(110 days)
Sleep Profiler is intended for use for the diagnostic evaluation by a physician to assess sleep quality and score sleep disordered breathing events 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, snoring and sleep disordered breathing events (obstructive apneas, hypopneas and respiratory event related arousals). Central and mixed apneas can be manually marked within the records.
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 acquired with the Advanced Brain Monitoring X4 System and the X8 System models SP40 and SP29. 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: Sleep stages Rapid Eye Movement (REM) and nREM (N1, N2, N3) and wake, Heart/pulse rate, Snoring loudness, Sleep/wake, Head movement and position, Snoring, sympathetic, behavioral and cortical arousals, ECG,EOG, EMG waveform, SpO2, Airflow, Respiratory Effort, Apneas and Hypopneas, Oxygen desaturations. 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). 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. The Sleep Profiler software can be used as a stand-alone application for use on Microsoft Windows 7 & 8 operating system platforms (desktop model). Alternatively, the user interface (i.e., entry or editing of information) can be delivered via a web-portal (portal model). The capability to enter or edit patient information, call the application to generate a study report, and/or download a report is provided using either the desktop PC application or web-portal application. The same analysis and report generation software is used for both the desktop and web-portal applications.
Here's a breakdown of the acceptance criteria and study information for the Sleep Profiler device, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Endpoint | Acceptance Criteria (Equivalent to Predicate Device) | Reported Device Performance (Sleep Profiler) |
|---|---|---|
| AHI for OSA Diagnosis | Minimum targeted positive likelihood ratios for AHI > 5 and AHI > 15 are 3.5 and 5.0 respectively (equivalent to predicate ARES). | Overall AHI: - AHI ≥ 5: Positive Likelihood Ratio = 6.67 - AHI ≥ 15: Positive Likelihood Ratio = 33.0 REM AHI: - AHI ≥ 5: Positive Likelihood Ratio = 8.84 - AHI ≥ 15: Positive Likelihood Ratio = 18.33 (These values exceed the minimum targeted likelihood ratios indicating equivalence) |
| Sleep Staging (Agreement with Expert Consensus) | Comparison of auto-detected staging to PSG results obtained by expert raters, showing equivalent agreement to the predicate Sleep Profiler (K130007). No specific numeric thresholds are explicitly stated as acceptance criteria, but generally high concordance is expected for substantial equivalence. | Overall (n=43 subjects, 3 raters): - Wake: Positive Agreement 0.73, Negative Agreement 0.94 - N1: Positive Agreement 0.25, Negative Agreement 0.93 - N2: Positive Agreement 0.77, Negative Agreement 0.84 - N3: Positive Agreement 0.76, Negative Agreement 0.94 - REM: Positive Agreement 0.74, Negative Agreement 0.97 (The document states "met" for this endpoint by comparison to the predicate.) |
2. Sample Sizes and Data Provenance for Test Set
- Sample Size (for AHI/OSA detection): 60 subjects for overall AHI, 40 subjects for REM AHI.
- Sample Size (for Sleep Staging): A subset of 43 subjects from the AHI study, with at least 4 hours of raw X8 diagnostic recording time.
- Data Provenance: The document states "signals acquired with the X8 System concurrent to polysomnography (PSG)." This implies the data was prospectively collected for this evaluation, likely from a clinical setting, but the country of origin is not specified.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
- Number of Experts:
- For AHI/OSA detection: "one rater per study" for PSG results.
- For Sleep Staging: "weighted majority agreement of three raters" for the 43-subject subset.
- Qualifications of Experts: Not explicitly stated beyond being "rater(s)" for PSG and "expert scoring" for sleep staging. Standard practice for such studies would imply board-certified sleep technologists or physicians experienced in PSG scoring.
4. Adjudication Method for the Test Set
- For AHI/OSA detection: "one rater per study." This implies no formal adjudication/consensus process among multiple independent reviewers, as only a single rater's PSG results were used as ground truth for each case.
- For Sleep Staging: "weighted majority agreement of three raters." This indicates an adjudication method where the consensus of three experts established the ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study is explicitly described where human readers' performance with and without AI assistance is compared. The study primarily focuses on the standalone performance of the Sleep Profiler software against expert-scored PSG.
6. Standalone Performance Study
- Yes, a standalone study was performed. The "Sleep Profiler software accuracy was clinically validated with signals acquired with the X8 System concurrent to polysomnography (PSG)." The results presented for AHI and sleep staging are for the algorithm's performance without human intervention, compared to human-scored PSG.
