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Anesthesia / Respiratory Filters
For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and / or expired gases is desired.
Model – HEPA filter 3000/04 – Single patient use for exhalation limb of circuit on NPB 700 series ventilators
Models – HEPA filters - 6500/01, 6888/01, 8222/01, 8444/01 Model – Non-HEPA filters - 4000/01 Single patient use up to 24 hours. Patient tidal volumes > 150 ml, when applicable.

The Air Safety HEPA and Non-HEPA filters are available in multiple sizes and shapes, and incorporate standard 15 / 22 mm connectors with or without a gas sampling luer port. Some models adapt to fit ventilator exhalation limb only. The depth (HEPA filtration) filter uses a pleated paper fiber for filtration. Filters are tested for rating performance according to EN 13328 Salt for Breathing System filtration performance. The "HEPA" performance was also tested in accordance to DOE-3025-99, DOE-3020-97 and ASTM D2986 - DOP. The electrostatic (non-HEPA filtration) filters are tested by Nelson Laboratories for BFE and VFE.

This document describes the safety and effectiveness of Air Safety HEPA and Non-HEPA Filters. However, it does not fit the typical format of a study designed to prove a device meets acceptance criteria, especially in the context of an AI/ML powered device. This is a 510(k) premarket notification for traditional medical devices (filters), and therefore, many of the requested categories are not applicable.

Here's an attempt to answer the questions based on the provided text, with clear indications where the information is not available or not relevant to this type of device submission.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present "acceptance criteria" in a pass/fail format with direct device performance comparison in a single table, as might be found in a study for an AI/ML device. Instead, it lists technical characteristics and performance standards that the device meets.

However, based on the General Technical Characteristics table, we can infer performance criteria and compare them to the device's reported performance:

Summary of "Study" to Prove Device Meets Criteria:

The document details the device characteristics and states that the devices were tested to specific performance standards. This is not a "study" in the clinical trial sense but rather a series of engineering and laboratory performance tests.

• Testing Methodologies:
  • Filtration Performance: Tested according to EN 13328 Salt for Breathing System filtration performance.
  • HEPA Performance (Specific models): Tested in accordance with DOE-3025-99, DOE-3020-97, and ASTM D2986 - DOP.
  • Electrostatic (non-HEPA) Filtration (BFE and VFE): Tested by Nelson Laboratories.
• Conclusion: The submission concludes that "The data within the submission demonstrates that the proposed devices when compared to the legally marketed predicate devices are safe and effective and substantially equivalent." This implies that the performance characteristics met or exceeded those of the predicate devices and applicable standards.

Information Not Applicable / Not Provided for this Device Type:

The following requested information is primarily relevant for AI/ML-powered diagnostic or predictive devices, or those requiring clinical studies with human assessors. The provided document concerns a physical filter, for which these criteria are generally not applicable or not detailed in this type of 510(k) submission.

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

• Not Applicable / Not provided in this context. For physical filters, testing typically involves laboratory samples of the filters themselves, not patient data in the sense of AI/ML. The number of filter units tested for each specific performance claim (e.g., BFE, VFE, resistance) is not specified. Data provenance like "country of origin" for test data is not a typical requirement for device performance testing in this manner.

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):

• Not Applicable. "Ground truth" established by experts (like radiologists for an image analysis AI) is not relevant for a breathing circuit filter. Performance is measured objectively through standardized laboratory tests (e.g., particle counts, pressure measurements).

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

• Not Applicable. Adjudication methods are used to resolve discrepancies in expert opinions, typically for establishing ground truth in clinical datasets. This is not relevant for the objective performance testing of a physical filter.

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:

• Not Applicable. This is a physical filter, not an AI/ML-powered diagnostic tool that assists human readers.

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

• Not Applicable. This is a physical filter, not an algorithm.

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

• Not Applicable. The "ground truth" for a filter's performance is derived from standardized physical and biological challenge tests (e.g., aerosolized particles, bacterial/viral suspensions) and measurements, not clinical expert consensus or pathology.

8. The sample size for the training set:

• Not Applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

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

• Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

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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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