(147 days)
Unknown
The description mentions "analyzes data" and "identifies sleep stages and position," which could potentially involve AI/ML, but there is no explicit mention of AI, ML, or related terms, nor is there information about training or test sets typically associated with AI/ML development.
No
The device is described as a "non-invasive home care aid in the evaluation of obstructive sleep apnea (OSA)", indicating it is for diagnosis or assessment, not treatment.
Yes
The "Intended Use" section explicitly states that the device is "a non-invasive home care aid in the evaluation of obstructive sleep apnea (OSA)". The "Device Description" further clarifies that it "detects respiratory events, identifies sleep stages and position" and "generates sleep parameters, e.g. apnea hypopnea index 'Sunrise AHI'", with collected data integrated into a report "for further interpretation by the healthcare provider." These functions indicate the device's role in diagnosing or aiding in the diagnosis of sleep apnea.
No
The device description explicitly states that the software analyzes data from a "sensor (Sunrise sensor 1 or Sunrise sensor 2)" which is a hardware component. The performance studies also include validation of the sensor's accuracy (SpO2, pulse rate, thermistor), indicating the device is a system comprising both hardware and software.
Based on the provided information, the Sunrise device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. This typically includes blood, urine, tissue, etc.
- The Sunrise device analyzes data from a sensor placed on the patient's chin. This is a non-invasive method of collecting physiological data (likely related to jaw movement, sound, or other indicators of breathing during sleep). It is not analyzing a biological sample taken from the body.
The device is described as a "non-invasive home care aid" that analyzes data from a sensor placed externally on the patient. This aligns with the definition of a medical device used for diagnosis or monitoring, but not specifically an IVD.
N/A
Intended Use / 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.
Product codes
QRS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Chin
Indicated Patient Age Range
18 years and older
Intended User / Care Setting
Home care aid (Home setting), interpretation by the healthcare provider.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance 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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
First clinical study:
Sensitivity: 0.99 (AHI>=5), 0.92 (AHI>=15), 0.81 (AHI>=30)
Specificity: 0.86 (AHI>=5), 0.94 (AHI>=15), 0.99 (AHI>=30)
Second clinical study:
Sensitivity: 1.00 (AHI>=5), 0.94 (AHI>=15), 0.87 (AHI>=30)
Specificity: 0.75 (AHI>=5), 1.00 (AHI>=15), 1.00 (AHI>=30)
Third clinical study:
Global accuracy for position discrete states: 93%
Fourth clinical study:
SpO2 accuracy (rms value): 2.70% over the range of 70-100%
Pulse rate accuracy (rms value): 1.95 beats per minute (bpm) for a claimed measurement range of 51 to 104 bpm
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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
2
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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3
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 device
Sunrise | Predicate
device
Sunrise sleep
disorder
diagnostic aid
(DEN210015) | Reference
device 1
NightOwl
(K191031) | Reference device 2
SOMNOscreen
plus (K201054) | Comparison |
|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
use/indication
s for use | The Sunrise
medical 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
SDDA 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 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 | The
SOMNOscreen®
plus is indicated for
use in the
recording,
displaying,
monitoring,
printing, and
storage of
biophysical
parameters for the
purpose of assisting
in the diagnosis of
Neurological and
Sleep Disorders.
The device is a non-
life-supporting
physiological signal
recording device
intended to be used
for studies testing
adults and | Same as
predicate
device |
| 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 | Accelerometer
Gyroscope
PPG (Sunrise sensor 2 only)
Thermistor
(Sunrise sensor 2 only) | Accelerometer
Gyroscope | Accelerometer
PPG | 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 movements
Discrete position
SpO2 (Sunrise sensor 2 only)
Pulse rate
(Sunrise sensor 2 only) | Mandibular movements
Discrete position | PAT
SpO2
Pulse 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 device
Sunrise | Predicate
device | Reference
device 1 | Reference device 2 | Comparison |
| | | Sunrise sleep
disorder
diagnostic aid
(DEN210015) | NightOwl
(K191031) | SOMNOscreen
plus (K201054) | |
| | Airflow
(Sunrise sensor
2 only) | | | | as reference
