Search Results

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)

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not available in the provided document. As the clearance is based on identicality to a predicate, no new performance testing data (and thus no test set or its provenance) for the subject device is presented. The document mentions "Bench testing: Testing was not listed in K081837" and "Identical to K081837" for the subject device. This suggests that the original predicate device (K081837) also didn't explicitly list specific bench testing details in its 510(k) summary, or at least not in a way that is reproduced here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable/not available. This is a physical device, not an AI or diagnostic imaging device that requires expert review for ground truth establishment.

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

This information is not applicable/not available for the same reasons as point 3.

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 information is not applicable/not available. This is a physical device (expiratory filter/water trap), not an AI-assisted diagnostic tool.

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

This information is not applicable/not available for the same reasons as point 5.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For the physical properties (VFE, BFE, flow resistance, leakage, dimensions, volume), the "ground truth" would be established through laboratory bench testing according to relevant standards. For biocompatibility, it's established through testing per ISO 10993. The document states identicality to the predicate for these, implying that the predicate's performance claims serve as the reference.

8. The sample size for the training set

This information is not applicable/not available. This is a manufactured physical device, not a machine learning model that requires a training set.

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

This information is not applicable/not available for the same reasons as point 8.

In summary, the "study" proving this device meets acceptance criteria (for a 510(k)) is simply the demonstration that it is geometrically and functionally identical to a previously cleared predicate device that has established safety and effectiveness. No new clinical or extensive performance studies were required for this specific 510(k) because of this identicality.

Ask a specific question about this device