Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes "Automated algorithms" but does not mention AI, ML, or any related terms like neural networks or deep learning. The performance evaluation focuses on agreement with human scorers and a predicate device, not on training or validation of a learning model.

Therapeutic

No.
Explanation: The device is intended as an aid for diagnosis, analysis, display, and reporting of data from monitoring devices, not for direct treatment or therapy.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that SOMNUM is "intended for use as an aid for the diagnosis of sleep and respiratory related sleep disorders."

SaMD (Software as a Medical Device)

Yes

The device is explicitly described as a "computer program (software)" and a "standalone software application" that analyzes previously recorded data. It does not include any hardware components.

IVD (In Vitro Diagnostic)

Based on the provided information, SOMNUM 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, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions.
SOMNUM's Function: SOMNUM analyzes digital data collected by monitoring devices during sleep studies (polysomnography). It processes physiological signals (like brain waves, breathing patterns, leg movements) that are recorded from the patient, but it does not directly analyze biological specimens taken from the patient's body.
Input Data: The input data for SOMNUM is described as "digital data collected by monitoring devices" and "raw signals," not biological samples.

Therefore, SOMNUM falls under the category of a medical device that analyzes physiological data, but it does not meet the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

SOMNUM is a computer program (software) intended for use as an aid for the diagnosis of sleep and respiratory related sleep disorders. SOMNUM is intended to be used for analysis (automatic scoring and manual re-scoring), display, redisplay(retrieve), summarize and reports generation of digital data collected by monitoring devices typically used to evaluate sleep and respiratory related sleep disorders. The device is to be used under the supervision of a physician. Use is restricted to files obtained from adult patients.

For respiratory events - Sleep Disordered Breathing (Apneas)- obstructive, central, mixed apneas, and hypopneas must be manually scored by physician. The device does not output specific apnea or hypopnea events and therefore should not be used for management decisions.

Product codes

OLZ

Device Description

SOMNUM is a standalone software application that analyze previously recorded physiological data obtained during level 1 sleep studies, referred to as polysomnography (PSG) records. The SOMNUM software can analyze any EDF files. Automated algorithms are applied to the raw signals in order to identify the occurrence of certain events. The software automates recognition of:

· Sleep Stage Events : Wake, Stage N1, Stage N2, Stage N3, Stage REM
Respiratory Events : Sleep Disordered Breathing (device output does not distinguish between Apneas and Hypopneas. Obstructive, central, mixed apneas, and hypopneas must be manually scored by physician)
· Arousal Events
· Leg Movement Events : Periodic Leg Movements during Sleep (PLMs)

The SOMNUM software can be used as a stand-alone application for use on Windows 10 operating system platform. All processing, scoring, and analysis of signal data occurs on local desktop PC.

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

Intended User / Care Setting

Physician / Healthcare Facility

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

Performance testing was completed by evaluating SOMNUM device performance using a cross-sectional experimental design on a representative N=48 subjects of data recorded in the sleep laboratory. Substantial Equivalence was established through a testing protocol that used full night studies data to evaluate the performance of SOMNUM. The performance was measured by epoch by epoch agreement between SOMNUM's scoring and the scoring of three technologists using 2/3 majority rule, that is, at least two out of three export scoring (medical professionals certified on PSG recording and analysis) agree on the presence of an event within an epoch.

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

Performance Test (Non-clinical test)
Sample Size: N=48 subjects
Study Type: Cross-sectional experimental design evaluating epoch by epoch agreement between SOMNUM's scoring and human scoring.
Key Metrics: PPA, NPA, OPA, Kappa for Sleep Stages, Arousal, SDB, and PLMs. Limits of Agreement (LOA) for summary variables (TST, SE, SOL, ROL, Wake, N1, N2, N1_N2, N3, REM, Arousal Index, PLMS Index, AHI Index).

