Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

Unknown
The document mentions "computer-assisted scoring modules" and "automated analysis of physiological signals," which could potentially utilize AI/ML. However, it does not explicitly state the use of AI, ML, DNN, or provide details about the algorithms used, making it impossible to definitively confirm the presence of AI/ML.

Therapeutic

No.
The device is intended for diagnosis of various sleep disorders, not for therapy or treatment.

Diagnostic

Yes

The "Intended Use" section explicitly states that the software is intended to "assist in the diagnosis of various sleep disorders" and that medical practitioners use the output "to provide diagnostic conclusions about the patient's condition."

SaMD (Software as a Medical Device)

Yes

The device description explicitly states it is a "software product that runs on a desktop or laptop computer and requires no specialized hardware." It focuses on collecting, digitizing, analyzing, and managing physiological signals through software applications and modules.

IVD (In Vitro Diagnostic)

Based on the provided information, the Sandman Elite software is not an In Vitro Diagnostic (IVD).

Here's why:

IVDs analyze specimens from the human body. The Sandman Elite software analyzes physiological signals (electrical voltages) collected directly from the patient's body during a polysomnography study. It does not analyze samples like blood, urine, or tissue.
The intended use is for polysomnography studies. Polysomnography is a sleep study that records various physiological parameters directly from the patient.
The device description focuses on collecting and analyzing electrical voltages of physiological signals. This aligns with in-vivo measurements rather than in-vitro analysis of specimens.

Therefore, the Sandman Elite software falls under the category of a medical device used for physiological monitoring and analysis, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Sandman Elite software is intended for Polysomnography studies on pediatric and adult patients, and allows recording, displaying, analysis, printing and storage of physiological signals to assist in the diagnosis of various sleep disorders. The Sandman software also allows:

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;
An optional 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.

The Sandman software is intended for use only by qualified and trained medical practitioners in research and clinical environments, who evaluate the software output with their clinical experience and judgment to provide diagnostic conclusions about the patient's condition.

Product codes (comma separated list FDA assigned to the subject device)

OLZ

Device Description

The Sandman Elite Application is a software product that runs on a desktop or laptop computer and requires no specialized hardware. It is a Windows based application used at sleep labs by trained clinicians to investigate sleep disorders.

The Sandman Elite application collects and digitizes the electrical voltages of patient physiological signals. After collecting and saving the signals, it provides tools and modules to analyze the signals, which aid in the interpretation of a sleep study. The software consists of four main applications:

Collection Real time collection of EEG and other physiological ● parameters.
. Analysis - Real time analysis of data to identify events which may require special attention from qualified medical professional in attendance.
Data Management - Allows the user to copy, move, back up, and delete collected patient files
. Configuration - Allows the user to change configuration settings such as your site information, the media used for file storage and to create and manage user preferences.

The Sandman Elite application also includes a separate independent Report Builder module. The Report Builder is a tool developed to assist the user in creating a customized report. All data are stored either locally or on a remote hard disk (network server). Provisions exist for archiving to several appropriate types of digital media, most frequently CD ROM.

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

pediatric and adult patients

Intended User / Care Setting

qualified and trained medical practitioners in research and clinical environments

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

Participants: Fifty-six (56) diagnostic PSG sleep studies were collected (one study per patient). All patients involved in this study were adult patients (>18 years old) with a clinical indication for a sleep study. The patient data were de-identified and applied as subject data to this study.

Dataset description:
Total Number of Subjects: 54 per event evaluated
Total Number of scored Epochs (30 Sec): > 49,704
Total Number of Hours: > 411.99
Mean number of epochs per subject: > 920.4
Minimum number of epochs per subject: 711
Maximum Number of epochs per subject: 1,147
Data from 54 subjects were evaluated for respiratory, limb movement and snore events. All epochs from these subjects were scored.

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

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

PSG analysis protocol: All physiologic data were collected and stored on a Sandman 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: .
- The peak signal excursions drop by ≥ 30% of pre-event baseline using a. 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.
- 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.
Separate from the expert review, all PSG studies were also analyzed by Sandman assisted-scoring modules at default values for:
Central apnea
Obstructive apnea ●
. Hypopnea
Limb movement .
. Snoring

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Clinical Study Summary - Respiratory, Limb Movement and Snore Event Assisted scoring Modules
Study Type: Validation study to establish that Sandman performance is equivalent to the performance of the predicate device.
Sample Size: Fifty-six (56) diagnostic PSG sleep studies (one study per patient), data from 54 subjects evaluated for respiratory, limb movement and snore events.
Reference standard: 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.
Key Results: Positive Percent Agreement (PPA) between Sandman assisted-scoring modules compared to the Reference standard were measured on an epoch basis.

