DeepRESP is an aid in the diagnosis of various sleep disorders where subjects are often evaluated during the initiation or follow-up of treatment of various sleep disorders. The recordings to be analyzed by DeepRESP can be performed in a hospital, a patient's home, or an ambulatory setting. It is indicated for use with adults (18 years and above) in a clinical environment by or on the order of a medical professional.

DeepRESP is intended to mark sleep study signals to aid in the identification of events and annotations of traces; automatically calculate measures obtained from recorded signals (e.g., magnitude, time, frequency, and statistical measures of marked events); and infer sleep staging with arousals with EEG and in the absence of EEG. All output is subject to verification by a medical professional.

Device Description

DeepRESP is a cloud-based software as a medical device (SaMD), designed to perform analysis of sleep study recordings, with and without EEG signals, providing data for the assessment and diagnosis of sleep-related disorders. Its algorithmic framework provides the derivation of sleep staging, including arousals, scoring of respiratory events, and key parameters such as the Apnea-Hypopnea Index (AHI) and Central Apnea-Hypopnea Index (CAHI).

DeepRESP (K252330) is hosted on a serverless stack. It consists of:

A web Application Programming Interface (API) intended to interface with a third-party client application, allowing medical professionals to access DeepRESP's analytical capabilities.
Predefined sequences called Protocols that run data analyses, including artificial intelligence and rule-based models for the scoring of sleep studies, and a parameter calculation service.
A Result storage using an object storage service to temporarily store outputs from the DeepRESP Protocols.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for DeepRESP, based on the provided FDA 510(k) clearance letter:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria (e.g., "DeepRESP must achieve AHI ≥ 5 PPA% of at least X%"). Instead, it reports the performance of the device and compares it to predicate devices to demonstrate substantial equivalence and non-inferiority. The "Observed paired differences" columns, particularly those where the confidence interval does not cross zero, imply a comparison to show that the new DeepRESP v2.0 performs at least as well as the previous version or the additional predicate.

For the purpose of this analysis, I will present the reported performance of the Subject Device (DeepRESP v2.0) as the "reported device performance." Since no explicit acceptance criteria thresholds are given, the comparison to predicates and the demonstration of non-inferiority served as the implicit acceptance path for the FDA clearance.

Reported Device Performance (DeepRESP v2.0)

Metric	Type I/II Studies (EEG) Reported Performance PPA% (NPA%, OPA%)	Type III HSAT-Flow Studies Reported Performance PPA% (NPA%, OPA%)	Type III HSAT-RIP Studies Reported Performance PPA% (NPA%, OPA%)
Severity Classification
AHI ≥ 5	87.7 (76.5, 87.3)	91.0 (78.0, 90.6)	93.7 (63.5, 92.8)
AHI ≥ 15	71.9 (94.8, 78.2)	78.1 (93.9, 81.7)	81.0 (91.1, 83.4)
CAHI ≥ 5	80.0 (98.0, 97.2)	80.7 (98.0, 97.2)	79.5 (97.6, 96.9)
Sleep Stages
Wake	92.8 (95.8, 95.1)	79.7 (96.6, 92.9)	79.7 (96.6, 92.9)
REM	82.5 (98.8, 96.5)	77.0 (98.1, 95.2)	77.0 (98.1, 95.2)
NREM1	43.1 (94.5, 91.7)	N/A (Only NREM total reported for Type III studies)	N/A (Only NREM total reported for Type III studies)
NREM2	78.1 (91.5, 85.3)	N/A (Only NREM total reported for Type III studies)	N/A (Only NREM total reported for Type III studies)
NREM3	87.5 (94.6, 93.7)	N/A (Only NREM total reported for Type III studies)	N/A (Only NREM total reported for Type III studies)
NREM (Total for Type III)	N/A	94.2 (80.1, 89.1)	94.2 (80.1, 89.1)
Respiratory Events
Respiratory events (overall)	71.2 (93.2, 85.0)	74.4 (92.0, 85.5)	75.0 (90.7, 84.8)
All apnea	83.7 (98.2, 97.1)	84.5 (98.2, 97.0)	81.1 (95.7, 94.5)
Central apnea	79.3 (99.2, 99.0)	77.5 (99.2, 99.0)	78.8 (99.2, 99.0)
Obstructive apnea	76.2 (98.4, 97.0)	78.4 (98.4, 97.0)	74.3 (96.0, 94.4)
Hypopnea	60.1 (92.9, 83.5)	63.9 (91.7, 83.3)	58.9 (90.7, 81.0)
Desaturation	98.5 (95.5, 96.1)	98.8 (96.3, 96.9)	98.8 (96.3, 96.9)
Arousal events	62.1 (89.1, 81.5)	64.0 (90.5, 83.1)	64.0 (90.5, 83.0)

PPA%: Positive Percent Agreement, NPA%: Negative Percent Agreement, OPA%: Overall Percent Agreement.

2. Sample Sizes and Data Provenance

The clinical validation was conducted using retrospective data.

Test Set Sample Size:
- Type I/II Scoring Validation: 4,030 PSG recordings
- Type III Scoring Validation: 5,771 sleep recordings
  - This comprised 4,037 Type I recordings and 1,734 Type II recordings, processed as Type III by using only the relevant subset of signals.
Data Provenance:
- Country of Origin: United States.
- Data Type: Manually scored sleep recordings from sleep clinics, collected as part of routine clinical work for patients suspected of suffering from sleep disorders.
- Settings: Urban, suburban, and rural areas.
- Demographics: Included individuals in all age groups (18-21, 22-35, 36-45, 46-55, 56-65, >65) and all BMI groups (<25, 25-30, <30). The recording collection for Type I/II scoring consisted of 44% Females, and for Type III scoring, 35% Females. High level of race/ethnicity diversity (Caucasian or White, Black or African American, Other).

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: Not explicitly stated. The document refers to "manually scored sleep recordings" and "medical professional" for verification. It also mentions "board-certified sleep physicians" in the context of the training set. However, the specific number of experts used to establish the ground truth for the test set is not detailed.
Qualifications of Experts: For the test set, it's implied that "medical professionals" performed the manual scoring, as the data originated from "routine clinical work." For the training set, "board-certified sleep physicians" were involved in establishing the ground truth.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method (e.g., 2+1, 3+1) for establishing the ground truth on the test set. It mentions "manually scored sleep recordings" but does not detail how potential disagreements between multiple scorers (if any were used) were resolved.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done.

