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The Electronic Nasal Aspirator is intermittent removal of nasal secretions and mucus from children (age 2-12 years old). This device is used in a home environment.

Electric nasal aspirator consists of main unit, and suction working together as one unit. The Electronic Nasal Aspirator is a portable device which is intended for suction of nasal passages in children 2-12 years of age. The motor pump provides a negative pressure which removes nasal secretions. The motor pump operates on a rechargeable battery. The rechargeable battery can be charged from the external power adapter(not included in this device) through the provided charging line. The user interface consists of buttons and LED display, and the user can control the vacuum pressure through the button.

The provided text describes a 510(k) premarket notification for an Electric nasal aspirator. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through extensive clinical trials. Therefore, the information typically requested in your prompt regarding acceptance criteria, specific performance metrics, and clinical study details (like sample size for test sets, expert qualifications, MRMC studies, effect size, etc.) for AI/ML-driven diagnostic devices is not extensively detailed for this product.

Here's an analysis of the provided information, addressing your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The submission states that a series of safety and performance tests were conducted and that the "Electric nasal aspirator meets the requirements of its predefined acceptance criteria and intended use." However, it does not provide a specific table of quantitative acceptance criteria alongside corresponding test results for parameters like "Product service life," "Software validation," or "Function test." Instead, it indicates compliance with recognized standards.

The study proving the device meets the acceptance criteria is the non-clinical testing described in section 6.1 and 7. These tests confirm the device's adherence to various international and enterprise standards related to safety, electromagnetic compatibility, biocompatibility, software, and performance.

2. Sample size used for the test set and the data provenance

The document explicitly states: "No clinical test data was used to support the decision of substantial equivalence." Therefore, there is no test set in the clinical sense, and thus no sample size or data provenance to report for a clinical test set. The testing performed was non-clinical (engineering and lab-based), using the device itself or its components.

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

Not applicable, as no clinical test data was used and hence no ground truth established by experts for a clinical test set. The "ground truth" for the non-clinical tests would be the requirements defined by the standards themselves, validated through engineering measurement and analysis.

4. Adjudication method for the test set

Not applicable, as no clinical test set requiring adjudication was used.

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

Not applicable. This device is an Electric Nasal Aspirator, a hardware medical device, not an AI/ML-driven diagnostic tool. Therefore, MRMC studies and AI assistance comparisons are not relevant.

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

Not applicable, as this is a hardware device, not an algorithm.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" is defined by the international and enterprise standards that the device conforms to (e.g., IEC 60601-1 for safety, ISO 10993 for biocompatibility). Compliance with these standards is considered sufficient for demonstrating safety and performance in the context of this 510(k) submission.

8. The sample size for the training set

Not applicable. This is a hardware device, not an AI/ML system that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this device.

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