Sleep Profiler is intended for the diagnostic evaluation by a physician to assess sleep quality in adults only. The Sleep Profiler is a software-only 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 and snoring.

Device Description

The Sleep Profiler is a software application that analyzes previously recorded physiological signals obtained during sleep. The Sleep Profiler software can analyze any EDF files meeting defined specifications, including signals acquired with the Advanced Brain Monitoring X4 System which is the subject of a separate 510(k). 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: a) sleep stage, b) snoring frequency and severity, c) pulse rate, d) cortical (EEG), sympathetic (pulse) and behavioral (actigraphy and snoring) arousals. A single channel of electrocardiography, electrooculargraphy, electromyography, or electroencephalography can be optionally presented for visual inspection and interpretation. The software identifies and rejects periods with poor electroencephalography signal quality. The full disclosure recording of derived signals and automated analyses can be visually inspected and edited prior to the results being integrated into a sleep study report. Medical and history information can be input from a questionnaire. Responses are analyzed to provide a pre-test probability of Obstructive Sleep Apnea (OSA) (a condition that cannot be diagnosed with Sleep Profiler) so an appropriate referral to a sleep physician is made. The automated analyses of physiological data are integrated with the questionnaire data, medical and history information to provide a comprehensive report. Several report formats are available depending on whether the user has acquired more than one night of data, wishes to obtain a narrative summary report or provide patient reports.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the Sleep Profiler device, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The acceptance criteria are implied by the comparison to a predicate device, MICHELE (K112102). The goal is to demonstrate "similar" performance. The specific metrics are overall percent agreement and agreement for each sleep stage.

Table 1: Sleep Profiler Performance vs. Predicate Device Performance (Sleep Staging)

Metric	Sleep Profiler Performance Data (from 44 subjects)	Predicate Device (MICHELE, K112102) Performance Data (from its study)
Overall % Agreement	Not explicitly stated as an overall value, but individual positive and negative agreements are provided.	82.6%
Agreement by Sleep Stage (Positive Agreement / Sensitivity)
Wake	0.79	89.9%
N1	0.40	50.4%
N2	0.80	82.9%
N3	0.76	82.9%
REM	0.72	89.8%
Agreement by Sleep Stage (Negative Agreement / Specificity)
Wake	0.95	96.4%
N1	0.91	94.7%
N2	0.83	89.6%
N3	0.97	97.5%
REM	0.97	98.5%

The summary states, "The positive and negative percent agreement obtained during clinical validation of the Sleep Profiler are similar to that obtained by the predicate device, MICHELE (K112102), which was validated using a different data set."

Study Details

Sample Size used for the test set and the data provenance:
- Test Set Sample Size: 44 subjects.
- Data Provenance: Not explicitly stated, but it's a "clinical validation" comparing to manual observation. It doesn't state whether it's retrospective or prospective, or the country of origin.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Three raters.
- Qualifications: "either sleep technicians or physicians."
Adjudication method for the test set:
- The table indicates a "No-Consensus" row for the experts, implying adjudication by consensus was used. Specifically, the "Epochs assigned by Expert Scoring" includes a "No-Consensus" category (653 epochs out of 39191 total), suggesting that if the three raters did not agree, those epochs were excluded from the primary agreement calculations for individual stages. The main performance metrics are likely based on epochs where there was full consensus (3 out of 3, or potentially 2 out of 3 if that's what "consensus" meant here, although the "No Consensus" row suggests agreement was required).
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. The study's purpose was to validate the "sleep staging algorithms by comparison to sleep staging made by manual observation by three raters." This is a standalone algorithm performance study compared to human experts as ground truth, not a study evaluating human performance with or without AI assistance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone algorithm performance study was done. The results presented in the table ("Epochs assigned by Sleep Profiler" vs. "Epochs assigned by Expert Scoring") directly report the algorithm's performance without human interaction or modification. The description also states the software "automates recognition" and that the "full disclosure recording of derived signals and automated analyses can be visually inspected and edited prior to the results being integrated into a sleep study report," but the presented validation data is for the automated algorithm's output.
The type of ground truth used:
- Expert Consensus. The ground truth for the test set was established by the "manual observation by three raters who were either sleep technicians or physicians."
The sample size for the training set:
- Not specified. The document does not provide details about the training set size or how it was established. It only discusses the clinical validation (test set) of the software.
How the ground truth for the training set was established:
- Not specified. Since details about the training set are not provided, how its ground truth was established is also not mentioned.

