ANNE Sleep is a wearable sensor system intended for use in the collection, and storage of physiological parameters to aid in the evaluation of sleep-related breathing disorders of adult patients suspected of sleep apnea. The device is intended for use in the clinical and home setting under the direction and interpretation by a Healthcare Professional (HCP).

Device Description

ANNE Sleep is a wireless physiological recorder for use as an aid in the diagnosis of sleep-related breathing disorders by healthcare professionals. The system features two skin-mounted, biointegrated sensors that pair with an associated proprietary software application for the transmission and storage of data. The sensors, which are placed on the chest and finger, measure peripheral arterial tonometry (PAT), oximetry (SpQ2), pulse rate, snoring, chest movement, body position, total sleep time, and heart rate. These data are uploaded to a cloud backend that can communicate with a compatible third-party software viewer, where they are reviewed by a qualified healthcare professional to identify sleep-disordered breathing events according to a scoring manual. The number of sleep-disordered breathing events per hour of sleep is the Sibel-AHI, a parameter that functions as an aid to diagnosis of sleep apnea by physicians. A sleep report is generated from this score and uploaded to a web portal, the ANNE Sleep Hub, where it can be stored and further reviewed.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the ANNE Sleep device, based on the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance (ANNE Sleep)
SpO2 Accuracy	Average root mean square error (A(rms)) ≤ 3% (range 70-100%)
	2.31% (meeting the requirements of ISO 80601-2-61)
Aid to Diagnosis of Moderate to Severe OSA (AHI≥15)	Sensitivity ≥ 90%
	90%
	Specificity ≥ 98%
	98%
Skin Tolerance (Chest Sensor)	No evidence of increased breakdown or skin dryness; small average increase in temporary redness in 32% of subjects.
Electrical Safety & EMC	Compliant with ANSI/AAMI ES60601-1:2005/(R)2012 and IEC 60601-1-2:2014, IEC 60601-1-11:2015.
Biocompatibility	Compliant with ISO 10993-1:2018, ISO 10993-5:2009, and ISO 10993-10:2010.
Wireless Coexistence	Compliant with ANSI IEEE C63.27-2017.
Software Verification & Validation	Compliant with IEC 62304:2015 and FDA guidance.
Shelf Life	Demonstrated safe and effective performance over intended device life cycle.
Mechanical Durability	Bench tested.
Usability	Compliant with FDA guidance.
Heart Rate, Body Position, PAT, Pulse Rate, Perfusion Index, Snore, Total Sleep Time, Chest Movement	Performance tested.
Precision and Repeatability	Performance tested over multiple nights of sleep.
Cybersecurity	Evaluated according to FDA draft guidance.
Software of Unknown Provenance	Assessed per FDA guidance.

Study Details

Sample Size used for the test set and the data provenance:
- SpO2 Accuracy Study: n=12 healthy subjects.
- Comparison to PSG Study: n=225 subjects.
- Data Provenance: The SpO2 accuracy study was conducted using healthy subjects. The Comparison to PSG study was a single-arm, open-label, multi-center clinical study conducted in the United States. The study subjects were adults (22 years or older) suspected of having OSA. The demographic breakdown was 44% male, 56% female, and ethnicity was 73% white, 12% Black or African American, 9% Asian, 0.4% American Indian or Alaska Native, and 4% multi-racial. This indicates a prospective clinical study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not explicitly state the number of experts used for establishing ground truth for either the SpO2 accuracy study or the PSG comparison study.
- For the SpO2 accuracy, the ground truth was "blood gas analysis", which typically refers to laboratory measurements and not expert interpretation.
- For the PSG comparison, the ground truth was "gold standard, polysomnography (PSG)". While PSG studies are typically scored by trained sleep technologists and interpreted by physicians, the document does not specify the number or qualifications of these individuals involved in establishing the ground truth for this specific test set. The device itself states that its Sibel-AHI is "based on manual scoring of data by HCP," implying that qualified healthcare professionals are involved in interpreting the data for diagnosis.
Adjudication method for the test set:
- The document does not specify an explicit adjudication method (e.g., 2+1, 3+1) for either study. For the PSG ground truth, standard PSG scoring guidelines are typically used, which implicitly involves a form of expert consensus, but a formal adjudication process beyond scoring rules is not mentioned.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not done or reported. The study compared the ANNE Sleep system's performance as a diagnostic aid (implying human interpretation of the results to aid in diagnosis) against the PSG gold standard. The device generates a "Sibel-AHI (based on manual scoring of data by HCP)," suggesting that human interpretation is an integral part of its intended use but not in an AI-assistance vs. no AI-assistance comparative evaluation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The device's Indications for Use state that it is "intended for use in the clinical and home setting under the direction and interpretation by a Healthcare Professional (HCP)." Furthermore, the "Sibel-AHI" is described as "based on manual scoring of data by HCP." This indicates that the device is not intended for standalone (algorithm-only) performance but rather as an aid requiring human interpretation. The reported sensitivity and specificity relate to the system as a "diagnostic aid," which aligns with the human-in-the-loop model defined in the indications.
The type of ground truth used:
- For SpO2 accuracy: Blood gas analysis.
- For OSA diagnosis accuracy: Polysomnography (PSG), considered the gold standard.
The sample size for the training set:
- The document does not provide information regarding the sample size used for a training set if machine learning or AI models were used in the device's classification or analysis algorithms. The description focuses on clinical validation, not algorithm development.
How the ground truth for the training set was established:
- Since information on a specific training set or machine learning model development is not provided, the method for establishing ground truth for a training set is not available in this document.

