The REMbrandt software is intended for Polysomnography studies and allows recording, displaying, printing and storage of physiological signals to assist in the diagnosis of various sleep disorders and sleep related respiratory disorders. The REMbrandt software allows: Automated analysis of physiological signals that is intended for use only in adults; An optional audio/visual alert for user defined threshold on calibrated DC input. These alerts are not intended for use as life support such as vital signs monitoring or continuous medical surveillance in intensive care units. Sleep report templates which summarize recorded and scored sleep data using simple measures including count, average, maximum and minimum values as well as data ranges for trended values; The REMbrandt software does not provide any diagnostic conclusion about the patient's condition and is intended to be used only by qualified and trained medical practitioners, in research and clinical environments.

Device Description

The REMbrandt software consists of three applications, DataLab, Analysis Manager and REMbrandt Manager, which run on a desktop or laptop computer and require no specialized hardware. They are Windows based applications used by trained medical professionals to investigate sleep disorders. The REMbrandt software collects and digitizes the electrical voltages of patient physiological signals. After collecting and saving the signals, it provides tools and detectors to analyze the signals, which aid in the interpretation of a sleep study. The software consists of four main functional areas: A. Data Acquisition & Display (REMbrandt DataLab), B. Scoring/Review & Analysis (REMbrandt Analysis Manager), C. Report Generation (REMbrandt Analysis Manager), D. Archiving & Data Management (REMbrandt Manager). The REMbrandt software contains eight (8) computer-assisted scoring analyzers. All automatic detection tools are provided as time saving aids to assist trained medical practitioners in the review and analysis of vast amounts of data. Each computer-assisted scoring analyzer runs a specific type of event marking or numeric value processing in the study and each can be enabled individually as needed at the discretion of the user. The scoring rule parameters used in the computer-assisted scoring analyzers depend on available input signals in the study as well as user defined settings. All output from computer assisted scoring analyzers require medical professional review and acceptance.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Device Performance Study for REMbrandt

The REMbrandt software includes eight computer-assisted scoring analyzers. The provided study specifically evaluates the performance of the Respiratory, Limb Movement, and Snore Event Assisted-scoring Detectors.

1. Table of Acceptance Criteria and Reported Device Performance

The study evaluates the "Positive Percent Agreement (PPA)" and "False Detection Rate per Hour (FD/h)" for the assisted-scoring detectors. While explicit acceptance criteria (e.g., "PPA must be >X%") are not directly stated as numerical thresholds in the provided text, the objective is to establish that the REMbrandt performance is "equivalent to the performance of the predicate device" and that its performance is "comparable to the manual markings of expert reviewers" and "clinically equivalent to the Reference standard." We can infer that the reported values demonstrate this equivalence or comparability.

Table: REMbrandt Event Detection Assisted Scoring Detectors Performance

Event	PPA Mean	95% CI (PPA)	FD/h Mean	95% CI (FD/h)
Central Apnea	99%	98.3% to 99.4%	0.7	0.4 to 1.5
Mixed Apnea	99.5%	98.6% to 99.8%	0.3	0.1 to 0.7
Obstructive Apnea	98%	96.6% to 98.7%	1.6	1.0 to 3.0
Hypopnea	90.4%	87.9% to 92.1%	4.0	3.2 to 5.1
Arousal	87.6%	84.3% to 89.6%	9.6	7.2 to 13.4
Limb Movement	88.7%	86.0% to 91.0%	11.1	8.5 to 14.6
Snore	87.1%	84.1% to 89.5%	12.3	9.5 to 16.2

The conclusion states that "Compared to the Reference standard, REMbrandt assisted-scoring detectors showed performance levels comparable to the manual markings of expert reviewers. The device performance is clinically equivalent to the Reference standard (majority rule) as constructed for this study, similar to results reported in the literature and to performance reported for other commercially available devices."

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

Sample Size: 50 diagnostic PSG sleep studies (one study per subject) for each event type evaluated.
Data Provenance: The text states, "All subjects involved in this study were adult (>18 years old) subjects with a clinical indication for a sleep study. The subject data were de-identified and applied as subject data to this study." The country of origin is not specified, but the submission is to the US FDA, implying a potentially diverse or US-centric origin, though not explicitly stated. The study is retrospective, as existing de-identified PSG studies were collected and then analyzed by experts and the device.