Sleep Stage Performance (OPA, Kappa):

Overall Sleep Staging: OPA 87.5% (87.2, 87.8), Kappa 82.1% (81.6, 82.5)
Awake: PPA 89.9% (89.2, 90.6), NPA 97.4% (97.3, 97.6)
N1: PPA 77.9% (77.0, 78.9), NPA 94.6% (94.4, 94.9)
N2: PPA 91.1% (90.7, 91.5), NPA 92.4% (92.0, 92.7)
N3: PPA 84.1% (82.6, 85.6), NPA 99.1% (99.0, 99.2)
REM: PPA 84.7% (83.8, 85.4), NPA 98.9% (98.8, 99.0)

Arousal Performance (OPA, Kappa):

OPA: 82.5% (82.2, 82.9), Kappa: 60.8% (60.1, 61.5)
PPA: 82.0% (81.4, 82.6), NPA: 82.8% (82.4, 83.2)

SDB & PLMS Performance (PPA, NPA, OPA, Kappa):

SDB: PPA 94.18% (93.79-94.52), NPA 91.29% (90.98-91.61), OPA 92.3% (92.1-92.6), Kappa 83.8% (83.2, 84.3)
PLMS: PPA 92.89% (92.18-93.55), NPA 94.30% (94.08-94.51), OPA 94.1% (93.9-94.4), Kappa 75.7% (74.7, 76.5)

Summary Variables Performance (Limits of Agreement - LOA):

TST, SE, ROL, Wake, N1, N2, N1_N2, and REM satisfy the provided Upper and Lower LOA.
SOL, N3, PLMS Index, and AHI Index show some differences from target ranges but are considered clinically acceptable based on absolute errors and clinician agreement error range.
The CI ranges of SOMNUM for LOA are narrower than those of the references except for AHI.

Key Results:

SOMNUM exceeded all performance targets for Sleep Stage and Arousal.
For SDB and PLMS, SOMNUM exceeded PPA targets. While NPA for SDB and PLMS were slightly lower than some references, they were considered within clinically acceptable ranges due to overall performance (OPA), and the inherent variability in manual scoring.
SOMNUM passed all pass/fail criteria for Endpoint 1 (detection of event types) and Endpoint 2 (summary variables).
Performance test results demonstrated that SOMNUM achieved sleep disordered breathing, arousal, PLMs events detection agreement that is substantially equivalent to the predicate device Ensosleep (K162627) and MICHELE Sleep Scoring (K112102) performance for all comparisons in all endpoints analyzed respectively.

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

Agreement metrics: PPA (Positive Percent Agreement), NPA (Negative Percent Agreement), OPA (Overall Percent Agreement), and Cohen's kappa.
LOA (Limits of Agreement) for summary variables.

Predicate Device(s):

K162627, K112102

Reference Device(s):

K162627, K112102

Predetermined Change Control Plan (PCCP) - All Relevant Information

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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August 16, 2023

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Honeynaps Co., Ltd Tony Lee Official Correspondent 4F. Marine Tech B/D. 529. Nonhyeon-ro. Gangnam-gu Seoul. 06126 Korea, South

Re: K223922

Trade/Device Name: Somnum (v.1.1.2.) Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLZ Dated: July 17, 2023 Received: July 17, 2023

Dear Tony Lee:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

1

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Patrick Antkowiak -S

for Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K223922

Device Name SOMNUM

Indications for Use (Describe)

SOMNUM is a computer program (software) intended for use as an aid for the diagnosis of sleep and respiratory related sleep disorders. SOMNUM is intended to be used for analysis (automatic scoring and manual re-scoring), display, redisplay(retrieve), summarize and reports generation of digital data collected by monitoring devices typically used to evaluate sleep and respiratory related sleep disorders. The device is to be used under the supervision of a physician. Use is restricted to files obtained from adult patients.

For respiratory events - Sleep Disordered Breathing (Apneas)- obstructive, central, mixed apneas, and hypopneas must be manually scored by physician. The device does not output specific apnea or hypopnea events and therefore should not be used for management decisions.

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for Honey Naps. The logo consists of a stylized letter "H" in two shades of blue, with the left side being a lighter blue and the right side being a darker blue. To the right of the "H" is the text "HONEY NAPS" in a dark blue sans-serif font. The word "HONEY" is above the word "NAPS".