device 2 for
airflow |
| Size and
weight | 42x17x6mm -
3g (Sunrise
sensor 1)
40x22x12mm -
8g (Sunrise
sensor 2) | 42x17x6mm -
3g | 19x28x11mm -
6g | Multiple sensors of
different sizes and
weights | Same as
predicate
device (Sunrise
sensor 1)
Substantially
equivalent to
predicate
device (Sunrise
sensor 2) |
| Raw data
recording | Streamed to
smartphone
(Sunrise sensor
- or on-board
memory
(Sunrise sensor -
| Streamed to
smartphone | Streamed to
smartphone or
on-board
memory | Streamed to
computer or on-
board memory | Same as
predicate
device (Sunrise
sensor 1)
Substantially
equivalent to
predicate
device and
same as
reference
device 1
(Sunrise sensor
2) |
| Power supply | Non-
rechargeable
lithium coin
battery | Non-
rechargeable
lithium coin
battery | Rechargeable
lithium
ion battery | Rechargeable
lithium
ion battery | Same as
predicate
device |
| User interface | Smartphone and
computer | Smartphone and
computer | Smartphone and
computer | Computer | Same as
predicate
device |
| Patient contact
type | In contact with
intact skin
surfaces for
limited duration | In contact with
intact skin
surfaces for
limited duration | In contact with
intact skin
surfaces for
limited duration | In contact with
intact skin surfaces
for limited duration | Same as
predicate
device |
| Wearable
sensor
software | Firmware is
limited to
control the
recording and
communication
s processes | Firmware is
limited to
control the
recording and
communication
s processes | Firmware is
limited to
control the
recording and
communication
s processes | Firmware is limited
to control the
recording and
communications
processes | Same as
predicate
device |
| Analysis
software | Analysis
performed off
the recording
device,
exclusively | Analysis
performed off
the recording
device,
exclusively | Analysis
performed off
the recording
device,
exclusively | Analysis performed
off the recording by
the proprietary
software | Same as
predicate
device |
| Item | Subject device
Sunrise | Predicate device
Sunrise sleep disorder diagnostic aid
(DEN210015) | Reference device 1
NightOwl
(K191031) | Reference device 2
SOMNOscreen plus (K201054) | Comparison |
| | the proprietary
software | the proprietary
software | the proprietary
software | | |
| Sterility | Non-sterile | Non-sterile | Non-sterile | Non-sterile | Same as
predicate
device |
| Reported
parameters | TST, SOL,
WASO, SE,
awakening
index, ArI,
light/deep/REM
sleep, REM
sleep latency,
AHI, AHI
supine, AHI
non supine,
AHI REM, AHI
NREM, ORDI,
ORDI supine,
ORDI non
supine, ORDI
REM, ORDI
NREM, RDI,
OAHI, CAHI,
AHI (4%),
RERA index,
RE, sleep time
in supine
position and
sleep time in
non supine
position
SpO2 and pulse
rate statistics
(Sunrise sensor
2 only) | TST, SOL,
WASO, SE,
ArI, ORDI,
sleep time in
supine position
and sleep time
in non supine
position | TST, REM
sleep, AHI,
AHI (4%),
SpO2 and pulse
rate statistics | TST, SOL, WASO,
SE, awakening
index, ArI,
light/deep/REM
sleep, REM sleep
latency, AHI, AHI
supine, AHI non
supine, AHI REM,
AHI NREM, ORDI,
ORDI supine,
ORDI non supine,
ORDI REM, ORDI
NREM, RDI,
OAHI, CAHI, AHI
(4%), RERA index,
RE, sleep time in
supine position,
sleep time in non
supine position,
SpO2 and pulse rate
statistics | Same as
predicate
device for TST,
SOL, WASO,
SE, ArI, ORDI,
sleep time in
supine position
and sleep time
in non supine
position, same
as reference
device 1 for
TST, REM
sleep, AHI,
AHI (4%),
SpO2 and pulse
rate statistics,
and same as
reference
device 2 for
TST, SOL,
WASO, SE,
awakening
index, ArI,
light/deep/RE
M sleep, REM
sleep latency,
AHI, AHI
supine, AHI
non supine,
AHI REM,
AHI NREM,
ORDI, ORDI
supine, ORDI
non supine,
ORDI REM,
ORDI NREM,
RDI, OAHI,
CAHI, AHI
(4%), RERA
index, RE,
sleep time in
supine position,
sleep time in
non supine |
| Item | Subject device
Sunrise | Predicate
device
Sunrise sleep
disorder
diagnostic aid
(DEN210015) | Reference
device 1
NightOwl
(K191031) | Reference device 2
SOMNOscreen
plus (K201054) | Comparison |
| | | | | | non supine
position, SpO2
and pulse rate
statistics |
| Pulse rate
accuracy and
measurement
range | Accuracy (rms
value) was
found to be 1.95
beats per
minute (bpm)
for a claimed
measurement
range of 51 to
104 bpm
(Sunrise sensor
2 only) | Not applicable | Accuracy (rms)
value was found
to be 2.26 beats
per minute
(bpm) for a
claimed
measurement
range of 50 to
118 bpm | Claimed
measurement range
of 18 to 300 beats
per minute (bpm) | Substantially
equivalent to
reference
device 1 |
| Means of
attachment | Adhesives | Adhesives | Adhesives | Multiple means
including adhesives | Same as
predicate
device |
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6
7
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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.
9
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
10
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.