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Disposable single patient use bidirectional filters used to reduce the possible bacterial and/or viral cross contamination of ventilatory and anesthesia equipment associated valves and hoses, from aerosols and particulates, which may be present in a patient's exhaled gas. These devices are intended for use on all patient populations to filter respiratory gases where infection from airborne bacteria and viruses is a concern.

The BFE/VFE filters, manufactured by Hsiner, ITD are disposable, single-use barrier type, bi-directional devices supplied to the customer packaged and non-sterile. These filter devices are fabricated with a filtering medium that is highly effective at reducing the numbers of both bacterial and viral contaminates present in a patient's exhaled gas. The devices are designed to minimize the resistance to air flow. They consist of two molded plastic housings enclosing a disk of filter media. The Hsiner filtered HME device also includes a reticulated foam that captures heat and moisture from the patient's breath.

The provided text is a 510(k) summary for the Hsiner Filters and Filtered HME, which are disposable bacterial/viral filters for breathing circuits. The document focuses on establishing substantial equivalence to predicate devices. It does not contain sections detailing acceptance criteria, study methodologies, or performance data in the format of a clinical study report.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving the device meets them because such details are not present in the provided text. The document is a regulatory submission summary and focuses on the declaration of substantial equivalence to existing devices rather than a detailed presentation of performance data from a specific study against acceptance criteria.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set or data provenance. The document mentions the devices are "equivalent in design and performance" to predicate devices, implying performance testing was done, but does not provide details of such tests beyond stating BFE/VFE filters are "highly effective."
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for the test set.
• Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
• Information on standalone algorithm performance (as this is a physical device, not an AI algorithm).
• The type of ground truth used.
• Sample size for the training set.
• How the ground truth for the training set was established.

The document is a declaration of intent to market and a statement of substantial equivalence based on the device's design and intended use being similar to existing cleared devices. It does not describe a study in the way outlined in your request.

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