The study design was a retrospective data study comparing the automatic scoring of DeepRESP to manual scoring (ground truth) and also comparing DeepRESP's performance to two predicate devices (DeepRESP K241960 and Nox Sleep System K192469). This is a standalone performance evaluation against expert-derived ground truth, with a direct comparison to existing automated systems, not an MRMC study assessing human reader improvement with AI assistance.

6. Standalone Performance Study

Yes, a standalone performance study was done. The reported PPA, NPA, and OPA values for DeepRESP v2.0 (Subject Device) represent its performance as a standalone algorithm without human-in-the-loop assistance. The subsequent comparison to the predicate devices also evaluated their standalone performance. The document explicitly states: "All output is subject to verification by a medical professional," indicating that while the device is intended to aid in diagnosis, its performance evaluation was conducted on its automated output before any human review.

7. Type of Ground Truth Used

The ground truth used was expert consensus (manual scoring). The study used "manually scored sleep recordings" from "routine clinical work" as the reference standard against which DeepRESP's automatic scoring was compared.

8. Sample Size for the Training Set

The document does not report the sample size used for the training set. It only states the sample sizes for the validation (test) sets: 4,030 PSG recordings for Type I/II validation and 5,771 sleep recordings for Type III validation.

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

The document states that the ground truth for the training set "was established through a rigorous process involving multiple board-certified sleep physicians." This implies an expert-driven process, likely involving consensus or reconciliation among several highly qualified professionals. However, the exact methodology (e.g., number of physicians, adjudication rules) is not detailed beyond "rigorous process."

Summary

FDA 510(k) Clearance Letter - DeepRESP

Page 1

November 17, 2025

Nox Medical ehf
℅ Hrishikesh Gadagkar
Senior Principal
Rqm+
2790 Mosside Blvd #800
Monroeville, Pennsylvania 15146

Re: K252330
Trade/Device Name: DeepRESP
Regulation Number: 21 CFR 882.1400
Regulation Name: Electroencephalograph
Regulatory Class: Class II
Product Code: OLZ
Dated: August 15, 2025
Received: August 19, 2025

Dear Hrishikesh Gadagkar:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

Page 2

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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).

Page 3

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

Page 4

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.

510(k) Number (if known): K252330

Device Name: DeepRESP

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Page 5

510(k) Summary

Document Number: REG-0040
DeepRESP v2.0 – Traditional 510(k)
Revision Number: 04

DATE PREPARED
November 13, 2025

MANUFACTURER AND 510(k) OWNER
Nox Medical ehf
Katrinartuni 2,
IS - 105 Reykjavik,
Iceland
Telephone: +354 570 7170
Official Contact: Elísabet Finnbogadóttir, Director, Regulatory Affairs

REPRESENTATIVE/CONSULTANT
Hrishikesh Gadagkar,
Sr. Principal, RQM+
2790 Mosside Blvd #800, Monroeville, PA
Telephone: +1 (410) 245-0501
Email: hgadagkar@rqmplus.com

DEVICE INFORMATION
Proprietary Name/Trade Name: DeepRESP
Common Name: Electroencephalograph, Automatic Event Detection Software for Polysomnograph with Electroencephalograph
Regulation Number: 882.1400
Class: II
Product Code: OLZ
Premarket Review: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A), Office of Neurological and Physical Medicine Devices (OHT5)
Review Panel: Neurology

PREDICATE DEVICE IDENTIFICATION

The DeepRESP (subject device) is substantially equivalent to the following predicate:

510(k) Number	Predicate Device Name / Manufacturer	Primary Predicate	Additional Predicate
K241960	DeepRESP / Nox Medical	x
K192469	Nox Sleep System / Nox Medical		x

DEVICE DESCRIPTION

Page 6

DeepRESP (K252330) is hosted on a serverless stack. It consists of:

A web Application Programming Interface (API) intended to interface with a third-party client application, allowing medical professionals to access DeepRESP's analytical capabilities.
Predefined sequences called Protocols that run data analyses, including artificial intelligence and rule-based models for the scoring of sleep studies, and a parameter calculation service.
A Result storage using an object storage service to temporarily store outputs from the DeepRESP Protocols.

Figure 1 – DeepRESP dataflow

The following constitute changes in DeepRESP (K252330) in comparison with DeepRESP (K241960) device:

a) Patient population extended to include patients 18 of age and above.
b) Automated Central Sleep Apnea (CSA) scoring.
c) Respiratory and Sleep staging model update to improve performance.

INDICATIONS FOR USE

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

Nox Medical believes that the DeepRESP (K252330) is substantially equivalent to the predicate devices listed below, based on the information summarized here:

Page 7

Trade/Device Name	Subject Device	Primary Predicate Device: DeepRESP	Additional Predicate Device: Nox Sleep System
Manufacturer	Nox Medical	Nox Medical	Nox Medical
510(k) Number	K252330	K241960	K192469
Regulation Number	21 CFR 882.1400	21 CFR 882.1400	21 CFR 882.1400
Regulation Name	Electroencephalograph	Electroencephalograph	Electroencephalograph
Regulatory Class	Class II	Class II	Class II
Product Code(s)	OLZ	OLZ	Primary: OLZ, Subsequent: KZM

Intended Use

Subject Device:
DeepRESP is a cloud-based artificial intelligence-enabled software application used for analysis (automatic scoring), retrieval, and summarization of data recorded with sleep monitoring devices. The device uses an algorithm to categorize sleep-related events that help aid in the diagnosis of sleep-related disorders. The results of the analyzed data are then transferred to another software for manual scoring, display and reporting

Primary Predicate Device:
DeepRESP is a cloud-based artificial intelligence-enabled software application used for analysis (automatic scoring), retrieval, and summarization of data recorded with sleep monitoring devices. The device uses an algorithm to categorize sleep-related events that help aid in the diagnosis of sleep-related disorders. The results of the analyzed data are then transferred to another software for manual scoring, display and reporting

Additional Predicate Device:
The Nox Sleep System is used as an aid in the diagnosis of different sleep disorders and for the assessment of sleep. The Nox Sleep System is used to measure, record, display, organize, analyze, summarize, and retrieve physiological parameters during sleep and wake. The Nox Sleep System allows the user to decide on the complexity of the study by varying the number and types of physiological signals measured. The Nox Sleep System allows for generation of user/pre-defined reports based on subject´s data. The user of the Nox Sleep System are medical professionals who have received training in the areas of hospital/clinical procedures, physiological monitoring of human subjects, or sleep disorder investigation. The intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test environments, including the patient's home.

