(110 days)
Apnea Risk Evaluation System (ARES), Model 610 (K112514)
No
The document describes "automated algorithms" but does not explicitly mention or provide details about the use of AI or ML techniques. The performance studies focus on traditional metrics like sensitivity, specificity, and agreement with expert scoring, which are common for rule-based or signal processing algorithms.
No
The device is described as a software-only device for diagnostic evaluation and analysis of sleep data, not for providing therapy.
Yes
This device is intended for "diagnostic evaluation by a physician to assess sleep quality and score sleep disordered breathing events." It also analyzes physiological signals to aid in the diagnosis of sleep disorders.
Yes
The device is explicitly described as a "software-only device" in the Intended Use section and the Device Description focuses solely on the software's analytical functions and platform compatibility. It analyzes pre-recorded physiological signals from specific hardware systems but is not itself a hardware component.
Based on the provided information, the Sleep Profiler is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Sleep Profiler's Function: The Sleep Profiler analyzes physiological signals recorded from the body during sleep (like EEG, EOG, EMG, SpO2, airflow, respiratory effort). It does not analyze specimens taken from the body.
- Intended Use: The intended use is for the diagnostic evaluation of sleep quality and sleep disordered breathing events by analyzing these physiological signals.
Therefore, the Sleep Profiler falls under the category of a medical device that analyzes physiological data, rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
OLZ
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, 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adults only
Intended User / Care Setting
Physician office (data analysis and reporting). No limitation on where data are acquired.
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
The Sleep Profiler software accuracy was clinically validated with signals acquired with the X8 System concurrent to polysomnography (PSG). The results compared auto-detected staging and sleep disordered breathing (i.e., apnea-hypopnea index) to PSG results obtained by one rater per study. 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical validation study.
Sleep disordered breathing analysis:
Sample size (n) = 60
AHI ≥ 5: Sensitivity = 1.00, Specificity = 0.85, Likelihood ratio+ = 6.67, Likelihood ratio- = 0.00
AHI ≥ 15: Sensitivity = 1.00, Specificity = 0.97, Likelihood ratio+ = 33.0, Likelihood ratio- = 0.00
REM AHI ≥ 5: Sensitivity = 0.84, Specificity = 0.90, Likelihood ratio+ = 8.84, Likelihood ratio- = 0.17
REM AHI ≥ 15: Sensitivity = 0.73, Specificity = 0.96, Likelihood ratio+ = 18.33, Likelihood ratio- = 0.28.
Sleep staging analysis:
Sample size (n) = 43 subjects, 31361 total epochs.
Overall weighted majority agreement of three expert raters with Sleep Profiler:
Wake: % agreement = 0.73, Positive = 0.73, Negative = 0.94
N1: % agreement = 0.25, Positive = 0.25, Negative = 0.93
N2: % agreement = 0.77, Positive = 0.77, Negative = 0.84
N3: % agreement = 0.76, Positive = 0.76, Negative = 0.94
REM: % agreement = 0.74, Positive = 0.74, Negative = 0.97
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity, Specificity, Likelihood ratio+, Likelihood ratio-, % agreement (for sleep staging), Positive (agreement for sleep staging), Negative (agreement for sleep staging). All values are listed in the "Summary of Performance Studies" section.
Predicate Device(s)
Sleep Profiler (K130007)
Reference Device(s)
Apnea Risk Evaluation System (ARES), Model 610 (K112514)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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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
1
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 Predicate
Device, ARES Model 610
(K112514) |
|-----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | OLZ, Automated Event
Detection Software for
Polysomnograph with
Electroencephalograph | OLZ, Automated Event
Detection Software for
Polysomnograph with
Electroencephalograph | MNR, Ventilatory Effort
Recorder |
| Specification | Sleep Profiler | Predicate Device,
Sleep Profiler (K130007) | Reference Predicate
Device, ARES Model 610
(K112514) |
| Indications for 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. | 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. | The Apnea Risk Evaluation
System (ARES) is indicated
for use in the diagnostic
evaluation by a physician of
adult patients with possible
sleep apnea. The ARES can
record and score
respiratory events during
sleep (e.g., apneas,
hypopneas, mixed apneas
and flow limiting events).