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

Number of Experts: Three (3) experienced and certified PSG specialists.
Qualifications of Experts: This group included "one board certified sleep specialist." The other two are described as "experienced and certified PSG specialists."

4. Adjudication Method for the Test Set

The adjudication method used to establish the "Reference standard" (ground truth) was a majority rule: "at least two out of three expert scorings (medical professionals certified on PSG recording and analysis) agree on the presence of an event within an epoch."

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted to assess how much human readers improve with AI vs. without AI assistance. This study focused on the standalone performance of the REMbrandt assisted-scoring detectors compared to a human-established ground truth. The software's role is described as "time saving aids to assist trained medical practitioners," implying a human-in-the-loop workflow, but a comparative effectiveness study with and without AI assistance for human readers was not part of this submission's performance testing.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

Yes, a form of standalone performance was implicitly done. The REMbrandt assisted-scoring detectors were run independently ("Separate from the expert review, all PSG studies were also analyzed by REMbrandt assisted-scoring detectors at default values"). The output of these detectors (algorithm only) was then compared against the "Reference standard" (expert consensus). The device is described as providing "computer-assisted event marking analyzers" and that "All output from computer assisted scoring analyzers require medical professional review and acceptance," indicating it's an aid, not a diagnostic tool unto itself. However, the performance metrics (PPA and FD/h) were derived from the algorithm's output before human review.

7. Type of Ground Truth Used

The type of ground truth used was expert consensus, specifically defined by a "majority rule" (at least two out of three expert scorings agree) on the presence of an event within an epoch. The criteria for event scoring (Apnea, Hypopnea, Limb Movement, Snore, Arousals) were clearly defined and applied by the experts.

8. Sample Size for the Training Set

The document does not specify the sample size for the training set. The clinical study summary focuses exclusively on the validation/test dataset.

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

The document does not provide information on how the ground truth for the training set (if any was used for algorithm development) was established. The "Clinical Study Summary" describes the ground truth process only for the test set.

Summary

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

April 11, 2017

Embla Systems Shane Sawall Regulatory Affairs Manager 1 Hines Road Suite 202 Kanata, Ontario, CA K2K 3C7

Re: K163617

Trade/Device Name: REMbrandt Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLZ Dated: March 8, 2017 Received: March 10, 2017

Dear Mr. Sawall:

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 devicerelated 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.

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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,

Michael J. Hoffmann -S

for Carlos L. Peña. PhD, MS 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) K163617

Device Name REMbrandt

Indications for Use (Describe)

Automated analysis of physiological signals that is intended for use only in adults;

An optional audio/visual alert for user defined threshold on calibrated DC input. These alerts are not intended for use as life support such as vital signs monitoring or continuous medical surveillance in intensive care units.

Sleep report templates which summarize recorded and scored sleep data using simple measures including count, average, maximum and minimum values as well as data ranges for trended values;

The REMbrandt software does not provide any diagnostic conclusion about the patient's condition and is intended to be used only by qualified and trained medical practitioners, in research and clinical environments.

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

Submitted by: Embla Systems 1 Hines Road Suite 202 Kanata, Ontario Canada K2K 3C7

Contact Person: Shane Sawall Regulatory Affairs Manager Tel.: (800) 356-0007 x8673 E-mail: shane.sawall@natus.com

Date Prepared: March 8, 2017

Proprietary Name: REMbrandt

Common Name: Polysomnograph software

Classification Name: Automatic Event Detection Software for Polysomnograph with Electroencephalograph

Product code: OLZ

Device Class: II

Requlation Number: 21 CFR 882.1400

Predicate Device: Natus SleepWorks K090277 (primary), REMbrandt K962865

Description:

1. Overview REMbrandt Software

2. Main Functional Areas

The REMbrandt software collects and digitizes the electrical voltages of patient physiological signals. After collecting and saving the signals, it provides tools and detectors to analyze the signals, which aid in the interpretation of a sleep study. The software consists of four main functional areas:

A. Data Acquisition & Display (REMbrandt DataLab)

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B. Scoring/Review & Analysis (REMbrandt Analysis Manager)
C. Report Generation (REMbrandt Analysis Manager)
D. Archiving & Data Management (REMbrandt Manager)

Data Acquisition & Display:

The REMbrandt DataLab application collects and displays continuous physiological waveform data (via a digital polysomnography amplifier), and digital audio/video (via standard audio/video equipment). The data is stored and displayed in real time by the REMbrandt DataLab software on the acquisition computer and made available for subsequent review and scoring by a sleep technologist followed by review and interpretation by a certified sleep medicine physician.

