(131 days)
The 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.
The Nasal Aspirator consists of silicone tips which has three models (A, B, C), host, tube, mucus collector. The accessory are charging cable-USB, clean brush, clip, sponge. The 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 exter (not included in this device) through the provided charging line. The user interface consists of buttons and indicator/ display, and 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 describes the 510(k) summary for the Nasal Aspirator (BC-021, BC-022, BC-023, BC-024, BC-025, BC-026). It does not contain information typically found in acceptance criteria or a study design for evaluating an AI/ML powered device. Instead, it focuses on the substantial equivalence of a medical device (a nasal aspirator) to a predicate device.
Therefore, many of the requested details about acceptance criteria, study design, ground truth, and expert involvement are not applicable or cannot be extracted from this document, as it is related to a conventional medical device rather than an AI/ML-powered one requiring such extensive performance studies as described in your prompt.
Here's an attempt to answer the questions based on the limited relevant information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" in the context of AI/ML performance metrics (e.g., sensitivity, specificity). Instead, it discusses the equivalence of technological characteristics and performance tests for a physical device.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (Nasal Aspirator) |
|---|---|
| Vacuum Pressure (similar to predicate) | 52 |
| Power Consumption (compliance with standards) | 5W (Predicate: 2.2W) - Different, but device complies with IEC 60601-1 and IEC 60601-1-2 |
| Power Source (compliance with standards) | DC 3.7 V / 1100mAh (Predicate: 700mAh) - Different, but device complies with IEC 60601-1 and IEC 60601-1-2 |
| Dimensions & Weight (flow rate tests confirm equivalence) | Weight: 272±5g (Predicate: 320±5g) - Differ, but vacuum pressure and flow rate tests indicate substantial equivalence. |
| Product Appearance Test | Conducted, implying satisfactory results. |
| Product Performance Test | Conducted, implying satisfactory results. |
| Human Factors Engineering Verification | Prepared and performed, implying satisfactory results for layperson use. |
| Compliance with Electrical Safety Standards | Complies with IEC 60601-1 and IEC 60601-1-2. |
2. Sample size used for the test set and the data provenance
Not applicable. The document describes tests for a physical medical device (Nasal Aspirator), not an AI/ML algorithm requiring a test set of data. The "tests" mentioned are product appearance tests, performance tests, and human factors engineering verification, which typically involve a limited number of physical units or usability testing, not large datasets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is not an AI/ML system that requires expert-established ground truth from a test set of data.
4. Adjudication method for the test set
Not applicable. This device is not an AI/ML system that requires adjudication of a test set.
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-assisted device, so an MRMC study comparing human readers with and without AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical nasal aspirator, not an algorithm.
7. The type of ground truth used
Not applicable in the context of AI/ML. For a physical device, "ground truth" would be related to physical measurements and compliance with established engineering and safety standards (e.g., the actual vacuum pressure measured, adherence to IEC standards).
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device, not an AI/ML algorithm.
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.