Aurora is a Software as a Medical Device (SaMD) that establishes sleep quality. Aurora automatically analyzes, displays, and summarizes Photoplethysmogram (PPG) data collected during sleep using compatible devices. Aurora is intended for use by and by order of a healthcare professional to aid in the diagnosis of sleep disorders including sleep apnea in adults.

The Aurora output, including automatically detected respiratory events and parameters, may be displayed and edited by a qualified healthcare professional. The Aurora output is not intended to be interpreted or clinical action taken without consultation of a qualified healthcare professional.

Aurora is not intended for use with polysomnography devices.

Device Description

Aurora is a Class II Software as a Medical Device (SaMD), intended to aid in the evaluation of sleep disorders, where it may inform or drive clinical management. Aurora is a software application that is indicated for use on a general-purpose computing platform. It is a cloud-based software-as-a-medicaldevice (SaMD) with a user interface that runs in a web browser.

Aurora automatically analyzes and displays photoplethsmography (PPG) signal data including SPO2 and pulse/heart rate only from compatible FDA-cleared medical purpose pulse oximeters that meet Aurora's data acquisition requirements for sampling rate, digital resolution, measurement range, and accuracy range.

Following upload of a compatible PPG study to the cloud software, the algorithm functions by verifying minimum signal quality, study length, and technical adequacy requirements, preprocessing the data including normalization, digital filtration, and artifact detection/rejection procedures, applying machine learning algorithms including multiple deep neural network machine learning models, statistical signal processing analyses including time-domain and time-frequency domain analyses over multiple time and resolution scales, and other analyses output a detected set of events and derived signals for the PPG study that are post-processed and logically filtered according to algorithm rules based on the American Academy of Sleep Medicine (AASM) recommended scoring event, desaturation, and association rules. Aurora algorithm outputs, including scored respiratory events, sleep stages, Aurora Apnea-Hypopnea Index (eAHI), Total Sleep Time (TST), Sleep Efficiency (SE), Sleep Latency (SL), Wake After Sleep Onset (WASO), and Oxygen Desaturation Events Index (ODI) measures, are stored and made available for display, editing, and review in Aurora by qualified healthcare professionals.

Aurora reports results of the automated data analysis based on AASM guidelines, including the Aurora output Apnea-Hypopnea Index (eAHI) and total sleep time (TST). The algorithm outputs are graphical and numerical displays and reports of sleep latency, sleep quality, and sleep pathologies including sleep disordered breathing. The Aurora displays and reports are for the order of physicians, trained technicians, or other healthcare professionals to evaluate sleep disorders where it may inform or drive clinical management taking into consideration other factors that normally are considered for clinical management of sleep disorders for adults.

The clinician can view raw data for interpretation, edit events, write clinical notes, and customize sleep reports for the patient.

Aurora output is not intended to be interpreted or clinical action taken without consultation of a qualified healthcare professional.

AI/ML Overview

The document provides detailed information about the performance evaluation of the Aurora device, a Software as a Medical Device (SaMD) intended to aid in the diagnosis of sleep disorders.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for Aurora are implied by the performance metrics reported, demonstrating its accuracy in detecting Apnea Hypopnea Index (eAHI) and performing sleep staging against polyomnography (PSG) ground truth. While explicit numerical "acceptance criteria" tables are not provided, the reported sensitivity, specificity, and regression/Bland-Altman statistics serve as the evidence of meeting performance expectations for substantial equivalence.

Table of Performance Data (Implied Acceptance Criteria)

