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The CareFusion MicroGard® II filter series is indicated for use in prevention of contamination of pulmonary function testing equipment and associated valves and hoses by aerosols and particulates which may be present in a patient's exhaled gas volumes. The MicroGard® II filter should be used only on patients with a minimum body weight of 27.5 kg.

The CareFusion MicroGard II filter is a disposable barrier type filter intended to protect both, patient and instrument, by preventing the transmission of pathogens by droplets and aerosolized particles between the patient and the spirometer, or pulmonary function testing instrument.

The provided text describes the acceptance criteria and the studies conducted to demonstrate the substantial equivalence of the MicroGard II filter to its predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The resistance and filter efficiency for B. atrophaeaus and MS-2 coliphage were measured at different flow rates or were new tests for the MicroGard II, indicating an improvement or additional testing for the modified device.

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

The document mentions that filtration efficiency has been tested at Nelson test laboratory in the USA and at Health Protection Agency in the UK. However, it does not explicitly state the sample size used for these tests. The data provenance is from USA and UK laboratories, and based on the context of testing a manufactured medical device, these would be prospective tests performed on the device.

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

This information is not provided in the document. The testing described (filtration efficiency, biocompatibility, resistance, dead space) are objective laboratory measurements, not subjective evaluations requiring expert interpretation of ground truth in the same way, for example, a diagnostic imaging study would.

4. Adjudication method for the test set:

This information is not applicable for the type of objective laboratory testing described. Adjudication methods are typically used when there are disagreements among experts in subjective evaluations.

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. The device described is a physical filter for pulmonary function testing equipment, not an AI-powered diagnostic tool requiring human reader studies.

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

This is not applicable. The device is a physical filter, not an algorithm.

7. The type of ground truth used:

For the performance specifications (resistance, dead space, filtration efficiency), the "ground truth" is established through standardized laboratory testing protocols and measurements. For biocompatibility, the ground truth is established through biocompatibility testing according to ISO 10993-1 standard.

8. The sample size for the training set:

This information is not applicable. The document describes a physical medical device (a filter), not an AI algorithm that requires a training set.

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

This information is not applicable as there is no training set for a physical filter.

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