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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 consists of silicone nozzle which has three models (conical nozzle, flat nozzle, angled nozzle), collection cup, air tube, tweezers, charging cable-USB and aspirator body. 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. Three different shapes of silicone nasal tips are provided to enable easier and more effective removal of the nasal mucus.

The provided text is a 510(k) clearance letter and summary for an Electric Nasal Aspirator. It details the device's characteristics and its comparison to a predicate device, along with the performance data submitted to demonstrate substantial equivalence.

However, the nature of this medical device (a nasal aspirator, essentially a suction pump) means the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are focused on engineering performance parameters (e.g., vacuum pressure, flow rate, safety standards) rather than clinical efficacy studies with human subjects that measure the device's ability to diagnose or treat a condition, which is what is typically discussed in the context of "human-in-the-loop performance," "ground truth," "expert consensus," and "MRMC studies" for AI/software-as-a-medical-device (SaMD).

Therefore, the requested information elements related to AI/SaMD (e.g., training set, test set, expert adjudication, MRMC studies, standalone performance, ground truth for image analysis) are not applicable to this specific device submission. The "study" here is a series of bench tests and electrical/biocompatibility assessments.

Below is a breakdown of the applicable acceptance criteria and the "study" (bench testing) as described in the provided text, while explicitly stating when an element is not applicable.

Acceptance Criteria and Device Performance for Electric Nasal Aspirator (K244033)

1. Table of Acceptance Criteria and Reported Device Performance

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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

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The Electronic 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 consists of main unit, and the suction portion 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 is a 510(k) summary for an Electric Nasal Aspirator. This document describes its substantial equivalence to a predicate device based on non-clinical testing. It explicitly states that "No clinical test data was used to support the decision of substantial equivalence."

Therefore, the requested information about acceptance criteria, study details, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth establishment for a clinical study to prove the device meets acceptance criteria cannot be extracted from this document, as no such clinical study was conducted or presented.

The document focuses on demonstrating substantial equivalence through non-clinical testing, which includes various safety and performance benchmarks.

However, based on the non-clinical tests mentioned, we can infer the acceptance criteria and reported performance for those specific tests:

1. Table of Acceptance Criteria and Reported Device Performance (Based on Non-Clinical Tests)

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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.

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