(269 days)
Sonu is indicated for the relief of moderate to severe nasal congestion due to allergic and non-allergic rhinitis. Sonu is a treatment to be used at home by individuals 12 and older.
Sonu is a non-invasive, over the counter (OTC) device designed for the relief of moderate to severe nasal congestion due to allergic and non-allergic rhinitis. Sonu uses acoustic resonance therapy to achieve its therapeutic effect. Sonu consists of an adjustable headband (Sonu Band) with integrated acoustic bone-conduction transducers (hardware), a USB-C Charging Cable (hardware), and a smartphone application (Sonu iOS App) (software) that connects to the Sonu Band. Sonu is indicated for individuals, aged 12 years old and above.
The provided text is related to an FDA 510(k) clearance for the Sonu device, which is an external mechanical stimulator for the relief of nasal congestion. The clearance is specifically for expanding the indications for use to include the pediatric population aged 12-21 years old.
However, the document does not explicitly state specific acceptance criteria in a quantitative manner (e.g., "device must achieve X accuracy"). Instead, it presents clinical study results and concludes that the device is substantially equivalent to its predicate. The "reported device performance" in this context refers to the outcomes of the clinical study, which are used to support this substantial equivalence.
Here's the information extracted and structured based on your request, with an emphasis on what's explicitly stated and what is inferred from the available text:
Acceptance Criteria and Device Performance
Since explicit, quantitative acceptance criteria are not provided in the document, the "acceptance criteria" are inferred from the demonstrated clinical improvement needed to support substantial equivalence for the expanded pediatric population. The device's performance is reported as the statistically significant improvement in the Total Nasal Symptom Score (TNSS) and its nasal congestion sub-score.
| Acceptance Criteria (Inferred from Study Success) | Reported Device Performance |
|---|---|
| Statistical evidence of improvement in nasal congestion for pediatric patients (12-21 years old). | Mean change in Total Nasal Symptom Score (TNSS): |
| -2.42 for 12 to |
N/A