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For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and / or expired gases is desired and to add and retain moisture in the circuit as required.

It is single patient use, disposable for patients with Tidal Volumes > 250 ml.

Duration of use < 24 hours.

The HydroMax™ HMEF is standard configuration housing with a CO2 sampling port.

The common features are:

• All have standard conical 15 mm / 22 mm fittings for connections ●
• Female luer lock port for gas sampling for end-tidal CO2 .

The principle of operation:

• The filter media is an electrostatic type of media and filters via electrostatic attraction .
• . The HME media a porous foam that has hygroscopic properties to retain and release moisture from the patient

The A-M Systems, Inc. HydroMax™ HMEF (Heat and Moisture Exchanger Filter) is a bacterial/viral filter intended for use with ventilators, anesthesia machines, and open flow systems to filter inspired and/or expired gases and retain moisture in the circuit. It is a single-patient use, disposable device for patients with tidal volumes greater than 250 ml and a duration of use of less than 24 hours. The device's performance was evaluated through bench testing.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the HydroMax™ HMEF are generally established by comparing its performance to a legally marketed predicate device, the GE (Engstrom) HMEF 1000 (K964204), and by meeting relevant international standards for medical devices (e.g., ISO 9360-1, ASTM F316-80). The "acceptance criteria" are implied by demonstrating substantial equivalence to the predicate and meeting the performance characteristics of the relevant standards.

Note: "N/A" for the predicate indicates the information was not provided in this specific comparison table, not necessarily that the predicate does not meet these parameters. The "Acceptance Criteria (Implied)" are derived from the direct comparison to the predicate device and the referenced ISO/ASTM standards.

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

The document does not explicitly state the sample sizes for each specific test (e.g., how many filters were tested for BFE, VFE, pressure drop, etc.). It refers to "a number of bench tests."

The data provenance is from bench testing performed by Nelson Laboratories (for Bacterial/Viral filtration efficiency) and potentially other internal or external labs for other physical characteristics.
The data is retrospective in the sense that the device was manufactured, and then tested. There is no information on the geographical origin of the data beyond "Nelson Laboratories" and "bench testing."

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

This section is not applicable as the study described is a non-clinical bench testing study of a medical device, not a human reader study or a diagnostic accuracy study involving human expert interpretation. The "ground truth" for these tests is established by standardized testing methodologies and instrument readings (e.g., filtration efficiency is determined by particle count, pressure drop by manometry).

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

This section is not applicable as the study is a non-clinical bench testing study. Adjudication methods like 2+1 or 3+1 are used in clinical studies or reader studies where human interpreters are involved in making decisions or interpretations that need to be reconciled.

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 section is not applicable as the study described is a non-clinical bench testing study for a physical medical device (a filter), not an AI-powered diagnostic tool. Therefore, there is no human reader component or AI assistance to evaluate.

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

This section is not applicable as the device is a physical medical device (filter), not an algorithm or AI product. The "standalone performance" refers to the device's inherent physical characteristics as measured by the bench tests.

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

For this non-clinical bench testing study, the "ground truth" for the device's performance characteristics is established by:

• Standardized laboratory measurements: Using calibrated equipment and established protocols (e.g., ISO 9360-1, ASTM F316-80) to measure physical properties like filtration efficiency, pressure drop, moisture output, etc.
• Predicate device performance: The performance of the legally marketed predicate device serves as a benchmark for substantial equivalence.

8. The sample size for the training set

This section is not applicable as this is a non-clinical bench testing study of a physical medical device, not a machine learning or AI model. Therefore, there is no "training set."

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

This section is not applicable for the same reasons as #8.

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This device is indicated for use on all patient populations, in conjunction with other respirations devices containing standard 15mm and/or 22mm fittings (such as breathing circuits) to filter respiratory gases where infection from airborne bacteria and viruses is a concern.

The A-M SYSTEMS VIROMAX Viral and Bacterial Filter is a non-sterile, single patient use breathing filter consisting of a gas permeable filter membrane enclosed in a transparent plastic housing. When the A-M SYSTEMS Viral and Bacterial Filter is inserted into a breathing circuit, the respiratory gas passes through the electrostatically-charged hydrophobic filter membrane, thus trapping bacteria and viruses.

The provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria for the A-M SYSTEMS VIROMAX Viral and Bacterial Filter.

The document is a 510(k) summary for the device, focusing on its substantial equivalence to a predicate device (K961914). It describes the device, its intended use, and a comparison of technological characteristics with the predicate device. However, it does not include details on specific performance metrics, acceptance criteria, or studies conducted to establish the device's performance against such criteria.

The "Safety and Effectiveness of the device" section explicitly states, "This device is safe and effective as the other predicate device cited above. This is better expressed in the tabulated comparison (Paragraph 14 below)." This indicates that the safety and effectiveness are established by demonstrating substantial equivalence to a legally marketed predicate device, rather than by presenting results from a de novo performance study against explicit acceptance criteria.

Therefore, I cannot extract the requested information (table of acceptance criteria and reported device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) from the provided text.

Ask a specific question about this device

Ask a specific question about this device