(134 days)
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.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device specifications do not result in different performance than predicate | "Performance testing has been completed," and "differences... do not result in different performance or raise new questions regarding safety and effectiveness." (No specific numerical data provided) |
| Device does not raise new questions regarding safety and effectiveness compared to predicate | "The device... is as safe and effective as the predicate device, and the device is determined to be substantially equivalent to the referenced predicate device." (No specific numerical data provided) |
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.
§ 868.5260 Breathing circuit bacterial filter.
(a)
Identification. A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit.(b)
Classification. Class II (performance standards).