(147 days)
The Sunrise device is a non-invasive home care aid in the evaluation of obstructive sleep apnea (OSA) in patients 18 years and older with suspicions of sleep breathing disorders.
The Sunrise device is a cloud-based software device that analyzes data from a sensor (Sunrise sensor 1 or Sunrise sensor 2) placed on the patient's chin. The device detects respiratory events, identifies sleep stages and position. The device generates sleep parameters, e.g. apnea hypopnea index "Sunrise AHI", and position discrete states. Data collected by the device is integrated in a report for further interpretation by the healthcare provider.
The provided text details the performance data for the Sunrise device to support its substantial equivalence determination. However, it does not explicitly state "acceptance criteria" in a表格 format as requested. Instead, it describes performance metrics (e.g., median measurement bias and LOA, sensitivity, specificity, global accuracy, and RMS values) for various parameters against pre-determined thresholds of clinical acceptability or against a gold standard (PSG).
Based on the provided information, I will infer the acceptance criteria from the reported performance, as these are the values the device did achieve and were deemed sufficient for substantial equivalence.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
As explicit acceptance criteria thresholds are not stated, the "Acceptance Criteria" column will reflect the reported performance that was deemed acceptable for substantial equivalence. The "Reported Device Performance" will reiterate these values.
| Parameter | Acceptance Criteria (Inferred from Reported Performance) | Reported Device Performance |
|---|---|---|
| Study 1 (Belgium, n=289) | ||
| TST Median Bias & LOA | Median bias within -4.50 min and LOA of -41.74 to +35.67 | -4.50 min (-41.74 to +35.67) |
| AHI Median Bias & LOA | Median bias within -0.46 event/h and LOA of -13.52 to +9.00 | -0.46 event/h (-13.52 to +9.00) |
| ORDI Median Bias & LOA | Median bias within +0.15 event/h and LOA of -10.70 to +10.12 | +0.15 event/h (-10.70 to +10.12) |
| Sensitivity (AHI>=5) | >= 0.99 | 0.99 |
| Sensitivity (AHI>=15) | >= 0.92 | 0.92 |
| Sensitivity (AHI>=30) | >= 0.81 | 0.81 |
| Specificity (AHI>=5) | >= 0.86 | 0.86 |
| Specificity (AHI>=15) | >= 0.94 | 0.94 |
| Specificity (AHI>=30) | >= 0.99 | 0.99 |
| Study 2 (France, n=31) | ||
| TST Median Bias & LOA | Median bias within -10.50 min and LOA of -37.42 to +25.79 | -10.50 min (-37.42 to +25.79) |
| AHI Median Bias & LOA | Median bias within +0.20 event/h and LOA of -12.30 to +6.30 | +0.20 event/h (-12.30 to +6.30) |
| ORDI Median Bias & LOA | Median bias within +1.01 event/h and LOA of -11.24 to +6.21 | +1.01 event/h (-11.24 to +6.21) |
| Sensitivity (AHI>=5) | >= 1.00 | 1.00 |
| Sensitivity (AHI>=15) | >= 0.94 | 0.94 |
| Sensitivity (AHI>=30) | >= 0.87 | 0.87 |
| Specificity (AHI>=5) | >= 0.75 | 0.75 |
| Specificity (AHI>=15) | >= 1.00 | 1.00 |
| Specificity (AHI>=30) | >= 1.00 | 1.00 |
| Study 3 (Belgium, n=10) | ||
| Position Discrete States Global Accuracy | >= 93% | 93% |
| Study 4 (SpO2 & Pulse Rate Accuracy) | ||
| SpO2 Accuracy (RMS) | <= 2.70% (over range 70-100%) | 2.70% (over range of 70-100%) |
| Pulse Rate Accuracy (RMS) | <= 1.95 bpm (over range 51-104 bpm) | 1.95 bpm (for a range of 51 to 104 bpm) |
| Thermistor Ability to Capture Airflow | Performance equivalent to PSG oronasal thermal airflow sensor | Equivalent to an oronasal thermal airflow sensor used in PSG |
2. Sample Sizes Used for the Test Set and Data Provenance
- Clinical Study 1: 289 patients, retrospective, comparative, open study. Performed in Belgium.
- Clinical Study 2: 31 patients, retrospective, comparative, open study. Performed in France.