7. Type of Ground Truth Used
- Expert Consensus / Human Scoring: The primary ground truth for both AHI detection and sleep staging was derived from Polysomnography (PSG) results scored by human experts/raters. For sleep staging, it was specifically based on the "weighted majority agreement of three raters."
8. Sample Size for the Training Set
- The document does not explicitly state the sample size used for the training set of the Sleep Profiler software. It describes the clinical validation study (test set) but not the development data.
9. How Ground Truth for the Training Set Was Established
- The document does not provide details on how the ground truth for the training set was established. Typically, for such devices, training data would also be derived from expert-scored PSG, similar to the test set, but this information is not included in the 510(k) summary.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 14, 2016
Advanced Brain Monitoring, Inc. % Adrienne Lenz Member Pathway Regulatory Consulting, LLC W324 S3649 County Road E Dousman. Wisconsin 53118
Re: K153412
Trade/Device Name: Sleep Profiler Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLZ Dated: February 9, 2016 Received: February 11, 2016
Dear Adrienne Lenz:
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.
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
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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 contact the Division of Industry and Consumer Education 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. 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
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 Industry and Consumer Education 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,
Michael J. Hoffmann -A
- Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K153412
Device Name Sleep Profiler
Indications for Use (Describe)
Sleep Profiler is intended for use for the diagnostic evaluation by a physician to assess sleep quality and score sleep disordered breathing events 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, snoring and sleep disordered breathing events (obstructive apneas, hypopneas and respiratory event related arousals). Central and mixed apneas can be manually marked within the records.
| 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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510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
DATE: March 11, 2016
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 Member 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: Sleep Profiler CLASSIFICATION NAMES: 882.1400 Electroencephalograph, Automatic Event Detection Software For Polysomnograph With Electroencephalograph REVIEW PANEL: Neurology PRODUCT CODE: OLZ
PREDICATE DEVICE(S):
Sleep Profiler (K130007)
Reference predicate device, Apnea Risk Evaluation System (ARES), Model 610 (K112514)
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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 acquired with the Advanced Brain Monitoring X4 System and the X8 System models SP40 and SP29.
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:
- Sleep stages Rapid Eye Movement (REM) and nREM (N1, N2, N3) and wake ●
- Heart/pulse rate
- Snoring loudness
- Sleep/wake
- Head movement and position
- Snoring, sympathetic, behavioral and cortical arousals
- ECG,EOG, EMG waveform
- SpOz
- Airflow
- o Respiratory Effort
- Apneas and Hypopneas
- Oxygen desaturations.
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). 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.
The Sleep Profiler software can be used as a stand-alone application for use on Microsoft Windows 7 & 8 operating system platforms (desktop model). Alternatively, the user interface (i.e., entry or editing of information) can be delivered via a web-portal (portal model). The capability to enter or edit patient information, call the application to generate a study report, and/or download a report is provided using either the desktop PC application or web-portal application. The same analysis and report generation software is used for both the desktop and web-portal applications.
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INTENDED USE:
Sleep Profiler is intended for use for the diagnostic evaluation by a physician to assess sleep quality and score sleep disordered breathing events 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, snoring and sleep disordered breathing events (obstructive apneas, hypopneas and respiratory event related arousals). Central and mixed apneas can be manually marked within the records.
TECHNOLOGY:
The proposed Sleep Profiler has similar indications for use and uses the same fundamental technology as the legally marketed predicate devices to which substantial equivalency is claimed, the previously cleared version of the Sleep Profiler (K130007) and reference predicate device Apnea Risk Evaluation System (ARES), Model 610 (K112514) for the new indications and features that have been added to the software.