Metric	Acceptance Criteria (Implied)	Reported Device Performance (Aurora)
Apnea Hypopnea Index (eAHI) - 3% Desaturation	High Sensitivity and Specificity at AHI >= 5 cutoff, comparable to predicate.	Sensitivity: 92.6% (87.2%, 97.2%) Specificity: 71.6% (59.2%, 83.7%)
Apnea Hypopnea Index (eAHI) - 4% Desaturation	High Sensitivity and Specificity at AHI >= 5 cutoff, comparable to predicate.	Sensitivity: 89.4% (81.6%, 96.1%) Specificity: 76.8% (67.1%, 85.4%)
Sleep Staging - Wake	High Sensitivity and Specificity for Wake epoch detection.	Sensitivity: 86.7% (86.5%, 87.0%) Specificity: 93.5% (93.4%, 93.7%)
Sleep Staging - Light NREM	High Sensitivity and Specificity for Light NREM epoch detection.	Sensitivity: 80.9% (80.6%, 81.2%) Specificity: 85.5% (85.2%, 85.7%)
Sleep Staging - Deep NREM	Reasonably high Sensitivity and Specificity for Deep NREM epoch detection, balancing known challenges in this stage.	Sensitivity: 63.4% (62.4%, 64.3%) Specificity: 95.9% (95.7%, 96.0%)
Sleep Staging - REM	High Sensitivity and Specificity for REM epoch detection.	Sensitivity: 83.6% (83.0%, 84.2%) Specificity: 97.5% (97.4%, 97.5%)
Sleep Profile & Oxygen Saturation Accuracy (eAHI 3%)	Deming Regression slope near 1, intercept near 0; Bland-Altman Mean Difference near 0, narrow limits.	Deming Regression: Slope: 0.936 (0.853, 1.033), Intercept: 0.023 (-1.185, 1.122) Bland-Altman: Mean Difference: 1.000 (0.630, 1.367), ULOA: 14.575 (13.779, 15.363), LLOA: -12.574 (-13.371, -11.786)
Sleep Profile & Oxygen Saturation Accuracy (eAHI 4%)	Deming Regression slope near 1, intercept near 0; Bland-Altman Mean Difference near 0, narrow limits.	Deming Regression: Slope: 0.982 (0.903, 1.130), Intercept: 1.219 (0.116, 1.985) Bland-Altman: Mean Difference: -1.039 (-1.326, -0.749), ULOA: 9.307 (8.692, 9.931), LLOA: -11.386 (-12.001, -10.763)
Sleep Profile & Oxygen Saturation Accuracy (TST)	Deming Regression slope near 1, intercept near 0; Bland-Altman Mean Difference near 0, narrow limits.	Deming Regression: Slope: 1.159 (1.035, 1.318), Intercept: -0.695 (-1.576, -0.005) Bland-Altman: Mean Difference: -0.093 (-0.132, -0.059), ULOA: 1.145 (1.060, 1.216), LLOA: -1.330 (-1.414, -1.259)
Sleep Profile & Oxygen Saturation Accuracy (SE)	Deming Regression slope near 1, intercept near 0; Bland-Altman Mean Difference near 0, narrow limits.	Deming Regression: Slope: 1.154 (1.031, 1.317), Intercept: -0.088 (-0.205, 0.003) Bland-Altman: Mean Difference: -0.011 (-0.017, -0.007), ULOA: 0.163 (0.151, 0.173), LLOA: -0.185 (-0.198, -0.176)
Sleep Profile & Oxygen Saturation Accuracy (SL)	Deming Regression slope near 1, intercept near 0; Bland-Altman Mean Difference near 0, narrow limits.	Deming Regression: Slope: 1.114 (0.997, 1.290), Intercept: -0.023 (-0.185, 0.090) Bland-Altman: Mean Difference: -0.129 (-0.154, -0.089), ULOA: 0.884 (0.831, 0.970), LLOA: -1.143 (-1.196, -1.057)
Sleep Profile & Oxygen Saturation Accuracy (WASO)	Deming Regression slope near 1, intercept near 0; Bland-Altman Mean Difference near 0, narrow limits.	Deming Regression: Slope: 1.073 (0.938, 1.219), Intercept: -0.271 (-0.436, -0.121) Bland-Altman: Mean Difference: 0.167 (0.140, 0.196), ULOA: 1.131 (1.073, 1.193), LLOA: -0.797 (-0.855, -0.735)
Sleep Profile & Oxygen Saturation Accuracy (ODI)	Deming Regression slope near 1, intercept near 0; Bland-Altman Mean Difference near 0, narrow limits.	Deming Regression: Slope: 0.962 (0.896, 1.056), Intercept: 1.667 (0.330, 2.847) Bland-Altman: Mean Difference: -1.046 (-1.417, -0.677), ULOA: 13.223 (12.426, 14.015), LLOA: -15.315 (-16.111, -14.522)

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

Test Set Sample Size:
- For eAHI performance (sensitivity/specificity): 158 adult patients.
- For Sleep Staging:
  - Wake: 52,622 epochs
  - Light NREM: 69,438 epochs
  - Deep NREM: 10,195 epochs
  - REM: 14,459 epochs
Data Provenance: The document does not explicitly state the country of origin but implies clinical settings where PSG (Polysomnography) and HSAT (Home Sleep Apnea Test) recordings are collected. The study involved simultaneous PSG and HSAT recordings, suggesting a prospective collection of data for testing purposes to facilitate direct comparison.

