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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

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated as a number of devices tested. The studies described are type testing (verification and validation) against engineering standards (e.g., IEC, ISO). This implies a representative sample of manufactured devices were tested to ensure design compliance. For biocompatibility, electrical safety, EMC, battery safety, and software V&V, these are typically conducted on a limited number of devices or components to demonstrate compliance with the standards' requirements for design verification.
• Data Provenance: The device manufacturer, Shenzhen Desida Technology Co., Ltd. (China), performed these tests. The data provenance is internal testing to support the 510(k) submission. These are bench tests, not clinical data.
  • Retrospective/Prospective: Not applicable as these are bench tests and not clinical studies involving patient data collected over time.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

• Not Applicable. For this type of medical device (Electric Nasal Aspirator), "ground truth" as typically applied to clinical or diagnostic AI/SaMD studies (e.g., for image interpretation) is not established through expert consensus on a test set. The validation relies on meeting pre-defined engineering and safety standards. The "experts" involved would be accredited test houses and engineers specializing in the relevant standards (e.g., electrical safety, biocompatibility).

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods (e.g., 2+1, 3+1) are used in clinical studies, particularly for establishing ground truth in diagnostic accuracy assessments involving human interpretation. This device's validation focuses on engineering performance, not interpretative accuracy.

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 is not an AI/SaMD device, and no MRMC study was conducted. The device is a physical product for suction, not a diagnostic or interpretive tool.

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

• Not Applicable. This is not an algorithm-based device. Performance testing for this device is "standalone" in the sense that the device itself is tested against its specifications and relevant safety standards, without continuous human operation being part of the assessment of device performance (though a human operates it to perform the tests).

7. The Type of Ground Truth Used

• Engineering and Safety Standards: The "ground truth" for this device's acceptance is adherence to established international and national engineering standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 62133-2, ISO 10993 series) and the manufacturer's own verified product requirements derived from these standards and the predicate device's performance. For biocompatibility, this typically involves laboratory assays confirming the absence of cytotoxicity, skin sensitization, and irritation based on ISO 10993 protocols. For physical properties, it involves measurements against specified ranges (e.g., 52-60 KPa vacuum pressure).
• Not clinical outcomes data, pathology, or expert consensus (in the traditional sense for diagnostic/AI devices).

8. The Sample Size for the Training Set

• Not Applicable. This device is a physical product, not an AI/Software device requiring a "training set."

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. As there is no "training set" for this physical device, there is no ground truth established for it in the context of machine learning. The device's design and manufacturing processes are validated against engineering principles and standards.

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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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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)

Points 2 through 9 are not applicable as no clinical study was performed or reported in this document.

2. Sample sizes used for the test set and the data provenance: Not applicable. No clinical test set discussed. Non-clinical tests would use a sample of devices for testing, but no specific numbers are given, nor is "data provenance" in the sense of patient data relevant.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical ground truth established.

4. Adjudication method for the test set: Not applicable.

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 is not an AI device, and no MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable for clinical ground truth. For non-clinical tests, the "ground truth" is defined by the technical specifications and international standards the device must meet (e.g., a certain decibel level for noise, a certain pressure for suction).

8. The sample size for the training set: Not applicable. No AI model or training set discussed.

9. How the ground truth for the training set was established: Not applicable.

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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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