Study Scoring/Review & Analysis:

The REMbrandt Analysis Manager application has features that facilitate study navigation, event marking, sleep stage scoring, review of synchronized digital video, and data trends required by medical professionals in order to properly analyze and interpret sleep study data. (See figure 1). In addition to allowing users to manually mark sleep events including Arousals. Respiratory Events (Apnea & Hypopnea), Oxygen Desaturations, Limb Movements, Snoring and sleep stages, the REMbrandt software also optionally provides computer assisted event marking analyzers for a subset of these events as well as analyzers that summarize digital data in data ranges.

Computer-assisted scoring modules:

The REMbrandt software contains eight (8) computer-assisted scoring analyzers. All automatic detection tools are provided as time saving aids to assist trained medical practitioners in the review and analysis of vast amounts of data. Each computer-assisted scoring analyzer runs a specific type of event marking or numeric value processing in the study and each can be enabled individually as needed at the discretion of the user. The scoring rule parameters used in the computer-assisted scoring analyzers depend on available input signals in the study as well as user defined settings. All output from computer assisted scoring analyzers require medical professional review and acceptance.

The computer-assisted scoring analyzers are as follows:

. Apnea/Hypopnea Detector: Marks potential Apneas & Hypopnea events.
Limb Movement Detector: Marks potential limb movement events .
. Arousal Detector: Marks arousal events on EEG traces
Snore Detector: Marks potential snore events
Desaturation Detector: Marks drops in oxygen saturation based on user . set threshold CO2 Analyzer: Summarizes CO2 data recorded from a third party Capnograph device.

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Heart Rate Detector: Indicates heart rate by processing EKG waveform ● and shows Heart Rate values; marks tachy-bradycardia events based on heart rate value thresholds that are user configurable.
. Body Position Detector: Converts DC inputs or values from gravity xv based position sensor into the body positions tagged in sleep studies (Upright, Supine, Left, Right, Prone and Unknown).
. Pulse Transit Time (PTT) Trace Generator: Derived calculation of pulse transit time (PTT) which is a measure of time difference between the ECG R top and the peak of the pleth waveform from a pulse oximeter.

Report Generation:

Once the digital polysomnography data has been acquired scored and reviewed by both a polysomnographic technologist and a sleep physician the REMbrandt software is used to generate a summary report of the sleep study which includes summary statistics of sleep staging describing the patients sleep architecture, summary of sleep events including maximum, minimum counts, indexes, duration, and range based data as well as graphical representations of each (trends). The generated sleep reports are part of the digital polysomnograph and the REMbrandt software also includes tools to customize report templates to conform to individual sleep center standards/policies and graphic norms.

Archiving & Data Management:

All data are stored either locally or on a remote hard disk (network server) Provisions exist for archiving to several appropriate types of digital storage. REMbrandt Manager also allows the user to copy, move, back up, and delete collected studies.

3. Diagnosis

The REMbrandt software does not make any decisions that result in anv automatic diagnosis or treatment. All software output is subject to review by the medical professional, and can be modified, overridden or deleted. The software allows the qualified user to review all raw data collected and perform data analysis as required. REMbrandt does not provide any final diagnostic conclusion about the patient's condition. Neither the computer nor the software controls the delivery of energy, the administration of drugs, or another form of life sustaining function to the patient.

The intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test environments. Users of the REMbrandt software are solely responsible for all data collected, and are expected to assess and analyze this data to ensure its accuracy and completeness.

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Indications for Use:

The REMbrandt software is intended for Polysomnography studies and allows recording, displaying, analysis, printing and storage of physiological signals to assist in the diagnosis of various sleep disorders and sleep related respiratory disorders. The REMbrandt software allows:

Automated analysis of physiological signals that is intended for use only in adults;
An optional audio/visual alert for user defined threshold on calibrated DC ● input. These alerts are not intended for use as life support such as vital signs monitoring or continuous medical surveillance in intensive care units.
Sleep report templates which summarize recorded and scored sleep data using simple measures including count, average, maximum and minimum values as well as data ranges for trended values;

The REMbrandt software does not provide any diagnostic conclusions about the patient's condition and is intended to be used only by qualified and trained medical practitioners, in research and clinical environments.