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: Three registered polysomnographic technologists were used for manual scoring, and one board-certified sleep physician reviewed each PSG.
Qualifications of Experts:
- Scorers: Registered polysomnographic technologists.
- Reviewer/Confirmer: Board-certified sleep physician.

4. Adjudication Method for the Test Set

Adjudication Method: A 2+1 consensus method. For an event to be officially scored or reported, a consensus of at least two-thirds among the three scorers was required. Additionally, each PSG was reviewed by a board-certified sleep physician to provide clinical confirmation of scoring and technical adequacy, serving as a final adjudication layer.

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

The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done to assess how much human readers improve with AI vs. without AI assistance. The study focuses on the standalone performance of the Aurora algorithm against expert-scored ground truth. The device output may be displayed and edited by a qualified healthcare professional, suggesting a human-in-the-loop workflow, but the study described does not quantify the effect of AI assistance on human reader performance.

6. Standalone Performance Study

Yes, a standalone performance study was done. The reported sensitivity, specificity, Deming regression, and Bland-Altman analyses directly evaluate the algorithm's performance (Aurora) against the expert-scored PSG as ground truth, without a human in the loop for the performance metrics themselves.

7. Type of Ground Truth Used

The type of ground truth used was expert consensus from manual scoring of Polysomnography (PSG) data. Specifically, PSG recordings were manually scored by three registered polysomnographic technologists using guidelines following the 3% desaturation guidance. This was further reviewed and confirmed by a board-certified sleep physician.

8. Sample Size for the Training Set

The document does not specify the sample size for the training set. The provided details pertain exclusively to the test set used for performance validation.

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

The document does not specify how the ground truth for the training set was established. Information regarding the training data, its collection, or annotation methods is not included in this summary.

Summary

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February 8, 2024

EnsoData Sigrid Schoepel Vice President Regulatory Affairs 10 E Doty St., Suite 449 Madison, Wisconsin 53703

Re: K231355

Trade/Device Name: Aurora Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: Class II Product Code: MNR Dated: January 10, 2024 Received: January 11, 2024

Dear Sigrid Schoepel:

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"

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(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 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-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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.

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-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,

Rachana Visaria -S

Rachana Visaria, Ph.D. Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia,

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Respiratory, ENT and Dental 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) K231355

Device Name Aurora

Indications for Use (Describe)

Aurora is not intended for use with polysomnography devices.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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K231355 Aurora Traditional 510(k) Summary Prepared in accordance with the content and format outlined in 21 CFR 807.92

I. SUBMITTER

Name:	EnsoData, Inc.
Address:	10 E. Doty Street, Suite 449Madison, WI 53703 USA
Phone:	(608)509-4704
Contact Person:	Sigrid Schoepel
Email:	sigrid@ensodata.com
Date:	January 11, 2024

SUBJECT DEVICE INFORMATION II.

Trade Name:	Aurora
Common Name:	Automatic Event Detection Software for Sleep Device Signals
Classification Name:	21 CFR 868.2375 Breathing Frequency Monitor
Regulatory Class:	II
Product Code:	MNR

Intended Use:

Aurora is not intended for use with polysomnography devices.

III. PREDICATE DEVICE

Trade Name:	SleepImage System
Common Name:	Automatic Event Detection Software for Sleep Device Signals
Classification Name:	21 CFR 868.2375 Breathing Frequency Monitor
Regulatory Class:	II
Product Code:	MNR

ensodata.com connect@ensodata.com

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510(k): K182618

IV. SUBJECT DEVICE DESCRIPTION

The clinician can view raw data for interpretation, edit events, write clinical notes, and customize sleep reports for the patient.