Traditional 510(k) Premarket Submission

510(k) Summary

Device Name : SOMNUM (V.1.1.2. Final finished device)

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Image /page/4/Picture/0 description: The image shows the logo for Honey Naps, a company that specializes in sleep products. The logo features a stylized "H" in blue, with the words "HONEY NAPS" in blue text to the right of the "H". Below the logo, the words "510(k) Summary" are written in a large, bold font.

In accordance with 21 CFR 807.92 the following summary of information is provided: Date : September 30, 2022

I. SUBMITTER

SUBMITTER :	Honeynaps
	529, Nonhyeon-ro, Gangnam-gu
	Seoul, Republic of Korea 06126
	Tel : +82-2-567-0134
CONTACT PERSON:	Honeynaps
	YoungJun Lee
	Chief Executive Officer
	tony.lee@honeynaps.com
PRIMARY CONTACT PERSON:	Honeynaps
	YoungJun Lee
	Chief Executive Officer
	tony.lee@honeynaps.com

II. DEVICE

Trade Name	SOMNUM
Common Name	Sleep Analysis System
Regulation Number	21 CFR 882.1400
Regulation Name	Electroencephalograph
Regulation Class	II
Classification Product Code	OLZ
Device Classification Name	Automatic Event Detection Software For Polysomnograph
with Electroencephalograph
Review Panel	Neurology

Ⅲ. PREDICATE DEVICE
510(k) Number	K162627
Applicant	ENSODATA
Device Name	EnsoSleep
Regulation Number	21 CFR 882.1400
Regulation Name	Electroencephalograph
Regulation Class	II
Classification Product Code	OLZ
Device Classification Name	Automatic Event Detection Software For Polysomnograph
with Electroencephalograph

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Image /page/5/Picture/0 description: The image contains a logo with the text "HONEY NAPS". To the left of the text is a stylized letter "H" made up of two vertical bars connected by a horizontal bar. The left vertical bar is a lighter shade of blue than the right vertical bar. The logo appears to be for a company or product called "Honey Naps".

510(k) Number	K112102
Applicant	YOUNES SLEEP TECHNOLOGIES
Device Name	MICHELE SLEEP SCORING SYSTEM
Regulation Number	21 CFR 868.2375
Regulation Name	Breathing Frequency Monitor
Regulation Class	II
Classification Product Code	MNR
Device Classification Name	Ventilatory Effort Recorder

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SOMNUM is a standalone software application that analyze previously recorded physiological data obtained during level 1 sleep studies, referred to as polysomnography (PSG) records. The SOMNUM software can analyze any EDF files. Automated algorithms are applied to the raw signals in order to identify the occurrence of certain events. The software automates recognition of:

· Sleep Stage Events : Wake, Stage N1, Stage N2, Stage N3, Stage REM
Respiratory Events : Sleep Disordered Breathing (device output does not distinguish between Apneas and Hypopneas. Obstructive, central, mixed apneas, and hypopneas must be manually scored by physician)
· Arousal Events
· Leg Movement Events : Periodic Leg Movements during Sleep (PLMs)

The SOMNUM software can be used as a stand-alone application for use on Windows 10 operating system platform. All processing, scoring, and analysis of signal data occurs on local desktop PC.

V. INDICATIONS FOR USE

SOMNUM is a computer program (software) intended for use as an aid for the diagnosis of sleep and respiratory related sleep disorders. SOMNUM is intended to be used for analysis(automatic scoring and manual re-scoring), display, redisplay(retrieve), summarize, reports generation of digital data collected by monitoring devices typically used to evaluate sleep and respiratory related sleep disorders. The device is to be used under the supervision of a physician Use is restricted to files obtained from adults patients.

For respiratory events - Sleep Disordered Breathing (Apneas and Hypopneas)- obstructive, central, mixed apneas, and hypopneas must be manually scored by physician. The device does not output specific apnea or hypopnea events and therefore should not be used for management decisions.

