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The Electric Nasal Aspirator is intended for 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 (model: BC026, BC025 and BC023) consists of main unit, and suction portion working together as one unit. The Electric 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 differences between BC026, BC025, and BC023 are as follows:

1. BC026 has 5 suction levels, while BC023 and BC025 have 3 suction levels.
2. BC026 and BC023 have "Light" function for distracting and pacifying the child. BC025 does not have this function.
3. BC026 and BC023 can pause suction during the suction process. BC025 does not have this feature.
4. BC026 and BC023 have 4 buttons, BC025 has 2 buttons.
5. In addition, BC026, BC025, and BC023 have different Display, Size, Weight, and Appearance.

The provided FDA 510(k) clearance letter and summary for the Electric Nasal Aspirator do not contain specific acceptance criteria for device performance such as sensitivity, specificity, accuracy, or other diagnostic metrics. This device is a powered suction pump and not a diagnostic device that would typically have such performance criteria. The clearance is based on demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical safety and performance testing.

Therefore, many of the requested fields cannot be extracted directly from the provided text as they pertain to clinical performance studies (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, ground truth establishment) that were explicitly not performed.

Here's the information that can be extracted, and an explanation for what cannot:

1. A table of acceptance criteria and the reported device performance

The study that proves the device meets the acceptance criteria is the Non-clinical testing which included product service life, software validation, electromagnetic compatibility and electrical safety, and function tests. The results demonstrated that the Electric Nasal Aspirator meets the requirements of its predefined acceptance criteria and intended use.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable / not provided. The submission explicitly states: "No clinical test data was used to support the decision of substantial equivalence." The testing performed was non-clinical (engineering and safety standards conformance) on the device itself, not on patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable / not provided. As above, no clinical studies with human "ground truth" were conducted.

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

This information is not applicable / not provided. No clinical studies with adjudication were performed.

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

This information is not applicable / not provided. The device is an Electric Nasal Aspirator, a hardware device, not an AI-assisted diagnostic tool.

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

This information is not applicable / not provided. The device is a physical product, not an algorithm.

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

This information is not applicable / not provided. "Ground truth" in the context of clinical studies or AI algorithm evaluation is not relevant as no such studies were conducted. The "truth" for this device's performance is derived from conformance to engineering and safety standards.

8. The sample size for the training set

This information is not applicable / not provided. This device is not an AI/ML algorithm that requires a training set.

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

This information is not applicable / not provided. As above, no training set or ground truth in that context was established.

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