelines.
Number of Experts: Not explicitly stated, but "expert scoring" typically implies one or more certified sleep technologists or sleep physicians. The mention of "human variability" often means comparison between at least two independent expert scorings.
Qualifications: "American Academy of Sleep Medicine (AASM) compliant polysomnography recordings" strongly suggests that the experts would be board-certified sleep physicians or registered polysomnographic technologists (RPSGTs) with experience in AASM sleep staging. The number of years of experience is not specified.

4. Adjudication Method for the Test Set:

Not explicitly defined in the provided text. However, for "expert scoring" and estimating "human variability," common adjudication methods include:
- Consensus: Multiple experts independently score, and a final consensus is reached (e.g., by discussion or a third adjudicator if initial scores differ significantly).
- Majority vote: If more than two experts, the majority decision prevails.
- Pairwise agreement: Often used to quantify inter-rater variability for tasks like sleep staging.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

The document does not report on an MRMC comparative effectiveness study where human readers improve with AI vs. without AI assistance for this specific submission (K242094). This submission is for a PCCP and relies on the predicate's performance.

6. Standalone (Algorithm Only) Performance Study:

Yes, the document implies that a standalone performance study was conducted for the predicate device (K223539). The algorithm "analyzes data from the headband EEG and accelerometer sensors" and "uses raw EEG data and accelerometer data to provide automatic sleep staging according to the AASM classification." The PCCP is about maintaining and improving this algorithm's standalone performance.
The "clinical performance validation will also be repeated, and will require that the performance of any modification to Dreem 3S to be non-inferior" to previous versions. This directly refers to the algorithm's standalone performance.

7. Type of Ground Truth Used:

Expert Consensus: The phrase "automatic sleep staging according to the AASM classification" and "comparison of expert scoring from 284 American Academy of Sleep Medicine (AASM) compliant polysomnography recordings" strongly indicates that the ground truth is established by expert scoring conforming to AASM guidelines. This is the standard for sleep staging.

8. Sample Size for the Training Set:

Not specified in this document. This refers to the original training data used for the predicate device (K223539). For future updates, the PCCP mentions "Retraining with an updated training/tuning dataset" but does not specify the size of these datasets.

9. How the Ground Truth for the Training Set Was Established:

Not explicitly specified for the training set itself, but it is highly probable that the ground truth for the training set was established through expert consensus scoring according to AASM guidelines, similar to how the test set's ground truth is (or will be for PCCP updates) established. This is standard practice for supervised machine learning models in this domain.

Summary

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November 22, 2024

Beacon Biosignals, Inc. Alexander Chan VP of Analytics and Machine Learning 22 Boston Wharf Road 7th Floor, Unit 41 Boston, Massachusetts 02210

Re: K242094

Trade/Device Name: Dreem 3S Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLZ, OLV Dated: October 18, 2024 Received: October 21, 2024

Dear Alexander Chan:

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 (the 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 available 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.

FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP). Under section 515C(b)(1) of the Act, a new premarket notification is not

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required for a change to a device cleared under section 510(k) of the Act, if such change is consistent with an established PCCP granted pursuant to section 515C(b)(2) of the Act. Under 21 CFR 807.81(a)(3), a new premarket notification is required if there is a major change or modification in the intended use of a device, or if there is a change or modification in a device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process. Accordingly, if deviations from the established PCCP result in a major change or modification in the intended use of the device, or result in a change or modification in the device that could significantly affect the safety or effectiveness of the a new premarket notification would be required consistent with section 515C(b)(1) of the Act and 21 CFR 807.81(a)(3). Failure to submit such a premarket submission would constitute adulteration and misbranding under sections 501(f)(1)(B) and 502(o) of the Act, respectively.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Jay R. Gupta -S

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

Submission Number (if known)

K242094

Device Name

Dreem 3S

Indications for Use (Describe)

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)

< Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/4/Picture/2 description: The image shows the logo for Beacon Biosignals. The logo consists of the word "BEACON" in bold, black letters above the word "BIOSIGNALS" in smaller, lighter letters. To the right of the text is a stylized graphic of a brain, formed by a series of connected, rounded lines in a light green color.

