(323 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 Ectosense NightOwl comprises a sensor that is worn on the fingertip (the "NightOwl Sensor") and cloud-based analysis software (the "NightOwl Software").
The NightOwl Sensor is a small biocompatible enclosure with a sensor window made from PMMA (bottom part) and ABS (top part). 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).
If the data is stored on the device, the data is retrieved when the NightOwl sensor is returned to the prescribing HCP and passed up to a cloud-based signal processing suite, the NightOwl Software.
If the device is used in Streaming mode, the data is stored by the Ectosense app on the smartphone during the recording. At the end of the recording, it is then passed directly up to the cloud-based signal processing suite.
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 the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly present acceptance criteria in a formal table with pass/fail thresholds. Instead, it describes various tests and their outcomes. The closest information related to "acceptance criteria" and "reported device performance" for the primary function (pAHI accuracy) is derived from the clinical study results.
Derived Acceptance Criteria & Reported Performance for pAHI Accuracy:
| Performance Metric | Implied Acceptance Criteria (based on reported results) | Reported Device Performance |
|---|---|---|
| pAHI Correlation to PSG | Strong correlation to PSG AHI | Regression line: AHI (Expert PSG) = 0.9981 x pAHI (NightOwl) + 2.235 |
| Sensitivity (AHI cutoff 5) | High sensitivity to detect sleep apnea | 0.943 (Belgium study), 0.936 (US study) |
| Specificity (AHI cutoff 5) | Moderate to high specificity to identify non-apnea cases | 0.813 (Belgium study), 0.727 (US study) |
Other Performance Data (No explicit criteria given, but compliance is stated):
- Biocompatibility: Passed tests (Cytotoxicity, Sensitization, Irritation) in accordance with ISO 10993-1.
- Electrical Safety & EMC: Complied with IEC60601-1:2012 and IEC60601-1-2:2014, including bench tests for close-proximity RF emitters.
- Software Verification & Validation: Documentation provided as per FDA guidance, considered "moderate" level of concern.
- SpO2 Accuracy: Within pass/fail criteria of ISO80601-2-61:2019 Clause 201.12.1.101.1.
- Pulse Rate RMS: 2.26 bpm for claimed range of 50 to 118 bpm (within acceptable limits per ISO 80601-2-61:2019 Annex EE.2, implied acceptance).
2. Sample Size Used for the Test Set and Data Provenance
The text mentions "three clinical studies" and then details two "comparison to PSG Sleep Lab Results" studies, one in Belgium and one in the United States, followed by a "pooled analysis." It doesn't explicitly state the sample size for each individual study, nor the combined sample size.
- Data Provenance: Belgium and United States (sleep lab settings).
- Retrospective or Prospective: Not explicitly stated, but the description of "clinical trials" and "repeat study" suggests prospective data collection for validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document refers to the "gold standard analysis of the polysomnography (PSG)" and "AHI (Expert PSG)" in the regression formula. However, it does not specify:
- The number of experts involved in establishing the PSG ground truth.
- The qualifications of these experts (e.g., board-certified sleep physicians, polysomnography technologists).
4. Adjudication Method for the Test Set
The document states that the ground truth was the "gold standard analysis of the polysomnography (PSG)." It does not mention any specific adjudication method (e.g., 2+1, 3+1 consensus) for establishing this PSG ground truth. It implies that the standard clinical PSG analysis was used as the ground truth.
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
The document does not describe an MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The studies focused on the standalone performance of the NightOwl device (its pAHI accuracy compared to PSG).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, a standalone study was done. The clinical studies described focused on validating the NightOwl device's accuracy in calculating pAHI against the "gold standard" PSG. This means the device's algorithm output was directly compared to the PSG, indicating a standalone performance evaluation.
7. The Type of Ground Truth Used
The primary ground truth used for the pAHI accuracy validation was:
- Polysomnography (PSG) Analysis: Referred to as the "gold standard" and "Expert PSG." This typically involves detailed scoring of sleep stages, respiratory events (apneas, hypopneas), and other physiological parameters by trained personnel following established scoring rules.
8. The Sample Size for the Training Set
The document does not provide any information about the sample size used for the training set of the NightOwl's algorithms. It only discusses the clinical validation studies (test sets).
9. How the Ground Truth for the Training Set was Established
Since the document does not mention the training set, it does not describe how the ground truth for any training set was established. The clinical studies described are clearly for validation/testing purposes.
§ 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).