Description	Subject Device	Predicate Device
	SOMNUM	ENSOSLEEP
(K162627)
Indications for Use	SOMNUM is a computer program
(software) intended for use as an
aid for the diagnosis of sleep and
respiratory related sleep disorders.
SOMNUM is intended to be used
for analysis(automatic scoring and
manual re-scoring), display,
redisplay(retrieve), summarize,
reports generation of digital data
collected by monitoring devices
typically used to evaluate sleep and
respiratory related sleep disorders.	EnsoSleep is intended for use for the
diagnostic evaluation by a physician to
assess sleep quality and as an aid for the
diagnosis of sleep and respiratory related
sleep disorders in adults only. EnsoSleep
is a software-only medical 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, leg movements, and sleep
disordered breathing events including
obstructive apneas. All automatically

Table 1. Comparison of Indications for Use

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| | The device is to be used under the
supervision of a physician Use is
restricted to files obtained from
adults patients.

For respiratory events - Sleep
Disordered Breathing (Apneas and
Hypopneas)- obstructive, central, mixed
apneas, and hypopneas must be
manually scored by physician. The
device does not output specific apnea
or hypopnea events and therefore
should not be used for management
decisions | scored events are subject to verification
by a qualified clinician. Central apneas,
mixed apneas, and hypopneas must be
manually marked within records. |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Analyze physiological data previously
recorded during sleep and present
a report. | Analyze physiological data previously
recorded during sleep and present a
report. |
| Environment of Use | Healthcare Facility | Healthcare Facility |

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Image /page/8/Picture/0 description: The image shows the logo for Honey Naps. The logo consists of a stylized letter "H" on the left and the words "HONEY NAPS" on the right. The "H" is made up of two vertical bars connected by a horizontal bar, with circles at the top and bottom of each vertical bar. The word "HONEY" is above the word "NAPS". The colors of the logo are shades of blue.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

There are no significant differences in the technological characteristics of this device compared to the predicate device which adversely affect safety or effectiveness. The below table is summarized and compared with the technological characteristics between the SOMNUM and the predicate device :

Table 2. Comparison of Technological Characteristics

| Description SOMNUM | Predicate Device
ENSOSLEEP
(K162627) |
-------------------------------------------------------------------------------------------------------------------------------|--------------------------|--------------------------------------------|
| | |
| YES | YES |
| YES | YES |
| YES | YES |
| YES | YES |
| YES | YES |
| YES | YES |
| YES | YES |
| YES |
Sleep Stage and Arousal Scoring: | | |
| YES | YES |
| YES | YES |
| YES | YES |
| YES | YES |
Respiratory Events Scoring : | | |
| YES | YES |
| YES | YES |

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Image /page/9/Picture/0 description: The image shows the logo for Honey Naps. The logo consists of a stylized letter H on the left and the words "HONEY NAPS" on the right. The letter H is made up of two vertical bars connected by a horizontal bar in the middle. The words "HONEY NAPS" are written in a sans-serif font.

Respiratory airflow	YES	YES
Thermister	YES	YES
Audio	NO	YES
Body position	NO	YES
Airway CO2	NO	YES
Data inputs for Leg Movement Scoring :
EMG recorded from right and
left legs	YES	YES
Additional Technical Criteria :
Polysomnography records
scored per 30 second epoch	YES	YES
Cardiac artifacts removed from
EEG, EMG and EOG channels	YES	YES
Others :
Standard of scoring manual	The AASM Manual for the Scoring of
Sleep and Associated Events, 2016	The AASM Manual for the Scoring of
Sleep and Associated Events, 2007
Re-scoring	YES	YES
File Format	.EDF, .XML, .JSON format	.EDF, .
Network	Access to Internet is not required.	Access to Internet is required
Operating System	Windows 10	Windows XP, Windows 7, Windows 10

VII. PERFORMANCE DATA

Software Verification & Validation

Support for the substantial equivalence of the SOMNUM Software was provided as a result of risk management and software testing. Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guideline for Industry and FDA Staff, "Guidance for the Content of Premarket Submission for Software Contained in Medical Device."(Document issued on : May 11, 2005)

· Verification of each independent software subsystem against defined requirements
· Verification of interfaces between software subsystems against defined interface requirements
· Validation of fully integrated system including all subsystems against overall system requirements

The results of the verification and validation activities that have been performed demonstrate that the software meets requirements to support substantial equivalence.

