Search Results

Humidifiers are defined as a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient.

The Airlife Bubble Humidifiers are comprised of polypropylene bottles with caps which are comprised of high impact polystyrene. These humidifiers are filled with sterile water and connected to an oxygen source to add moisture to, and sometimes to warm, the breathing gases for administration to a patient.

The provided document describes the acceptance criteria and study for the Airlife® Bubble Humidifiers. Here's an analysis based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size: Not explicitly stated in the document. The document refers to "All materials used in the fabrication," implying that the testing was performed on the components of the device rather than a specific patient test set.
• Data Provenance: Not explicitly stated. The tests were performed in accordance with ISO 10993 Part-1 and "industry recognized test methods." The location or nature (retrospective/prospective clinical data) of any study involving human or animal subjects is not detailed, beyond the guinea pig maximization test.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable/Not mentioned. This document pertains to the biological and material safety of a medical device, not diagnostic performance where expert ground truth would typically be established. The "ground truth" here is the acceptance of material safety based on established ISO standards and test results.

4. Adjudication method for the test set

• Not applicable/Not mentioned. Adjudication methods are typically used in clinical studies involving interpretation, which is not the primary focus of the reported testing for this device.

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 document does not describe an MRMC study or any AI component.

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

• Not applicable. This document does not describe an algorithm or AI.

7. The type of ground truth used

• Biological Qualification Safety Tests: The ground truth for the safety and acceptability of the materials was established based on the results of standard biological qualification safety tests (cytotoxicity, skin irritation, and sensitization) as outlined in ISO 10993 Part-1 and "industry recognized test methods." The "ground truth" is adherence to these established safety standards.

8. The sample size for the training set

• Not applicable. This document does not describe an AI/ML algorithm that would require a training set. The testing described relates to material validation.

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

• Not applicable. As no training set is mentioned, this question is not relevant to the provided text.

Ask a specific question about this device