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Geonic Nasal Aspirator (Model Name: AH2, S1) and Geonic Nasal Cleaner (Model Name: H2) are hand-held, noninvasive, electronic medical devices that pressure to remove nasal secretions and mucus from children (age 2-12 years old). Geonic Nasal Cleaner (Model Name: H2) additionally provide positive pressure to moisturize the nasal cavities by using saline solution in the form of spray for adults and pediatrics (3 years old). The nasal aspirator and nasal cleaner are intended for over-the-counter (OTC) use at home environment.

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I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, or any studies conducted to prove the device meets specific criteria. The document is an FDA 510(k) clearance letter for the "Geonic Nasal Aspirator" and "Geonic Nasal Cleaner," which grants market authorization based on substantial equivalence to predicate devices, rather than an evaluation of specific performance metrics against pre-defined acceptance criteria.

The document includes:

• Device Name and Regulation Information
• Indications for Use: Describes the intended use of the devices (removing nasal secretions and mucus from children for the aspirator, and additionally moisturizing nasal cavities for the cleaner).
• Type of Use: Specifies Over-The-Counter (OTC) use.

It does not provide the following information from your request:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts and their qualifications for ground truth establishment.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study details.
6. Standalone performance study details.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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