Performance Test (Non-clinical test)

Performance testing was completed by evaluating SOMNUM device performance using a cross-sectional experimental design on a representative N=48 subjects of data recorded in the sleep laboratory. Substantial Equivalence was established through a testing protocol that used full night studies data to evaluate the performance of SOMNUM. The goal of the test reported here is to establish that SOMNUM performance is equivalent to the performance of the predicate device. We confirm that SOMNUM does not present any new concerns about safety or effectiveness compared to the predicate device, MICHELE Sleep Scoring System(K112102). The performance was measured by epoch by epoch agreement between SOMNUM's

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Image /page/10/Picture/0 description: The image contains the logo for Honey Naps. The logo consists of a stylized "H" made of rounded rectangles and circles, with the left side in a lighter blue and the right side in a darker blue. To the right of the "H" are the words "HONEY" stacked on top of "NAPS", both in the same darker blue color as the right side of the "H".

ing and the scoring of three technologists using 2/3 majority rule, that is, at least two out of three export scoring(medical professionals certified on PSG recording and analysis) agree on the presenceof an event within an epoch. SOMNUM device performance was evaluated using the defined test design, statistical methodology, and controls across the following two endpoints:

Endpoint 1. As SOMNUM is intended to analyze physiological signals and automatically score sleep study results, including sleep staging and detection of respiratory events, PLMs events, device performance for detecting each event type must be validated.

Endpoint 2. As SOMNUM is intended to present summary variables that appear in the clinical report used by physician to assess sleep disorders.

Test Result Summary

Data for End point 1

Sleep Stage

		SOMNUM					Reference[2]
		W	N1	N2	N3	R	W	N1	N2	N3	R
	W	89.96	6.93	0.86	0.14	4.13	82.2	35.9	4.0	0.5	5.8
		(89.22-	(6.35-	(0.73-	(0.00-	(3.69-
		90.67)	7.51)	0.98)	0.32)	4.61)
	N1	6.15	77.93	5.46	0.28	5.88	9.6	26.1	4.7	0.4	8.7
		(5.63-	(76.95-	(5.16-	(0.09-	(5.38-
		6.73)	78.86)	5.78)	0.52)	6.43)
Scorers	N2	2.06	13.21	91.13	15.52	5.37	3.8	33.2	85.0	16.0	12.3
		(1.75-	(12.42-	(90.71-	(14.02-	(4.84-
		2.41)	13.96)	91.47)	16.95)	5.84)
	N3	0.01	0.07	1.84	84.04	0.00	0.2	0.2	5.4	82.3	0.0
	R	1.81	1.86	0.72	0.05	84.62	4.2	4.7	0.8	0.8	73.2
		(1.49-	(1.53-	(0.60-	(0.00-	(83.81-
		2.14)	2.19)	0.84)	0.14)	85.48)

Table 3. Performance Comparison of sleep stage.

Arousal

Table 4. Performance Comparison of sleep stage.

SOMNUM				Reference[3]
Event
Total
Epoch	PPA	NPA	OPA	Event
Total
Epoch	PPA	NPA	OPA
13108	82.02
(81.42-82.64)	82.78
(82.41-83.17)	82.5
(82.2-82.9)	6468	76.82	82.48	-

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Image /page/11/Picture/0 description: The image contains the logo for Honey Naps. The logo consists of a stylized letter "H" made of two vertical bars connected by a horizontal bar in the middle. The left vertical bar is light blue, while the right vertical bar is dark blue. To the right of the "H" are the words "HONEY" and "NAPS" stacked on top of each other, both in dark blue.

