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The Baby Nasal Aspirator is intended for intermittent removal of nasal secretions and mucus from children (age 2~12 years old). This device is ued in a home environment.

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

The provided text is a 510(k) summary for a Baby Nasal Aspirator. It describes the device, its intended use, and a comparison with a predicate device to establish substantial equivalence. However, it does not include acceptance criteria, performance data in a table format, or details about a study proving the device meets acceptance criteria in the way typically expected for an AI/ML device.

Here's an analysis based on the information provided, highlighting what's present and what's missing in relation to your request about acceptance criteria and a study:

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

• Missing. The document states: "In order to verify and assure the performance of the Baby Nasal Aspirator, we have conducted the product appearance test (color, dimension, weight, etc.), product performance test (vacuum pressure, noise level, flow rate, etc.), and verification on lithium battery power indication."
• It mentions "vacuum pressure (52 - 60 Kpa) is the same as the predicate device" but does not explicitly state this as an acceptance criterion with a numerical target and then present the measured performance in a table. It also refers to compliance with IEC 60601-1 and IEC 60601-1-2 which are standards for medical electrical equipment, indicating safety and essential performance criteria were met, but details are not provided.

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

• Not applicable / Missing. This device is a physical medical device (a nasal aspirator), not an AI/ML or software device that processes data. Therefore, there is no "test set" in the context of data for an algorithm. The "tests" performed were physical product performance tests. The document does not specify the number of units tested for appearance, vacuum pressure, noise level, or flow rate.

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)

• Not applicable. As this is a physical device and not an AI/ML algorithm requiring expert opinion for ground truth, this information is not relevant or provided.

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

• Not applicable. No adjudication method is described as this is not a study assessing interpretations of data by multiple experts.

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 a standalone nasal aspirator, not an AI-assisted diagnostic or interpretive tool for "human readers." No MRMC study was conducted or is relevant.

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

• Not applicable. This is a physical device, not an algorithm.

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

• Not applicable. For a physical device like a nasal aspirator, "ground truth" would relate to objective measurements against engineering specifications and safety standards (e.g., measured vacuum pressure against a specified range, noise levels against acceptable limits, compliance with electrical safety standards). These are typically verified through direct measurement and testing rather than expert-derived ground truth as in AI/ML applications.

8. The sample size for the training set

• Not applicable. This refers to AI/ML algorithms. There is no concept of a "training set" for a physical device like a nasal aspirator.

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

• Not applicable. See point 8.

Summary based on the provided document:

The document describes the regulatory clearance for a physical medical device, a Baby Nasal Aspirator. The "study" mentioned for demonstrating substantial equivalence consisted of non-clinical performance tests.

• Acceptance Criteria (Implicit/Inferred from the text):

  • Vacuum pressure: 52 - 60 Kpa (same as predicate device).
  • Compliance with safety standards: IEC 60601-1 and IEC 60601-1-2.
  • Product appearance: Conformance to design (color, dimensions, weight).
  • Noise level: Within acceptable limits ( implied by "product performance test").
  • Flow rate: Conformance (implied by "product performance test").
  • Lithium battery power indication: Verification conducted.

• Reported Device Performance:

  • "The vacuum pressure (52 - 60 Kpa) is the same as the predicate device."
  • "The device complies with IEC 60601-1 and IEC 60601-1-2 requirements."
  • Other tests (appearance, noise level, flow rate, battery indication) were "conducted to verify and assure the performance" and "demonstrate substantial equivalence," implying they met their respective criteria, although specific numerical results are not detailed.

• Study Description:

  • Type of Study: Non-clinical bench testing.
  • Tests Performed: Product appearance test (color, dimension, weight), product performance test (vacuum pressure, noise level, flow rate), and verification on lithium battery power indication.
  • Sample Size: Not specified for any of the individual tests. This is common for bench testing of physical devices where a small representative sample is typically used to confirm design specifications.
  • Data Provenance: Not applicable in the sense of patient data. The testing was conducted on manufactured device units.
  • Ground Truth: Objective measurements against engineering specifications and recognized safety standards (IEC 60601-1, IEC 60601-1-2).
  • No clinical data: The document explicitly states, "Not applicable, there is no clinical data."

In conclusion, the request is largely framed for an AI/ML device or a diagnostic device involving human interpretation, which does not align with the nature of the Baby Nasal Aspirator described in the provided FDA 510(k) summary. The document confirms that the device underwent non-clinical performance testing to demonstrate substantial equivalence to a predicate device, meeting relevant safety and performance standards.

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