	PPA			False Detection Rate Per Hour
		95% CI			95% CI
Event	Mean	Lower	Upper	Mean	Lower	Upper
Central apnea	95.1%	88.1%	97.4%	3.8	2.4	6.4
Mixed apnea	97.6%	88.7%	99.5%	0.8	0.4	1.4
Obstructive apnea	92.0%	86.0%	94.1%	7.7	6.1	9.6
Hypopnea	85.9%	79.8%	88.2%	15.4	13.3	17.8
Limb movement	86.0%	83.0%	88.5%	16.8	14.0	20.5
Snoring	82.0%	78.3%	84.7%	21.6	18.3	26.0

Clinical Study Conclusion: Compared to the Reference standard, Sandman assisted-scoring modules 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Positive Percent Agreement (PPA), False Detection Rate Per Hour.

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Sandman (K934599), Natus SleepWorks (K090277)

Reference Device(s):

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

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

June 23, 2016

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

Re: K153353

Trade/Device Name: Sandman Elite Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLZ Dated: Mav 20, 2016 Received: May 24, 2016

Dear Shane 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 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

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) K153353

Device Name Sandman Elite

Indications for Use (Describe)

The Sandman Elite software is intended for Polysomnography studies on pediatric and allows recording, displaying, analysis, printing and storage of physiological signals to assist in the diagnosis of various sleep disorders. The Sandman software also allows:

•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;
•An optional 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.

The Sandman software is intended for use only by qualified and trained medical practitioners in research and clinical environments, who evaluate the software output with their clinical experience and judgment to provide diagnostic conclusions about the patient's condition.

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: June 22, 2016

Proprietary Name: Sandman Elite

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: Sandman (K934599); Natus SleepWorks (K090277)

Description:

1. Overview Sandman Elite Software

The Sandman Elite Application is a software product that runs on a desktop or laptop computer and requires no specialized hardware. It is a Windows based application used at sleep labs by trained clinicians to investigate sleep disorders.

2. Main Applications

The Sandman Elite application collects and digitizes the electrical voltages of patient physiological signals. After collecting and saving the signals, it provides tools and modules to analyze the signals, which aid in the interpretation of a sleep study. The software consists of four main applications:

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Collection Real time collection of EEG and other physiological ● parameters.
. Analysis - Real time analysis of data to identify events which may require special attention from qualified medical professional in attendance.
Data Management - Allows the user to copy, move, back up, and delete collected patient files
. Configuration - Allows the user to change configuration settings such as your site information, the media used for file storage and to create and manage user preferences.

The Sandman Elite application also includes a separate independent Report Builder module. The Report Builder is a tool developed to assist the user in creating a customized report. All data are stored either locally or on a remote hard disk (network server). Provisions exist for archiving to several appropriate types of digital media, most frequently CD ROM.

3. Typical work flow using the Sandman Elite Application software

During the Collection phase, the software collects data based on user selected sampling rates, amplifier set-up, and amplifier calibrations. These three factors define how the software collects and displays the data in real-time. The recording is saved on the hard disk of the user's computer in a raw data format. The user can customize displays, observations, event markers, and tags.

4. Computer-assisted scoring modules

The Sandman Elite application software contains a number of computerassisted scoring modules. All computer assisted-scoring modules are provided to assist trained medical practitioners in the review and analysis of vast amounts of polysomnography data. The computer assisted-scoring modules are for analysis of adult patient data only. Each computer-assisted scoring module runs a specific type of event scoring on the patient file. The scoring rule parameters used in the computer-assisted scoring modules depend on the montage type associated with the study.

The ten computer-assisted scoring modules are:

· Respiratory module
· Desaturation module
· pH module
· ECG module
· Associations module
EtC02 module
· PLM module

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Snoring module
Bad Data module • XactTrace module

5. Diagnosis

The Sandman Elite application software is intended for use by qualified and trained medical practitioners in research and clinical environments. who evaluate the software output with their clinical experience and judgement to provide diagnostic conclusions about the patient's condition. The Sandman Elite software does not control the delivery of energy, the administration of drugs, or any form of life sustaining function to the patient.

