(158 days)
The Sunrise Air 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 Air consists of the Sunrise software (v1.28.00), which analyzes data from one of three compatible sensors (Sunrise sensor 1, Sunrise sensor 2, or Sunrise Air) placed on the patient's chin. Sunrise sensor 1 was approved through DEN210015, while Sunrise sensor 2 was cleared through K222262. The current version of the Sunrise device introduces a new sensor, Sunrise Air. The Sunrise device is intended to detect respiratory events, identify sleep stages and position, and generate key sleep parameters—such as the apnea-hypopnea index ("Sunrise AHI") and positional states classifications. The collected data is compiled into a report for further interpretation by a healthcare provider.
The provided FDA 510(k) clearance letter for the Sunrise Air device primarily focuses on demonstrating substantial equivalence to a predicate device, rather than detailing a comprehensive clinical study to prove the device meets specific acceptance criteria for its claimed indications.
The document highlights bench testing for technical equivalence, but lacks the detailed clinical study information typically provided for direct performance claims against established ground truth. Specifically, it states that "No modifications have been made to the Sunrise algorithm used to generate sleep parameters," and that a "validation study of SpO₂ and pulse rate accuracy for the subject device was conducted using raw PPG data acquired during the clinical validation for the Sunrise sensor 2 (K222262)." This suggests reliance on prior clearances for core algorithm performance and a specific re-validation for only the PPG data processing change.
Therefore, many of the requested details about acceptance criteria, clinical study design, and ground truth establishment for the overall device performance (e.g., AHI calculation, OSA evaluation) are not explicitly present in this summary.
Given the information in the provided document, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance:
Based on the information provided, the "acceptance criteria" are implied by the comparisons to the predicate and reference devices, and some specific performance metrics are given for SpO2 and pulse rate. The primary acceptance criterion for the device's main function (evaluation of OSA via AHI) is that "No modifications have been made to the Sunrise algorithm used to generate sleep parameters," implying continued equivalence to the predicate's performance.
| Performance Metric | Acceptance Criteria (Implied/Direct) | Reported Device Performance (Sunrise Air) |
|---|---|---|
| Overall Device Performance (OSA Evaluation) | Implied substantial equivalence to predicate device (Sunrise K222262) in the evaluation of OSA, as no changes were made to the core AHI algorithm. | "No modifications have been made to the Sunrise algorithm used to generate sleep parameters." The device generates "key sleep parameters—such as the apnea-hypopnea index ('Sunrise AHI')." |
| SpO₂ Accuracy | Not explicitly stated but inferred from previous predicate's clearance (K222262). Common standards are often |
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