Aurora output is not intended to be interpreted or clinical action taken without consultation of a qualified healthcare professional.

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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE V. PREDICATE DEVICE

The table below compares the predicate device, "SleepImage System" with the subject device Aurora.

Element	Predicate DeviceMyCardio, LLC dba SleepImageK182618SleepImage System	Subject DeviceEnsoData, Inc.K231355Aurora	Equivalency
Indications for use	The SleepImage System is Software as aMedical Device (SaMD) that establishes sleepquality. The SleepImage System analyzes,displays and summarizes Electrocardiogram(ECG) or Plethysmogram (PLETH) data,typically collected during sleep, that is intendedfor use by or on the order of a HealthcareProfessional to aid in the evaluation of sleepdisorders, where it may inform or drive clinicalmanagement for children, adolescents andadults.The SleepImage Apnea Hypopnea Index(sAHI), presented when oximeter data isavailable, is intended to aid healthcareprofessionals in diagnosis and management ofsleep disordered breathing.The SleepImage System output is not intendedto be interpreted or clinical action taken withoutconsultation of a qualified healthcareprofessional.	Aurora is a Software as a Medical Device(SaMD) that establishes sleep quality. Auroraautomatically analyzes, displays, and summarizesPhotoplethysmogram (PPG) data collected duringsleep. Aurora is intended for use by and by orderof a healthcare professional to aid in the diagnosisof sleep disorders including sleep apnea in adults.The Aurora output, including automaticallydetected respiratory events and parameters, maybe displayed and edited by a qualified healthcareprofessional. The Aurora output is not intended tobe interpreted or clinical action taken withoutconsultation of a qualified healthcareprofessional.Aurora is not intended for use withpolysomnography devices.	Similar
Intended Use	The SleepImage System is Software as aMedical Device (SaMD) that establishes sleepquality, intended for use by or on the order of aHealthcare Professional to aid in the evaluationof sleep disorders based on Electrocardiogram(ECG) or Plethysmogram (PLETH) recordings,typically collected during sleep.	Aurora is intended for use by and by order of ahealthcare professional to aid in the diagnosis andevaluation of sleep disorders including sleepapnea, where it may inform or drive clinicalmanagement for adults.	Similar
Patient Population	Children, Adolescents and Adults	Adults	SimilarAurora operates ona subset of thepopulation ofSleepImage
Environment of Use	N/A (Software)(Clinicians use the device within their clinic toview and edit the automatically scored sleeptests)	N/A (Software)(Clinicians use the device within their clinic toview and edit the automatically scored sleep tests)	Same
Method of Access	General-purpose computing platform withinternet connection	General-purpose computing platform withinternet connection	Same
Element	Predicate Device	Subject Device	Equivalency
	MyCardio, LLC dba SleepImageK182618SleepImage System	EnsoData, Inc.K231355Aurora
Principle ofOperation	Cloud-based web application Software as aMedical Device (SaMD)	Cloud-based web application Software as aMedical Device (SaMD)	Same
Input Source	HSAT and PSG devices	EDF signal files from compatible FDA-clearedmedical purpose pulse oximeters PPG devices	SimilarAurora uses asubset of the inputsources
Signals Analyzed	ECG or PPG; with oximetry	PPG and oximetry	Similar
	Without referencing a particular, or a list ofparticular, ECG [or PPG] signal sources orrecording devices.	Aurora analyzes PPG and oximetry data for thepurposes of sleep analysis and sleep disorderdetection with compatible FDA-cleared medicalpurpose PPG and oximetry signal sources andrecording devices.	Aurora uses asubset of thepredicate signals
		PPG and oximetry are recorded by a third-partyPPG device, converted into EDF (European DataFormat), and the EDF files are analyzed by theAurora system.
Interoperable DataFormat	EDF; ASCII	EDF	Similar
Output Parameters	Sleep duration (total sleep time), sleep latency,sleep efficiency, wake after sleep onset, sleepstages, sleep quality, fragmentation &periodicity, oxygen desaturation	Sleep duration (total sleep time), sleep latency,wake after sleep onset, sleep stages, sleepefficiency, duration and percentage of sleep andwake, oxygen saturation and desaturation	Similar
Analysis of Sleep-DisorderedBreathing Events	The SleepImage Apnea Hypopnea Index(sAHI), presented when oximeter data isavailable, is intended to aid healthcareprofessionals in diagnosis and management ofsleep disordered breathing.	Automatic detection of sleep-disordered breathingevents, for calculation of eAHI when both PPGand oximetry data are present, is intended to aidhealthcare professionals in diagnosis andmanagement of sleep disordered breathing.	Similar
DiagnosticParameters	SQI, SAI, RDI, ODI, AHI (AHI, oAHI, cAHI),WASO, TST	Apnea-Hypopnea Index (eAHI), Total Sleep Time(TST), Sleep Efficiency (SE), Sleep Latency (SL),Wake After Sleep Onset (WASO), and OxygenDesaturation Events Index (ODI)	SimilarAurora offers asubset of thepredicatediagnosticparameters
Display of AnalysisResults	Graphical and numerical presentations andreports	Graphical and numerical presentations and reports	Same
Edits andCorrections toAutomatic Analysis	The clinician can view raw data forinterpretation, adjust events, write clinical notes,and customize sleep reports for the patient.Clinicians may review and utilize the results to	The clinician can view raw data for interpretation,adjust events, write clinical notes, and customizesleep reports for the patient.	Same
Element	Predicate DeviceMyCardio, LLC dba SleepImageK182618SleepImage System	Subject DeviceEnsoData, Inc.K231355Aurora	Equivalency
	make recommendations for further testing,referral, and/or therapy.	Clinicians may review and utilize the results tomake recommendations for further testing,referral, and/or therapy.
Intended Users	Used by or on the order of physicians, trainedtechnicians, or other healthcare professionals toevaluate sleep disorders where it may inform ordrive clinical management taking intoconsideration other factors that normally areconsidered for clinical management of sleepdisorders.	Used by or on the order of physicians, trainedtechnicians, or other healthcare professionals toevaluate sleep disorders where it may inform ordrive clinical management taking intoconsideration other factors that normally areconsidered for clinical management of sleepdisorders.	Same
Cybersecurity	Use of secure authentication protocolsData is transferred between user's general-purpose computing platform and cloud- basedserver, utilizing secure authentication protocolsover the Internet	Authentication controls, authorization controls,cryptographic controls, access controls, checksumcontrols, software distribution controls, intrusiondetection system controls, network and systemscontrols, and database controls.	Same