- Clinical Study 3: 10 patients, retrospective, comparative, open study. Performed in Belgium.
- Clinical Study 4 (SpO2 & Pulse Rate): Not explicitly stated, but validated in accordance with ISO 80601-2-61:2019 and FDA guidance. This is typically a controlled bench study with a human subject population, but the document does not break down the sample size for this specific validation.
- Thermistor Validation: Not explicitly stated (the text mentions "a validation study was conducted").
All mentioned clinical studies are described as retrospective, comparative, and open studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number or qualifications of experts used to establish the ground truth (PSG data). It only refers to "the gold-standard PSG" as the comparison. In typical PSG studies, the PSG data is scored by trained sleep technologists and sometimes reviewed by a sleep physician, but this detail is not provided.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method for the test set. The ground truth is stated to be "the gold-standard PSG."
5. 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 MRMC study comparing human readers with and without AI assistance is mentioned. The studies focus on the performance of the device (algorithm) itself against PSG.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the clinical studies describe the performance of the "algorithm" and the "device" against PSG, indicating a standalone (algorithm only) evaluation. The text states: "The algorithm was used to analyze sensor data and evaluate the performance of the device compared to PSG."
7. The Type of Ground Truth Used
The primary ground truth used for OSA parameters (TST, AHI, ORDI, OSA severity) and position discrete states was Polysomnography (PSG), referred to as the "gold-standard PSG." For SpO2 and pulse rate accuracy, the ground truth was established in accordance with ISO 80601-2-61:2019 and relevant FDA guidance, which typically involves comparison against a reference oximeter or validated measurement system. For the thermistor, it was compared to an "oronasal thermal airflow sensor used in PSG."
8. The Sample Size for the Training Set
The document does not explicitly state the sample size for the training set. The clinical studies mentioned (n=289, n=31, n=10) are described as performance evaluation studies for the device, not necessarily for training. It states the "Sunrise algorithm... has been updated," implying a development process that would include training, but the specifics of the training dataset are not provided.
9. How the Ground Truth for the Training Set Was Established
The document does not provide information on how the ground truth for any potential training set was established. It focuses solely on the performance evaluation of the device against the "gold-standard PSG" for its validation studies.
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December 22, 2022
Sunrise SA Gregoire Lejeune R&D project manager Chaussee de Marche 598/02 Namur, 5101 Belgium
Re: K222262
Trade/Device Name: Sunrise Regulation Number: 21 CFR 868.2376 Regulation Name: Device For Sleep Apnea Testing Based On Mandibular Movement Regulatory Class: Class II Product Code: QRS Dated: November 14, 2022 Received: November 18, 2022
Dear Gregoire Lejeune:
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 -S
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 K22262
Device Name Sunrise
Indications for Use (Describe)
The Sunrise device is a non-invasive home care aid in the evaluation of obstructive sleep apnea (OSA) in patients 18 years and older with suspicions of sleep breathing disorders.
| 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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510(K) SUMMARY
1. SUBMITTER
Sunrise SA Chaussée de Marche 598/02 5101 Namur Belgium
Phone: +32 81 26 11 26
Contact Person: Grégoire Lejeune Date Prepared: December 22, 2022
2. DEVICE
Name of Device: Sunrise Common or Usual Name: Sleep apnea testing Classification Name: Device for sleep apnea testing based on mandibular movement Regulatory Class: II Product Code: QRS Regulation: 21 CFR 868.2376 Classification Panel: Anesthesiology
3. PREDICATE DEVICE
Predicate Device: Sunrise Sleep Disorder Diagnostic Aid (DEN210015) Reference Devices: NightOwl (K191031), SOMNOscreen plus (K201054)
4. DEVICE DESCRIPTION
The Sunrise device is a cloud-based software device that analyzes data from a sensor (Sunrise sensor 1 or Sunrise sensor 2) placed on the patient's chin. The device detects respiratory events, identifies sleep stages and position. The device generates sleep parameters, e.g. apnea hypopnea index "Sunrise AHI", and position discrete states. Data collected by the device is integrated in a report for further interpretation by the healthcare provider.
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5. INDICATIONS FOR USE
The Sunrise device is a non-invasive home care aid in the evaluation of obstructive sleep apnea (OSA) in patients 18 years and older with suspicions of sleep breathing disorders.
