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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.

Additional Study Information:

1. Sample size used for the test set and the data provenance:

   • Sample Size: 31 subjects (15 for 12 to <16 years old, 16 for 16 to <22 years old).
   • Data Provenance: Not explicitly stated, but the study was described as an "interventional study," suggesting prospective data collection. The country of origin is not specified.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This information is not provided in the document. The study uses patient-reported scores (TNSS and nasal congestion sub-score) as outcome measures, which are subjective assessments by the subjects themselves rather than an expert-established "ground truth" in the traditional sense (like expert review of imaging).

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • This information is not provided as the study did not involve expert adjudication for establishing a ground truth.

4. 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:

   • A multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This study design is typically used for diagnostic devices involving human interpretation (e.g., radiologists reading images) and comparing performance with and without AI assistance. The Sonu device is a therapeutic device, and the clinical study focuses on treatment effectiveness.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • The Sonu device itself is the standalone therapeutic device; its performance is measured by its direct effect on patient symptoms. The study evaluates the device's therapeutic effect directly in subjects. While there is a "Sonu iOS App" (software), its function is to control the device, and the effectiveness is tied to the complete system, not just the software in isolation in a diagnostic context. Therefore, a "standalone" algorithm-only performance study in the typical diagnostic AI sense was not performed or relevant.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" (or primary outcome measures) used for the clinical study consisted of patient-reported outcomes data, specifically the Total Nasal Symptom Score (TNSS) and its nasal congestion sub-score. These are subjective measures of symptom severity reported by the subjects themselves.

7. The sample size for the training set:

   • This information is not applicable and not provided. The clinical study described is an interventional study to assess the device's therapeutic effect, not a study to train a machine learning algorithm. The software component (Sonu iOS App) indicates "software development and testing was executed in compliance with IEC 62304," but this refers to software validation, not algorithm training data.

8. How the ground truth for the training set was established:

   • This information is not applicable as there was no explicit "training set" for a machine learning algorithm described in the clinical study.

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