Summary

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July 11, 2022

Sibel Inc. Peter Xu Chief Operating Officer 6650 W. Touhy Ave. Niles, Illinois 60714

Re: K220095

Trade/Device Name: ANNE Sleep Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: Class II Product Code: MNR Dated: June 7, 2022 Received: June 8, 2022

Dear Peter Xu:

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

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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 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 (OS) 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,

Rachana Visaria, Ph.D. Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, 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) K220095

Device Name ANNE Sleep

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)

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510(K) Summary

-Submitter:

Sibel Inc. 6650 W. Touhy Avenue, Niles, IL 60714 Tel: (224) 251-8859

Official Correspondent: Sarah Coughlin, Regulatory Affairs and Quality Assurance Engineer 6650 W. Touhy Avenue, Niles, IL 60714 Tel: (224) 251-8859

Date Prepared: 7/10/2022

II. Device Information

Name of Device: ANNE Sleep 510(k) Number: K220095 Classification Name: Breathing Frequency Monitor Regulation: 21 CFR §868.2375 Regulatory Class: Class II Product Classification Code: MNR

lll. Predicate Device

Trade Name: WatchPAT One 510(k): K183559 Device Manufacturer: Itamar Medical, Ltd.

IV. Reference Device

Trade Name: ANNE One 510(k): K211305 Device Manufacturer: Sibel Inc.

V. Device Description

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qualified healthcare professional to identify sleep-disordered breathing events according to a scoring manual. The number of sleep-disordered breathing events per hour of sleep is the Sibel-AHI, a parameter that functions as an aid to diagnosis of sleep apnea by physicians. A sleep report is generated from this score and uploaded to a web portal, the ANNE Sleep Hub, where it can be stored and further reviewed.

VI. Indications for Use

ANNE Sleep is a wearable sensor system intended for use in the collection, analysis, display, and storage of physiological parameters to aid in the evaluation of sleep-related breathing disorders of adult patients suspected of sleep apnea. The device is intended for use in the clinical and home setting under the direction and interpretation by a Healthcare Professional (HCP).

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	Subject deviceANNE Sleep	Primary predicate deviceItamar Medical, Ltd.	Reference deviceSibel Inc.	Variances / Equivalence
Trade Name	ANNE Sleep	WatchPat One	ANNE One
510(k) Number	K220095	K183559	K211305	N/A
Class	II	II	II	Equivalent
Product Code	MNR	MNR	DRG, MWI, FLL	EquivalentANNE Sleep's product code isequivalent to WatchPat One.
RegulationNumber andRegulation Name	868.2375Breathing Frequency Monitor	868.2375Breathing Frequency Monitor	870.2910Transmitters and Receivers,Physiological Signal,Radiofrequency	EquivalentANNE Sleep's regulation numberand name is equivalent toWatchPat One.
Indications forUse	ANNE Sleep is a wearablesensor system intended for usein the collection, analysis,display, and storage ofphysiological parameters to aid inthe evaluation of sleep-relatedbreathing disorders of adultpatients suspected of sleepapnea. The device is intended foruse in the clinical and homesetting under the direction andinterpretation by a HealthcareProfessional (HCP).	The WatchPAT One (WP1)device is a non-invasive homecare device for use with patientssuspected to have sleep relatedbreathing disorders. The WP1 isa diagnostic aid for the detectionof sleep related breathingdisorders, sleep staging (RapidEye Movement (REM) Sleep,Light Sleep, Deep Sleep, andWake), snoring level, and bodyposition. The WP1 generates aperipheral arterial tonometry(

