(170 days)
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).
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.
Here's a summary of the acceptance criteria and the studies that prove the device meets those criteria, based on the provided text:
AcuPebble Ox200 Acceptance Criteria and Performance Study Summary
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Target or Reference Performance) | Reported Device Performance (AcuPebble Ox200) |
|---|---|---|
| OSA Diagnostic Indexes | AHI (3% desaturation criteria): Diagnostic Sensitivity > 81.3% (from reference device) | 92.73% |
| AHI (4% desaturation criteria): Diagnostic Sensitivity > 81.3% (from reference device) | 95.92% | |
| AHI (3% desaturation criteria): Diagnostic Specificity > 82.1% (from reference device) | 96.84% | |
| AHI (4% desaturation criteria): Diagnostic Specificity > 82.1% (from reference device) | 97.03% | |
| Pulse Rate (Acoustics) | 50-120bpm, RMS error |
§ 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).