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For use on all patient populations, in conjunction with other respiratory devices containing standard 15 mm and/or 22 mm fittings (such as breathing circuits and the like) to filter respiratory gases where infection from airborne bacteria and viruses is a concern.

The Hudson RCI Cat. No. 1605 Bacteria / Viral Filter is a disposable, single patient use breathing filter consisting of a gas-permeable filter medium captured between two clear plastic housings. When the Hudson RCI Cat. No. 1605 Bacteria / Viral Filter is inserted into a breathing circuit, the respiratory gas passes through the electrostatically-charged hydrophobic filter medium within the filter. The medium traps bacteria and viruses carried within the airstream.

This document describes a medical device, the Hudson RCI Cat. No. 1605 Bacteria / Viral Filter, and its comparison to a predicate device, the Gibeck product no. 1910 Iso-Gard Depth Filter. The provided text is a non-confidential 510(k) Summary of Safety and Effectiveness submission and does not detail an AI/ML device or a study involving human readers or AI assistance. Therefore, it is impossible to extract information related to AI-specific criteria, such as multi-reader multi-case (MRMC) studies, effect size of AI improvement, standalone algorithm performance, or ground truth establishment for training sets.

However, based on the provided text, I can infer the acceptance criteria (performance of the predicate device) and the reported device performance for the physical filter.

Here's a breakdown of the available information:

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. The text mentions "The Hudson RCI Bacteria/Viral Filter and the Gibeck filter have been tested by an independent laboratory for bacterial and viral filtration performance." This implies a test set was used for each filter, but the number of samples is not provided.
• Data Provenance: The testing was conducted by an "independent laboratory." No country of origin is specified. The study appears to be retrospective in the sense that the performance data for both devices was collected and then compared.

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

This is not applicable as the device is a physical filter, not an AI/ML diagnostic tool. The "ground truth" for filter performance is based on laboratory testing against established bacterial and viral challenges.

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

This is not applicable for a physical filter performance study. The reported efficiency values are likely direct measurements from laboratory tests.

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 is not applicable as the device is a physical filter. This document does not describe an AI/ML device or a study involving human readers.

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

This is not applicable as the device is a physical filter. This document does not describe an AI/ML device.

7. The type of ground truth used:

The ground truth for the performance metrics (BFE, VFE, Dead Space) was established through laboratory testing using standardized methods for bacterial and viral challenge, and dead space measurement.

8. The sample size for the training set:

This is not applicable as the device is a physical filter and not an AI/ML model that requires training data.

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

This is not applicable as the device is a physical filter and not an AI/ML model that requires training data.

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