Who is the manufacturer of TipTraQ (TTQ001)?

Pranaq Pte. , Ltd. filed the 510(k) submission for TipTraQ (TTQ001) (K243268).

What is the FDA product code for TipTraQ (TTQ001)?

MNR. It is classified under 21 CFR 868.2375 as a Class 2 device in the Anesthesiology panel.

What is the regulatory pathway for TipTraQ (TTQ001)?

510(k) clearance (submission type: Traditional).

Does TipTraQ (TTQ001) use AI or machine learning?

Yes. TipTraQ (TTQ001) (K243268) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

Who can help prepare an FDA 510(k) submission like TipTraQ (TTQ001)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like TipTraQ (TTQ001) get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

TipTraQ (TTQ001)

K243268 · Pranaq Pte. , Ltd. · MNR · Feb 3, 2025 · Anesthesiology

Device Facts

Record ID	K243268
Device Name	TipTraQ (TTQ001)
Applicant	Pranaq Pte. , Ltd.
Product Code	MNR · Anesthesiology
Decision Date	Feb 3, 2025
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.2375
Device Class	Class 2
Attributes	AI/ML

Intended Use

The TipTraQ is a wearable device intended for aiding in sleep apnea evaluation/diagnosis for adult patients suspected of sleep apnea in both home-based and clinical-use environments.

Device Story

TipTraQ is a prescription-only fingertip wearable device for sleep apnea evaluation. It collects PPG waveforms (green, red, infrared light) and 3-axis accelerometer data to monitor blood volume changes and actigraphy. Data is transferred via smartphone to a cloud-based system where the TipTraQ Algorithm calculates sleep parameters including AHI, TST, REM time, and ODI. The device is used in home or clinical environments by patients; results are reviewed by healthcare professionals to aid in sleep apnea diagnosis. The system includes a rechargeable sensor and charging case. By providing automated analysis of physiological signals, it assists clinicians in identifying sleep-disordered breathing, potentially facilitating earlier diagnosis and management for patients.

Clinical Evidence

Clinical validation included an SpO2 study (n=12) comparing sensor to arterial blood gas, yielding an Arms of 1.41 (70-100% range). A sleep validation study (n=147) compared TipTraQ to in-lab PSG. Primary endpoints included AHI accuracy and sleep staging. AHI performance (1b rule) showed sensitivity/specificity of 0.924/0.801 (cutoff 5), 0.909/0.908 (cutoff 15), and 1.000/0.933 (cutoff 30). Sleep stage accuracy was 0.837 (Wake) and 0.905 (REM).

Technological Characteristics

Wearable fingertip sensor (PC, silicone rubber, nylon fabric). PPG sensing (green, red, infrared) and 3-axis accelerometer. Rechargeable Li-ion battery. Connectivity via smartphone/wireless. Non-sterile. Complies with ISO 10993-1:2018 (biocompatibility), IEC 60601-1:2020 (electrical safety), IEC 60601-1-2:2014 (EMC), and IEC 60601-1-11:2020 (home environment). Cloud-based analysis software.

Indications for Use

Indicated for adult patients (22+ years) suspected of sleep apnea to aid in evaluation/diagnosis in home or clinical settings.

Regulatory Classification

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.

Predicate Devices

NightOwl (K220028)

Reference Devices

Belun Sleep System BLS-100 (K222579)
EnsoSleep PPG (formerly Aurora) (K231355)

Related Devices

K213463 — NightOwl · Ectosense NV · Dec 16, 2021
K220028 — NightOwl · Ectosense NV · Feb 24, 2022
K191031 — NightOwl · Ectosense NV · Mar 6, 2020
K080427 — WATCH-PAT MODEL 100S-2 · Itamar Medical · May 23, 2008
K243092 — AcuPebble Ox (200) · Acurable Limited · Mar 19, 2025