| Specification | Sleep Profiler | Predicate Device,Sleep Profiler (K130007) | Reference PredicateDevice, ARES Model 610(K112514) |
|---|---|---|---|
| Classification | OLZ, Automated EventDetection Software forPolysomnograph withElectroencephalograph | OLZ, Automated EventDetection Software forPolysomnograph withElectroencephalograph | MNR, Ventilatory EffortRecorder |
| Specification | Sleep Profiler | Predicate Device,Sleep Profiler (K130007) | Reference PredicateDevice, ARES Model 610(K112514) |
| Indications for Use | Sleep Profiler is intendedfor use for the diagnosticevaluation by a physician toassess sleep quality andscore sleep disorderedbreathing events in adultsonly. The Sleep Profiler is asoftware-only device to beused under the supervisionof a clinician to analyzephysiological signals andautomatically score sleepstudy results; including thestaging of sleep, detectionof arousals, snoring andsleep disordered breathingevents. (obstructiveapneas, hypopneas andrespiratory event relatedarousals). Central andmixed apneas can bemanually marked withinthe records. | Sleep Profiler is intendedfor the diagnosticevaluation by a physicianto assess sleep quality inadults only. The SleepProfiler is a software-only device to be usedunder the supervision ofa clinician to analyzephysiological signals andautomatically score sleepstudy results, includingthe staging of sleep,detection of arousals andsnoring. | The Apnea Risk EvaluationSystem (ARES) is indicatedfor use in the diagnosticevaluation by a physician ofadult patients with possiblesleep apnea. The ARES canrecord and scorerespiratory events duringsleep (e.g., apneas,hypopneas, mixed apneasand flow limiting events).The device is designed forprescription use in homediagnosis of adults withpossible sleep-relatedbreathing disorders. |
| Intended Use | Analyze physiological dataacquired during sleep. | Analyze physiological dataacquired during sleep. | Analyze physiological dataacquired during sleep. |
| Patient Population | Adults | Adults | Adults |
| Environment of Use | Physician office (dataanalysis and reporting) | Physician office (dataanalysis and reporting) | Physician office (dataanalysis and reporting) |
| No limitation on wheredata are acquired. | No limitation on wheredata are acquired. | Home (data acquisition) | |
| Specification | Sleep Profiler | Predicate Device,Sleep Profiler (K130007) | Reference PredicateDevice, ARES Model 610(K112514) |
| Derived Signals | • Sleep stages Rapid EyeMovement (REM) andnREM (N1, N2, N3) andwake• Heart/pulse rate• Snoring loudness• Sleep/wake• Head movement andposition• Snoring, sympathetic,behavioral and corticalarousals• ECG,EOG, EMG waveform• SpO2• Airflow• Respiratory Effort• Apneas and Hypopneas• Oxygen desaturations | • Sleep stages Rapid EyeMovement (REM) andnREM (N1, N2, N3) andwake• Pulse rate• Snoring loudness• Sleep/wake• Head movement andposition• Snoring, sympathetic,behavioral and corticalarousals• ECG,EOG, EMGwaveform | • Sleep stages Rapid EyeMovement (REM) andnREM• Pulse rate• Snoring loudness• Sleep/wake• Head movement andposition• Snoring, sympathetic,behavioral arousals• SpO2• Airflow• Respiratory Effort(Optional)• Apneas andHypopneas• Oxygen desaturations |
| Signal quality | Auto-rejects bad signalquality in EEG with optionalairflow and SpO2. | Auto-rejects bad signalquality in EEG. | Auto-rejects bad signalquality in EEG, airflow andSpO2 |
| Sleep Measures | • Sleep, REM and N3onset• Total sleep andrecording times• Sleep efficiency• % time by sleep stage• Awakenings per hour• Wake after sleep onset | • Sleep, REM and N3onset• Total sleep andrecording times | • Sleep onset• Total sleep andrecording times• Sleep efficiency• % time by sleep stage |
| Sleep Staging | Based on one foreheadEEG signals to differentiateWake (W), REM (R), NREMstage 1 (N1), NREM stage 2(N2) and slow wave sleep(N3, includes both stages 3and 4) | Based on one foreheadEEG signals to differentiateWake (W), REM (R), NREMstage 1 (N1), NREM stage2 (N2) and slow wavesleep (N3, includes bothstages 3 and 4) | Based on one foreheadEEG signal to differentiateREM and non-REM sleep,and behavioral measuresfrom actigraphy, snoringand airflow to detect sleepfrom wake |
| Specification | Sleep Profiler | Predicate Device,Sleep Profiler (K130007) | Reference PredicateDevice, ARES Model 610(K112514) |