Comparison to Predicate Device:

	Predicate	Predicate	Subject Device
	Rembrandt K962865	SleepWorks K090277	REMbrandt
Device Class	Class II	Class II	Class II
Class Name	Apnea Monitor	Electroencephalograph	Electroencephalograph
Product Code	FLS = Monitor (Apnea Detector), Ventilatory Effort	OLZ = Automatic Event Detection Software for Polysomnograph with Electroencephalograph	Same as SleepWorks
Intended User	Medical Professional	Medical Professional	Medical Professional

Indications forUse	The MedcareRembrandt System is aphysiological signalrecorder intended foruse in sleepLaboratories. It is usedas a paperlesspolygraph, collectingraw data. It is used tomanually analyze therecorded data. Theuser may manually tagsleep stages, arousals,apnea and hypopneaand Periodic LegMovement. TheRembrandt Systemprocesses the manualscoring to generateSummary Reports.A polysomnographerwould typically reviewthe recorded signals.The RembrandtSystem by MedcareAutomation does notprovide any indicationsduring recording. Itdoes not do anyanalysis, monitoring ordiagnosis of thepatient. It does notissue any alarms.	The Sleepworks softwareworks in conjunction withConnex, Trex or Netlinkamplifiersintended forpolysomnography studies.The software allowsrecording, displaying,analysis, printing andstorage of physiologicalsignals to assist in thediagnosis of varioussleep disorders and sleeprelated respiratorydisorders.The Sleepworks allows:Automated analysis ofphysiological signals thatis intended for use only inadults.An optional Audio /visual alert for userdefined threshold oncalibrated DC input.These alerts are notintended for use as lifesupport such as vitalsigns monitoringor continuous medicalsurveillance in intensivecare units.Sleep report templatesare provided whichsummarize recorded andscored sleepdata using simplemeasures including count,average, maximum andminimumvalues as well as dataranges for trended values;Sleep Works softwaredoes not provide anydiagnostic conclusionabout the patient'scondition and is intendedto be used only by	The REMbrandtsoftware is intended forPolysomnographystudies and allowsrecording, displaying,analysis, printing andstorage of physiologicalsignals to assist in thediagnosis of varioussleep disorders andsleep related respiratorydisorders. TheREMbrandt softwareallows:Automated analysisof physiological signalsthat is intended for useonly in adults;An optionalaudio/visual alert foruser defined thresholdon calibrated DC input.These alerts are notintended for use as lifesupport such as vitalsigns monitoring orcontinuous medicalsurveillance in intensivecare units.Sleep reporttemplates whichsummarize recordedand scored sleep datausing simple measuresincluding count,average, maximum andminimum values as wellas data ranges fortrended values;The REMbrandtsoftware does notprovide any diagnosticconclusion about thepatient's condition andis intended to be usedonly by qualified andtrained medical
		qualified and trainedmedical practitioners;in research and clinicalenvironments.	practitioners, inresearch and clinicalenvironments.
User input	Mouse/keyboard	Mouse/keyboard	Mouse/keyboard
Acquire,display, store,and archivePSG data	Yes (post acquisitionanalysis only)	Yes (post acquisition andreal-time analysis	Yes (post acquisitionand real-time analysis)
Signal digitized	Amplifier included aspart of the system	By separate proprietaryamplifier	By separate proprietaryamplifier
FFT Analysis(Spectralanalysis on anydigitizedchannel	Yes	Yes	Yes
SoftwareDetectors
Respiratoryevent marking	Yes (Manual)	Yes (Manual & ComputerAssisted)	Yes (Manual &Computer Assisted)
Sleep staging/scoring	Yes (Manual)	Yes (Manual/computerassisted)	Yes (Manual)
Arousal EventMarking	Yes (Manual)	Yes (Manual/computerassisted)	Yes (Manual &Computer Assisted)
Limbmovementsevent marking	Yes (Manual)	Yes (Manual & ComputerAssisted)	Yes (Manual &Computer Assisted)
Snore eventmarking	Yes (Manual)	Yes (Manual & ComputerAssisted)	Yes (Manual &Computer Assisted)
OxygenDesaturationevent marking	Yes (Manual)	Yes (Manual & ComputerAssisted)	Yes (Manual &Computer Assisted)
Heart Rate datatrend &summary(including HeartRate Variability)	No	Yes	Yes
CO2 data trend& summary	No	Yes	Yes
Associaterelated events	No	Yes (Manual & ComputerAssisted)	Yes (Manual &Computer Assisted)
Derivedrespiratorytraces	No	Yes, Effort Sum,difference, average, FlowVolume Loop	Yes, XactTrace modulecleared to market viaK162140
Synchronizedpatient video	Yes	Yes	Yes
Oximetry datadisplay andreporting	Yes	Yes	Yes
Data storage	Local or remote, harddisk	Local or remote, hard disk	Local or remote, harddisk
Audio/ VisualAlerts OnCalibratedChannels	No	Yes	Yes
Signalsrecorded(output)	Respiratory Effort (abdomen and chest) Airflow Pressure Snore Body Position Pulse Rate Oximeter ECG EEG EMG EOG DC Leg Movement and other signals required for sleep studies	Respiratory Effort (abdomen and chest) Airflow Pressure Snore Body Position Pulse Rate Oximeter ECG EEG EMG EOG DC Leg Movement and other signals required for sleep studies	Respiratory Effort (abdomen and chest) Airflow Pressure Snore Body Position Pulse Rate Oximeter ECG EEG EMG EOG DC Leg Movement and other signals required for sleep studies
Reportgenerationincluding countsindexes,max/min/average/duration,range baseddatasummaries.Numeric &graphicalrepresentations	Yes, customizabletemplates	Yes, customizabletemplates	Yes, customizabletemplates

