AcuPebble SA100 is indicated to sense, record, and interpret a patient's physiological signals (including respiratory pattern) during sleep for the purpose of prescreening patients for obstructive sleep apnea (OSA) syndrome. The designed for use in home-screening of adults with suspected possible sleep breathing disorders (although it can also be used in clinic). Results are used to assist the healthcare professional's in the patient's evaluation.

The system is not intended as a substitute for full polysomnography when additional parameters such as sleep stages, limb movements, or EEG activity are required.

Device Description

AcuPebble SA100 comprises a sensor that is worn on the front of the neck around the suprasternal notch area (the "AcuPebble SA100 sensor"), a mobile device app that guides the patient through the steps of the test, collects the data from the sensor, and uploads them in the "AcuPebble SA100 app"), and a cloud-based analysis software (the "AcuPebble SA100 algorithms". The "AcuPebble SA100 Sensor" consists of a small biocompatible enclosure with very low power sensors and electronics inside. It is attached to the front of the neck (somewhere between the Adam's apple and the suprasternal notch area) by single-use biocompatible adhesive tape. The sensor measures physiological body sounds. The data sensed is streamed via a Bluetooth link to the "AcuPebble SA100 app" on a smart device (mobile phone/tablet). The data can be uploaded into the cloud where it is analyzed, any time after the sleep study test is finished at the tap of a button in the app. AcuPebble SA100 signal processing algorithms produce a number of OSA diagnostic traces and parameters. These can be accessed by the Health Care Professional through a healthcare professional portal, which can be accessed from any computer or smart device with an Internet connection.

AcuPebble SA100 is not intended to be used with patients with pacemakers or other implantable devices, or with patients with known or suspected arrhythmias. This device has not been validated in patients with congestive heart failure or patients with neuromuscular disorders. Patients with significant cardiopulmonary or neurological disorders need to be excluded from using the device.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Device Name: AcuPebble SA100
Intended Use: To sense, record, and interpret a patient's physiological signals (including respiratory pattern) during sleep for the purpose of prescreening patients for obstructive sleep apnea (OSA) syndrome. Designed for home-screening of adults with suspected possible sleep breathing disorders to assist healthcare professionals in patient evaluation. Not a substitute for full polysomnography.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined "acceptance criteria" with numerical thresholds for diagnostic accuracy (PPV, NPV, LR+, LR-). Instead, it presents the results of the clinical validation study for several diagnostic indices (AHI3, AHI4, ODI3, ODI4) and heart rate accuracy. The implicit acceptance is that these values demonstrate substantial equivalence to the predicate device.

Implicit Acceptance Criteria (Performance Benchmarks from Predicate/Context): Not explicitly stated with numerical targets in the provided text. The submission focuses on demonstrating substantial equivalence to the predicate (Drowzle, K173974) and reference devices (NightOwl, K191031; Sleep Strip II, K112822). The reported values in the table are the result of meeting the substantial equivalence standard, rather than being against pre-set numerical acceptance criteria.

Reported Device Performance:

Diagnostic Index	Positive Predictive Value (PPV)	Negative Predictive Value (NPV)	Positive Likelihood Ratio (LR+)	Negative Likelihood Ratio (LR-)
AHI3 (for airflow reductions and 3% desaturations)	94.44% (CI 84.78%- 98.11%)	95.83% (CI 89.94%- 98.34%)	29.36 (CI 9.62 to 89.64)	0.08 (CI 0.03 to 0.19)
AHI4 (for 4% desaturations)	94.00% (CI 83.69%- 97.95%)	98.00% (CI 92.65% to 99.48%)	32.29 (CI 10.58 to 98.59)	0.04 (CI 0.01 to 0.16)
ODI3 (considering 3% desaturations)	93.42% (CI 85.87%- 97.07%)	90.54% (CI 82.48%- 95.11%)	13.11 (CI 5.61 to 30.62)	0.10 (CI 0.05 to 0.20)
ODI4 (considering 4% desaturations)	85.71% (CI 75.50%- 92.11%)	98.94% (CI 93.03%- 99.85%)	12.37 (CI 6.35-24.08)	0.02 (CI 0.00-0.15)

Heart Rate Accuracy:

Bias (µ) ≤ ±1 bpm	Bias (µ) ≤ ±3 bpm	Bias (µ) ≤ ±5 bpm	Standard Deviation (σ) ≤ 2 bpm	Standard Deviation (σ) ≤ 5 bpm	Standard Deviation (σ) ≤ 8 bpm
62.0%	94.0%	98.7%	28.7%	93.3%	98.7%