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VI. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination. Since this is a software-only medical device that does not control other devices the performance data do not include biocompatibility, electrical safety, electromagnetic compatibility, mechanical, acoustic, or animal testing.

The device was designed and tested under the following standards and guidelines:

. EN ISO 13485 Third Edition 2016/A11 Medical devices - Quality management systems -Requirements for regulatory purposes
. EN ISO 14971 Third Edition 2019-12 Medical devices - Application of risk management to medical devices
IEC 62304 Edition 1.1 2015-06 Medical device software - Software life cycle processes
Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket ● Submissions - FDA guidance issued September 27, 2023
. Content of Premarket Submissions for Device Software Functions - FDA guidance issued June 14, 2023

The primary metric for assessing performance of Aurora (subject device) is the Aurora Apnea Hypopnea Index (eAHI). The eAHI depends on the number of sleep disordered breathing events detected, normalized by a determination of total sleep time (TST), where the TST is the total amount of sleep time during the recording period.

The performance testing validated Aurora's determination of the eAHI on single channel photoplethysmography (PPG) and oximetry signals for adult patients. Supportive performance testing validated Aurora's determination of Wake, Light non-rapid eye movement (NREM), Deep NREM, and

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REM Sleep, and performance metrics for TST; Sleep Efficiency (SE); Sleep Latency (SL); Wake After Sleep Onset (WASO); and Oxygen Desaturation Events Index (ODI).

Simultaneous polysomnography (PSG) and home sleep apnea test (HSAT) recordings were collected for adult patients (n=158) using Philips Respironics Sleepware G3 (K202142), Natus Sandman Elite (K153353), and Polysmith Sleep System (K161650) for PSG recordings, and Viatom Checkme O2 (K191088) for HSAT recordings. Each of the PSG recordings were manually scored by three registered polysomnographic technologists using guidelines following the 3% desaturation guidance. For an event to be officially scored or reported, a consensus of at least two-thirds among the scorers was required. Each PSG was reviewed by a board-certified sleep physician to provide clinical confirmation of scoring and technical adequacy.