Summary

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510(k) Summary

K120450

In accordance with 21 CFR 807.92 the following summary of information is provided:

DATE: September 6, 2012

SUBMITTER:

Advanced Brain Monitoring 2237 Faraday Avenue, Suite 100 Carlsbad, CA 92008 T 760.720.0099 F 760.720.3337

PRIMARY CONTACT PERSON:

Adrienne Lenz, RAC Founder Pathway Regulatory Consulting, LLC T 262-290-0023

SECONDARY CONTACT PERSON:

Dan Levendowski President and Co-founder Advanced Brain Monitoring, Inc.

DEVICE:

TRADE NAME: Sleep Profiler

COMMON/USUAL NAME: automatic event detection software for polysomnograph with electroencephalograph

CLASSIFICATION NAMES: 882.1400 Electroencephalograph

PRODUCT CODE: OLZ

PREDICATE DEVICE(S):

K112514 Apnea Risk Evaluation System (ARES), Model 610

K112102 MICHELE Sleep Scoring System

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DEVICE DESCRIPTION:

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: a) sleep stage, b) snoring frequency and severity, c) pulse rate, d) cortical (EEG), sympathetic (pulse) and behavioral (actigraphy and snoring) arousals. A single channel of electrocardiography, electrooculargraphy, electromyography, or electroencephalography can be optionally presented for visual inspection and interpretation. The software identifies and rejects periods with poor electroencephalography signal quality. The full disclosure recording of derived signals and automated analyses can be visually inspected and edited prior to the results being integrated into a sleep study report.

Medical and history information can be input from a questionnaire. Responses are analyzed to provide a pre-test probability of Obstructive Sleep Apnea (OSA) (a condition that cannot be diagnosed with Sleep Profiler) so an appropriate referral to a sleep physician is made. The automated analyses of physiological data are integrated with the questionnaire data, medical and history information to provide a comprehensive report. Several report formats are available depending on whether the user has acquired more than one night of data, wishes to obtain a narrative summary report or provide patient reports.

INTENDED USE:

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TECHNOLOGY:

The Sleep Profiler software is similar to software in the ARES Model 610 and MICHELE Sleep Scoring System. The following table highlights similarities and differences in technology.

Specification	Sleep Profiler	ARES Model 610(K112514)	MICHELE SleepScoring System(K112102)	Discussion Differences
Indicationsfor Use	Sleep Profiler isintended for thediagnostic evaluation bya physician to assesssleep quality in adultsonly. The Sleep Profileris a software-onlydevice to be used underthe supervision of aclinician to analyzephysiological signals andautomatically scoresleep study results,including the staging ofsleep, detection ofarousals and snoring.	The Apnea RiskEvaluation System (ARES)is indicated for use in thediagnostic evaluation bya physician of adultpatients with possiblesleep apnea. The AREScan record and scorerespiratory events duringsleep (e.g., apneas,hypopneas, mixedapneas and flow limitingevents). The device isdesigned for prescriptionuse in home diagnosis ofadults with possiblesleep-related breathingdisorders.	The MICHELE SleepScoring System is acomputer program(software) intendedfor use as an aid forthe diagnosis ofsleep andrespiratory relatedsleep disorders.The MICHELE SleepScoring System isintended to be usedfor analysis(automatic scoringand manualrestoring), display,redisplay (retrieve),summarizing,reports generationand networking ofdigital datacollected bymonitoring devicestypically used toevaluate sleep andrespiratory relatedsleep disorders.The device is to beused under thesupervision of aphysician. Use isrestricted to filesobtained from adultpatients.	Equivalent. The Sleep Profileris a software applicationapplied to previously acquireddata which is similar toMICHELE. The ARES includesboth data acquisition andanalyses, and is cleared todetect sleep vs. wake and REMvs. Non-REM.Sleep Profiler, MICHELE andARES have the same intendeddiagnostic effect in stagingsleep. The Sleep Profiler'sindication is a subset of theARES and MICHELE as it doesnot analyze respiratory data.