6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The Sunrise software, subject of the De Novo DEN210015 with the Sunrise sensor 1, is now compatible with the Sunrise sensor 2. The Sunrise algorithm, component of the Sunrise software, has been updated to provide new sleep parameters.
The Sunrise sensor 2 presents the same features as the Sunrise sensor 1, with the following improvements:
- Addition of a PPG sensor to provide SpO2 and pulse rate measurement; ●
- Addition of a thermistor to provide airflow measurement; ●
- Battery for up to three nights of recording (compared to one night for the Sunrise sensor 1):
- On-board memory to record raw data for transfer at the end of the night. ●
| Item | Subject deviceSunrise | PredicatedeviceSunrise sleepdisorderdiagnostic aid(DEN210015) | Referencedevice 1NightOwl(K191031) | Reference device 2SOMNOscreenplus (K201054) | Comparison |
|---|---|---|---|---|---|
| Intendeduse/indications for use | The Sunrisemedical deviceis a non-invasive homecare aid in theevaluation ofobstructivesleep apnea(OSA) inpatients 18years and olderwith suspicionsof sleepbreathingdisorders. | The SunriseSDDA device isa non-invasivehome care aidin theevaluation ofobstructivesleep apnea(OSA) inpatients 18years and olderwith suspicionsof sleepbreathingdisorders. | The NightOwlis a wearabledevice intendedfor use in therecording,analysis,displaying,exporting, andstorage ofbiophysicalparameters toaid in theevaluation ofsleep-relatedbreathingdisorders ofadult patientssuspected ofsleep apnea.The device isintended for theclinical andhome setting | TheSOMNOscreen®plus is indicated foruse in therecording,displaying,monitoring,printing, andstorage ofbiophysicalparameters for thepurpose of assistingin the diagnosis ofNeurological andSleep Disorders.The device is a non-life-supportingphysiological signalrecording deviceintended to be usedfor studies testingadults and | Same aspredicatedevice |
| Item | Subject device | Predicate device | Reference device 1 | Reference device 2 | Comparison |
| Sunrise | Sunrise sleep disorder diagnostic aid (DEN210015) | NightOwl (K191031) | SOMNOscreen plus (K201054) | ||
| use under the direction of a Healthcare Professional (HCP). | children/adolescents suspected of having sleep-related breathing disorders. This device is NOT designed to be used in a Life Support situation. This device is not designed for use on patients with cardiac pacemakers. | ||||
| Target population | 18 years and older | 18 years and older | 22 years and older | 2 years and older | Same as predicate device |
| Type of use | Prescription | Prescription | Prescription | Prescription | Same as predicate device |
| Intended use environment | Home | Home | Home | Clinical or home | Same as predicate device |
| Wearable sensor location | Chin | Chin | Fingertip | Multiple locations including chin and fingertip | Same as predicate device |
| Sensors | AccelerometerGyroscopePPG (Sunrise sensor 2 only)Thermistor(Sunrise sensor 2 only) | AccelerometerGyroscope | AccelerometerPPG | Multiple sensors including accelerometer, PPG and thermistor | Same as predicate device for accelerometer and gyroscope, same as reference device 1 for PPG and same as reference device 2 for thermistor |
| Channels | Mandibular movementsDiscrete positionSpO2 (Sunrise sensor 2 only)Pulse rate(Sunrise sensor 2 only) | Mandibular movementsDiscrete position | PATSpO2Pulse rate | Multiple channels including discrete position, SpO2, pulse rate and airflow | Same as predicate device for mandibular movements and discrete position, same as reference device 1 for SpO2 and pulse rate and same |
| Item | Subject deviceSunrise | Predicatedevice | Referencedevice 1 | Reference device 2 | Comparison |
| Sunrise sleepdisorderdiagnostic aid(DEN210015) | NightOwl(K191031) | SOMNOscreenplus (K201054) | |||
| Airflow(Sunrise sensor2 only) | as referencedevice 2 forairflow | ||||
| Size andweight | 42x17x6mm -3g (Sunrisesensor 1)40x22x12mm -8g (Sunrisesensor 2) | 42x17x6mm -3g | 19x28x11mm -6g | Multiple sensors ofdifferent sizes andweights | Same aspredicatedevice (Sunrisesensor 1)Substantiallyequivalent topredicatedevice (Sunrisesensor 2) |
| Raw datarecording | Streamed tosmartphone(Sunrise sensor1) or on-boardmemory(Sunrise sensor2) | Streamed tosmartphone | Streamed tosmartphone oron-boardmemory | Streamed tocomputer or on-board memory | Same aspredicatedevice (Sunrisesensor 1)Substantiallyequivalent topredicatedevice andsame asreferencedevice 1(Sunrise sensor2) |