SDB & PLMS

	SOMNUM				Reference[4]
	Event
Total
Epoch	PPA	NPA	OPA	Event
Total
Epoch	PPA	NPA	OPA	Event
Total
Epoch	PPA	NPA	OPA
SDB	15984	94.18
(93.79-94.52)	91.29
(90.98-91.61)	92.3
(92.1-92.6)	2439	75.5	98.1	93.0	4705	67
(58, 75)	93
(92, 94)	91
(90, 92)
PLMS	5215	92.89
(92.18-93.55)	94.30
(94.08-94.51)	94.1
(93.9-94.4)	1741	78.4	97.6	95.7	5796	71
(60, 80)	90
(89, 92)	89
(87, 90)

Table 5. Performance Comparison of sleep stage.

Please note that Event total Epoch means the total number of epochs with events. The total epoch is 43971 epochs (event epoch + non-event epoch).

Discussion:

For Sleep Stage and Arousal, SOMNUM exceeded all performance targets, while for SDB and PLMS, SOMNUM exceeded the performance targets for PPA. Comparing NPA of SOMNUM with that of predicate device, the NPA of SOMNUM' is 3.3% lower. however, it is unknown whether a statistically significant comparison can be made due to lack of Cl. Therefore, the NPA of K162627 was compared as the reference device, and in this case, SOMNUM showed good performance by 4.3%. In conclusion, the NPA performance for PLMS is considered to be within clinically acceptable range. The NPA for SDB showed a performance that was 1.7% lower than K162627 and about 6.8% lower than K112102. However, considering both PPA and OPA of SOMNUM, the overall performance of SOMNUM is better than that of K162627. In addition, considering the situation where there is no standard reference, it cannot be said that this difference shows the low performance of SOMNUM. Furthernore, the manual scorer agreement[8], which is generally acceptable in clinical practice, is considered to have an error range of around 15%, these performance differences are considered to be within the clinically acceptable error range.

In conclusion, SOMNUM passed all pass/fail criteria for Endpoint 1.

Data for End point 2:

Table 6. Performance Comparison of Relevant Scoring Variables Between SOMNUM and Performance Target for Endpoint

| Variable | Type Of
Limit | SOMNUM | abs. MAX | Target | abs. MAX | Unit |
|----------|------------------|--------|----------|--------|----------|-------|
| TST | U | 10 | 20 | 60 | 120 | [min] |
| | L | -20 | | -120 | | |

12

	NAPS						Variable	LOA	SOMNUM	References	Ref. No.	Unit
SE	U	2.5	5	10	13	%	TST
(Total Sleep Time)	U	7.8	35	[5]	[min]
	L	-5		-13				L	-14.21	-70
SOL	U	8	23	40	40	[min]	SE
(Sleep Efficiency)	U	1.69	10		%
	L	-23		-5				L	-3.31	-12	[7]
ROL	U	120	120	170	170	[min]	SOL
(Sleep On Latency)	U	2.93	15	[7]	[min]
	L	-70		-130				L	-4.21	-11
Wake	U	22	22	60	60	[min]	ROL
(REM On Latency)	U	62.01	70	[5]	[min]
	L	-10		-45				L	-60.69	-90
N1	U	30	45	80	80	[min]	Wake	U	14.21	70	[7]	[min]
	L	-45		-60				L	-7.80	-45
N2	U	65	65	70	120	[min]	N1	U	25.30	30	[5]	[min]
	L	-50		-120				L	-17.29	-30
N1_N2	U	55	55	70	70	[min]	N2	U	31.61	10	[5]	[min]
	L	-35		-60				L	-29.10	-75
N3	U	30	40	140	140	[min]	N1_N2	U	31.58	30	[5]	[min]
	L	-40		-10				L	-19.17	-75
REM	U	20	40	50	80	[min]	N3	U	18.83	65	[5]	[min]
	L	-40		-80				L	-30.45	-5
Arousal Index	U	30	30	-		events/hour	REM	U	6.07	18	[5]	[min]
	L	-20		-	-			L	-31.95	-55
PLMS Index	U	43		7		events/hour	Arousal Index	U	23.91	-	-	events/hour
	L	-2	43	-43	43			L	-15.21	-
AHI Index	U	18		7		events/hour	PLMS Index
(Periodic Limb
Movements of Sleep
Index)	U	12.24	13		events/hour
	L	-7	18	-20	20			L	-0.37	-15	[6]
AHI Index
(Apnea-Hypopnea Index)	U	8.79	4	[5]	events/hour
	L	-3.28	-2

Discussion: TST, SE, ROL, Wake, N1, N2, N1_N2, and REM satisfy the provided Upper and Lower LOA.