| Sleep DisorderedBreathing (whenrespiratory signalsare acquired) | • Detects apneas withairflow signal. Eachapnea is classified asobstructive but can beedited to be central ormixed apneas.• Detects hypopneas withairflow signal. Changesin SpO2 are used todetermine hypopneaseverity (i.e., 4% or 3%events).• Detects RERAs withairflow signal andcortical arousals (i.e.,hypopneas that do notmeet the desaturationcriteria) | None | • Detects apneas withairflow signal• Each apnea classifiedwith the automatedalgorithms is labeled asan obstructive Apnea(Ap) or Apnea witharousal (ApA).• Detects hypopneas withairflow signal. Changes inSpO2 are used todetermine hypopneaseverity• Hypopnea with arousalsand a 4%, 3%, 1%, or 0%desaturation (H4A, H3A,H1A, H0A)• Hypopnea with noassociated arousal (H4,H3, H1).• Hypopneas that do notmeet the minimal 1%desaturation criteriamust have at least onearousal indicator to belabeled. |
| Heart rate accuracy | 20 to 250 bpm ± 5 bpm | 20 to 250 bpm ± 5 bpm | 20 to 250 bpm ± 5 bpm |
| Head Position | Via accelerometers | Via accelerometers | Via accelerometers |
| Position accuracy 3° @ 30°C | Position accuracy 3° @ 30°C | Position accuracy 3° @ 30°C | |
| Snoring Level | From microphone | From microphone | From microphone |
| 40 dB @ 3% of dynamicrange (min) | 40 dB @ 3% of dynamicrange (min) | 40 dB @ 3% of dynamicrange (min) | |
| 70 dB @ 90% of dynamicrange (max) | 70 dB @ 90% of dynamicrange (max) | 70 dB @ 90% of dynamicrange (max) | |
| Accuracy 0.2 dB at midrange | Accuracy 0.2 dB at midrange | Accuracy 0.2 dB at midrange | |
| Specification | Sleep Profiler | Predicate Device, Sleep Profiler (K130007) | Reference Predicate Device, ARES Model 610 (K112514) |
| User Editing | Allows editing of sleep stage Allows editing of auto-scored obstructive and quality events User can insert missed events or convert obstructive to central | Allows editing of sleep stage | Allows editing of sleep stage Allows editing of auto-scored obstructive and quality events User can insert missed events or convert obstructive to central |
| Reports | Graphic, narrative and patient Hx Record time Sleep time Valid sleep time Sleep latency (onset) Sleep efficiency Sleep times and %time per sleep stage Sleep stage graph by EEG with cortical arousals Pulse rate graph with autonomic activations Snoring level graph with snoring arousals %time snoring > 30, 40, 50 and 60 dB Head movement graph with behavioral arousals Head position graph Excluded EEG data Medical history Disease management comments Physician review and signature. Optional: AHI, numerical and graphical, supine and non-supine RDI, numerical and graphical, supine and non-supine | Graphic, narrative, and patient Hx Record time Sleep time Valid sleep time Sleep latency (onset) Sleep efficiency Sleep times and %time per sleep stage Sleep stage graph by EEG with cortical arousals Pulse rate graph with autonomic activations Snoring level graph with snoring arousals %time snoring > 30, 40, 50 and 60 dB Head movement graph with behavioral arousals Head position graph Excluded EEG data Medical history Disease management comments Physician review and signature. | Graphic, narrative and patient Hx Recording time Sleep time Valid sleep time Sleep latency (Onset) Sleep efficiency AHI, numerical and graphical, supine and non-supine RDI, numerical and graphical, supine and non-supine #Apneas #Hypopneas Mean SpO2, %time < 90 %SpO2 %time snoring > 30, 40, 50 and 60 dB Pulse rate graph with autonomic activiations Snoring level graph with snoring arousals Head movement graph with behavioral arousals Head position graph Sleep vs. wake hypnogram Physician interpretation and comments (free text) Clinical History (narrative and tabular) Sleep study findings Treatment considerations |
| Specification | Sleep Profiler | Predicate Device, Sleep Profiler (K130007) | Reference Predicate Device, ARES Model 610 (K112514) |
| Reports, continued | o #Apneaso #Hypopneaso #RERAso Mean SpO2, %time < 90 and < 88% SpO2 | o Disease management considerationso Physician review and signature. | |
| Two Night Reports | Multi-night and test-retest comparison table of statistics listed | Multi-night and test-retest comparison table of statistics listed | Multi-night and test-retest comparison table of statistics listed |
| Disease management comments | On report, drop down selection.o Cardiac Dysrhythmiao Restless Leg Syndromeo Sleep Disordered Breathingo Depression | On report, drop down selection.o Cardiac Dysrhythmiao Restless Leg Syndromeo Sleep Disordered Breathingo Depression | On report, drop down selection.o Cardiac Dysrhythmiao Restless Leg Syndromeo Central sleep apneaPlus automatically generated requiring confirmation or editing from user.o Numerous messages related to sleep apnea. |