| Power supply | Non-rechargeablelithium coinbattery | Non-rechargeablelithium coinbattery | Rechargeablelithiumion battery | Rechargeablelithiumion battery | Same aspredicatedevice |
| User interface | Smartphone andcomputer | Smartphone andcomputer | Smartphone andcomputer | Computer | Same aspredicatedevice |
| Patient contacttype | In contact withintact skinsurfaces forlimited duration | In contact withintact skinsurfaces forlimited duration | In contact withintact skinsurfaces forlimited duration | In contact withintact skin surfacesfor limited duration | Same aspredicatedevice |
| Wearablesensorsoftware | Firmware islimited tocontrol therecording andcommunications processes | Firmware islimited tocontrol therecording andcommunications processes | Firmware islimited tocontrol therecording andcommunications processes | Firmware is limitedto control therecording andcommunicationsprocesses | Same aspredicatedevice |
| Analysissoftware | Analysisperformed offthe recordingdevice,exclusively | Analysisperformed offthe recordingdevice,exclusively | Analysisperformed offthe recordingdevice,exclusively | Analysis performedoff the recording bythe proprietarysoftware | Same aspredicatedevice |
| Item | Subject deviceSunrise | Predicate deviceSunrise sleep disorder diagnostic aid(DEN210015) | Reference device 1NightOwl(K191031) | Reference device 2SOMNOscreen plus (K201054) | Comparison |
| the proprietarysoftware | the proprietarysoftware | the proprietarysoftware | |||
| Sterility | Non-sterile | Non-sterile | Non-sterile | Non-sterile | Same aspredicatedevice |
| Reportedparameters | TST, SOL,WASO, SE,awakeningindex, ArI,light/deep/REMsleep, REMsleep latency,AHI, AHIsupine, AHInon supine,AHI REM, AHINREM, ORDI,ORDI supine,ORDI nonsupine, ORDIREM, ORDINREM, RDI,OAHI, CAHI,AHI (4%),RERA index,RE, sleep timein supineposition andsleep time innon supinepositionSpO2 and pulserate statistics(Sunrise sensor2 only) | TST, SOL,WASO, SE,ArI, ORDI,sleep time insupine positionand sleep timein non supineposition | TST, REMsleep, AHI,AHI (4%),SpO2 and pulserate statistics | TST, SOL, WASO,SE, awakeningindex, ArI,light/deep/REMsleep, REM sleeplatency, AHI, AHIsupine, AHI nonsupine, AHI REM,AHI NREM, ORDI,ORDI supine,ORDI non supine,ORDI REM, ORDINREM, RDI,OAHI, CAHI, AHI(4%), RERA index,RE, sleep time insupine position,sleep time in nonsupine position,SpO2 and pulse ratestatistics | Same aspredicatedevice for TST,SOL, WASO,SE, ArI, ORDI,sleep time insupine positionand sleep timein non supineposition, sameas referencedevice 1 forTST, REMsleep, AHI,AHI (4%),SpO2 and pulserate statistics,and same asreferencedevice 2 forTST, SOL,WASO, SE,awakeningindex, ArI,light/deep/REM sleep, REMsleep latency,AHI, AHIsupine, AHInon supine,AHI REM,AHI NREM,ORDI, ORDIsupine, ORDInon supine,ORDI REM,ORDI NREM,RDI, OAHI,CAHI, AHI(4%), RERAindex, RE,sleep time insupine position,sleep time innon supine |
| Item | Subject deviceSunrise | PredicatedeviceSunrise sleepdisorderdiagnostic aid(DEN210015) | Referencedevice 1NightOwl(K191031) | Reference device 2SOMNOscreenplus (K201054) | Comparison |
| non supineposition, SpO2and pulse ratestatistics | |||||
| Pulse rateaccuracy andmeasurementrange | Accuracy (rmsvalue) wasfound to be 1.95beats perminute (bpm)for a claimedmeasurementrange of 51 to104 bpm(Sunrise sensor2 only) | Not applicable | Accuracy (rms)value was foundto be 2.26 beatsper minute(bpm) for aclaimedmeasurementrange of 50 to118 bpm | Claimedmeasurement rangeof 18 to 300 beatsper minute (bpm) | Substantiallyequivalent toreferencedevice 1 |
| Means ofattachment | Adhesives | Adhesives | Adhesives | Multiple meansincluding adhesives | Same aspredicatedevice |
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7. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility
The device includes four patient-contacting components which are in contact with the skin of the chin of the patient during the sleep study: housing, PPG window, double-sided adhesive and additional adhesive bandage. Biocompatibility evaluation was conducted, and documentation was provided as recommended by the FDA guidance document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1 : Evaluation and testing within a risk management process".