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The logos are displayed side-by-side. February 3, 2025 PranaO Pte. Ltd. % Amv Herder Founder & Principal Consultant MedIgnite Consulting, LLC 1709 Saracen Rd Austin, Texas 78733 Re: K243268 Trade/Device Name: TipTraO (TTO001) Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: Class II Product Code: MNR Dated: October 15, 2024 Received: January 3, 2025 Dear Amy Herder: 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. {1}------------------------------------------------ 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" (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 (OS) 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 (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-device-advicecomprehensive-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-device-safety/medical-device-reportingmdr-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/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-regulatory {2}------------------------------------------------ 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). Sincerely, # Rachana Visaria -S Rachana Visaria, Ph.D. Assistant Director DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use Submission Number (if known) K243268 Device Name TipTraQ (TTQ001) Indications for Use (Describe) The TipTraQ is a wearable device intended for aiding in sleep apnea evaluation/diagnosis for adult patients suspected of sleep apnea in both home-based and clinical-use environments. 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 numb {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for PranaQ. The word "prana" is written in a dark gray sans-serif font. To the right of the word "prana" is a large letter "Q" in a teal color. The letter "Q" is stylized with a small curved line extending from the bottom right of the circle. # 510(k) Summary [Prepared in accordance with 21 CFR 807.92] Date: February 3, 2025 ### CONTACT DETAILS I. Submitter: PranaQ Pte. Ltd. 331 NORTH BRIDGE ROAD, #12 - 03 ODEON TOWERS, SINGAPORE 188720 | | +65 3158 4380 | | |---------------|-----------------------|--| | Contact Name: | Jerry Chen | | | | jerry.chen@pranaq.com | | ### II. DEVICE NAME | Device Name: | TipTraQ (TTQ001) | |-----------------|-----------------------------| | Common Name: | Breathing frequency monitor | | Classification: | Ventilatory Effort Recorder | | Regulation: | 21 CFR 868.2375 | | Product Code: | MNR | ### III. PREDICATE Predicate Device(s): K220028, NightOwl (Primary) K222579, Belun Sleep System BLS-100 (Reference Device) K231355, EnsoSleep PPG (formerly Aurora) (Reference Device) ### IV. DEVICE DESCRIPTION SUMMARY TipTraQ is a prescription-only medical device aiding in sleep apnea evaluation/diagnosis comprising a fingertip wearable device, a companion mobile app, a cloud-based AI analysis and an information display system. It collects essential physiological waveform information, including Photoplethysmogram (PPG) and accelerometer data. The TipTraQ Algorithm System determines Total Sleep Time (TST), Total REM Time (TREMT), Oxygen Desaturation Index (ODI), and Apnea-Hypopnea Index (AHI) from the recorded waveform signals. {5}------------------------------------------------ TipTraQ Sensor includes a PPG sensor, which uses light sources (green, red, and infrared) and two photodetectors to measure the blood volume changes in the microvascular bed of tissue. Additionally, the TipTraQ Sensor utilizes an Inertial Measurement Unit (IMU) with three-axis accelerometers (device-function) and three-axis gyroscopes (non-device function), monitoring movement and actigraphy to assess sleep stages. The TipTraQ Expert Panel can display recorded physiological waveforms, while the TipTraQ API System generates output for essential physiological parameters analyzed by the TipTraQ Algorithm System. The TipTraQ Sensor is rechargeable and designed to provide at least 12 hours of usage after fully charged. The TipTraQ Charging Case, which is also rechargeable, provides a battery capacity of eight full charges of the TipTraQ Sensor for user convenience. The TipTraQ Charging Case can be powered and charged using an external USB-C. ### INTENDED USE / INDICATIONS FOR USE V. The TipTraQ is a wearable device intended for aiding in sleep apnea evaluation/diagnosis for adult patients suspected of sleep apnea in both home-based and clinical-use environments. {6}------------------------------------------------ | Characteristic | TipTraQ, K243268 (Subject Device) | NightOwl, K220028 (Primary Predicate) | Belun Sleep System BLS- 100, K222579 (Reference Device 1) | EnsoSleep PPG (formerly Aurora), K231355 (Reference Device 2) | |---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use/ Indications for Use | The TipTraQ is a wearable device intended for aiding in sleep apnea evaluation/diagnosis for adult patients suspected of sleep apnea in both home-based and clinical- use environments. | The NightOwl is a wearable device intended for use in the recording, analysis, displaying, exporting, and storage of biophysical parameters to aid in the evaluation of sleep-related breathing disorders of adult patients suspected of sleep apnea. The device is intended for the clinical and home setting use under the direction of a Healthcare Professional (HCP). | The Belun Sleep System BLS-100 is a wearable device intended to record, analyze, display, export, and store biophysical parameters to aid in evaluating moderate to severe sleep-related breathing disorders of adult patients suspected of sleep apnea. The device is intended for use in clinical and home settings under the direction of a Healthcare Professional (HCP). | 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. 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 | | Characteristic | TipTraQ, K243268 (Subject Device) | NightOwl, K220028 (Primary Predicate) | Belun Sleep System BLS- 100, K222579 (Reference Device 1) | EnsoSleep PPG (formerly Aurora), K231355 (Reference Device 2) | | | | | | consultation of a qualified healthcare professional. Aurora is not intended for use with polysomnography devices. | | Intended Environment | Recording in the home environment or clinical environment with the report interpretation performed in the clinical setting. | Recording in the home environment with the report interpretation performed in the clinical setting. | Recording in the home environment with the report interpretation performed in the clinical setting. | N/A (Software) | | Prescription | Prescription only | Prescription only | Prescription only | Prescription only | | Target Population | 22 years old and older | 22 years old and older | 22 years old and older | Adults | | Channels | 1. Photoplethysmography (PPG) 2. Pulse rate 3. Oximetry 4. Actigraphy | 1. PAT 2. Pulse rate 3. Oximetry 4. Actigraphy | 1. Photoplethysmography (PPG) 2. Pulse rate 3. Oximetry 4. Actigraphy | 1. Photoplethysmography (PPG) 2. Oximetry | | Characteristic | TipTraQ, K243268 (Subject Device) | NightOwl, K220028 (Primary Predicate) | Belun Sleep System BLS- 100, K222579 (Reference Device 1) | EnsoSleep PPG (formerly Aurora), K231355 (Reference Device 2) | | Sensors | Optical plethysmography sensor (Red, Infrared Red, Green), accelerometer | Optical plethysmography sensor (Red, Infrared Red), accelerometer | Optical plethysmography sensor (Red, Infrared Red), accelerometer | N/A (Software) | | Wearable sensor location | The photoplethysmography (PPG) sensor and accelerometer components are worn on the fingertip. | The photoplethysmography (PPG) sensor and accelerometer components are worn on the fingertip. | The photoplethysmography (PPG) sensor and accelerometer components are worn on the proximal phalanx of index finger. | N/A (Software) | | Sensor Software | Firmware is limited to control the recording and communications processes. Presentation of test results to the patient only after confirmed by HCP. Data analyzed and presented in a separate software suite. | Firmware is limited to control the recording and communications processes. No presentation of test results to the patient. Data analyzed and presented in a separate software suite. | Firmware is limited to control the recording and communications processes. No presentation of test results to the patient. Data analyzed and presented in a separate software suite. | N/A (Software) | | Analysis Software - location | Analysis performed off the recording device, exclusively cloud-based by the TipTraQ software. | Analysis performed off the recording device, exclusively cloud-based by the NightOwl software. | Analysis performed off the recording device, exclusively stand-alone by the Belun software. | Analysis performed off the recording device, exclusively cloud-based by the EnsoSleep software. | | Characteristic | TipTraQ, K243268 (Subject Device) | NightOwl, K220028 (Primary Predicate) | Belun Sleep System BLS- 100, K222579 (Reference Device 1) | EnsoSleep PPG (formerly