Indications for Use

Subject Device:
DeepRESP is an aid in the diagnosis of various sleep disorders where subjects are often evaluated during the initiation or follow-up of treatment of various sleep disorders. The recordings to be analyzed by DeepRESP can be performed in a hospital, a patient's home, or an ambulatory setting. It is indicated for use with adults (18 years and above) in a clinical environment by

Primary Predicate Device:
DeepRESP is an aid in the diagnosis of various sleep disorders where subjects are often evaluated during the initiation or follow-up of treatment of various sleep disorders. The recordings to be analyzed by DeepRESP can be performed in a hospital, patient home, or an ambulatory setting. It is indicated for use with adults (22 years and above) in a clinical environment by or on

Page 8

Trade/Device Name	Subject Device	Primary Predicate Device: DeepRESP	Additional Predicate Device: Nox Sleep System
	or on the order of a medical professional. DeepRESP is intended to mark sleep study signals to aid in the identification of events and annotations of traces; automatically calculate measures obtained from recorded signals (e.g., magnitude, time, frequency, and statistical measures of marked events); and infer sleep staging with arousals with EEG and in the absence of EEG. All output is subject to verification by a medical professional.	the order of a medical professional. DeepRESP is intended to mark sleep study signals to aid in the identification of events and annotation of traces; automatically calculate measures obtained from recorded signals (e.g., magnitude, time, frequency, and statistical measures of marked events); infer sleep staging with arousals with EEG and in the absence of EEG. All output is subject to verification by a medical professional.	varying the number and types of physiological signals measured. The Nox Sleep System allows for generation of user/pre-defined reports based on subject´s data. The user of the Nox Sleep System are medical professionals who have received training in the areas of hospital/clinical procedures, physiological monitoring of human subjects, or sleep disorder investigation. The intended environments are hospitals, institutions, sleep centers, sleep clinics, or other test environments, including the patient's home.
Use Environment	Physician office. No limitation on where data are acquired.	Physician office. No limitation on where data are acquired.	Physician office. No limitation on where data are acquired.
Patient Population	18 years and older	22 years and older	22 years and older
Type of Use	Prescription Use only	Prescription Use only	Prescription Use only
Signals analyzed	EEG, Chin EMG, EOG, Abdomen and Thorax RIP, SpO2, Nasal pressure (Cannula flow), Body position	EEG, Chin EMG, EOG, Abdomen and Thorax RIP, SpO2, Nasal Pressure (Cannula flow), Body position	EEG, Chin EMG, EOG Abdomen and Thorax RIP, SpO2; Nasal pressure (Cannula flow); Body position
Sleep Scoring with EEG	Automatic ready for review by medical professional	Manual through a 3rd party application. Automatic ready for review by medical professional	Manual through a 3rd party application. Automatic ready for review and interpretation by a physician. Manual
Sleep Scoring Without EEG	Automatic ready for review by medical professional	Automatic ready for review by medical professional	Not available
Score Sleep Disorder Respiratory Events	Automatic ready for review by medical professional	Manual through a 3rd party application. Automatic ready for review by medical professional	Manual through a 3rd party application. Automatic Manual
Score Arousal Events with EEG	Automatic ready for review by medical professional	Manual through a 3rd party application. Automatic ready for review by medical professional	Manual through a 3rd party application. Manual
Score Arousal Events without EEG	Automatic ready for review by medical professional	Automatic ready for review by medical professional	Not available
Score Central Sleep Apneas and Obstructive Sleep Apneas	Automatic ready for review by medical professional	Not available	Automatic ready for review and interpretation by a physician.
Score Body Position	Automatic ready for review by medical professional	Manual through a 3rd party application. Automatic ready for review by medical professional	Manual through a 3rd party application. Automatic Manual
Manual Review of Automatic Scoring	Yes	Yes	Yes
Sleep Study Reporting	Yes	Yes	Yes

Page 9

Clinical Performance

Trade/Device Name	Subject Device: DeepRESP v2.0	Primary Predicate Device: DeepRESP v1.0 (K241960)	Additional Predicate Device: Nox Sleep System (K192469)	Observed paired differences (ΔPPA, ΔNPA, ΔOPA) between subject device and predicate devices. Bootstrapped 95% CI

Clinical performance Type I/II studies

Severity classification

AHI ≥ 5
PPA%: 87.7
NPA%: 76.5
OPA%: 87.3

AHI ≥ 15
PPA%: 71.9
NPA%: 94.8
OPA%: 78.2

CAHI ≥ 5
PPA%: 80.0
NPA%: 98.0
OPA%: 97.2

Sleep stages

Wake
PPA%: 92.8
NPA%: 95.8
OPA%: 95.1

REM
PPA%: 82.5
NPA%: 98.8
OPA%: 96.5

NREM1
PPA%: 43.1
NPA%: 94.5
OPA%: 91.7

NREM2
PPA%: 78.1
NPA%: 91.5
OPA%: 85.3

NREM3
PPA%: 87.5
NPA%: 94.6
OPA%: 93.7

Respiratory events
PPA%: 71.2
NPA%: 93.2

Primary Predicate Device:

Severity classification

AHI ≥ 5
PPA%: 87.5
NPA%: 91.9
OPA%: 87.9

AHI ≥ 15
PPA%: 74.1
NPA%: 94.7
OPA%: 81.5

CAHI ≥ 5
N/A

Sleep stages

Wake
PPA%: 95.4
NPA%: 94.6
OPA%: 94.8

REM
PPA%: 84.3
NPA%: 98.3
OPA%: 96.3

NREM1
PPA%: 42.8
NPA%: 89.7
OPA%: 87.1

NREM2
PPA%: 74.2
NPA%: 82.8
OPA%: 78.7

NREM3
PPA%: 43.1
NPA%: 98.5
OPA%: 91.6

Respiratory events
PPA%: 72.0
NPA%: 94.2

Additional Predicate Device:

Severity classification

AHI ≥ 5
Not used in comparison.