However, SOL has a target of -5 to 40, while SOMNUM has a range of -23 to 8, and N3 has a target of -10 to 140, while SOMNUM has a range of -40 to 30. The PLMS index has a target of -40 to 10, but SOMNUM has a range of -2 to 43, and the AHI index has a target of -20 to 7, but SOMNUM has a range of -7 to 18.

When considering the actual range of absolute errors, SOL has a target of 40 minutes, while SOMNUM has 23 minutes, and N3 has a target of 140, while SOMNUM has 40 minutes. The AHI index has a target of 22, but SOMNUM has 18, resulting in smaller absolute errors.

PLMS index has a target of 43, while SOMNUM has 43, it shows the almost same value. However, considering the 15% error among scorers presented in Reference [8], it cannot be said that it affects the performance.

In addition, we compared the LOA of Relevant Sleep Scoring Variables of SOMNUM and those of References. The table 12 showed the LOA of SOMNUM and References.

13

Image /page/13/Picture/0 description: The image shows the logo for Honey Naps. The logo consists of a stylized letter "H" on the left, with the word "HONEY" above the word "NAPS" on the right. The letter "H" is made up of two vertical bars connected by a horizontal bar, with circles at the top and bottom of each vertical bar. The left vertical bar is light blue, and the right vertical bar is dark blue. The words "HONEY NAPS" are also dark blue.

Table 7. Performance Comparison of LOA between SOMNUM and References for Endpoint 2

When comparing the LOA ranges of SOMNUM and References, the CI ranges of SOMNUM is narrower than those of the references except for AHI. In conclusion, SOMNUM passed all pass/fail criteria for Endpoint 2.

Output Comparison Data

14

Image /page/14/Picture/0 description: The image contains the logo for Honey Naps. The logo consists of a stylized letter "H" on the left, with the words "HONEY" and "NAPS" stacked on top of each other to the right of the "H". The "H" is made up of two vertical bars connected by a horizontal bar in the middle, with circles at the top and bottom of each vertical bar. The logo is colored in shades of blue.

| SCORING

FUNCTION	SOMNUM				ENSOSLEEP(K162627)
	Total
Epochs	PPA
(%)	NPA
(%)	OPA
(%)	kappa
(%)	Total
Epochs	PPA
(%)	NPA
(%)	OPA
(%)	kappa
(%)
SLEEP
STAGING	43971			87.5
(87.2,87.8)	82.1
(81.6,82.5)	59719	78
(77,80)	95
(94,95)	91
(91,92)
Awake	6719	89.9
(89.2,90.6)	97.4
(97.3,97.6)			17459	86
(82,88)	97
(95,98)	94
(92,95)
N1	6522	77.9
(77.0,78.9)	94.6
(94.4,94.9)			3293	41
(33,48)	94
(93, 96)	91
(90,93)
N2	20448	91.1
(90.7,91.5)	92.4
(92.0,92.7)			26839	77
(73,81)	87
(85,90)	83
(80,85)
N3	1012	84.1
(82.6,85.6)	99.1
(99.0,99.2)			5587	81
(74,88)	93
(91,95)	92
(90,94)
REM	7364	84.7
(83.8,85.4)	98.9
(98.8,99.0)			6541	79
(72,84)	99
(98,99)	96
(96,97)
No Consensus	756				1432
AROUSAL	43971			82.5
(82.2,82.9)	60.8
(60.1,61.5)	59719			87
(85,88)	-
Yes	13108	82
(81.4,82.6)	82.8
(82.4,83.2)			7686	66
(61,71)	90
(88,91)
None	30863
No Consensus	0				0
PLMS	43971			94.1
(93.9,94.4)	75.7
(74.7,76.5)	59719			89
(87,90)	-
Yes	8509	92.9
(92.1,93.6)	94.3
(94.1, 94.5)			5796	71
(60,80)	90
(89,92)
None	35462
No Consensus	0				0
RESPIRATORY
EVENTS	43971			92.3
(92.1,92.6)	83.8
(83.2,84.3)	59719			91
(90,92)	-
YES	15984	94.2
(93.8,94.5)	91.3
(91.0,91.6)			4705	67
(58,75)	93
(92,94)
None	27987
No Consensus	0				0

