(50 days)
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 NightOwl comprises a sensor that is worn on the fingertip (the "NightOwl Sensor") over-night whilst the subject is sleeping and cloud-based analysis software (the "NightOwl Software"). The NightOwl Sensor has a small biocompatible enclosure. The sensor has 2 LEDs, one in the red spectrum and the other in the infrared spectrum, and an accelerometer. The sensor is attached to the fingertip by single-use biocompatible adhesive tape, with the sensor window applied against the fingerprint area of the fingertip. The sensor measures the reflected red/infrared signals to record the photoplethysmograph (PPG) signal. The accelerometer is used to detect movement. The data recorded by the NightOwl Sensor can either be stored in on-board memory ("Offline" mode) or streamed via a Bluetooth link to an Ectosense app on a smartphone ("Streaming" mode). The NightOwl Software signal processing algorithms produce a number of sleep and sleep-disordered breathing related traces and parameters. The trace and parameter information are passed to a company-managed database for storage and access by the prescribing Health Care Professional in the Ectosense Dashboard.
Here's a breakdown of the acceptance criteria and study information for the NightOwl device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document focuses on the validation of the "Total REM Time" calculation, as this was the new feature introduced by the device modification. The acceptance criteria themselves are not explicitly stated as numerical thresholds (e.g., "correlation must be > X"). Instead, the performance metrics reported serve as the basis for demonstrating substantial equivalence. The implication is that the reported performance is acceptable for the device's intended use, particularly when compared to the established performance of the previously cleared device for Total Sleep Time.
| Endpoint Parameter | Reported Device Performance (NightOwl, Current Device) |
|---|---|
| Patient Population Size | 71 |
| Total REM Time Root Mean Square Difference | 22.72 minutes |
| Total REM Time Correlation | 0.51 |
| Total REM Time Bias | -1.96 minutes |
| Total REM Time Upper Limit of Agreement | 42.72 minutes |
| Total REM Time Lower Limit of Agreement | -46.64 minutes |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 71 patients
- Data Provenance: The study was conducted in a "US population," implying that the data was collected prospectively for this clinical validation.
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. It states that the NightOwl performance for Total REM Time determination was "compared to the gold standard polysomnography (PSG)." PSG is typically scored by trained polysomnographic technologists and/or sleep physicians, but the exact number and qualifications are not detailed here.
4. Adjudication Method for the Test Set
The document does not explicitly state an adjudication method (e.g., 2+1, 3+1). The comparison is made against the "gold standard polysomnography (PSG)," which implies that the PSG results were considered the definitive ground truth without a separate adjudication process for the test set scores of the device.
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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not reported. This study focuses on the standalone performance of the device's algorithm for Total REM Time against the PSG gold standard. There is no mention of human readers or AI assistance for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance study was done. The "Performance of modified device (Subject)" table directly reports algorithm performance metrics (Root Mean Square Difference, Correlation, Bias, Limits of Agreement) when compared to the "gold standard polysomnography (PSG)." This indicates the algorithm's performance without human intervention in the scoring process.
7. The Type of Ground Truth Used
The type of ground truth used was Polysomnography (PSG), which is referred to as the "gold standard." PSG involves comprehensive physiological monitoring during sleep, typically including electroencephalography (EEG), electrooculography (EOG), electromyography (EMG), and respiratory parameters, among others, from which sleep stages (including REM) are scored by trained professionals.
8. The Sample Size for the Training Set
The document does not provide information regarding the sample size for the training set. The reported study focuses solely on the clinical validation of the modified device's performance for Total REM Time using a test set of 71 patients.
9. How the Ground Truth for the Training Set Was Established
The document does not provide information on how the ground truth for any training set was established. It only details the ground truth used for the validation (test) set (PSG). It states that the "Total REM Time was validated using the identical method and protocol used to validate the TST supporting the previously cleared 510(k)," implying that similar PSG-based ground truth would have been used for any prior training as well, but no specifics are given.
§ 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).