AHI ≥ 15
Not used in comparison.

CAHI ≥ 5
Not reported in K192469.

Non-inferiority is demonstrated in next column.

Sleep stages

Wake
Not used in comparison.

REM
Not used in comparison.

NREM1
Not used in comparison.

NREM2
Not used in comparison.

NREM3
Not used in comparison.

Respiratory events
Not used in comparison.

Observed paired differences:

Severity classification

DeepRESP (K241960)
AHI ≥ 5
ΔPPA%: -4.7 [-5.6, -3.9]
ΔNPA%: 27.0 [19.2, 35.3]
ΔOPA%: -3.5 [-4.4, -2.6]

AHI ≥ 15
ΔPPA%: -3.2 [-4.3, -2.1]
ΔNPA%: 4.9 [3.3, 6.7]
ΔOPA%: -1.0 [-1.9, -0.1]

Nox Sleep System (K192469)
CAHI ≥ 5
ΔPPA%: 26.6 [18.4, 34.6]
ΔNPA%: -1.0 [-1.5, -0.5]
ΔOPA%: 0.3 [-0.3, 1.0]

Sleep stages

DeepRESP (K241960)
Wake
ΔPPA%: -2.8 [-3.0, -2.6]
ΔNPA%: 1.5 [1.4, 1.7]
ΔOPA%: 0.6 [0.5, 0.7]

REM
ΔPPA%: -2.4 [-2.7, -2.1]
ΔNPA%: 0.3 [0.2, 0.3]
ΔOPA%: -0.1 [-0.2, -0.1]

NREM1
ΔPPA%: 1.7 [1.0, 2.3]
ΔNPA%: 4.6 [4.4, 4.9]
ΔOPA%: 4.5 [4.3, 4.7]

NREM2
ΔPPA%: 4.4 [3.9, 5.0]
ΔNPA%: 8.0 [7.7, 8.3]
ΔOPA%: 6.4 [6.1, 6.6]

NREM3
ΔPPA%: 45.6 [44.4, 46.8]
ΔNPA%: -4.0 [-4.1, -3.8]
ΔOPA%: 2.0 [1.8, 2.2]

Respiratory events

DeepRESP (K241960)
ΔPPA%: -1.0 [-1.3, -0.6]
ΔNPA%: 2.3 [2.1, 2.5]

Page 10

ΔOPA%: 1.2 [1.0, 1.3]

All apnea
PPA%: 83.7
NPA%: 98.2
OPA%: 97.1

Central apnea
PPA%: 79.3
NPA%: 99.2
OPA%: 99.0

Obstructive apnea
PPA%: 76.2
NPA%: 98.4
OPA%: 97.0

Hypopnea
PPA%: 60.1
NPA%: 92.9
OPA%: 83.5

Desaturation
PPA%: 98.5
NPA%: 95.5
OPA%: 96.1

Arousal events
PPA%: 62.1
NPA%: 89.1
OPA%: 81.5

Primary Predicate Device:

All apnea
PPA%: 85.1
NPA%: 97.7
OPA%: 96.7

Central apnea
N/A

Obstructive apnea
N/A

Hypopnea
PPA%: 59.6
NPA%: 94.2
OPA%: 85.4

Desaturation
PPA%: 96.4
NPA%: 99.6
OPA%: 98.9

Arousal events
PPA%: 62.2
NPA%: 89.3
OPA%: 81.4

Additional Predicate Device:

All apnea
Not used in comparison.

Central apnea
PPA, NPA, and OPA not reported in K192469. Non-inferiority is demonstrated in next column

Obstructive apnea
PPA, NPA, and OPA not reported in K192469. Non-inferiority is demonstrated in next column

Hypopnea
Not used in comparison.

Desaturation
Not used in comparison.

Arousal events
N/A

Observed paired differences:

All apnea (Bootstrapped paired median differences)

DeepRESP (K241960)
ΔPPA%: 0.0 [-0.7, 0.8]
ΔNPA%: 0.9 [0.8, 1.0]
ΔOPA%: 0.8 [0.7, 0.9]

Central apnea

Nox Sleep System (K192469)
ΔPPA%: 21.4 [16.2, 27.0]
ΔNPA%: -0.4 [-0.5, -0.4]
ΔOPA%: -0.2 [-0.3, -0.2]

Obstructive apnea (Bootstrapped paired median differences)

Nox Sleep System (K192469)
ΔPPA%: 9.8 [7.6, 11.9]
ΔNPA%: -0.5 [-0.6, -0.4]
ΔOPA%: 0.2 [0.0, 0.3]

Hypopnea (Bootstrapped paired median differences)

DeepRESP (K241960)
ΔPPA%: -0.2 [-0.7, 0.2]
ΔNPA%: 2.0 [1.8, 2.2]
ΔOPA%: 1.3 [1.2, 1.5]

Desaturation (Bootstrapped paired median differences)

DeepRESP (K241960)
ΔPPA%: 0.5 [0.5, 0.6]
ΔNPA%: -0.9 [-0.9, -0.9]
ΔOPA%: -0.6 [-0.6, -0.6]

Arousal events

DeepRESP (K241960)
ΔPPA%: -0.8 [-0.8, -0.7]
ΔNPA%: 0.2 [0.2, 0.2]
ΔOPA%: -0.1 [-0.1, -0.1]

Clinical performance Type III studies HSAT-Flow

Trade/Device Name	Subject Device: DeepRESP v2.0	Primary Predicate Device: DeepRESP v1.0 (K241960)	Additional Predicate Device: Nox Sleep System (K192469)	Observed paired differences (ΔPPA, ΔNPA, ΔOPA) between subject device and predicate devices. Bootstrapped 95% CI

Severity classification

AHI ≥ 5
PPA%: 91.0
NPA%: 78.0
OPA%: 90.6

AHI ≥ 15
PPA%: 78.1
NPA%: 93.9
OPA%: 81.7

Primary Predicate Device:

Severity classification

AHI ≥ 5
PPA%: 93.1
NPA%: 81.1
OPA%: 92.5

AHI ≥ 15
PPA%: 82.1
NPA%: 92.3
OPA%: 84.7

Additional Predicate Device:

Severity classification

AHI ≥ 5
Not used in comparison

AHI ≥ 15
Not used in comparison

Observed paired differences:

Severity classification

DeepRESP (K241960)
AHI ≥ 5
ΔPPA%: -4.1 [-4.7, -3.5]
ΔNPA%: 33.9 [26.7, 42.0]
ΔOPA%: -3.0 [-3.6, -2.3]

AHI ≥ 15
ΔPPA%: -3.6 [-4.5, -2.8]
ΔNPA%: 6.7 [5.1, 8.3]
ΔOPA%: -1.2 [-1.9, -0.4]

Page 11

ΔOPA%: 1.2 [1.0, 1.3]

All apnea
PPA%: 83.7
NPA%: 98.2
OPA%: 97.1

Central apnea
PPA%: 79.3
NPA%: 99.2
OPA%: 99.0

Obstructive apnea
PPA%: 76.2
NPA%: 98.4
OPA%: 97.0

Hypopnea
PPA%: 60.1
NPA%: 92.9
OPA%: 83.5

Desaturation
PPA%: 98.5
NPA%: 95.5
OPA%: 96.1

Arousal events
PPA%: 62.1
NPA%: 89.1
OPA%: 81.5

Primary Predicate Device:

All apnea
PPA%: 85.1
NPA%: 97.7
OPA%: 96.7

Central apnea
N/A

Obstructive apnea
N/A

Hypopnea
PPA%: 59.6
NPA%: 94.2
OPA%: 85.4

Desaturation
PPA%: 96.4
NPA%: 99.6
OPA%: 98.9

Arousal events
PPA%: 62.2
NPA%: 89.3
OPA%: 81.4

Additional Predicate Device:

All apnea
Not used in comparison.

Central apnea
PPA, NPA, and OPA not reported in K192469. Non-inferiority is demonstrated in next column

Obstructive apnea
PPA, NPA, and OPA not reported in K192469. Non-inferiority is demonstrated in next column

Hypopnea
Not used in comparison.

Desaturation
Not used in comparison.

Arousal events
N/A

Observed paired differences:

All apnea (Bootstrapped paired median differences)

DeepRESP (K241960)
ΔPPA%: 0.0 [-0.7, 0.8]
ΔNPA%: 0.9 [0.8, 1.0]
ΔOPA%: 0.8 [0.7, 0.9]

Central apnea

Nox Sleep System (K192469)
ΔPPA%: 21.4 [16.2, 27.0]
ΔNPA%: -0.4 [-0.5, -0.4]
ΔOPA%: -0.2 [-0.3, -0.2]

Obstructive apnea (Bootstrapped paired median differences)

Nox Sleep System (K192469)
ΔPPA%: 9.8 [7.6, 11.9]
ΔNPA%: -0.5 [-0.6, -0.4]
ΔOPA%: 0.2 [0.0, 0.3]

Hypopnea (Bootstrapped paired median differences)

DeepRESP (K241960)
ΔPPA%: -0.2 [-0.7, 0.2]
ΔNPA%: 2.0 [1.8, 2.2]
ΔOPA%: 1.3 [1.2, 1.5]

Desaturation (Bootstrapped paired median differences)

DeepRESP (K241960)
ΔPPA%: 0.5 [0.5, 0.6]
ΔNPA%: -0.9 [-0.9, -0.9]
ΔOPA%: -0.6 [-0.6, -0.6]

Arousal events

DeepRESP (K241960)
ΔPPA%: -0.8 [-0.8, -0.7]
ΔNPA%: 0.2 [0.2, 0.2]
ΔOPA%: -0.1 [-0.1, -0.1]

Clinical performance Type III studies HSAT-Flow

Trade/Device Name	Subject Device: DeepRESP v2.0	Primary Predicate Device: DeepRESP v1.0 (K241960)	Additional Predicate Device: Nox Sleep System (K192469)	Observed paired differences (ΔPPA, ΔNPA, ΔOPA) between subject device and predicate devices. Bootstrapped 95% CI

Severity classification

AHI ≥ 5
PPA%: 91.0
NPA%: 78.0
OPA%: 90.6

AHI ≥ 15
PPA%: 78.1
NPA%: 93.9
OPA%: 81.7

Primary Predicate Device:

Severity classification

AHI ≥ 5
PPA%: 93.1
NPA%: 81.1
OPA%: 92.5

AHI ≥ 15
PPA%: 82.1
NPA%: 92.3
OPA%: 84.7

Additional Predicate Device:

Severity classification

AHI ≥ 5
Not used in comparison

AHI ≥ 15
Not used in comparison

Observed paired differences:

Severity classification

DeepRESP (K241960)
AHI ≥ 5
ΔPPA%: -4.1 [-4.7, -3.5]
ΔNPA%: 33.9 [26.7, 42.0]
ΔOPA%: -3.0 [-3.6, -2.3]

AHI ≥ 15
ΔPPA%: -3.6 [-4.5, -2.8]
ΔNPA%: 6.7 [5.1, 8.3]
ΔOPA%: -1.2 [-1.9, -0.4]

Page 12

CAHI ≥ 5
PPA%: 80.7
NPA%: 98.0
OPA%: 97.2

Sleep states

Wake
PPA%: 79.7
NPA%: 96.6
OPA%: 92.9

REM
PPA%: 77.0
NPA%: 98.1
OPA%: 95.2

NREM
PPA%: 94.2
NPA%: 80.1
OPA%: 89.1

Respiratory events
PPA%: 74.4
NPA%: 92.0
OPA%: 85.5

All apnea
PPA%: 84.5
NPA%: 98.2
OPA%: 97.0

Central apnea
PPA%: 77.5
NPA%: 99.2
OPA%: 99.0

Obstructive apnea
PPA%: 78.4
NPA%: 98.4
OPA%: 97.0

Hypopnea
PPA%: 63.9
NPA%: 91.7
OPA%: 83.3

Desaturation
PPA%: 98.8
NPA%: 96.3
OPA%: 96.9

Primary Predicate Device:

CAHI ≥ 5
N/A

Sleep states

Wake
PPA%: 76.2
NPA%: 96.8
OPA%: 92.7

REM
PPA%: 79.1
NPA%: 98.1
OPA%: 95.4

NREM
PPA%: 94.5
NPA%: 79.0
OPA%: 89.2

Respiratory events
PPA%: 75.4
NPA%: 87.8
OPA%: 83.7

All apnea
PPA%: 84.9
NPA%: 96.7
OPA%: 95.8

Central apnea
N/A

Obstructive apnea
N/A

Hypopnea
PPA%: 64.0
NPA%: 89.1
OPA%: 82.6

Desaturation
PPA%: 96.9
NPA%: 99.5
OPA%: 98.8

Additional Predicate Device:

CAHI ≥ 5
Not reported in K192469. Non-inferiority is demonstrated in next column

Sleep states

Wake
Not used in comparison.

