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For use with ventilators, anesthesia machines, and open flow systems where filtration of inspired and / or expired gases is desired. To be placed at the machine-side of the circuit only. Single patient use. Duration of use up to 24 hours.

The Munktell Gard Filter is a machine-side filter and incorporate standard 15 / 22 mm connectors. The depth filter uses a pleated paper fiber for filtration.

Here's a breakdown of the acceptance criteria and study information for the Munktell Gard Filter, based on the provided documents:

Acceptance Criteria and Device Performance

Study Information:

The provided documents describe a premarket notification (510(k)) for substantial equivalence, not a comprehensive clinical study in the typical sense of evaluating diagnostic performance. The "study" here refers to the data presented to demonstrate substantial equivalence to predicate devices.

1. Sample size used for the test set and the data provenance:

• Sample Size: Not applicable in the context of a diagnostic test set. The submission focuses on comparing the technical characteristics and performance specifications of the proposed device against predicate devices and relevant standards.
• Data Provenance: The performance data (Bacterial and Viral filtration effectiveness) is attributed to "Nelson Lab." This suggests laboratory testing data. The other technical characteristics are stated directly for the device, implying internal testing or design specifications. The document does not specify a country of origin for the data beyond Nelson Lab.
• Retrospective or Prospective: Not applicable as this is a device characteristic comparison, not a study on patient data.

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

• Not applicable. Ground truth, in this context, refers to established performance standards (e.g., ISO for connectors, or the performance of legally marketed predicate devices for filtration efficacy and resistance). Expert panels for ground truth determination are not mentioned or required for this type of submission.

3. Adjudication method for the test set:

• Not applicable. No "test set" of cases or images requiring adjudication by experts is described.

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

• No. An MRMC study was not done. The submission is for a breathing circuit filter, not a diagnostic imaging device that would typically undergo such a study.

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

• Yes, effectively. The performance data (e.g., bacterial/viral filtration efficiency, resistance to flow) are presented as inherent characteristics of the device itself, independent of human interaction once installed. This is the standalone performance of the filter.

6. The type of ground truth used:

• Regulatory Standards and Predicate Device Performance: The primary "ground truth" used is the established performance of predicate devices that are already legally marketed, as well as adherence to relevant industry standards (e.g., ISO 5356-1 for connectors) and general safety principles. For filtration efficiency, the "ground truth" is the measured efficacy by a recognized lab (Nelson Lab).

7. The sample size for the training set:

• Not applicable. There is no mention of a "training set" as this is not an AI/ML device submission involving learned algorithms from datasets.

8. How the ground truth for the training set was established:

• Not applicable for the reasons stated above.

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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.

For patients with a tidal volume 150-500 ml (pediatrics) and >250 ml (adults).

Single patient use. Duration of use up to 24 hours.

The Munktell Bacstop Filter and Filter / HME are available in multiple sizes and incorporate standard 15 / 22 mm connectors with a gas sampling luer port. The depth filter uses electrostatic media for filtration and a foam media for the HME media.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Munktell Bacstop Filter and Filter/HME:

Acceptance Criteria and Device Performance

Study Information

Based on the provided Non-Confidential Summary of Safety and Effectiveness (510(k) K014282), the "study" is primarily a bench-testing and comparison to predicate devices to demonstrate substantial equivalence, rather than a clinical trial with human subjects.

Here's the breakdown of the requested information based on the document:

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

   • Sample size: Not explicitly stated for specific tests. The document refers to "Nelson Lab." for bacterial and viral filtration, implying laboratory testing. For other parameters like resistance and humidification, it would involve testing multiple units to ensure consistency, but specific numbers are not provided.
   • Data provenance: "Nelson Lab." is mentioned for BFE and VFE, which is a known independent testing laboratory. The overall data likely originates from testing performed by or for Munktell Filter AB (Sweden). The studies appear to be prospective bench tests designed to evaluate specific performance attributes.

2. 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 question is not applicable to this type of device submission. Medical device filters do not typically use expert ground truth for performance metrics in the same way an imaging AI algorithm would. Performance is measured against physical standards and laboratory methods (e.g., measuring pressure drop, bacterial retention, water vapor content). The "ground truth" is defined by the physical or microbiological measurement standards themselves.

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

   • None. Adjudication methods are typically used in clinical studies or expert review of image interpretation, which is not relevant for the bench testing of a breathing circuit filter.

4. 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

   • No. An MRMC study is relevant for an AI-powered diagnostic imaging device involving human readers. This submission is for a medical filter, which does not involve human readers or AI assistance in its function.

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

   • Yes, in spirit. The performance metrics (BFE, VFE, resistance, humidification) are "standalone" in that they measure the device's intrinsic physical and biological filtering capabilities without human intervention during its operation. There is no "algorithm" in the sense of software interpreting data, but the filter itself performs its function independently.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

   • The "ground truth" for the performance claims in this submission is the measured output from standardized laboratory testing. For example:
     • Bacterial Filtration (BFE) and Viral Filtration (VFE): Ground truth is established by standardized microbiological testing methods (e.g., aerosol challenge tests) that measure the percentage of bacteria/viruses retained by the filter.
     • Resistance to flow: Ground truth is established by physical measurement of pressure drop across the filter at specified flow rates using calibrated equipment.
     • Humidification Output: Ground truth is established by standardized tests (e.g., ISO 9360) that measure the absolute humidity delivered by the HME.

7. The sample size for the training set

   • Not applicable. This device is hardware (a filter), not an AI algorithm that requires a "training set."

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

   • Not applicable. As above, there is no "training set" for this type of device.

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