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REMbrandt also includes derived calculation of pulse transit time (PTT) which is a measure of time difference between the ECG R top and the peak of the pleth waveform from the pulse oximeter. The reference predicate for this feature of REMbrandt is K142988 Sleepware G3.

Brief Summary of Performance Tests:

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Biocompatibility

The REMbrandt is a software-only device. Biocompatibility testing is not applicable.

Electrical Safety and EMC

The REMbrandt is a software-only device. Electrical safety evaluation and EMC evaluation is not applicable.

Software Verification

Testing of the REMbrandt was performed in compliance with the Natus Medical incorporated design control process. It was found that the REMbrandt software meets the design specification and performs as specified.

Animal Study

There were no animal studies performed for this submission.

Clinical Study Summary - Respiratory, Limb Movement and Snore Event Assistedscoring Detectors

1.1. Participants

Fifty (50) diagnostic PSG sleep studies were collected (one study per subject). All subjects involved in this study were adult (>18 years old) subjects with a clinical indication for a sleep study. The subject data were de-identified and applied as subject data to this study.

1.2. Dataset description

Total Number of Subjects: 50 per event evaluated Total Number of scored Epochs (30 Sec): > 45.074 Total Number of Hours: 375:37:00 Mean number of epochs per subject: >903.5 Minimum number of epochs per subject: 698 Maximum number of epochs per subject: 1078

Data from 50 subjects were evaluated for respiratory, arousal, limb movement and snore events. All epochs from these subjects were scored.

1.3. Objective of the study

The goal of the validation study reported here is to establish that REMbrandt performance is equivalent to the performance of the predicate device. For the purpose of this study "Reference standard" is defined using majority rule, that is, at least two out of three expert scorings (medical professionals certified on PSG recording and analysis) agree on the presence of an event within an epoch.

1.4. PSG acquisition protocol

For this study, the following signals were recorded from each subject:

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Six (6) Electroencephalogram ([EEG] channels: F3, F4, C3, C4, O1, and O2. ●
Two (2) Electrooculogram (EOG) channels ●
Submental and bilateral tibial electromyogram (EMG) .
. Electrocardiogram (ECG)
Airflow (nasal-oral thermistor and nasal pressure sensors or PAP flow)
Chest and abdominal movement using respiratory inductance Plethysmography. ●
Pulse oximetry (SpO2) and pulse rate ●
Body position ●
Snoring .

1.5. PSG analvsis protocol

All physiologic data were collected and stored on a REMbrandt System. The ECG, EEG, EMG, EOG and Snoring channels were sampled at 200 Hz. The Airflow and Chest, abdominal movement channels were sampled at 25 Hz. The Pulse oximetry channel was sampled at 10 Hz. The Body Position channel was sampled at 1 Hz.