The device is designed for
prescription use in home
diagnosis of adults with
possible sleep-related
breathing disorders. |
| Intended Use | Analyze physiological data
acquired during sleep. | Analyze physiological data
acquired during sleep. | Analyze physiological data
acquired during sleep. |
| Patient Population | Adults | Adults | Adults |
| Environment of Use | Physician office (data
analysis and reporting) | Physician office (data
analysis and reporting) | Physician office (data
analysis and reporting) |
| | No limitation on where
data are acquired. | No limitation on where
data are acquired. | Home (data acquisition) |
| Specification | Sleep Profiler | Predicate Device,
Sleep Profiler (K130007) | Reference Predicate
Device, ARES Model 610
(K112514) |
| Derived Signals | • 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 | • Sleep stages Rapid Eye
Movement (REM) and
nREM (N1, N2, N3) and
wake
• Pulse rate
• Snoring loudness
• Sleep/wake
• Head movement and
position
• Snoring, sympathetic,
behavioral and cortical
arousals
• ECG,EOG, EMG
waveform | • Sleep stages Rapid Eye
Movement (REM) and
nREM
• Pulse rate
• Snoring loudness
• Sleep/wake
• Head movement and
position
• Snoring, sympathetic,
behavioral arousals
• SpO2
• Airflow
• Respiratory Effort
(Optional)
• Apneas and
Hypopneas
• Oxygen desaturations |
| Signal quality | Auto-rejects bad signal
quality in EEG with optional
airflow and SpO2. | Auto-rejects bad signal
quality in EEG. | Auto-rejects bad signal
quality in EEG, airflow and
SpO2 |
| Sleep Measures | • Sleep, REM and N3
onset
• Total sleep and
recording times
• Sleep efficiency
• % time by sleep stage
• Awakenings per hour
• Wake after sleep onset | • Sleep, REM and N3
onset
• Total sleep and
recording times
| • Sleep onset
• Total sleep and
recording times
• Sleep efficiency
• % time by sleep stage |
| Sleep Staging | Based on one forehead
EEG signals to differentiate
Wake (W), REM (R), NREM
stage 1 (N1), NREM stage 2
(N2) and slow wave sleep
(N3, includes both stages 3
and 4) | Based on one forehead
EEG signals to differentiate
Wake (W), REM (R), NREM
stage 1 (N1), NREM stage
2 (N2) and slow wave
sleep (N3, includes both
stages 3 and 4) | Based on one forehead
EEG signal to differentiate
REM and non-REM sleep,
and behavioral measures
from actigraphy, snoring
and airflow to detect sleep
from wake |
| Specification | Sleep Profiler | Predicate Device,
Sleep Profiler (K130007) | Reference Predicate
Device, ARES Model 610
(K112514) |
| Sleep Disordered
Breathing (when
respiratory signals
are acquired) | • Detects apneas with
airflow signal. Each
apnea is classified as
obstructive but can be
edited to be central or
mixed apneas.
• Detects hypopneas with
airflow signal. Changes
in SpO2 are used to
determine hypopnea
severity (i.e., 4% or 3%
events).
• Detects RERAs with
airflow signal and
cortical arousals (i.e.,
hypopneas that do not
meet the desaturation
criteria) | None | • Detects apneas with
airflow signal
• Each apnea classified
with the automated
algorithms is labeled as
an obstructive Apnea
(Ap) or Apnea with
arousal (ApA).
• Detects hypopneas with
airflow signal. Changes in
SpO2 are used to
determine hypopnea
severity
• Hypopnea with arousals
and a 4%, 3%, 1%, or 0%
desaturation (H4A, H3A,
H1A, H0A)
• Hypopnea with no
associated arousal (H4,
H3, H1).
• Hypopneas that do not
meet the minimal 1%
desaturation criteria
must have at least one
arousal indicator to be
labeled. |
| 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 dynamic
range (min) | 40 dB @ 3% of dynamic
range (min) | 40 dB @ 3% of dynamic
range (min) |
| | 70 dB @ 90% of dynamic
range (max) | 70 dB @ 90% of dynamic
range (max) | 70 dB @ 90% of dynamic
range (max) |
| | Accuracy 0.2 dB at mid
range | Accuracy 0.2 dB at mid
range | Accuracy 0.2 dB at mid
range |
| 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 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 #Apneas
o #Hypopneas
o #RERAs
o Mean SpO2, %time 2 Ghz Operating system: Win Server 2008. RAM: > 2GB Certificates: Signed SSL .NET framework:
version 2.0 – web server version 3.5 – processing server
or Win Server 2008 Database: SQL server 2005 Physical server: Processor: > 2 Ghz Operating system: Win Server 2008
Enterprise 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 server
or Win Server 2008 Database: SQL server 2005 Physical server: Processor: > 2 Ghz Operating system: Win Server 2008
Enterprise 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 server
or Win Server 2008 Database: SQL server 2005 Physical server: Processor: > 2 Ghz Operating system: Win Server 2008
Enterprise edition (for virtual servers). RAM: > 2GB |
| Computer/portal
Security | 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 predicate
device(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 for
detection of sleep disordered breathing for use in diagnosing OSA based on a minimum
targeted 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 | |
| Epochs | |||||||||
| assigned | |||||||||
| by | |||||||||
| Expert | |||||||||
| Scoring | 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 | ||
| Epochs | |||||||||
| assigned | |||||||||
| by | |||||||||
| Expert | |||||||||
| Scoring | 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.