REM
Not used in comparison.

NREM
Not used in comparison.

Respiratory events
Not used in comparison.

All apnea
Not used in comparison.

Central apnea
PPA, NPA, and OPA not reported in K192469. Non-inferiority is demonstrated in next column

Obstructive apnea
PPA, NPA, and OPA not reported in K192469. Non-inferiority is demonstrated in next column

Hypopnea
Not used in comparison.

Desaturation
Not used in comparison.

Observed paired differences:

Nox Sleep System (K192469)
CAHI ≥ 5
ΔPPA%: 24.3 [17.0, 31.0]
ΔNPA%: -0.6 [-1.0, -0.2]
ΔOPA%: 0.5 [-0.1, 1.0]

Sleep states

DeepRESP (K241960)
Wake
ΔPPA%: 2.3 [2.1, 2.4]
ΔNPA%: 0.6 [0.6, 0.7]
ΔOPA%: 1.0 [1.0, 1.0]

REM
ΔPPA%: 0.4 [0.3, 0.5]
ΔNPA%: 0.1 [0.1, 0.1]
ΔOPA%: 0.1 [0.1, 0.2]

NREM
ΔPPA%: 0.7 [0.7, 0.7]
ΔNPA%: 1.2 [1.1, 1.3]
ΔOPA%: 0.9 [0.8, 0.9]

Respiratory events

DeepRESP (K241960)
ΔPPA%: -0.5 [-0.8, -0.3]
ΔNPA%: 2.7 [2.5, 2.8]
ΔOPA%: 1.5 [1.4, 1.6]

All apnea (Bootstrapped paired median differences)

DeepRESP (K241960)
ΔPPA%: 0.0 [-0.5, 0.5]
ΔNPA%: 1.0 [0.9, 1.1]
ΔOPA%: 0.9 [0.8, 1.0]

Central apnea

Nox Sleep System (K192469)
ΔPPA%: 15.2 [11.4, 19.1]
ΔNPA%: -0.4 [-0.5, -0.4]
ΔOPA%: -0.3 [-0.3, -0.3]

Obstructive apnea (Bootstrapped paired median differences)

Nox Sleep System (K192469)
ΔPPA%: 2.4 [1.1, 3.7]
ΔNPA%: -0.0 [-0.1, 0.1]
ΔOPA%: 0.2 [0.1, 0.3]

Hypopnea (Bootstrapped paired median differences)

DeepRESP (K241960)
ΔPPA%: 0.3 [0.0, 0.6]
ΔNPA%: 2.3 [2.2, 2.4]
ΔOPA%: 1.7 [1.6, 1.8]

Desaturation (Bootstrapped paired median differences)

DeepRESP (K241960)
ΔPPA%: 0.6 [0.6, 0.6]
ΔNPA%: -1.0 [-1.0, -0.9]
ΔOPA%: -0.6 [-0.6, -0.5]

Page 13

CAHI ≥ 5
PPA%: 80.7
NPA%: 98.0
OPA%: 97.2

Sleep states

Wake
PPA%: 79.7
NPA%: 96.6
OPA%: 92.9

REM
PPA%: 77.0
NPA%: 98.1
OPA%: 95.2

NREM
PPA%: 94.2
NPA%: 80.1
OPA%: 89.1

Respiratory events
PPA%: 74.4
NPA%: 92.0
OPA%: 85.5

All apnea
PPA%: 84.5
NPA%: 98.2
OPA%: 97.0

Central apnea
PPA%: 77.5
NPA%: 99.2
OPA%: 99.0

Obstructive apnea
PPA%: 78.4
NPA%: 98.4
OPA%: 97.0

Hypopnea
PPA%: 63.9
NPA%: 91.7
OPA%: 83.3

Desaturation
PPA%: 98.8
NPA%: 96.3
OPA%: 96.9

Arousal events
PPA%: 64.0
NPA%: 90.5
OPA%: 83.1

Primary Predicate Device:

CAHI ≥ 5
N/A

Sleep states

Wake
PPA%: 76.2
NPA%: 96.8
OPA%: 92.7

REM
PPA%: 79.1
NPA%: 98.1
OPA%: 95.4

NREM
PPA%: 94.5
NPA%: 79.0
OPA%: 89.2

Respiratory events
PPA%: 75.4
NPA%: 87.8
OPA%: 83.7

All apnea
PPA%: 84.9
NPA%: 96.7
OPA%: 95.8

Central apnea
N/A

Obstructive apnea
N/A

Hypopnea
PPA%: 64.0
NPA%: 89.1
OPA%: 82.6

Desaturation
PPA%: 96.9
NPA%: 99.5
OPA%: 98.8

Arousal events
PPA%: 66.8
NPA%: 86.8
OPA%: 81.8

Additional Predicate Device:

CAHI ≥ 5
Not reported in K192469. Non-inferiority is demonstrated in next column

Sleep states

Wake
Not used in comparison.

REM
Not used in comparison.

NREM
Not used in comparison.

Respiratory events
Not used in comparison.

All apnea
Not used in comparison.

Central apnea
PPA, NPA, and OPA not reported in K192469. Non-inferiority is demonstrated in next column

Obstructive apnea
PPA, NPA, and OPA not reported in K192469. Non-inferiority is demonstrated in next column

Hypopnea
Not used in comparison.

Desaturation
Not used in comparison.

