(170 days)
No
The summary explicitly states that the OSA diagnostic indexes are extracted using the "same algorithms" as the previously cleared device (K222950) and "remain unchanged". There is no mention of AI or ML being used for analysis or any other function.
No.
The device is intended for the recording, analysis, displaying, exporting, and storage of biophysical parameters to aid in the evaluation of adult patients with, or with suspected, obstructive sleep apnea. It does not provide therapy or treatment.
Yes.
The device is intended to aid in the evaluation of adult patients with, or with suspected, obstructive sleep apnea (OSA), which inherently points to a diagnostic purpose.
No
The device description explicitly states that the AcuPebble Ox200 comprises hardware components: a microphone/accelerometer sensor and a PPG/accelerometer sensor.
Based on the provided information, the AcuPebble Ox200 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- AcuPebble Ox200 Function: The AcuPebble Ox200 is a wearable device that records biophysical parameters directly from the patient's body (neck, finger, forehead). It analyzes these signals to aid in the evaluation of obstructive sleep apnea. It does not analyze specimens taken from the body.
Therefore, while it is a medical device used for diagnosis, it falls under the category of a physiological monitoring device rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
AcuPebble Ox200 is a wearable device intended for use in the recording, analysis, displaying, exporting, and storage of biophysical parameters to aid in the evaluation of adult patients with, or with suspected, obstructive sleep apnea (OSA). The device is primarily intended for home setting use (although can also be used in healthcare settings) under the direction of a Healthcare Professional (HCP).
Product codes
MNR
Device Description
AcuPebble Ox200 is prescribed by a Health Care Professional for the patient to use in the home as a 'home sleep apnea test' (HSAT). AcuPebble Ox200 comprises: 1- A small microphones/accelerometer sensor, identical to the one in the previously cleared devices AcuPebble SA100 (K210480) and AcuPebble Ox100 (K222950) that is worn on the front of the neck around the suprasternal notch area (the "AcuPebble SA100 sensor"), and attaches with a single use biocompatible adhesive tape (same one as for "AcuPebble SA100" and "AcuPebble Ox100)); 2- Another PPG/accelerometer sensor ("AcuPebble_oximetry sensor") worn either on the finger or on the forehead; 2- A mobile device app (the "AcuPebble Ox200 app") that guides the patient through the steps of the test, collects the data from the sensors, and uploads them in the cloud ; 3- A cloud-based software that analyses the collected signals as in the previously cleared devices; 4- A web app user interface for healthcare professionals where they can set up a study and see the results, including different physiological channel traces and OSA diagnostic parameters, as in the previously cleared devices.
The differences between AcuPebble Ox200 and the previously cleared device (K222950) are:
- A new sensor for sensing the PPG signal and extraction of the SpO2 and pulse rate channel from. This new sensor can be placed either on the finger or the forehead.
- The addition of new parameters extracted from the acoustic neck sensor including position, respiratory efforts and respiratory rate channels.
The OSA diagnostic indexes are still extracted from the signals measured with the identical sensor as in the predicate (neck sensor only), and with the same algorithms, remain unchanged with respect to the predicate device (K222950) and hence have not been separately tested in this device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
front of the neck around the suprasternal notch area, finger, forehead
Indicated Patient Age Range
adult patients
Intended User / Care Setting
Healthcare Professional (HCP) / home setting (can also be used in healthcare settings)
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
SpO2 and pulse rate output validation:
- Sample size: 12 subjects
- Data source: Independent testing lab
- Annotation protocol: Not specified. Validated as per ISO 80601-2-61:2017.
Respiratory rate validation:
- First study:
- Sample size: 31 healthy subjects
- Data source: Laboratory conditions against capnography (K150272)
- Annotation protocol: Not specified.
- Second study:
- Sample size: 150 patients
- Data source: Natural sleep in patients referred for diagnosis of OSA to the Sleep and Ventilation clinic at the Royal Free London Hospital NHS Foundation Trust (Trial registration number: NCT03544086). Compared to the chest and abdomen respiratory effort band of Embletta MPR Sleep Data Recording System (K122516).
- Annotation protocol: Not specified.
Respiratory effort detection validation:
- Sample size: 150 patients
- Data source: Natural sleep in patients referred for OSA diagnosis at the Sleep and Ventilation Clinic at the Royal Free London Hospital NHS Foundation Trust (Trial registration number: NCT03544086). Validated against respiratory inductance plethysmography (RIP) bands.
