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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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For use with ventilators, anesthesia machines, and open flow systems where filtration of inspired and / or expired gases is desired and to add maintain and retain moisture for the exhaled breathe of the patient. Model with tidal volumes ranging from 20-70 cc for neonate, 70-250 cc for pediatric and >150 cc for adults. Use up to 24 hours.

The EMS Filter and combined Filter / HME are available in multiple sizes and shapes, rectangular and round, 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 EMS Electra Filter and Filter/HME device, focusing on acceptance criteria and the study proving it meets those criteria:

The provided document is a 510(k) Premarket Notification, which is a submission to the FDA to demonstrate that the device to be marketed is substantially equivalent to a legally marketed predicate device. This type of submission relies on comparing the new device's characteristics and performance to those of existing, legally marketed devices, rather than comprehensive clinical trials for novel devices.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly define "acceptance criteria" as a separate, formal list against which the device was tested as one might see in a clinical trial. Instead, it presents general technical characteristics of the proposed device and demonstrates their equivalence to predicate devices. The "acceptance criteria" are implicitly defined by the performance of the predicate devices and existing standards for such devices.

2. Sample Size Used for the Test Set and Data Provenance:

The document details performance data derived from laboratory testing, specifically mentioning "Nelson Lab." for Bacterial and Viral filtration efficiency. This indicates the data is likely from professional testing laboratories rather than human clinical trials.

• Sample Size: Not explicitly stated for each test. For filtration efficiency, usually multiple samples of the filter media are tested. For resistance and humidification, often a set number of devices are tested according to a standard protocol.
• Data Provenance: The document states "Nelson Lab." for BFE and VFE, implying a specialized testing facility. The country of origin is not specified, but Nelson Labs is a well-known US-based testing laboratory. The data is prospective in the sense that the new device was fabricated and then tested to determine its performance characteristics. It is not retrospective in the sense of analyzing past patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

This information is not applicable as the evaluations are based on objective physical and biological performance tests, not subjective expert assessment of images or patient outcomes. The "ground truth" for these tests are the established scientific methodologies and standards by which filter performance, resistance, and humidification are measured.

4. Adjudication Method for the Test Set:

This is not applicable as the evaluation relies on direct measurement of physical properties and performance characteristics, not on subjective assessments that would require adjudication (e.g., medical image interpretation).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

This is not applicable. The device is a filter/heat and moisture exchanger (HME), not an imaging or diagnostic AI system. Therefore, an MRMC study related to human reader improvement with AI assistance is irrelevant to this device.

6. Standalone (Algorithm Only) Performance:

This is not applicable. The device is a physical medical device (a filter), not an algorithm or AI system.

7. Type of Ground Truth Used:

The ground truth used is objective laboratory measurement data and established performance standards. For example:

• For resistance, the ground truth is the measured pressure drop across the filter at specified flow rates.
• For filtration efficiency, the ground truth is the measured percentage of bacteria/viruses removed according to standardized laboratory testing protocols (e.g., using bacterial aerosols like Staphylococcus aureus).
• For humidification output, the ground truth is the gravimetric measurement of water vapor produced by the HME under specific temperature, humidity, and tidal volume conditions as per ISO 9360.

8. Sample Size for the Training Set:

This is not applicable. Since this device is a physical product and not an AI/machine learning model, there is no "training set." Its design and performance capabilities would be based on engineering principles, materials science, and testing iterations, not data training.

9. How the Ground Truth for the Training Set Was Established:

This is not applicable for the same reason as point 8. The "ground truth" for the device's design would stem from engineering specifications, industry standards (like ISO for connectors and HME moisture output), and the performance characteristics observed in predicate devices.

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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 maintain and retain moisture for the exhaled breathe of the patient

The EMS HEPA Filter and combined HEPA filter / HME are available in multiple sizes and shapes, recogular and round, and incorporate standard 15 / 22 mm connectors with a gas sampling luer port. recoalignar and round, and morporativer for filtration and a foam media for the HME media. Each filter is individually tested for rating performance according to BS 3928 Sodium Flame for Air filters. The "HEPA" performance was in accordance to DOE 3202-97 and ASTM D2986 – DOP.

The provided text describes a 510(k) premarket notification for the EMS HEPA Filter and HEPA Filter / HME, which are bacterial/viral filters and heat and moisture exchangers. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a full study report with detailed performance metrics against those criteria.

However, the "General Technical Characteristics" table [1] lists several performance attributes of the proposed devices, which can be interpreted as acceptance criteria based on established standards and the characteristics of predicate devices. The "Reported Device Performance" column reflects the device's measured or designed specifications.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" and "reported device performance" in separate columns, nor does it present a formal study showing the device meets these criteria with numerical results from a specific test. Instead, it lists technical characteristics, which by their nature in a 510(k) summary, imply that the device performance meets or is equivalent to these values for substantial equivalence.

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