Arousal events
N/A

Observed paired differences:

Nox Sleep System (K192469)
CAHI ≥ 5
ΔPPA%: 24.3 [17.0, 31.0]
ΔNPA%: -0.6 [-1.0, -0.2]
ΔOPA%: 0.5 [-0.1, 1.0]

Sleep states

DeepRESP (K241960)
Wake
ΔPPA%: 2.3 [2.1, 2.4]
ΔNPA%: 0.6 [0.6, 0.7]
ΔOPA%: 1.0 [1.0, 1.0]

REM
ΔPPA%: 0.4 [0.3, 0.5]
ΔNPA%: 0.1 [0.1, 0.1]
ΔOPA%: 0.1 [0.1, 0.1]

NREM
ΔPPA%: 0.7 [0.7, 0.7]
ΔNPA%: 1.2 [1.1, 1.3]
ΔOPA%: 0.9 [0.8, 0.9]

Respiratory events

DeepRESP (K241960)
ΔPPA%: 0.0 [-0.2, 0.3]
ΔNPA%: 1.4 [1.2, 1.5]
ΔOPA%: 0.9 [0.8, 1.0]

All apnea (Bootstrapped paired median differences)

DeepRESP (K241960)
ΔPPA%: -3.3 [-4.3, -2.5]
ΔNPA%: -1.5 [-1.7, -1.3]
ΔOPA%: -1.6 [-1.8, -1.5]

Central apnea

Nox Sleep System (K192469)
ΔPPA%: 16.6 [12.9, 20.2]
ΔNPA%: -0.5 [-0.5, -0.5]
ΔOPA%: -0.3 [-0.4, -0.3]

Arousal events

DeepRESP (K241960)
ΔPPA%: -0.8 [-0.9, -0.8]
ΔNPA%: 0.5 [0.5, 0.5]
ΔOPA%: 0.1 [0.1, 0.2]

Clinical performance Type III studies HSAT-RIP

Trade/Device Name	Subject Device: DeepRESP v2.0	Primary Predicate Device: DeepRESP v1.0 (K241960)	Additional Predicate Device: Nox Sleep System (K192469)	Observed paired differences (ΔPPA, ΔNPA, ΔOPA) between subject device and predicate devices. Bootstrapped 95% CI

Severity classification

AHI ≥ 5
PPA%: 93.7
NPA%: 63.5
OPA%: 92.8

AHI ≥ 15
PPA%: 81.0
NPA%: 91.1
OPA%: 83.4

Primary Predicate Device:

Severity classification

AHI ≥ 5
PPA%: 93.1
NPA%: 81.1
OPA%: 92.5

AHI ≥ 15
PPA%: 82.1
NPA%: 92.3
OPA%: 84.7

Additional Predicate Device:

Severity classification

AHI ≥ 5
Not used in comparison

AHI ≥ 15
Not used in comparison

Observed paired differences:

Severity classification

DeepRESP (K241960)
AHI ≥ 5
ΔPPA%: -1.4 [-1.9, -0.8]
ΔNPA%: 19.3 [12.0, 26.9]
ΔOPA%: -0.8 [-1.4, -0.2]

AHI ≥ 15
ΔPPA%: -0.6 [-1.5, 0.3]
ΔNPA%: 3.9 [2.3, 5.6]
ΔOPA%: 0.5 [-0.3, 1.2]

Page 14

CAHI ≥ 5
PPA%: 79.5
NPA%: 97.6
OPA%: 96.9

Sleep states

Wake
PPA%: 79.7
NPA%: 96.6
OPA%: 92.9

REM
PPA%: 77.0
NPA%: 98.1
OPA%: 95.2

NREM
PPA%: 94.2
NPA%: 80.1
OPA%: 89.1

Respiratory events
PPA%: 75.0
NPA%: 90.7
OPA%: 84.8

All apnea
PPA%: 81.1
NPA%: 95.7
OPA%: 94.5

Central apnea
PPA%: 78.8
NPA%: 99.2
OPA%: 99.0

Obstructive apnea
PPA%: 74.3
NPA%: 96.0
OPA%: 94.4

Hypopnea
PPA%: 58.9
NPA%: 90.7
OPA%: 81.0

Desaturation
PPA%: 98.8
NPA%: 96.3
OPA%: 96.9

Arousal events
PPA%: 64.0
NPA%: 90.5
OPA%: 83.0

Primary Predicate Device:

CAHI ≥ 5
N/A

Sleep states

Wake
PPA%: 76.2
NPA%: 96.8
OPA%: 92.7

REM
PPA%: 79.1
NPA%: 98.1
OPA%: 95.4

NREM
PPA%: 94.5
NPA%: 79.0
OPA%: 89.2

Respiratory events
PPA%: 75.4
NPA%: 87.8
OPA%: 83.7

All apnea
PPA%: 84.9
NPA%: 96.7
OPA%: 95.8

Central apnea
N/A

Obstructive apnea
N/A

Hypopnea
PPA%: 64.0
NPA%: 89.1
OPA%: 82.6

Desaturation
PPA%: 96.9
NPA%: 99.5
OPA%: 98.8

Arousal events
PPA%: 66.8
NPA%: 86.8
OPA%: 81.8

Additional Predicate Device:

CAHI ≥ 5
Not reported in K192469. Non-inferiority is demonstrated in next column

Sleep states

Wake
Not used in comparison.

REM
Not used in comparison.

NREM
Not used in comparison.

Respiratory events
Not used in comparison.

All apnea
Not used in comparison.

Central apnea
PPA, NPA, and OPA not reported in K192469. Non-inferiority is demonstrated in next column

Obstructive apnea
PPA, NPA, and OPA not reported in K192469. Non-inferiority is demonstrated in next column

Hypopnea
Not used in comparison.

Desaturation
Not used in comparison.