Apnea Hypopnea Index (eAHI vs sAHI)
Device	Desaturation	Sample Size(n)	Sensitivity	Specificity
AuroraSubjectK231355	3%	158	92.6%(87.2%, 97.2%)	71.6%(59.2%, 83.7%)
	4%	158	89.4%(81.6%, 96.1%)	76.8%(67.1%, 85.4%)
SleepImagePredicateK182618	Unspecified	189	98.7%(97.0%, 100%)	84.8%(72.6%, 97.1%)

Performance in terms of sensitivity and specificity was assessed at an AHI cut-off of AHI >= 5.

Sleep Staging
Device	Category	Sample Size(n)	Sensitivity	Specificity
AuroraSubjectK231355	Wake	52,622	86.7%(86.5%, 87.0%)	93.5%(93.4%, 93.7%)
	LightNon-REM	69,438	80.9%(80.6%, 81.2%)	85.5%(85.2%, 85.7%)
	DeepNon-REM	10,195	63.4%(62.4%, 64.3%)	95.9%(95.7%, 96.0%)
	REM	14,459	83.6%(83.0%, 84.2%)	97.5%(97.4%, 97.5%)

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Sleep Profile and Oxygen Saturation
Device		Deming Regression		Bland-Altman
	Category	Slope ẞ1	Intercept ß0	MeanDifference(MD)	Upper Limit(ULOA)	Lower Limit(LLOA)
AuroraSubjectK231355	eAHI (3%)[events/hour]	0.936(0.853, 1.033)	0.023(-1.185, 1.122)	1.000(0.630, 1.367)	14.575(13.779, 15.363)	-12.574(-13.371,-11.786)
	eAHI (4%)[events/hour]	0.982(0.903, 1.130)	1.219(0.116, 1.985)	-1.039(-1.326, -0.749)	9.307(8.692, 9.931)	-11.386(-12.001,-10.763)
	Total Sleep Time[hours]	1.159(1.035, 1.318)	-0.695(-1.576, -0.005)	-0.093(-0.132, -0.059)	1.145(1.060, 1.216)	-1.330(-1.414, -1.259)
	Sleep Efficiency[hours/hours]	1.154(1.031, 1.317)	-0.088(-0.205, 0.003)	-0.011(-0.017, -0.007)	0.163(0.151, 0.173)	-0.185(-0.198, -0.176)
	Sleep Latency[hours]	1.114(0.997, 1.290)	-0.023(-0.185, 0.090)	-0.129(-0.154, -0.089)	0.884(0.831, 0.970)	-1.143(-1.196, -1.057)
	Wake AfterSleep Onset[hours]	1.073(0.938, 1.219)	-0.271(-0.436, -0.121)	0.167(0.140, 0.196)	1.131(1.073, 1.193)	-0.797(-0.855, -0.735)
	OxygenDesaturationIndex [events/hours]	0.962(0.896, 1.056)	1.667(0.330, 2.847)	-1.046(-1.417, -0.677)	13.223(12.426, 14.015)	-15.315(-16.111,-14.522)

CONCLUSION

The subject device met objective performance goals for eAHI, staging, sleep profile, and saturation analysis of the compatible pulse oximeter device in comparison to the manually scored simultaneously collected PSG sleep tests. The subject device agreement with single-channel PPG is considered substantially equivalent to the predicate device and the subject device does not raise new or additional questions of safety and effectiveness.

VII. CONCLUSIONS

The subject device is similar in intended use and functionality to the predicate device. The subject device has the same technological characteristics and features as the predicate device and does not raise new questions of safety or effectiveness as demonstrated through the system design and testing. Software verification and validation, cybersecurity, and performance testing were conducted to confirm the device design met user needs and specifications and was acceptable to qualified users.

The conclusions drawn from the clinical and nonclinical tests demonstrate that the proposed subject device is as safe, as effective, and performs as well as the legally marketed predicate device.

Regulation Number and Section

§ 868.2375 Breathing frequency monitor.

(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).