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AG Industries filters are replacement filters intended for use in oxygen concentrator machines to help remove contaminants, including air borne bacteria and other particulate debris from an air stream. When used with oxygen concentrator machines, the replacement filters may be used in the home, nursing home, hospital, patient care facility, etc.

Room air is drawn into the compressor of a respiratory device through the bacterial intake filter. From the compress, the air passes through the Compressor Filter, if one is installed on the machine and proceeds to the sieve beds. The sieve beds condition the air by removing nitrogen from the air stream, which results in higher concentration of oxygen. The air then passes through the final filter before being supplied to the patient.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the AG Industries Compressor & Bacteria Filters:

1. Table of Acceptance Criteria and Reported Device Performance

For the purpose of this analysis, the "acceptance criteria" are implied by the performance of the legally marketed predicate devices, and the "reported device performance" is that of the AG Industries filters. The key performance metric explicitly stated for comparison is Bacterial Filtration Efficiency (BFE) and Air Flow Resistance. Other features like material and connection type are also compared.

Note on Acceptance Criteria: The submission implicitly uses the predicate device's performance as the acceptance criteria for "substantial equivalence." The AG Industries devices are expected to meet or exceed these values for key performance indicators like filtration efficiency and demonstrate comparable (or better) airflow resistance. For some models, the AG Industries device states a slightly lower BFE (e.g., 99.9+% vs 99.999%), but the overall conclusion of "substantial equivalence" suggests these differences were deemed acceptable by the FDA for the intended use. The air flow resistance is presented with different units (scfh vs Lpm) and flow rates sometimes, making direct numerical comparison difficult without conversion, but the goal is to show comparable or better (lower) resistance.

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

The document does not explicitly state the sample size used for the performance tests (Bacterial Filtration Efficiency, Dioctyl Phthalate (DOP) Aerosol Test) or biocompatibility tests (ISO Guinea Pig Maximization Test, ISO Acute Systemic Injection Test, MEM Elution Test, Material Mediated Rabbit Pyrogen Test).

The data provenance is not specified (e.g., country of origin, retrospective/prospective). It is implied that these are laboratory tests conducted to demonstrate the performance characteristics of the manufactured filters.

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

This type of information is not applicable to this submission. The "ground truth" for filter performance is established through standardized laboratory testing methods (e.g., BFE, DOP aerosol tests) rather than expert human interpretation of results. Biocompatibility tests also follow established protocols.

4. Adjudication Method for the Test Set

This is not applicable. As mentioned above, the performance assessment relies on standardized test methods and quantitative measurements, not on expert adjudication of outcomes.

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 is not applicable. This submission is for medical device filters, not an AI or imaging diagnostic device that would involve human readers or cases.

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

This is not applicable. This submission is for medical device filters, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance claims of these filters is based on standardized laboratory test results. Specifically:

• Performance (Filtration Efficiency, Air Flow Resistance): Established by physical and microbiological testing methods (e.g., Bacterial Filtration Efficiency, Dioctyl Phthalate (DOP) Aerosol Test) that quantitatively measure the filter's ability to remove particulates and resist airflow under controlled conditions.
• Biocompatibility: Established by adherence to ISO standards for evaluating biological effects of medical devices (e.g., ISO Guinea Pig Maximization Test, ISO Acute Systemic Injection Test, MEM Elution Test, Material Mediated Rabbit Pyrogen Test).

8. The Sample Size for the Training Set

This is not applicable. This submission is for medical device filters and does not involve AI or machine learning that would require a "training set."

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

This is not applicable for the same reason as point 8.

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The AG Industries Breathing Filter Bacterial/Viral is a single use replacement filter intended for use in mechanical ventilators, anesthesia machines, manual resuscitation devices, and IPPB machines to reduce the passage of particulate that may carry airborne bacteria and/or viruses. When used with mechanical that may our and resuscitation devices, the replacement filter may be used in the hospital, home, or transport applications.

The Breathing Filter is a replacement filter for use mechanical ventilators, anesthesia machines, manual resuscitation devices, and IPPB machines. The product is composed of 3 main elements. These include a top housing, a bottom housing, and a filter element. The filter material is secured in the top and bottom housing using a sonic weld joint.

• The top housing is made of plastic and has a clear polish finish and has a standard 22mm ID connection port.
• The bottom housing is made of plastic and has a clear polish finish and has a standard 15mm ID/22mm OD connection port for universal usage.
• The filter element is composed of electrostatic material, with a bonded scrim, on one side of the filter element only.

The provided text describes a 510(k) premarket notification for a medical device, the AG Industries Breathing Filter Bacterial/Viral. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than conducting new clinical studies with defined acceptance criteria and detailed performance reporting.

Therefore, many of the requested categories are not applicable or cannot be extracted from this document, as the submission focuses on comparative analysis rather than new performance studies against specific acceptance criteria.

Here's a breakdown of the information that can be extracted, and where the requested information is not available:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated as numerical performance metrics in this document. The "acceptance criteria" here is implicitly "demonstrating substantial equivalence" to the predicate device.
• Reported Device Performance: The document states: "Performance testing has been completed on the AG Industries Breathing Filter Bacterial/Viral. The differences between the AG Industries Breathing Filter Bacterial/Viral specifications and the predicate device specifications do not result in different performance or raise new questions regarding safety and effectiveness." However, no specific numerical performance data or results from this testing are provided in this summary.

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 provided in the 510(k) summary. The document mentions "Performance testing has been completed," but does not detail the nature of these tests, the number of samples used, or data provenance. Since it's a device like a filter, the "test set" would likely refer to the number of filter units tested, not patient data.

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 is not applicable/not provided. For a physical device like a filter, "ground truth" would be established through laboratory measurements and standardized testing methods, not typically by human experts evaluating a "test set" in the way it applies to diagnostic algorithms.

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

• This is not applicable/not provided. Adjudication methods are typically relevant for studies involving human interpretation (e.g., radiologists reviewing images) to establish a consensus ground truth. This document does not describe such a study.

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 is not applicable. An MRMC study is relevant for AI-powered diagnostic devices that assist human readers. The AG Industries Breathing Filter Bacterial/Viral is a physical filter device, not an AI diagnostic tool.

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

• This is not applicable. This is a physical filter device, not an algorithm.

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

• As this is a physical device (filter), the "ground truth" for performance would be based on standardized laboratory test results for parameters such as bacterial/viral filtration efficiency, pressure drop, and airflow resistance. The document states "Performance testing has been completed," implying such testing, but it does not specify the exact nature of the ground truth or tests used beyond stating that performance testing occurred.

8. The sample size for the training set

• This is not applicable. This is a physical device, not a machine learning model that requires a "training set."

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

• This is not applicable. As above, no training set for a machine learning model.

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