- Annotation protocol: Manual scoring by two clinicians against RIP band scoring. Automatic scoring from the FDA-cleared device Embla RemLogic (K162140).
Body position detection validation:
- First study:
- Sample size: 17 volunteers
- Data source: Laboratory conditions.
- Annotation protocol: Not specified.
- Second study:
- Sample size: 60 patients
- Data source: Data collected during natural sleep from patients referred for OSA diagnosis at Virgen Macarena Hospital, Spain (Trial registration number: NCT04028011).
- Annotation protocol: Not specified.
Summary of Performance Studies
SpO2 and pulse rate output validation:
- Study type: Clinical validation
- Sample size: 12 subjects
- Key results:
- SpO2 Arms (70% to 100% range): 1.86 (forehead), 2.25 (finger).
- SpO2 Arms (lightest skin tone): 1.63 (forehead), 1.44 (finger).
- SpO2 Arms (darkest skin tone): 0.66 (forehead), 1.36 (finger).
- Pulse rate (clinical): Average RMSE 1.23 bpm (forehead and finger).
- Pulse rate (functional simulator): Average RMSE 0.55 bpm, worst case RMSE 1.66 bpm.
Respiratory rate validation:
- Study type: Clinical validation
- Sample size: 31 healthy subjects (laboratory), 150 patients (natural sleep)
- Key results:
- Overall RMSD: 2.52 bpm (laboratory, 4-30bpm range).
- RMSD: 2.46 bpm (natural sleep).
Respiratory effort detection validation:
- Study type: Clinical validation
- Sample size: 150 patients
- Key results:
- Agreement in differentiating between apnoea with no breathing effort vs with effort (manual scoring): 96.8%.
- Accuracy of AcuPebble's respiratory effort channels (automatic scoring): 96.3%.
- Accuracy of RIP bands (automatic scoring): 75.9%.
Body position detection validation:
- Study type: Clinical validation
- Sample size: 17 volunteers (laboratory), 60 patients (natural sleep)
- Key results:
- Overall accuracy (laboratory): 93.93%.
- Accuracy (natural sleep): 79.00%.
- Accuracy in detecting supine versus non-supine positions (natural sleep): 83.59%.
Key Metrics
- Diagnostic Sensitivity: 92.73% /95.92% (CI- 82.41% to 97.98% /86.02% to 99.50%)
- Diagnostic Specificity: 96.84% /97.03%
- Pulse rate validation accuracy: 3.62bpm (from acoustics), Arms
§ 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).
0
March 19, 2025
Image /page/0/Picture/1 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 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.
Acurable Limited Esther Rodriguez-Villegas CSO 2 Leman Street London, E1W 9US United Kingdom
Re: K243092
Trade/Device Name: AcuPebble Ox200 Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: Class II Product Code: MNR Dated: February 10, 2025 Received: February 10, 2025
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 (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.
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"
1
(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 (QS) 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 OS 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 Rue"). 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-devices/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 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).
2
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)
Device Name
AcuPebble Ox200
Indications for Use (Describe)
AcuPebble Ox200 is a wearable device intended for use in the recording, analysis, displaying, exporting, and storage of biophysical parameters to aid in the evaluation of adult patients with, or with suspected, obstructive sleep apnea (OSA). The device is primarily intended for home setting use (although can also be used in healthcare settings) under the direction of a Healthcare Professional (HCP).
Type of Use (Select one or both, as applicable)
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
4
QCU
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 Limited
2 Leman Street, London E1W 9US, UK |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Professor Esther Rodriguez-Villegas
CSO
Acurable Ltd
20 Victoria Street, SW1H ONB, London, UK
esther@acurable.com
+442075946193 |
| Date summary prepared: | 18th Mar 2025 |
| Trade Name: | AcuPebble Ox200 |
| Product Classification Name: | Ventilatory effort recorder |
| Regulation number: | 21 CFR §868.2375 (Breathing Frequency
Monitor) |
| Product Code: | MNR |
| Classification Panel: | Anaesthesiology |
| Device Classification: | Class II |
5
1. Intended Use / Indications for Use
AcuPebble Ox200 is a wearable device intended for use in the recording, analysis, displaying, exporting, and storage of biophysical parameters to aid in the evaluation of adult patients with, or with suspected, obstructive sleep apnea (OSA). The device is primarily intended for home setting use (although can also be used in healthcare settings) under the direction of a Healthcare Professional (HCP).
