(147 days)
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.
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.
The provided text details the performance data for the Sunrise device to support its substantial equivalence determination. However, it does not explicitly state "acceptance criteria" in a表格 format as requested. Instead, it describes performance metrics (e.g., median measurement bias and LOA, sensitivity, specificity, global accuracy, and RMS values) for various parameters against pre-determined thresholds of clinical acceptability or against a gold standard (PSG).
Based on the provided information, I will infer the acceptance criteria from the reported performance, as these are the values the device did achieve and were deemed sufficient for substantial equivalence.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
As explicit acceptance criteria thresholds are not stated, the "Acceptance Criteria" column will reflect the reported performance that was deemed acceptable for substantial equivalence. The "Reported Device Performance" will reiterate these values.
| Parameter | Acceptance Criteria (Inferred from Reported Performance) | Reported Device Performance |
|---|---|---|
| Study 1 (Belgium, n=289) | ||
| TST Median Bias & LOA | Median bias within -4.50 min and LOA of -41.74 to +35.67 | -4.50 min (-41.74 to +35.67) |
| AHI Median Bias & LOA | Median bias within -0.46 event/h and LOA of -13.52 to +9.00 | -0.46 event/h (-13.52 to +9.00) |
| ORDI Median Bias & LOA | Median bias within +0.15 event/h and LOA of -10.70 to +10.12 | +0.15 event/h (-10.70 to +10.12) |
| Sensitivity (AHI>=5) | >= 0.99 | 0.99 |
| Sensitivity (AHI>=15) | >= 0.92 | 0.92 |
| Sensitivity (AHI>=30) | >= 0.81 | 0.81 |
| Specificity (AHI>=5) | >= 0.86 | 0.86 |
| Specificity (AHI>=15) | >= 0.94 | 0.94 |
| Specificity (AHI>=30) | >= 0.99 | 0.99 |
| Study 2 (France, n=31) | ||
| TST Median Bias & LOA | Median bias within -10.50 min and LOA of -37.42 to +25.79 | -10.50 min (-37.42 to +25.79) |
| AHI Median Bias & LOA | Median bias within +0.20 event/h and LOA of -12.30 to +6.30 | +0.20 event/h (-12.30 to +6.30) |
| ORDI Median Bias & LOA | Median bias within +1.01 event/h and LOA of -11.24 to +6.21 | +1.01 event/h (-11.24 to +6.21) |
| Sensitivity (AHI>=5) | >= 1.00 | 1.00 |
| Sensitivity (AHI>=15) | >= 0.94 | 0.94 |
| Sensitivity (AHI>=30) | >= 0.87 | 0.87 |
| Specificity (AHI>=5) | >= 0.75 | 0.75 |
| Specificity (AHI>=15) | >= 1.00 | 1.00 |
| Specificity (AHI>=30) | >= 1.00 | 1.00 |
| Study 3 (Belgium, n=10) | ||
| Position Discrete States Global Accuracy | >= 93% | 93% |
| Study 4 (SpO2 & Pulse Rate Accuracy) | ||
| SpO2 Accuracy (RMS) |
N/A