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

Sample Size for Test Set: 150 consecutive evaluation patients.
Data Provenance: Not specified in terms of country of origin. The study was a "Clinical Investigation," conducted in accordance with ISO 14155:2011 and 21 CFR 812.28(a)(1) (GCP for clinical investigations). This implies a prospective study design for data collection, as it refers to "consecutive evaluation patients."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The document does not specify the number or qualifications of experts used to establish the ground truth. It states that the ground truth for diagnostic accuracy was based on "the AASM for airflow reductions and desaturations" and "established thresholds, for OSA (i.e. 5, 15 and 30)". For heart rate, the ground truth was the "PPG signal of the polygraphy system." This implies that the ground truth was derived from a gold-standard PSG (Polysomnography) system, rather than expert interpretation of the device's output alone.

4. Adjudication Method for the Test Set

The document does not mention any specific adjudication method (e.g., 2+1, 3+1, none) for the test set. Ground truth appears to be derived from the gold standard PSG, rather than expert review of the device's output.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not described. The clinical validation focuses on the device's accuracy compared to a polysomnography system, not on assisting human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Yes, the clinical validation study appears to be a standalone performance evaluation. The device (AcuPebble SA100) generates diagnostic indices (AHI, ODI) and heart rate output, and these are compared directly against a polygraphy system, which serves as the ground truth. The role of a human healthcare professional is described as using the results to "assist" in patient evaluation, implying the device provides direct outputs.

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth for OSA diagnostic indices (AHI, ODI) was established using definitions from the "AASM" (American Academy of Sleep Medicine) for airflow reductions and desaturation criteria (3% and 4%). This indicates comparison against polysomnography (PSG), which is the gold standard for sleep apnea diagnosis. For heart rate, the ground truth was "the heart rate obtained from the PPG signal of the polygraphy system," further confirming PSG as the reference.

8. The Sample Size for the Training Set

The document does not specify the sample size used for the training set. The clinical validation section only refers to the "150 consecutive evaluation patients" used for the accuracy validation clinical study (i.e., the test set).

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, as the training set details are not provided.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 6, 2021

Acurable Limited Esther Rodriguez-Villegas CSO Finsgate, 5-7 Cranwood Street London, London EC1V 9EE United Kingdom

Re: K210480

Trade/Device Name: AcuPebble SA100 Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: Class II Product Code: MNR Dated: Mav 28, 2021 Received: June 4, 2021

Dear Esther Rodriguez-Villegas:

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 ENT, 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

Device Name AcuPebble SA100

Indications for Use (Describe)

The system is not intended as a substitute for full polysomnography when additional parameters such as sleep stages, limb movements, or EEG activity are required.

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."

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Q

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.

510(k) Submitter:	Acurable LimitedFinsgate5-7 Cranwood StreetLondon EC1V 9EEUnited Kingdom
Contact person:	Professor Esther Rodriguez-VillegasCSOAcurable Ltd5th Floor, 21 Knightsbridge, LondonSW1X 7LY, UKesther@acurable.com+442075946193
Date summary prepared:	July 6, 2021
Trade Name:	AcuPebble SA100
Product Classification Name:	Ventilatory effort recorder
Regulation number:	21 CFR §868.2375 (Breathing FrequencyMonitor)
Product Code:	MNR
Classification Panel:	Anaesthesiology
Device Classification:	Class II

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1. Intended Use / Indications for Use

AcuPebble SA100 is indicated to sense, record, and interpret a patient's physiological signals (including respiratory pattern) during sleep, for the purpose of prescreening patients for obstructive sleep apnea (OSA) syndrome. The device is designed for use in home-screening of adults with suspected possible sleep breathing disorders. Results are used to assist the healthcare professional in the patient's evaluation.

The system is not intended as a substitute for full polysomnography when additional parameters such as sleep stages, limb movements, or EEG activity are required.