Indications for Use:

The Sandman Elite software is intended for Polysomnography studies on pediatric and adult patients, and allows recording, displaying, analysis, printing and storage of physiological signals to assist in the diagnosis of various sleep disorders. The Sandman software also allows:

. 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;
An optional 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.

The Sandman software is intended for use only by qualified and trained medical practitioners in research and clinical environments, who evaluate the software output with their clinical experience and judgment to provide diagnostic conclusions about the patient's condition.

Comparison to Predicate Device:

	Predicate	Predicate	Subject Device
	Sandman K934599	SleepWorks K090277	Sandman Elite
Device Class	Class II	Class II	Class II
Class Name	Electroencephalograph	Electroencephalograph	Electroencephalograph
Product Code	OLV = Standard
Polysomnograph with
Electroencephalograph	OLZ = Automatic Event
Detection Software for
Polysomnograph with	OLZ = Automatic Event
Detection Software for
Polysomnograph with
	Predicate	Predicate	Subject Device
	Sandman K934599	SleepWorks K090277	Sandman Elite
		Electroencephalograph	Electroencephalograph
Intended User
Indications for
Use	Medical Professional
The SANDMAN
provides paperless
digital recording and
handling of
physiological signals
intended for a sleep
EEG laboratory.	Medical Professional
The Sleepworks software
works in conjunction with
Connex, Trex or Netlink
amplifiers intended for
polysomnography studies.
The software 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 Sleepworks 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
are provided 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;
Sleep Works software
does not provide any
diagnostic conclusion	Medical Professional
The Sandman Elite
software is intended for
Polysomnography
studies on pediatric and
adult patients, and
allows recording,
displaying, analysis,
printing and storage of
physiological signals to
assist in the diagnosis
of various sleep
disorders. The
Sandman software also
allows:

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;

An optional
automated analysis of
physiological signals
that is intended for use
only in adults;

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Brief Summary of Performance Tests:

Biocompatibility

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

Electrical Safety and EMC

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

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Software Verification

Testing of the Sandman Elite was performed in compliance with the Natus Medical incorporated design control process. It was found that the Sandman Elite 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 Modules

1.1. Participants

Fifty-six (56) diagnostic PSG sleep studies were collected (one study per patient). All patients involved in this study were adult patients (>18 years old) with a clinical indication for a sleep study. The patient data were de-identified and applied as subject data to this study.

1.2. Dataset description

Total Number of Subjects: 54 per event evaluated Total Number of scored Epochs (30 Sec): > 49,704 Total Number of Hours: > 411.99 Mean number of epochs per subject: > 920.4 Minimum number of epochs per subject: 711 Maximum Number of epochs per subject: 1,147

Data from 54 subjects were evaluated for respiratory, limb movement and snore events. All epochs from these subjects were scored.

1.3. Obiective of the study

The goal of the validation study reported here is to establish that Sandman performance is equivalent to the performance of the predicate device. For the purpose of this study "Reference standard" is defined using maiority 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:

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

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Image /page/10/Picture/1 description: The image contains the logo for Natus Neurology. The word "natus" is in a larger, teal-colored, sans-serif font. Below it, in a smaller, black, italicized font, is the word "neurology". The logo is simple and modern.

1.5. PSG analysis protocol

All physiologic data were collected and stored on a Sandman 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: .
- The peak signal excursions drop by ≥ 30% of pre-event baseline using a. 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.
- 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.

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

Central apnea
Obstructive apnea ●
. Hypopnea

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Limb movement .
. Snoring

The Sandman assisted-scoring module default values applied for the clinical study are listed in the following table.

