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The Servo Guard is a bacterial/viral filter for applications in respiratory care.The filter is intended to be used in patient circuits to reduce the spread of viruses and bacteria from patient/persomel and to protect the patient circuits and ventilators from contamination. The filter shall only be used with the ventilators Servo-i and Servo-s.

A Breathing Circuit Bacteria Filter is intended to protect from contamination as well as to reduce particles such as dust and microbiological matters from gases used in the patient circuit of a respiratory device. The bacterial/viral filter is a disposable accessory normally used on the expiratory limb of the ventilator breathing system to reduce possible cross contamination between patient and equipment and between patient. It can also be used on the inspiratory pipe, in order to reduce dust particles to the patient.

This document is a 510(k) summary for the Servo Guard bacterial/viral filter. It describes non-clinical testing performed to demonstrate substantial equivalence to a predicate device.

Here's the information requested based on the provided text, focusing on the study that proves the device meets the acceptance criteria:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

The document describes non-clinical testing (laboratory studies), not a clinical trial with human subjects. Therefore, the concept of "test set" in the context of data provenance and sample size of human data is not directly applicable here. The tests were performed on the device itself.

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

Not applicable. The ground truth for these non-clinical tests is established by standardized test methods (e.g., ISO, ASTM) and physical/chemical measurements, not by expert human interpretation.

4. Adjudication Method for the Test Set

Not applicable, as this refers to human expert review processes in clinical studies.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No. This document describes non-clinical performance testing of a medical device (a filter), not a study involving human readers or comparative effectiveness of AI vs human performance.

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

Not applicable. This is not an AI device or an algorithm. It's a physical filter.

7. The type of ground truth used

The ground truth used for these tests is based on standardized physical and chemical measurements according to established international and national standards (ISO 23328-1, ASTM F2101-14, ISO 18562-2, ISO 18562-3). For example:

• Filter efficiency is measured precisely through laboratory methods.
• Bacterial and viral filtration efficiency is measured with specific microbial challenge tests.
• Particulate matter and VOC emissions are measured using analytical chemistry techniques.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/machine learning algorithm that requires a training set.

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

Not applicable, for the same reason as above.

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