2. DEVICE DESCRIPTION

3. Predicate Device

The predicate device is shown in the Table below:

K number	Product Code	Class	Device Name
K173974	MNR	II	Drowzle

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4. Summary of Comparison to Predicate

	DEVICE SUBJECTOF THISAPPLICATION	PREDICATE DEVICE (1)	REFERENCEDEVICE(1)	REFERENCEDEVICE (2)
	AcuPebble SA100by Acurable Ltd	Drowzle by Resonea,K173974	NightOwl, K191031,by Ectosense	Sleep StripII, K112822(Note: thisdevice wasclaimed aspredicate ofDrowzle(predicate (1) inthis application)
Indicationsfor use	AcuPebble SA100 isindicated to sense,record, and interpret apatient's physiologicalsignals (includingrespiratory pattern)during sleep for thepurpose of prescreeningpatients for obstructivesleep apnea (OSA)syndrome. The deviceis designed for use inhome-screening ofadults with suspectedpossible sleep breathingdisorders. Results areused to assist thehealthcare professionalin the patient'sevaluation.The system is notintended as a substitutefor fullpolysomnography whenadditional parameterssuch as sleep stages,limb movements, orEEG activity arerequired.	DROWZLE is indicated torecord a patient'srespiratory pattern duringsleep for the purpose ofprescreening patients forobstructive sleep apnea(OSA) syndrome. Thedevice is designed for usein home-screening ofadults with suspectedpossible sleep breathingdisorders. Results areused to assist thehealthcare professional indetermining the need forfurther diagnosis andevaluation.The system is not intendedas a substitute for fullpolysomnography whenadditional parameters suchas sleep stages, limbmovements, or EEGactivity are required.	The NightOwl is awearable deviceintended for use in therecording, analysis,displaying, exporting,and storage ofbiophysical parametersto aid in the evaluationof sleep-relatedbreathing disorders ofadult patientssuspected of sleepapnea. The device isintended for the clinicaland home setting useunder the direction of aHealthcare Professional(HCP).	The SleepStripII is intended tomeasure apneahypopneaevents duringsleep for thepurpose ofprescreeningpatients forsleep apneasyndrome. Thedevice isintended to beused by adultpatients asprescribed by aphysician ineither home,hospital orfacility usesettings.
COMPARISON		Substantially equivalent
Regulationnumber	868.2375	868.2375	868.2375	868.2375
COMPARISON		Same
ProductCode	MNR	MNR	MNR	MNR
COMPARISON	Same