Software
The device has a moderate level of concern software component. Software verification and validation testing were conducted, and documentation was provided as recommended by the FDA guidance document Guidance for the Content of Premarket Submissions for Software contained in Medical Devices.
Documentation was provided in accordance with the FDA guidance document Content of Premarket Submissions for Management of Cybersecurity in Medical Device to support adequate cybersecurity measures have been taken and will be monitored and updated throughout the device life cycle.
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Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical safety and EMC testing were conducted on the device to demonstrate compliance with IEC 60601-1 standard for safety, IEC 60601-1-2 standard for EMC and IEC 60601-1-11 standard for home healthcare environment.
Bench Testing
Bench testing was conducted to demonstrate technical equivalency between the subject device and the predicate device. The measured signals of the accelerometer and of the gyroscope between the two sensors were compared and performance found to be equivalent.
Clinical Studies
The primary objective of the first three clinical studies was to compare the agreement of sleep parameters between the device and the gold-standard PSG. The algorithm was used to analyze sensor data and evaluate the performance of the device compared to PSG. The performance of the device for sleep parameters was evaluated by Bland-Altman analysis and percentiles-based limits of agreement (LOA) against pre-determined thresholds of clinical acceptability. The performance of the device for OSA severity output was evaluated as standard diagnostic metrics compared to the PSG at three different AHI cut-offs.
The first clinical study was a retrospective, comparative and open study performed in Belgium in 289 patients. Median measurement bias and LOA were -4.50 min (-41.74 to +35.67), -0.46 event/h (-13.52 to +9.00) and +0.15 event/h (-10.70 to +10.12) for TST, AHI and ORDI. respectively. Performance for OSA severity was as following: sensitivity of 0.99, 0.92, 0.81 and specificity of 0.86, 0.94 and 0.99 for AHI>=5, AHI>=15 and AHI>=30, respectively.
The second clinical study was a retrospective, comparative and open study performed in France in 31 patients. Median measurement bias and LOA were -10.50 min (-37.42 to +25.79), +0.20 event/h (-12.30 to +6.30) and +1.01 event/h (-11.24 to +6.21) for TST, AHI and ORDI, respectively. Performance for OSA severity was as following: sensitivity of 1.00, 0.94, 0.87 and specificity of 0.75, 1.00 and 1.00 for AHI>=5, AHI>=15 and AHI>=30. respectively.
The third clinical study was a retrospective, comparative and open study performed in Belgium in 10 patients. The performance of the device for position discrete states was evaluated as global accuracy compared to the PSG: 93%.
For the fourth clinical study, SpO2 and pulse rate accuracies for the Sunrise sensor 2 were validated in accordance with ISO 80601-2-61:2019 201.12.1.101.2 and Annex EE.2 as recommended by the FDA guidance document Pulse Oximeters - Premarket Notification Submissions [510(k)s]. The SpO2 accuracy (rms value) was found to be 2.70% over the range of 70-100%. The pulse rate accuracy (rms value) was found to be 1.95 beats per minute (bpm) for a claimed measurement range of 51 to 104 bpm.
In addition, a validation study was conducted to demonstrate the ability of the Sunrise
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sensor 2 thermistor to capture airflow. The signal measured by the Sunrise sensor 2 thermistor was compared to that of an oronasal thermal airflow sensor used in PSG and the performance was found to be equivalent for capturing breathing patterns.
8. CONCLUSION
Based on the performance data, the Sunrise device is as safe and as effective as the predicate device and performs equivalently. Therefore, the Sunrise device is substantially equivalent to the predicate device.
N/A