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Specification	Sleep Profiler	ARES Model 610(K112514)	MICHELE SleepScoring System(K112102)	Discussion Differences
DerivedSignals	• Sleep stages RapidEye Movement(REM) and nREM(N1, N2, N3)Pulse rate• Snoring loudness• Sleep/wake• Head movementand position• Snoring,sympathetic,behavioral andcortical arousals• ECG,EOG, EMGwaveform	• Sleep stages RapidEye Movement (REM)and nREM• Pulse rate• Snoring loudness• Sleep/wake• Head movementand position• Snoring,sympathetic,behavioral arousals• SpO2• Airflow• Respiratory Effort(Optional)• Apneas andHypopneas	• Sleep stagesRapid EyeMovement (REM)and nREM (N1,N2, N3) and wake• Arousals• Periodic LegMovements• Apneas andHypopneas	Equivalent. Sleep Profilerprocesses raw data, appliesfilters, derives a subset ofsignals, and applies ananalysis to those signalslike ARES. Display ofECG/EOG/EMG is similar todisplay of the otherwaveforms; no analysis ofthese waveforms areperformed. Unlike ARES,Sleep Profiler does notmeasure SpO2, airflow orrespiratory effort, or detectApneas/Hypopneas.
Reports	• Single night graphicand patient Hx• Two nightcomparison table	• Single night graphic,narrative and patientHx• Two night comparisontable	Not specified	Equivalent. Both ARES andSleep Profiler reportsprovide sleep time, sleepefficiency, sleep/wake,medical history and diseasemanagement comments.The ARES report identifiesstatistics and presentsgraphs relevant to sleepapnea whereas the SleepProfiler report identifiesstatistics and presentsgraphs related to sleepstaging.

DETERMINATION OF SUBSTANTIAL EQUIVALENCE:

SUMMARY OF NON-CLINICAL TESTS:

The following quality assurance measures were applied to the development of the Sleep Profiler Software:

. .

Risk Analysis .
Software Validation ●

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SUMMARY OF CLINICAL TESTS:

The Sleep Profiler software has been the subject of clinical testing which validates the sleep staging algorithms by comparison to sleep staging made by manual observation by three raters who were either sleep technicians or physicians. There were 44 subjects. The results are presented in the table below:

		Epochs assigned by Sleep Profiler						% agreement
	Overall	Wake	N1	N2	N3	REM	Total	Positive	Negative
Epochsassigned	Wake	6730	921	557	27	296	8531	0.79	0.95
by	N1	807	1962	1652	40	493	4954	0.40	0.91
Expert	N2	348	1426	11848	958	218	14798	0.80	0.83
Scoring	N3	36	24	1194	3928	8	5190	0.76	0.97
	REM	178	530	681	35	3641	5065	0.72	0.97
	No-Consensus	124	91	324	67	47	653
	Total	8223	4954	16256	5055	4703	39191

The positive and negative percent agreement obtained during clinical validation of the Sleep Profiler are similar to that obtained by the predicate device, MICHELE (K112102), which was validated using a different data set. The published results from their study are reported below.

	MICHELE
SCORING FUNCTION	Totalby Techs.	APPA	ANPA	Overall %Agreement	kappa(%)
SLEEP STAGING	24967			82.6	76.5
Awake	6563	89.9	96.4
N1	2411	50.4	94.7
N2	9846	82.9	89.6
N3	2862	82.9	97.5
Rem	3285	89.8	98.5
No Consensus	283

CONCLUSION:

Advanced Brain Monitoring considers the Sleep Profiler software to be as safe, as effective, and substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular emblem with the department's name encircling a stylized image of an eagle or bird-like figure. The bird figure is composed of three curved lines that suggest wings or feathers, and it appears to be in flight or taking off. The overall design is simple and symbolic, representing the department's role in health and human services.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

SEP 19 2012

Advanced Brain Monitoring c/o Mr. Daniel J. Levendowski President and Co-Founder 2237 Faraday Avenue, Suite 100 Carlsbad, CA 92008

Re: K120450

Trade/Device Name: Sleep Profiler Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLZ Dated: September 6, 2012 Received: September 10, 2012

Dear Mr. Levendowski:

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. 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.

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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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm11.5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Kesia Alexander

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

K120450

Device Name:

Sleep Profiler

Indications for Use:

Prescription Use_X

AND/OR

Over-The-Counter Use_

(Part 21 CFR 801 Subpart D)

(Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Q. Hoang

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K120450

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).