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GenericDeviceName	VentilatoryEffort Recorder	Ventilatory Effort Recorder	Ventilatory EffortRecorder	VentilatoryEffortRecorder
COMPARISON	Same
Prescription	Prescription	Prescription	Prescription	Prescription
COMPARISON	Same
Targetpopulation	Adults	Adults	22 years old and older	Adults
COMPARISON	Substantially equivalent
Intendedenvironmentfor use	Primarily homeenvironment, althoughit can be used inhealthcareenvironments	Home Environment	Clinical and Homeenvironment	Home orhealthcaresettings
COMPARISON	Substantially equivalent
Sensorplacement	Front of the Neck	Smartphone placed within24 inches of pillow	Thephotoplethysmography(PPG) sensor andaccelerometercomponentsare worn on thefingertip.	Over the lip,under thenose
COMPARISON	The sensor is placed in a different location which is directly contacting the patient compared tothe predicate which is not directly contacting the patient. This is similar to the reference devicewhich has direct contact. Having AcuPebble SA100 in contact with the body does not raisedifferent safety or effectiveness questions (see conformity with consensus standards.)
Sensingelements	Microphones	Microphones	LEDs/ accelerometer	Pressuresensor
COMPARISON	Same
Patientcontact	Yes	No	Yes	Yes
COMPARISON	Different but justified. Refer to the clinical validation data showing the equivalentperformance of AcuPebble SA100 with respect to the predicate. Also, this type of contactapproach has been used by the reference devices.
Means ofattachment	Adhesive (patient self-applied)	NA	Adhesive (patient self-applied)	Adhesive(patient self-applied)
COMPARISON	Different but it is justified. Refer to the clinical validation data showing equivalentperformance of AcuPebble SA100 with respect to the predicate. Also, substantiallyequivalent means of attachment to Reference Devices.
Sleep nightuse	Multiple nightspossible	Multiple nights possible	Multiple nightspossible	Single use
COMPARISON	Same
Portability	Yes (Wearable)	NA	Yes (wearable)	Yes(wearable)
Comparison	Not direct comparison with the predicate but Reference Devices are also wearable
Size andweight	29.5mm diameter x16mm height7g	NA	19x28x11mm6g	Exactdimensionsunknown butfrom photos itlooks similar involume (withdifferent formfactor)
Recordingdevice	Mobile device recordssound streamed fromthe sensor anduploads them into acloud-based server	Mobile device recordssound and uploads theminto a cloud-based server	Mobile device recordsdata streamed fromthe sensor anduploads them into acloud-based server	Contained inthe device
Comparison	Same
Channels todeterminefeaturesleading todiagnosticindexes	Sounds (Cardiacfeatures, respiratoryfeatures, movementfeatures))	Sounds (absence of them)	PAT, pulse rate,oxygen saturation,movement	Airflow
COMPARISON	Substantially equivalent
CalculatedOSA indexes	ACU-AHI (with 3%desaturation criteria),ACU-AHI (with 4%desaturation criteria),ACU-ODI (for 3% and4% desaturationcriteria)	Proprietary ResoneaIndex	AHI (from PAT), oximetry	AHI with 4%desaturationcriteria
COMPARISON	Substantially equivalent
ClinicalMetricsReported	Calculated AHI/ODIindexes as per AASMdefinitions (and level ofOSA severity for eachindex, following theAASM thresholds (i.e.0-5, 5-15, 15-30 and>30); average heart(pulse).	Number of breathingsound gaps >10seconds; Averagenumber of >10second breathingsound gaps per hour;Risk classificationbased on standardquestionnaires:	Calculated AHI index fromPAT. they output validatedoximetry values and fromthere the ODI can beobtained.	Countsapnea/hypopnea events
		STOP-BANG EpworthSleepinessScale; CalculatedResonea Index
COMPARISON	Substantially equivalent
DataTransfer	From the sensor to themobile phone usingBluetooth and from thephone to the cloud(server) through asmartphone bywireless connection.	Wireless connection	From the sensor to themobile phone usingBluetooth and from thephone to the cloud(server) through asmartphone bywireless connection.	Not applicable
COMPARISON	Substantially equivalent
Microcontroller+Communication chip	Nordic nRF52832(Bluetoothcommunication)	NA	Nordic nRF52832(Bluetoothcommunication)	NA
Comparison	Substantially equivalent
SensorPowerSource	Rechargeable lithiumpolymer battery	NA	Rechargeable lithiumion battery	Battery
COMPARISON	Substantially equivalent
SensorSoftware	Firmware is limited tocontrol the recordingand communicationsprocesses. Nopresentation of testresults to the patient.Data analyzed andpresented in aseparate softwaresuite.	NA	Firmware is limited tocontrol the recordingand communicationsprocesses. Nopresentation of testresults to the patient.Data analyzed andpresented in aseparate softwaresuite.	Not applicable
COMPARISON	Same as Reference Device (1) (Not directly comparable to Predicate becausethere is not a worn part of the system)
AnalysisSoftware -location	Analysis performed offthe recording device,exclusively cloud-based, by theproprietary software.	Analysis performed off therecording device,exclusively cloud-based bythe proprietary software.	Analysis performed offthe recording device,exclusively cloud-based by theproprietary software.	Analysisperformed inthe device
COMPARISON	Same
Display type	Smartphone (or tablet)for patients;smartphone (or tablet)or computer screen for	Smartphone	Smartphone forpatients. Forhealthcareprofessionals, one orseveral of:	LED display
	healthcareprofessionals		smartphone (or tablet)or computer screen(unclear which ones)
COMPARISON	Substantially equivalent
Patientconnection	Device has nogalvanic connectionsto mains as it is abattery-operateddevice.	NA	Device has nogalvanic connectionsto mains as it is abattery-operateddevice.	Device hasno galvanicconnectionsto mains as itis a battery-operateddevice.
COMPARISON	Same as the Reference Devices
Sterilization	Non sterile	Not applicable	Non sterile	Non sterile
COMPARISON	Same as the Reference Devices
Heart/PulseRate OutputRange	50-120bmp	NA	50-118bmp	NA
COMPARISON	Substantially Equivalent to the reference device (the difference is notsignificant)
Heart/PulseRatevalidationaccuracy	3.62 bpm (patientssignals from 50bpm-110bpm during a nightsleep), 0.664 (artificialsignals as per clause201.12.1.101.15 ofIEC 60601-2-27:2011,from 50bpm to120bpm)	NA	2.26bmp	NA
COMPARISON	Substantially Equivalent to the reference device (the difference is notsignificant when taking into account the intended use)
Reusability/Reprocessing	Yes (cleaning afteruse)	Yes (cleaning after use)	Yes (cleaning afteruse)	No

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5. PERFORMANCE DATA

Biocompatibility

Theenclosure of AcuPebble SA100 has undergone biocompatibility testing as per the recognized consensus standard ISO 10993 (Biological Evaluation of Medical Devices) with passing results.