Target Population	22 years of age and older	PAHIc is indicated for use inpatients 17 years and older. Allother parameters are indicatedfor 12 years and older.	Adults, 18 years of age and older	Substantially EquivalentThe ANNE Sleep targetpopulation is more restrictivethan WatchPAT One.
Use Environment	Recording in the homeenvironment with the report andinterpretation performed in theclinical setting.	Recording in the homeenvironment with the report andinterpretation performed in theclinical setting.	Hospital Setting	EquivalentThe intended use environmentfor ANNE Sleep is equivalent toWatchPAT One.
SensorPlacement	Finger and Chest	Finger, Chest, and Wrist	Finger and Chest	Substantially EquivalentANNE Sleep does not have asensor located on the wrist
Components	Limb SensorChest SensorAccelerometerECG ModulePPG ModuleANNE Sleep ApplicationSoftware	uPAT Finger ProbeActigraphControllerMicrophoneAccelerometerZzzPAT SoftwareChest Sensor	Limb SensorChest SensorAccelerometerECG ModuleANNE View Application Software	Substantially EquivalentANNE Sleep does not include amicrophone or controller.Performance testingdemonstrates that this differencedoes not influence overall safetyand effectiveness.
		from an external integratedsnoring and body positionsensor. The WP1's PSTAGESand snoring level and bodyposition provide supplementalinformation to itsPRDI/PAHI/PAHIc. The WP1'sPSTAGES and snoring level andbody position are not intended tobe used as the sole or primarybasis for diagnosing any sleeprelated breathing disorder,prescribing treatment, ordetermining whether additionaldiagnostic assessment iswarranted. PAHIc is indicated foruse in patients 17 years andolder. All other parameters areindicated for 12 years and older.	heart rate on ambulatorypatients.

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	ANNE Hub Software
Channels	PATPulse RateOximetrySnoringBody PositionChest MovementHeart Rate	PATPulse RateOximetryActigraphySnoringBody PositionChest Movement	Heart RateRespiratory RateBody PositionTemperature	Substantially EquivalentANNE Sleep collects the samechannels as WatchPAT One, aswell as heart rate, which issupported by the referencedevice
Analysis Outputs	Sibel-AHI (based on manualscoring of data by HCP)Body Position Discrete StatesHeart RateTotal Sleep TimeSpO2	pRDIpAHIpAHIcSleep StagesSnoring LevelBody Position Discrete States	Heart RateRespiratory RateStep CountFall CountTemperature	Substantially EquivalentSibel-AHI is a device specificapproximation of AHI that ismanually scored by an HCP andis similar to the pAHI value that isautomatically calculated byWatchPAT. ANNE Sleep is notintended for sleep staging or thediscrimination between centraland obstructive sleep apneicevents. Snoring level and pRDIare supplemental parametersthat are not directly utilized in thediagnosis of sleep disorderedbreathing. Performance testing ofSpO2 and heart ratemeasurements with ANNE Sleepdemonstrate that output of theseparameters do not influence theoverall safety and effectivenessof the device.
Performance	Pulse Rate: 30-300 bpm ± 3 bpmHeart Rate: 30-300 bpm ± thegreater of ± 10% or ± 5 bpmSpO2: ARMS ≤ 3% (range 70-100%)	Pulse Rate: 30-150 bpm ± 1 bpmSpO2: ARMS ≤ 3% (range 70-100%)	Heart Rate: 30-270 bpm ± thegreater of ± 10% or ± 5 bpmTemperature: 73.4°F - 109.4°F ±0.54°F	Substantially Equivalent
	Aid to Diagnosis of Moderate toSevere OSA (AHI≥15): Sensitivity90%, Specificity 98%
Data Collectionand Transfer	Patient data is wirelesslytransferred via Bluetooth from thesensors to a mobile phone. Datais then wirelessly transferredfrom the phone to the cloud whenconnected to the internet.	Patient data is wirelesslytransferred via Bluetooth from thesensors to a mobile phone. Datais then wirelessly transferredfrom the phone to the cloud whenconnected to the internet.	Data transmitted wirelessly viaBluetooth from sensors to mobiledevice	EquivalentData collection and transfer withANNE Sleep is equivalent toWatchPAT One.
RecordingCapacity	36 hours of continuous use	Approx. 10 hours	36 hours of continuous use	EquivalentANNE Sleep is equivalent inrecording capacity to ANNE One.Differences between WatchPATOne and ANNE Sleep do notinfluence safety or effectivenessas both can operate over a fullnight of sleep.
Energy Source	Rechargeable Lithium PolymerBattery	One OTS 1.5V Alkaline AAABattery	Rechargeable Lithium PolymerBattery	Equivalent
Analysis Software	Analysis performed off therecording device, on acompatible cloud-based softwareplatform.	Analysis performed off therecording device, on the PC orcloud-based by the zzzPATsoftware.	None	Substantially Equivalent