2. Device Description
AcuPebble Ox200 is prescribed by a Health Care Professional for the patient to use in the home as a 'home sleep apnea test' (HSAT). AcuPebble Ox200 comprises: 1- A small microphones/accelerometer sensor, identical to the one in the previously cleared devices AcuPebble SA100 (K210480) and AcuPebble Ox100 (K222950) that is worn on the front of the neck around the suprasternal notch area (the "AcuPebble SA100 sensor"), and attaches with a single use biocompatible adhesive tape (same one as for "AcuPebble SA100" and "AcuPebble Ox100)); 2- Another PPG/accelerometer sensor ("AcuPebble_oximetry sensor") worn either on the finger or on the forehead; 2- A mobile device app (the "AcuPebble Ox200 app") that guides the patient through the steps of the test, collects the data from the sensors, and uploads them in the cloud ; 3- A cloud-based software that analyses the collected signals as in the previously cleared devices; 4- A web app user interface for healthcare professionals where they can set up a study and see the results, including different physiological channel traces and OSA diagnostic parameters, as in the previously cleared devices.
The differences between AcuPebble Ox200 and the previously cleared device (K222950) are:
- A new sensor for sensing the PPG signal and extraction of the SpO2 and pulse rate channel from. This new sensor can be placed either on the finger or the forehead.
- The addition of new parameters extracted from the acoustic neck sensor including position, respiratory efforts and respiratory rate channels.
The OSA diagnostic indexes are still extracted from the signals measured with the identical sensor as in the predicate (neck sensor only), and with the same algorithms, remain unchanged with respect to the predicate device (K222950) and hence have not been separately tested in this device.
3. Predicate Device
The predicate device is shown in the Table below:
| K number | Product Code | Class | Device Name |
|---|---|---|---|
| K222950 | MNR | II | AcuPebble Ox100 |
The reference devices are shown in the Table below:
6
| K number | Product Code | Class | Device Name |
|---|---|---|---|
| K242798 | BZQ | II | Airmod |
| K240285 | MNR | II | Huxley SANSA Home Sleep |
| Apnea Test (1000-00) |
7
4. Summary of Comparison to Predicate
| | DEVICE SUBJECT OF
THIS APPLICATION | PREDICATE DEVICE | REFERENCE DEVICE (1) | REFERENCE DEVICE (2) | COMPARISON |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
| | AcuPebble Ox200
K243092, by
Acurable Ltd | AcuPebble Ox100,
K222950, by
Acurable Ltd | AIRMOD,
K242798, by Heroic
Faith International Ltd. | HUXLEY SANSA HOME
SLEEP APNEA TEST
(1000-00),
K240285, by Huxley
Medical | |
| Indications for
use | AcuPebble Ox200 is a
wearable device intended
for use in the recording,
analysis, displaying,
exporting, and storage of
biophysical parameters to
aid in the evaluation of
adult patients with, or
with suspected,
obstructive sleep apnea
(OSA).The device is
primarily intended for
home setting use
(although it can also be
used in healthcare
settings) under the
direction of a Healthcare
Professional (HCP). | AcuPebble Ox200 is a
wearable device intended for
use in the recording, analysis,
displaying, exporting, and
storage of biophysical
parameters to aid in the
evaluation of adult patients
with, or with suspected,
obstructive sleep apnea
(OSA).The device is primarily
intended for home setting use
(although it can also be used
in healthcare settings) under
the direction of a Healthcare
Professional (HCP). | Airmod, when used in
conjunction with AccurSound
Electronic Stethoscope AS-101,
is a software as medical device
intended to be used for the
continuous, non-invasive
monitoring of respiratory rate
(RR) in adult patients who are
subjected to procedural
sedation and/or anesthesia.
Airmod is intended for use by
healthcare professionals in
hospitals and healthcare
facilities who are legally
credentialed to perform
procedural sedation and/or
anesthesia. Airmod is intended
for Android-based devices only | The Huxley Home Sleep Apnea
Test (SANSA) is a wearable device
intended for use in the recording,
analysis, and storage of
biophysical parameters to aid in
the evaluation of sleep-related
breathing disorders of adults
suspected of sleep apnea. The
device is intended for the clinical
and home use setting under the
direction of a Healthcare
Professional (HCP). | Same as predicate |
| Regulation
number | 868.2375 | 868.2375 | 868.2375 | 868.2375 | Same as predicate |
18th Mar 2025 V- 4 of 14
8
| Product
Code | MNR | MNR | BZQ | MNR/BZQ | Same as predicate | Means of
attachment | Adhesive (patient self-
applied) | Adhesive (patient self-
applied) | N/A | Adhesive | Same as predicate |
|------------------------------------|-----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|---------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Generic
Device Name | Ventilatory Effort
Recorder | Ventilatory Effort Recorder | Breathing Frequency Monitor | Ventilatory Effort
Recorder/Breathing Frequency
Monitor | Same as predicate | Sleep night
use | Multiple nights possible | Multiple nights possible | N/A | Multiple nights possible | Same as predicate |
| Prescription | Prescription | Prescription | Prescription | Prescription | Same as predicate | Portability | Yes (Wearable) | Yes (Wearable) | N/A | Yes (Wearable) | Same as predicate |
| Target
population | Adults | Adults | Adults undergoing procedural
sedation and/or anesthesia | Adults (22 years age and older) | Same as predicate | Size and
weight | 29.5mm diameter x
16mm height, 7g weight
for neck sensor.