| Compatibility | Sleep Profiler will operate on any personal computer with Windows XP operating system and at least 2 GB of RAM. The speed by which a study will process is dependent on the computer processer and the amount of RAM. | Sleep Profiler will operate on any personal computer with Windows XP operating system and at least 2 GB of RAM. The speed by which a study will process is dependent on the computer processer and the amount of RAM. | Personal computer with Pentium 4, 1 GB RAM or higher processor (or equivalent with Windows XP or 7 Operating System |
| Web interface computer requirements | • Processor : Minimum 2.8 GHz• Operating System: Windows XP or 7• Java version 6 or greater• RAM: 1GB• USB port: 1• Internet connection: constant• Web browser: Internet Explorer, or Firefox | • Processor : Minimum 2.8 GHz• Operating System: Windows XP or 7• Java version 6 or greater• RAM: 1GB• USB port: 1• Internet connection: constant• Web browser: Internet Explorer, Firefox or Chrome, Opera | • Processor : Minimum 2.8 GHz• Operating System: Windows XP or 7• JAVA version 6 or greater• RAM: 1GB• USB port: 1• 6. Internet connection: constant• Web browser: Internet Explorer, Firefox or Chrome |
| Specification | Sleep Profiler | Predicate Device, Sleep Profiler (K130007) | Reference Predicate Device, ARES Model 610 (K112514) |
| Web interfaceserverrequirements. | Virtual server:Processor: > 2 Ghz Operating system: Win Server 2008. RAM: > 2GB Certificates: Signed SSL .NET framework:version 2.0 – web server version 3.5 – processing serveror Win Server 2008 Database: SQL server 2005 Physical server: Processor: > 2 Ghz Operating system: Win Server 2008Enterprise edition (for virtual servers). RAM: > 2GB | Virtual server:Processor: > 2 Ghz Operating system: Win Server 2008. RAM: > 2GB Certificates: Signed SSL .NET framework:version 2.0 – web server version 3.5 – processing serveror Win Server 2008 Database: SQL server 2005 Physical server: Processor: > 2 Ghz Operating system: Win Server 2008Enterprise edition (for virtual servers). RAM: > 2GB | Virtual server:Processor: > 2 Ghz Operating system: Win Server 2008. RAM: > 2GB Certificates: Signed SSL .NET framework:version 2.0 – web server version 3.5 – processing serveror Win Server 2008 Database: SQL server 2005 Physical server: Processor: > 2 Ghz Operating system: Win Server 2008Enterprise edition (for virtual servers). RAM: > 2GB |
| Computer/portalSecurity | The person installing the Java applet must have administrator privileges. User must have rights to the account and group to access data via the portal. The firewall is not configured to prevent input or output communication with access to the server via ports 22 and 30-39. | The person installing the Java applet must have administrator privileges. User must have rights to the account and group to access data via the portal. The firewall is not configured to prevent input or output communication with access to the server via ports 22 and 30-39. | The person installing the Java applet must have administrator privileges. User must have rights to the account and group to access data via the portal. The firewall is not configured to prevent input or output communication with access to the server via ports 22 and 30-39. |
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DETERMINATION OF SUBSTANTIAL EQUIVALENCE:
SUMMARY OF NON-CLINICAL TESTS:
Support for the substantial equivalence of the Sleep Profiler was provided as a result of risk management and software testing. Software verification testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
The Sleep Profiler software has been thoroughly tested through verification of specifications and system level validation. The results of the verification activities that have been performed demonstrate that the software meets requirements for safety, function, and intended use.
SUMMARY OF CLINICAL TESTS:
The Sleep Profiler software accuracy was clinically validated with signals acquired with the X8 System concurrent to polysomnography (PSG). The following endpoints were evaluated and met:
| Endpoint | The accuracy of the Sleep Profiler-PSG2 software will be equivalent to the predicatedevice(s): |
|---|---|
| 1 | when applied to signals obtained with the FleX8 and compared to PSG to stage sleep. |
| 2 | when applied to signals obtained with the FleX8 and PSG, and compared to PSG fordetection of sleep disordered breathing for use in diagnosing OSA based on a minimumtargeted positive likelihood ratios for an AHI > 5 and 15 are 3.5 and 5.0 respectively. |
Where, AHI is the Apnea-Hypopnea Index. The AHI is the number of apnea and hypopnea events per hour of sleep.