The adhesive is also medical grade, and was tested as per ISO 10993, with passing results. The tests conducted were: in vitro cytotoxicity; mem elution; primary skin irritation; Guinea pig sensitization.

General Requirements for Safety and Electromagnetic Compatibility (EMC)

AcuPebble SA100 has been tested and found to comply with the following recognized consensus standards:

IEC 60601-1:2006 +A11:2011+A1:2013- Medical electrical equipment Part 1: General requirements for basic safety and essential performance.
IEC 60601-1-2:2015- Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.

Home Healthcare Environment Safety

AcuPebble SA100 has been tested and found to comply with the following recognized consensus standard:

IEC 60601-1-11:2015: Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.

Usability

AcuPebble SA100 has been developed, tested and complies with the following recognized consensus standards:

IEC 62366-1:2015 Medical devices-Part 1: Application of usability engineering to medical devices
IEC60601-1-6: 2013Medical electrical equipment Part 1-6: General requirements for basic safety ● and essential performance - Collateral standard: Usability.

Risk Management

AcuPebble SA100 risk management complies with the recognised consensus standard ISO 14971:2012 "Application of risk management to medical devices".

Quality Management

Acurable is ISO 13485:2016 certified by MTIC InterCert SRL.

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Software Verification and Validation Testing

AcuPebble SA100 has been tested and found to comply with the recognised consensus standard IEC 62304:2006/A1:2016 ("Medical device software - Software life cycle processes"). The software level of concern is moderate.

Acurable Software Verification and Validation Testing included 3 levels of testing, as defined in the Verification and Validation Plan:

Unit testing at component level
. Integration testing at component level
Full system or end-to-end testing at product level.

Additionally, usability testing is carried out for system validation purposes.

Clinical Validation

An accuracy validation clinical study, in compliance with the recognized consensus standard ISO 14155:2011 ("Clinical investigation of medical devices for human subjects - Good clinical practice") was carried out to further support the substantial equivalence claims. The Clinical Investigations were hence conducted in accordance with good clinical practice (GCP) as described in 21 CFR 812.28(a)(1). The study involved 150 consecutive evaluation patients. A summary of the outcomes of the study is presented in the table below.

Diagnostic index	PositivePredictive Value(PPV)	NegativePredictive Value(NPV)	PositiveLikelihood Ratio(LR+)	NegativeLikelihood Ratio(LR-)
AHI3(AHI as defined bythe AASM forairflow reductionsand 3%desaturations)	94.44%(CI 84.78%- 98.11%)	95.83%(CI 89.94%- 98.34%)	29.36(CI 9.62 to 89.64)	0.08(CI 0.03 to 0.19)
AHI4(As above, but for4% desaturations)	94.00%(CI 83.69%-97.95%)	98.00%(CI 92.65% to99.48%)	32.29(CI 10.58 to98.59)	0.04(CI 0.01 to 0.16)
ODI3(ODI considering3% desaturations)	93.42%(CI 85.87%- 97.07%)	90.54%(CI 82.48%- 95.11%)	13.11(CI 5.61 to 30.62)	0.10(CI 0.05 to 0.20)
ODI4(ODI considering4% desaturations)	85.71%(CI 75.50%-92.11%)	98.94%(CI 93.03%-99.85%)	12.37(CI 6.35-24.08)	0.02(CI 0.00-0.15)

The diagnostic criteria were based on the established thresholds, for OSA (i.e. 5, 15 and 30).

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The performance of heart rate output was evaluated for the same 150 patients, using as an index test the heart rate obtained from the PPG signal of the polygraphy system.

The following table lists the percentage of subjects with bias and standard deviation within a certain range.

Heart Rate- Percentage of subjects with bias and standard deviations within differentranges
Bias (μ)			Standard Deviation (σ)
≤ ±1 bpm	≤ ±3 bpm	≤ ±5 bpm	≤ 2 bpm	≤ 5 bpm	≤ 8 bpm
62.0%	94.0%	98.7%	28.7%	93.3%	98.7%

6. Conclusion

Based on the performance data and testing in conformance to consensus standards, AcuPebble SA100 has been demonstrated to be substantially equivalent to the 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).