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The AVEA Disposable Expiratory Filter/ Water Trap is an expiratory filter and water trap for use with the AVEA Ventilator.

It would be used in an institutional healthcare environment (e.g., hospitals). It may be used on adult, pediatric, and neonatal patients.

It should be operated by properly trained clinical personnel, under the direction of a physician.

The AVEA disposable expiratory filter/water trap is designed to be used exclusively with the AVEA Ventilator.

This document is a 510(k) clearance letter for the AVEA Disposable Expiratory Filter/Water Trap. It declares the device substantially equivalent to a predicate device and provides the regulatory information. Crucially, it does not describe a clinical study of the device against acceptance criteria for performance; instead, it relies on demonstrating identicality to a previously cleared predicate device.

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, and expert details for a test set.
• Ground truth establishment and adjudication methods.
• MRMC comparative effectiveness study results.
• Standalone AI algorithm performance (as this is a physical medical device, not an AI software).
• Training set sample size or ground truth establishment for a training set.

The document explicitly states:

• "The subject and predicate devices are identical in all ways."
• "The subject device and the predicate – AVEA disposable expiratory filter/water trap – K081837 is substantially equivalent based upon identicality."

This means that the study proving the device meets acceptance criteria for this specific 510(k) relies purely on the fact that it is a direct copy of a previously cleared device. The "acceptance criteria" here are essentially "be identical to the predicate device."

Here's what can be extracted from the document related to performance, based on the predicate device's listed performance:

1. Table of Acceptance Criteria (as per predicate device's listed performance) and Reported Device Performance (by virtue of identicality)

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