510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92.

SUBMITTER

Applicant	Beacon Biosignals, Inc.22 Boston Wharf Rd.7th Floor, Unit 41Boston, MA 02210
Contact	Alexander ChanVP of Analytics and Machine LearningEmail: alex.chan@beacon.bio
Date Prepared	21 June 2024

DEVICE INFORMATION

Subject Device

Name of Device	Dreem 3S
Regulation	21 CFR 882.1400
Product Code	OLZ, OLV
Device Class	Class II
Review Panel	Neurology

Predicate Device

Predicate Manufacturer	Beacon Biosignals, Inc.
Predicate Trade Name	Dreem 3S
Predicate 510(k)	K223539

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.

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Image /page/5/Picture/0 description: The image shows the logo for Beacon Biosignals. The logo consists of a stylized graphic of several vertical lines of varying heights, resembling a signal or waveform. To the right of the graphic is the text "BEACONBIOSIGNALS" in a simple, sans-serif font. The color scheme is primarily light blue and white, giving the logo a clean and modern appearance.

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 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 previous version of the Dreem 3S (K223539) based on the technological and performance characteristics as described in the summary table below.

The subject device Dreem 3S and the predicate Dreem 3S (K223539) have identical technological characteristics except for the presence of a Predefined Change Control Plan (PCCP) that is a new characteristic of the subject device. The PCCP allows for the algorithmic components of the Dreem 3S device. Both subject and predicate device are 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 the previously cleared version of the Dreem 3S (K223539).

The comparison table below is provided as a summary of the most relevant characteristics of the Dreem 3S relative to the predicate device.

TechnologicalCharacteristic	Subject Device	Predicate Device	Comparison toPredicate Device
Device Name	Dreem 3S	Dreem 3S (K223539)	N/A
Manufacturer	Beacon Biosignals, Inc.	Beacon Biosignals, Inc.	Same
Regulation Number	21 CFR 882.1400	21 CFR 882.1400	Same
Class	2	2	Same
DeviceClassification Name	Automatic EventDetection Softwarefor PSG with EEG	Automatic EventDetection Softwarefor PSG With EEG	Same
Product Codes	OLZ, OLV	OLZ, OLV	Same
Portable Design	Yes	Yes	Same
Patient Worn Device	Yes	Yes	Same
Physical dimensions	Head perimeter540mm to 620mm.One size fits all.Adjustable with XS, S,M, L spacers.	Head perimeter540mm to 620mm.One size fits all.Adjustable with XS, S.M, L spacers.	Same
Weight	130g	130g	Same
Materials	ABS Soft polyesterfabric	ABS Soft polyesterfabric	Same
Method of Connectionto Patient	6 dry electrodes forEEG assessment onthe headband.3D-accelerometer formovement/bodyposition assessment.Bone conductionaudio system.	6 dry electrodes forEEG assessment onthe headband.3D-accelerometer formovement/bodyposition assessment.Bone conductionaudio system.	Same
Data Analysis	Automatic scoring andderived sleep metricsare provided to thehealth care providerthrough a specificreport, in a pdf file.Manual analysis andmarking are availableon raw data.	Automatic scoring andderived sleep metricsare provided to thehealth care providerthrough a specificreport, in a pdf file.Manual analysis andmarking are availableon raw data.	Same
#Channels of datarecorded	- 5 EEG channelsfrom 5 electrodes(4 frontal-occipitalderivations, 1frontal-frontalderivation)- 3 Triaxialaccelerometerchannels	- 5 EEG channelsfrom 5 electrodes(4 frontal-occipitalderivations, 1frontal-frontalderivation)- 3 Triaxialaccelerometerchannels	Same
Operating Time	Up to 24 hours	Up to 24 hours	Same
Recording Time	Same as the operatingtime. Up to 24 hours.	Same as the operatingtime. Up to 24 hours.	Same
PredeterminedChange Control Plan	Includes PCCP thatallows for the updateof the signalpreprocessing,machine learningmodel, and probabilitypostprocessing.	No PCCP	Different - Predicatedevices does notinclude a PCCP