Arousal events
N/A

Observed paired differences:

Nox Sleep System (K192469)
CAHI ≥ 5
ΔPPA%: 23.0 [15.3, 31.1]
ΔNPA%: -0.9 [-1.3, -0.5]
ΔOPA%: 0.1 [-0.4, 0.6]

Sleep states

DeepRESP (K241960)
Wake
ΔPPA%: 2.3 [2.1, 2.4]
ΔNPA%: 0.6 [0.6, 0.7]
ΔOPA%: 1.0 [1.0, 1.0]

REM
ΔPPA%: 0.4 [0.3, 0.5]
ΔNPA%: 0.1 [0.1, 0.1]
ΔOPA%: 0.1 [0.1, 0.1]

NREM
ΔPPA%: 0.7 [0.7, 0.7]
ΔNPA%: 1.2 [1.1, 1.3]
ΔOPA%: 0.9 [0.8, 0.9]

Respiratory events

DeepRESP (K241960)
ΔPPA%: 0.0 [-0.2, 0.3]
ΔNPA%: 1.4 [1.2, 1.5]
ΔOPA%: 0.9 [0.8, 1.0]

All apnea (Bootstrapped paired median differences)

DeepRESP (K241960)
ΔPPA%: -3.3 [-4.3, -2.5]
ΔNPA%: -1.5 [-1.7, -1.3]
ΔOPA%: -1.6 [-1.8, -1.5]

Central apnea

Nox Sleep System (K192469)
ΔPPA%: 16.6 [12.9, 20.2]
ΔNPA%: -0.5 [-0.5, -0.5]
ΔOPA%: -0.3 [-0.4, -0.3]

Obstructive apnea (Bootstrapped paired median differences)

Nox Sleep System (K192469)
ΔPPA%: -1.7 [-3.4, -0.2]
ΔNPA%: -2.5 [-2.6, -2.3]
ΔOPA%: -2.4 [-2.6, -2.2]

Hypopnea (Bootstrapped paired median differences)

DeepRESP (K241960)
ΔPPA%: -4.7 [-5.1, -4.2]
ΔNPA%: 1.2 [1.1, 1.4]
ΔOPA%: -0.6 [-0.7, -0.4]

Desaturation (Bootstrapped paired median differences)

DeepRESP (K241960)
ΔPPA%: 0.6 [0.6, 0.6]
ΔNPA%: -1.0 [-1.0, -0.9]
ΔOPA%: -0.6 [-0.6, -0.5]

Arousal events

DeepRESP (K241960)
ΔPPA%: -0.8 [-0.9, -0.8]
ΔNPA%: 0.5 [0.5, 0.5]
ΔOPA%: 0.1 [0.1, 0.2]

SUMMARY OF NON-CLINICAL TESTING

Software verification and validation testing were performed per IEC 62304:2006/A1:2015 Medical device software – Software life cycle processes, IEC 82304-1:2017 Health Software – general requirements for product safety, and the FDA guidance General Principles of Software Validation. Nox Medical demonstrated safety and effectiveness based on current industry standards. All documentation was prepared as recommended in the FDA Guidance for Industry and FDA Staff, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.

SUMMARY OF CLINICAL TESTING

A retrospective study validated the clinical performance of the subject device DeepRESP. It used manually scored sleep recordings, originating from sleep clinics in the United States, performed as part of routine clinical work, matching the indicated use of the study device and patient population.

The performance of DeepRESP with regard to scoring sleep recordings with electroencephalography (EEG) (i.e., Type I and II), and sleep recordings without EEG (i.e., Type III) was validated. Two separate studies were conducted, one to validate DeepRESP with scoring Type I-II recordings and a second one with scoring Type III recordings. The performance of DeepRESP on Type III recordings was validated in two configurations: one where thorax and abdomen RIP, nasal pressure, and SpO2 are available (HSAT-Flow), the second where thorax and abdomen RIP and SpO2 are available (HSAT-RIP). The studies were done by evaluating the agreement in scoring and clinical indices resulting from the automatic scoring by DeepRESP compared to manual scoring. The performance of DeepRESP was compared to the agreement between the automatic scoring of the predicate device and manual scoring. The same collection of sleep recordings and the same manual scoring were used when

Page 15

comparing the automatic scoring of DeepRESP and the predicate device. The study method was a retrospective data study comparing paired differences.

In both studies, the subject device DeepRESP's performance was validated against the primary predicate DeepRESP (K241960). To evaluate the performance scoring of central sleep apnea (CSA) and obstructive sleep apnea (OSA), Nox Sleep System (K192469) was used as a comparator.

To assess the performance of the subject device DeepRESP for use in patients aged 18 years and older, an evaluation of the performance of the primary endpoints was validated in the subgroup aged between 18 and 21 years old compared to the other sub-groups ages. The performance of classifying sleep recordings was validated for AHI ≥ 5, AHI ≥ 15, and CAHI ≥ 5. The PPA, NPA, and OPA for these classifications were evaluated for this age group as well as age groups of older patients. Further analysis was done by plotting histograms of the AHI and CAHI values of the patients in each age group, and plotting histograms of the AHI and CAHI values of the misclassified sleep recordings in each age group. This analysis demonstrated that misclassifications occurred most frequently for AHI and CAHI values close to the decision boundary. This behavior was consistent across all age groups. Therefore, it was concluded that the patient's age did not impact the performance of the subject device.

For validating scoring performance for Type I/II PSG recordings, a total of 4,030 PSG recordings were used. For validating scoring performance for Type III recordings, a total of 5,771 sleep recordings were used, including 4,037 Type I recordings and 1,734 Type II recordings. The Type I and II recordings were processed as Type III recordings by utilizing only the subset of signals from them that are common to Type III recordings.

The recording collection used for validation of Type I/II scoring consisted of 44% Females, had individuals in all age groups (18-21, 22-35, 36-45, 46-55, 56-65, >65), and all BMI groups (<25, 25-30, <30). The recording collection used for validation of Type III scoring consisted of 35% females, had individuals in all age groups (18-21, 22-35, 36-45, 46-55, 56-65, >65), and all BMI groups (<25, 25-30, <30). Type I and II sleep recordings were collected as part of standard clinical care for patients suspected of suffering from sleep disorders. The patients came from urban, suburban, and rural areas with a high level of race/ethnicity diversity (Caucasian or White, Black or African American, Other). The patient population was therefore considered representative of patients seeking medical services for sleep disorders in the United States. Medical professionals should assess whether DeepRESP's outputs are reliable for rare disease presentations, as such cases may be underrepresented in their training and validation data.

CONCLUSION

Based on the verification and validation testing performed in accordance with IEC 62304:2006/A1:2015, it can be concluded that DeepRESP (K252330) does not raise new issues of safety or effectiveness compared to the primary predicate device. The subject device DeepRESP has been demonstrated to be substantially equivalent to the predicate devices.

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).