Discussion : Except for the NPA of Arousal, SOMNUM is superior to the predicate device in all PPA and NPA. However, the NPA of arousal is about 8% lower, but this is within the limit that can be seen between general scorers. The manual scorer agreement[8], which is generally acceptable in clinical practice, is considered to have an error range of around 15%, these performance differences are considered to be within the clinically acceptable error range.

15

Image /page/15/Picture/0 description: The image contains the logo for Honey Naps. The logo consists of a stylized "H" made of two vertical bars connected by a horizontal bar in the middle. The "H" is colored in shades of blue. To the right of the "H" is the text "HONEY NAPS" in a sans-serif font, with "HONEY" in a lighter blue and "NAPS" in a darker blue.

Clinical Test Summarv

No clinical studies were considered necessary and performed.

Summary

In summary, performance test results demonstrated that SOMNUM achieved sleep disordered breathing, arousal, PLMs events detection agreement that is substantially equivalent to the predicate device Ensosleep (K162627) and MICHELE Sleep Scoring(K112102) performance for all comparisons in all endpoints analyzed respectively. The SOMNUM performance validation testing demonstrates the safety and effectiveness of SOMNUM whenused for the defined indications for use. The performance data demonstrates that the SOMNUM device performs comparably to the predicate device that is currently marketed for the same intended use.

References

[1] FDA, 510(k) Summary(MICHELE Sleep Scoring System, K112102)

[2] DJ Levendowski, et. al. "The Accuracy, Night-to-Night Variability, and Stability of Frontopolar Sleep Electroencephalography Biomarkers" Journal of Clinical Sleep Medicine, Vol. 13, No. 6, pp.791 - 803, 2017

[3] F De Carli, et. al, "A Method for the Automatic Detection of Arousals During Sleep, Vol. 22, No. 5, pp. 561~572, 1999

[4] FDA, K162627 510K summary report

[5] Atul Malhotra, et. al., "Performance of an Automated Polysomnography Scoring System Versus Computer-Assisted Manual Scoring" SLEEP, Vol. 36, No. 4, pp. 573-582, 2013

(6) S. D. Pittman, et. al., "Assessment of Automated Scoring of Polysomnographic Recordings in a Population with Suspected Sleep-disordered Breathing", SLEEP, Vol. 27, No. 7, 2004 pp.1394-1403

[7] C. Stepnowsky, et. al, "Scoring accuracy of automated sleep staging from a bipolar recording compared to manual scoring by multiple raters, Sleep Medicine 14 (2013) 1199-1207

[8] T. Penzel, "Sleep scoring moving from visual scoring", SLEEP, 2022, Vol. 45, No. 10. pp. 1 – 3.

16

Image /page/16/Picture/0 description: The image shows the logo for Honey Naps, which is a blue stylized H with two circles on the left, and the words "HONEY NAPS" in blue on the right. Below the logo, the words "VIII. CONCLUSIONS" are written in black. The text is in a simple, sans-serif font.

Based on a comparison of the intended use and technological characteristics, performance test, the SOMNUM software is substantially equivalent to the identified predicate device. Minor differences in technological and performance characteristics did not raise new or different questions of safety and effectiveness. Additionally, the non-clinical testing supports that the system performs in accordance with its intended use and is as safe, as effective, and performs as well as the predicate device.