17.25mm x 24.6mm x
12.6 mm, 6g weight for
finger/forehead sensor. | 29.5mm diameter x 16mm
height, 7g weight for neck
sensor.
38mm x 30mm x38mm, 15g
weight for finger sensor. | N/A | 131mmx74mmx11mm, 13g,
60mm x51mm x16mm, 45g | Substantially equivalent. The
finger sensor is smaller. This
does not pose any new
questions of safety and
effectiveness. |
| Intended
environment
for use | Primarily home
environment, although it
can be used in
healthcare environments | Primarily home
environment, although it
can be used in healthcare
environments | Hospitals and healthcare
facilities | Clinics and Home Use | Same as predicate | Recording
device | Mobile device records
signals streamed from
the sensors and uploads
them into a cloud-based
server | Mobile device records
signals streamed from the
sensor and uploads them
into a cloud-based server | Compatible stethoscope with
microphone records acoustic
signals | Chest patch sensor record
signals then transferred via USB | Same as predicate |
| Sensor
placement | Front of the neck and
either finger or forehead | Front of the neck and finger | Neck | Chest | Same as predicate if placed in
finger. If placed in the forehead
substantially equivalent.
Performance validated as per
ISO 80601-2-61:2017. | Channels | SPO2, PPG, Pulse rate (x2
from PPG and from
sounds), activity
(movement), heart
sounds, respiration
inhalation and exhalation
patterns, airflow,
respiratory effort,
respiratory rate, snoring,
position | SPO2, PPG, Pulse rate (x2
from PPG and from sounds),
activity (movement), heart
sounds, respiration
inhalation and exhalation
patterns, airflow, snoring | Respiratory rate | Oximetry, Heartrate, Chest
movement, Snoring, Body
position, Respiratory effort,
Actigraphy, Sleep stage
(Sleep/Wake), ECG (Reference
channel only) | AcuPebble Ox200 is
substantially equivalent to the
predicate device. While
AcuPebble Ox200 outputs
additional channels compared
to the predicate device, these
outputs are technologically
consistent with those of the
reference device. Validation
testing has demonstrated that
the additional outputs perform |
| Physical
sensing
elements | Piezoelectric
(microphones)/
LED+photodiode/acceler
ometers | Piezoelectric (microphones)/
LED+photodiode/accelerom
eters | N/A (Software to be used in
conjunction with AccurSound
Electronic Stethoscope AS-
101) | Accelerometer, ECG,
Reflectance
Photoplethysmography | Same as predicate | | | | | | |
| Patient
contact | Yes | Yes | N/A | Yes | Same as predicate | | | | | | |
9
10
| | Types of
events used
for OSA
indexes | Apneas/hypopneas | Apneas/hypopneas | N/A | N/A | equivalently to the reference
device, and no new questions
of safety and effectiveness are
raised. |
|--------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Calculated
OSA AASM
recommende
d indexes | AHI (with 3%
desaturation criteria),
AHI (with 4%
desaturation criteria) | AHI (with 3% desaturation
criteria), AHI (with 4%
desaturation criteria) | N/A | SDB | Same as predicate |
| | Diagnostic
Sensitivity | 92.73% /95.92%
(CI- 82.41% to 97.98%
/86.02% to 99.50%) | 92.73% /95.92%
(CI- 82.41% to 97.98%
/86.02% to 99.50%) | N/A | 88.2% (CI: 81.3% to 93.2%) | Same as predicate |
| | Diagnostic
Specificity | 96.84% /97.03% | 96.84% /97.03% | N/A | 87.3% (CI: 82.1% to 91.5%) | Same as predicate |
| | Pulse rate | 50-120bpm (3.62bpm
validation accuracy from
acoustics,
Arms