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VII. Clinical Studies

SpO2 Accuracy: Sibel validated the accuracy of SpO2 measurements compared to blood gas analysis in n=12 healthy subjects over the range of 70-100% oxygen saturation according to Section 201.12.1 of ISO 80601-2-61 and Pulse Oximeters - Premarket Notification Submissions [510(k)s]: Guidance for Industry and Food and Drug Administration Staff, Issued March 2013. Enrolled subjects had skin tones varving from Fitzpatrick 2-5, with two subjects having darker skin pigmentation (Fitzpatrick 5). The average root mean square error (Asws) was 2.31%, meeting the requirements of the above-mentioned standard.

Comparison to PSG: The performance of the ANNE Sleep system as a diagnostic aid for moderate to severe obstructive sleep apnea (OSA) in adults was evaluated compared to the gold standard, polysomnography (PSG), in a single-arm, open-label, multi-center clinical study with n=225 subjects that was conducted in the United States. Subjects were representative of the intended target population, individuals 22 years of age or older who are suspected of having OSA. Subjects were 44% male and 56% female. Subjects were 73% white, 12% Black or African American. 9% Asian. 0.4% American Indian or Alaska Native, and 4% multi-racial. The results of the study indicate that ANNE Sleep is sufficiently accurate as an aid to the diagnosis of moderate to severe OSA, with a sensitivity and specificity of 90% and 98%, respectively. Additionally, skin tolerance was assessed following removal of the chest sensor for n=184 patients. No evidence of increased breakdown or skin dryness was reported, and only a small average increase in temporary redness was observed in 32% of subjects. No adverse events were reported during the study.

VIII. Performance Data

The following consensus standards and bench testing were used to evaluate the safety and effectiveness of ANNE Sleep:

Electrical safety and electromagnetic compatibility testing according to ANSI/AAMI ● ES60601-1:2005/(R)2012 and IEC 60601-1-2:2014 standards. Electrical safety testing in the home healthcare environment per IEC 60601-1-11:2015.
Safety and Performance testing of pulse oximeter per ISO 80601-2-61:2017. ●
. Biocompatibility testing according to ISO 10993-1:2018, ISO 10993-5:2009, and ISO 10993-10:2010 for new patient contacting materials.
Wireless coexistence testing according to ANSI IEEE C63.27-2017.
Software verification and validation testing according to IEC 62304:2015 and the FDA guidance document, Content of Premarket Submissions for Software Contained in Medical Devices.
Shelf life testing of the adhesive to demonstrate safe and effective performance over the intended device life cycle.
Bench testing to demonstrate the mechanical durability of the sensors.
Usability testing in accordance with the FDA guidance document, Applying Human Factors and Usability Engineering to Medical Devices
Performance testing of heart rate, body position, PAT, pulse rate, perfusion index, snore, . total sleep time, and chest movement parameters.
. Performance testing to demonstrate the precision and repeatability of the system over multiple nights of sleep.

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Cybersecurity evaluation according to the requirements of the FDA draft guidance . document, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
Assessment of Software of Unknown Provenance per the FDA quidance document. Off-● The-Shelf Software Use in Medical Devices

IX. Summarv

ANNE Sleep is substantially equivalent to its predicate, the WatchPAT One, in regards to both intended use and technology characteristics. Both devices function as aids to the diagnosis of sleep-related breathing disorders. The WatchPAT One is composed of skin-mounted sensors located on the finger, wrist, and chest. The WatchPAT chest sensor measures snoring, body position, and chest movements. The ANNE Chest Sensor collects similar data as the WatchPAT chest sensor, with the addition of ECG-derived heart rate. Both the ANNE Limb Sensor and WatchPAT finger sensor collect a PPG signal for PAT and SpO2 measurements. Performance of both devices were validated in clinical studies against PSG and in testing according to the same recognized consensus standards.

X. Conclusion

The results of the substantial equivalence assessment, taken together with the clinical and performance testing data, demonstrate that ANNE Sleep's performance characteristics are substantially equivalent to the predicate devices in both technology and intended use.

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).