Aurora), K231355 (Reference Device 2) | | Analysis Software - algorithm- AHI | TQ-AHI calculation tuned to the AASM's '1A Rule' for the scoring of hypopnea AND TQ-AHI calculation tuned to the AASM's '1B Rule' for the scoring of hypopnea | pAHI calculation tuned to the AASM's '1A Rule' for the scoring of hypopnea AND pAHI calculation tuned to the AASM's '1B Rule' for the scoring of hypopnea | bAHI calculation tuned to the AASM's '1B Rule' for the scoring of hypopnea | N/A | | Analysis Software - algorithm - Sleep Time | Total Sleep Time (TQ- TST) calculation, and, Total REM Time (TQ- TREMT) calculation | Total Sleep Time (TST) calculation, and, Total REM Time calculation | bTST calculation (time summation of REM and NREM stages) | N/A | | Analysis Software - algorithm - Sleep Stage | Sleep Stages (Wake, REM, NREM) | N/A | bSTAGES: WAKE, NREM and REM | N/A | | Characteristic | TipTraQ, K243268 (Subject Device) | NightOwl, K220028 (Primary Predicate) | Belun Sleep System BLS- 100, K222579 (Reference Device 1) | EnsoSleep PPG (formerly Aurora), K231355 (Reference Device 2) | | Data transfer | Data transfer through a smartphone by wireless connection. | Data transfer through a smartphone by wireless connection. | Data transfer by physical or wireless connection. | N/A (Software) | | Power Source recorder | Internal rechargeable li- ion battery | Battery powered by coin cell | 3.7V Lithium Battery | N/A (Software) | | Patient Isolation | Device has no galvanic connections to mains as it is a battery-operated device. | Device has no galvanic connections to mains as it is a battery-operated device. | N/A | N/A (Software) | | Sterilization | Non-sterile | Non-sterile | N/A | N/A (Software) | | Material(s) in primary contact | 1. PC 2. Silicone rubber 3. Nylon-based fabric | 1. Biocompatible polyethylene foam and polyester film with acrylic adhesive layer | 1. TPE 2. PC | N/A (Software) | | Characteristic | TipTraQ, K243268 (Subject Device) | NightOwl, K220028 (Primary Predicate) | Belun Sleep System BLS- 100, K222579 (Reference Device 1) | EnsoSleep PPG (formerly Aurora), K231355 (Reference Device 2) | | Contact duration (biocompatibility) | Prolonged duration (>24 hours to 30 days), cumulatively | Limited duration (Up to 24 hours) | Prolonged duration (>24 hours to 30 days), cumulatively | N/A (Software) | | Bio-compatibility | Assessed to ISO 10993- 1:2018 | Assessed to ISO 10993-1:2009 requirements for sensitization, irritation, and cytotoxicity | Tested in accordance to ISO 10993-1:2018 for sensitization, irritation, and cytotoxicity | N/A (Software) | | EMC | IEC 60601-1-2:2014 +AMD1:2020 | IEC 60601-1-2:2014 | IEC 60601-1-2:2014 | N/A (Software) | | Electrical Safety | IEC 60601-1:2005 +A1:2012+A2:2020 | IEC 60601-1:2005 +AMD1:2012 | IEC 60601-1:2005 +A1:2012 | N/A (Software) | | Environmental Testing | IEC 60601-1-11:2015 + A1:2020 | IEC 60601-1-11:2010 | IEC 60601-1-11:2015 | N/A (Software) | | Characteristic | TipTraQ, K243268 (Subject Device) | NightOwl, K220028 (Primary Predicate) | Belun Sleep System BLS- 100, K222579 (Reference Device 1) | EnsoSleep PPG (formerly Aurora), K231355 (Reference Device 2) | | Output parameters | 1. TQ-AHI 2. Total Sleep Time 3. Total REM Time 4. Sleep Stages (Wake, REM, NREM) 5. Sleep Efficiency 6. Sleep Latency 7. Wake After Sleep Onset 8. SpO2 (min, max) 9. ODI 3%, ODI 4% 10. T90 11. Pulse Rate (PR) (mean, PR > 100 bpm, PR < 40 bpm) | 1. pAHI 2. Total Sleep Time 3. Total REM Time 4. SpO2 (min, max) 5. ODI 3%, ODI 4% 6. T90, T88 7. Pulse Rate (PR) (mean, PR > 100 bpm, PR < 40 bpm, Min, Max) | 1. bAHI 2. Total Sleep Time 3. Sleep Stages (Wake, REM, NREM) 4. SpO2 5. Pulse Rate 6. Low Perfusion | 1. eAHI 2. Total Sleep Time 3. Sleep Stages 4. Sleep Efficiency 5. Sleep latency 6. Wake After Sleep Onset 7. ODI | | AHI Performance Using AASM 1a Rule | | | | | | AHI 1a cutoff = 5 | Sensitivity: 0.868 Specificity: 0.741 | Sensitivity: 0.936 Specificity: 0.727 | N/A | Sensitivity: 0.926 Specificity: 0.716 | | AHI la cutoff = 15 | Sensitivity: 0.876 Specificity: 0.755 | Sensitivity: 0.978 Specificity: 0.704 | N/A | N/A | | Characteristic | TipTraQ, K243268 (Subject Device) | NightOwl, K220028 (Primary Predicate) | Belun Sleep System BLS- 100, K222579 (Reference Device 1) | EnsoSleep PPG (formerly Aurora), K231355 (Reference Device 2) | | AHI 1a cutoff = 30 | Sensitivity: 0.806 Specificity: 0.905 | Sensitivity: 0.964 Specificity: 0.844 | N/A | N/A | | AHI Performance Using AASM 1b Rule | | |…