Table 1 : Comparison of technological characteristics

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Image /page/6/Picture/0 description: The image shows the logo for Beacon Biosignals. The logo consists of a stylized graphic of several vertical lines of varying heights, resembling a signal or waveform. To the right of the graphic is the text "BEACONBIOSIGNALS" in a simple, sans-serif font. The text is in a dark gray color, while the graphic is in a light teal color.

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PERFORMANCE TESTING

No bench testing, animal testing, or clinical testing was performed to support this submission. Because this submission only involves the additional inclusion of the Predetermined Change Control Plan, the performance characteristics of the submitted device are the same as previously reported for the predicate device (K223539).

PREDETERMINED CHANGE CONTROL PLAN

Dreem 3S includes an authorized Predetermined Change Control Plan (PCCP) that allows for planned updates of the machine learning software device function (ML-DSF) and non-ML algorithmic components to improve sleep staging performance within the existing intended use and indications for use. This PCCP allows for the modification of the algorithmic components of Dreem 3S including the signal preprocessing, machine learning model, or postprocessing to achieve increased sleep staging performance. The three modifications are summarized in the table below.

#	Modification	Description
1	Update of SignalPreprocessingSteps	Dreem 3S's EEG signal preprocessing may be modified for thepurposes of improving sleep staging performance within the intendeduse population by:Updating the parameters of the digital signal processing steps(e.g., filtering) applied to the Dreem 3S headband signalsbefore being input to the machine learning model
2	Update of MachineLearning Model	Dreem 3S's sleep staging neural network may be modified for thepurposes of improving sleep staging performance within the intendeduse population by:Retraining with an updated training/tuning dataset Retraining with updated hyper-parameters, loss function,optimizer Retraining with updated model selection criteria Retraining with an updated neural network architecture withlimitations on model size and type
3	Update ofProbabilityPostprocessing	Dreem 3S's probability postprocessing may be modified for thepurposes of improving sleep staging performance within the intendeduse population by:Updating the methods by which sleep stages are generatedfrom the model output sleep stage probabilities

Modifications 1 and 2 above would trigger re-training of the machine learning model, while modification 3 would not trigger re-training of the machine learning model.

The testing of any modification to Dreem 3S within the scope of the PCCP will include comprehensive software verification and validation testing, including repeating unit, integration, and system level tests related to the software components affected by the change. All of these software

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Image /page/8/Picture/0 description: The image shows the logo for Beacon Biosignals. The logo consists of a stylized graphic of brainwaves in a light teal color, followed by the text "BEACONBIOSIGNALS" in a simple, sans-serif font. The text is in a light gray color.

verification tests must pass for a modification to be considered valid. In addition, clinical performance validation will also be repeated, and will require that the performance of any modification to Dreem 3S to be non-inferior to the all previously released versions of the Dreem 3S device. Non-inferiority marqins were selected based on the level of human variability estimated from comparison of expert scoring from 284 American Academy of Sleep Medicine (AASM) compliant polysomnography recordings.

Recordings that are used for any purpose (e.g., training, tuning, failure analysis, etc.) that might lead to direct or indirect insight regarding the performance of a modified sleep staging algorithm on this recording, other than execution of the clinical performance validation per the methods specified in the PCCP, are excluded from the test dataset. Quality checks will ensure that the test data are sufficiently high quality and representative of the intended use population.

Upon a release of an updated version of Dreem 3S based on this PCCP, communication will be provided to all clinical users of Dreem 3S, informing them that a new version of Dreem 3S is available, with a description of the release and its updated performance.

CONCLUSIONS

The Dreem 3S is substantially equivalent to the previous version of the legally marketed Dreem 3S (K223539) and presents no new concerns about safety or effectiveness.

Regulation Number and Section

§ 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).