The results compared auto-detected staging and sleep disordered breathing (i.e., apneahypopnea index) to PSG results obtained by one rater per study. The results confirm Sleep Profiler's positive likelihood ratio for overall AHI vs. PSG is equivalent to the predicate ARES. The Sleep Profiler achieves a positive likelihood ratio for REM AHI vs. PSG REM AHI equivalent to the ARES positive likelihood ratio across all sleep stages.
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| ARES | Sleep Profiler Overall | Sleep Profiler REM | ||||
|---|---|---|---|---|---|---|
| AHI ≥ 5 | AHI ≥ 15 | AHI ≥ 5 | AHI ≥ 15 | AHI ≥ 5 | AHI ≥ 15 | |
| Sample size (n) | 73 | 73 | 60 | 60 | 40 | 40 |
| Sensitivity | 0.98 | 0.92 | 1.00 | 1.00 | 0.84 | 0.73 |
| Specificity | 0.76 | 0.91 | 0.85 | 0.97 | 0.90 | 0.96 |
| Likelihood ratio+ | 4.08 | 10.22 | 6.67 | 33.0 | 8.84 | 18.33 |
| Likelihood ratio- | 0.03 | 0.09 | 0.00 | 0.00 | 0.17 | 0.28 |
Where likelihood ratio + is the likelihood ratio of a positive test and likelihood ratio – is the likelihood ratio of negative test. The likelihood ratio + is the ratio of the false negative rate (1sensitivity) and true negative rate (specificity); calculated as (1-sensitivity)/specificity. The likelihood ratio – is the ratio of the true positive rate (sensitivity) and false positive rate (1specificity); calculated as sensitivity/(1-specificity)
Additionally the Sleep Profiler staging algorithms were compared in a sub-set of subjects (n=43) with at least 4 hours of X8 diagnostic recording time. The results for the weighted majority agreement of three raters are presented in the cross-tabulation below:
| Epochs assigned by Sleep Profiler | % agreement | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Overall | Wake | N1 | N2 | N3 | REM | Total | Positive | Negative | |
| EpochsassignedbyExpertScoring | Wake | 5449 | 950 | 567 | 45 | 413 | 7424 | 0.73 | 0.94 |
| N1 | 564 | 431 | 600 | 44 | 113 | 1752 | 0.25 | 0.93 | |
| N2 | 582 | 801 | 9673 | 1408 | 118 | 12582 | 0.77 | 0.84 | |
| N3 | 34 | 19 | 1035 | 3591 | 25 | 4704 | 0.76 | 0.94 | |
| REM | 194 | 221 | 550 | 1 | 2783 | 3749 | 0.74 | 0.97 | |
| No-Cons | 378 | 220 | 325 | 46 | 181 | 1150 | |||
| Total | 7201 | 2642 | 12750 | 5135 | 3633 | 31361 |
The results from the previously cleared application of the Sleep Profiler auto-staging software to signals frontal PSG leads is presented below.
| Overall | Epochs assigned by Predicate Sleep Profiler | % agreement | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Wake | N1 | N2 | N3 | REM | Total | Positive | Negative | ||
| EpochsassignedbyExpertScoring | Wake | 6730 | 921 | 557 | 27 | 296 | 8531 | 0.79 | 0.95 |
| N1 | 807 | 1962 | 1652 | 40 | 493 | 4954 | 0.40 | 0.91 | |
| N2 | 348 | 1426 | 11848 | 958 | 218 | 14798 | 0.80 | 0.83 | |
| N3 | 36 | 24 | 1194 | 3928 | 8 | 5190 | 0.76 | 0.97 | |
| REM | 178 | 530 | 681 | 35 | 3641 | 5065 | 0.72 | 0.97 | |
| No-Cons | 124 | 91 | 324 | 67 | 47 | 653 | |||
| Total | 8223 | 4954 | 16256 | 5055 | 4703 | 39191 |
{14}------------------------------------------------
Differences between the two studies are the result of inter-rater variability in the application of the American Academy of Sleep Medicine scoring rules to wake and stage N1 resulting from sleep disordered breathing are explained with supplemental analyses. A new software feature marks epochs that may benefit from manual review to improve the accuracy of the staging during manual review.
CONCLUSION:
Advanced Brain Monitoring considers the Sleep Profiler to be substantially equivalent to the predicate devices.
§ 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).