Respiratory Module Default Settings me
Analysis rules	Default Value
Processing window width	120.0 sec
Average number of breaths per minute	15.0
Maximum airflow amplitude for Apnea	26.0%
Maximum airflow amplitude for Hypopnea	70.0%
Minimum SaO2 desaturation drop for Hypopnea	3.00%
Typical delay from the start of a respiratory event to the
start of a desaturation	100.00 sec
Minimum duration for a respiratory event	10 sec
Keep user scored/validated events?	Keep
Does the file need to be stage scored before running
analysis	Yes
Always assume a respiratory event has an arousal	Do not assume
Analysis Parameters	Default Value
Analysis Range	Entire File
(Lights Out to Lights On)
Analysis Channels: Airflow, Chest and Abdomen	None
(Applicable channel selected
by the user)
Periodic Limb Movement (PLM) Module Default Settings
Analysis rules	Default Value
Base Amplitude Increase	5.0 μν
Maximum Event Termination Voltage above baseline	2.0 μν
Minimum Event Termination Duration	0.5 sec
Minimum Event Length	0.5 sec
Maximum Event Length	10.0 sec
Minimum Event Interval	5.0 sec
Maximum Event Interval	90.0 sec
Maximum Left and Right Interval	5.0 sec
Minimum number of events per Episode	4
Keep user scored/validated events	Keep
Does the file need to be stage scored before running
analysis	Yes
Always Assume Events have Arousals	No
Use a Band Pass Filter on the Left Leg?	Yes
Low Frequency for the Left Leg Band Pass Filter	10.0 Hz
High Frequency for the Left Leg Band Pass Filter	100.0 Hz
Use a Band Pass Filter on the Right Leg?	Yes
Low Frequency for the Right Leg Band Pass Filter	10.0 Hz
High Frequency for the Right Leg Band Pass Filter	100.0 Hz
Use a Band Pass Filter on Combined Legs?	Yes
Low Frequency for Combined Legs Band Pass Filter	10.0 Hz
High Frequency for Combined Legs Band Pass Filter	100.0 Hz
Use a Notch Filter on the Left Leg?	No
Use a Notch Filter on the Right Leg?	No
Use a Notch Filter on Combined Legs?	No
Frequency for the Notch Filter	60.0 HZ
Analysis Parameters	Default Value
Analysis Time Range	Entire File
(Lights Out to Lights On)
Analysis Channels:
Left Leg, Reference Channel for Left Leg
Right Leg, Reference Channel for Right Leg
Combined Legs
Referenced Channel for Combined Legs	None
(Applicable channel selected
by the user)
Snore Module Default Settings
Analysis rules	Default Value
Snoring Sensitivity	4.0 x
Percentage above Baseline (Fine Adjustment)	350.0 %
Minimum Event Length	0.5 sec
Maximum Event Length	5.0 sec
Keep user scored/validated events	Keep
Does the file need to be stage scored before running analysis	Yes
Use a Software Notch Filter	No
Frequency of Notch Filter	60 Hz
Use a Band Pass filter of Snore Channel	Yes
Low Frequency for the Snore channel Band Pass Filter	10.0 Hz
High Frequency for the Snore channel Band Pass Filter	100.0 Hz
Analysis Parameters	Default Value
Analysis Time Range	Entire File
(Lights Out to Lights On)
Analysis Channels: Snore	Automatic
(User applied Snore#2)

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Image /page/13/Picture/0 description: The image shows the logo for Natus Neurology. The word "natus" is in a teal sans-serif font, with a small registered trademark symbol next to it. Below "natus" is the word "neurology" in a smaller, black, italicized sans-serif font. The logo is simple and modern.

PLEASE NOTE: Performance results reported here were obtained using default parameters for the assisted-scoring modules evaluated. Performance of the Sandman assisted scoring modules at settings different than the noted Default Values have not been validated and may result in performance different than reported here.

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1.6. Outcomes

Positive Percent Agreement (PPA) between Sandman assisted-scoring modules 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 modules are shown in the following table.

	PPA			False Detection Rate Per Hour
		95% CI			95% CI
Event	Mean	Lower	Upper	Mean	Lower	Upper
Central apnea	95.1%	88.1%	97.4%	3.8	2.4	6.4
Mixed apnea	97.6%	88.7%	99.5%	0.8	0.4	1.4
Obstructive apnea	92.0%	86.0%	94.1%	7.7	6.1	9.6
Hypopnea	85.9%	79.8%	88.2%	15.4	13.3	17.8
Limb movement	86.0%	83.0%	88.5%	16.8	14.0	20.5
Snoring	82.0%	78.3%	84.7%	21.6	18.3	26.0

PPA and False Detection Rate Per Hour of Sandman Event Detection Assisted Scoring Modules

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1.7. Clinical Study Conclusion

Compared to the Reference standard, Sandman assisted-scoring modules 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 Sandman Elite 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 Sandman Elite device should perform as intended in the specified use conditions. The clinical validation of the computer-assisted scoring modules demonstrates that the Sandman Elite device performs comparably to the predicate device that is currently marketed for the same intended use.