The raw PSG recordings were de-identified, randomized and provided to three experienced and certified PSG specialists, including one board certified sleep specialist, who independently marked events of interest in each epoch, applying the following criteria:

Apnea is scored when both of the following criteria are met: ●
- There is a drop in the peak signal excursion by > 90% of pre-event baseline a. respiratory nasal pressure or flow sensor signal.
- b. The duration of the > 90% drop in sensor signal is > 10 seconds.
- The apnea is Obstructive if it meets apnea criteria and is associated with continued or increased inspiratory effort throughout the entire period of absent airflow.
- . The apnea is Central if it meets apnea criteria and is associated with absent inspiratory effort throughout the entire period of absent airflow.
- . The apnea is Mixed if it meets apnea criteria and is associated with absent inspiratory effort in the initial portion of the event followed by resumption of inspiratory effort in the second portion of the event.
Hypopnea is scored if all of the following criteria are met: .
- a. The peak signal excursions drop by > 30% of pre-event baseline using nasal pressure, PAP device flow or alternative hypopnea sensor.
- b. The duration of the ≥ 30% drop in signal excursion is ≥ 10 seconds.
- There is a > 3% oxygen desaturation from pre-event baseline or the event C. is associated with an arousal.
Limb movement is scored if the following significant leg movement (LM) events . are indicated:
- a. The minimum duration of a LM event is 0.5 seconds.
- b. The maximum duration of a LM event is 10 seconds.

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The minimum amplitude of a LM event is an 8 µV increase in EMG voltage C. above resting EMG.
. Snore: The scoring of snore events relies on clinical interpretation
Arousals: Score arousals during sleep stages (N1, N2, N3 or R) if there is an ● abrupt shift of EEG frequency including alpha, theta and/or frequencies greater than 16 Hz (but not spindles) that lasts at least 3 seconds, with at least 10 seconds of stable sleep preceding the change. Scoring of arousal in REM requires a concurrent increase in submental EMG lasting at least 1 second.

Separate from the expert review, all PSG studies were also analyzed by REMbrandt assisted-scoring detectors at default values for:

Central apnea
. Mixed apnea
Obstructive apnea
Hypopnea ●
Limb movement ●
Snoring
Arousals ●

1.6. Outcomes

Positive Percent Agreement (PPA) between REMbrandt assisted-scoring detectors compared to the Reference standard were measured on an epoch basis. The mean and 95% confidence interval (CI) of the PPA and false detection rate per hour for event detection assisted-scoring detectors are shown in the following table.

PPA and False Detection Rate Per Hour of REMbrandt Event Detection Assisted Scoring Detectors

	REMbrandt
	PPA		FD/h
Event	Mean	95% CI	Mean	95% CI
Central Apnea	99%	98.3% to 99.4%	0.7	0.4 to 1.5
Mixed Apnea	99.5%	98.6% to 99.8%	0.3	0.1 to 0.7
Obstructive Apnea	98%	96.6% to 98.7%	1.6	1.0 to 3.0
Hypopnea	90.4%	87.9% to 92.1%	4.0	3.2 to 5.1
Arousal	87.6%	84.3% to 89.6%	9.6	7.2 to 13.4
Limb Movement	88.7%	86.0% to 91.0%	11.1	8.5 to 14.6
Snore	87.1%	84.1% to 89.5%	12.3	9.5 to 16.2

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1.7. Clinical Study Conclusion

Compared to the Reference standard, REMbrandt assisted-scoring detectors showed performance levels comparable to the manual markings of expert reviewers. The device performance is clinically equivalent to the Reference standard (majority rule) as constructed for this study, similar to results reported in the literature and to performance reported for other commercially available devices.

510(k) Summary Conclusions:

The substantial equivalence of the REMbrandt with the predicate Natus SleepWorks product was demonstrated by software verification testing and clinical validation. The non-clinical data support the safety of the device. The software verification and validation demonstrate that REMbrandt device should perform as intended in the specified use conditions. The clinical validation of the computer-assisted scoring detectors demonstrates that the REMbrandt device performs comparably to the predicate device that is currently marketed for the same intended use.

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).