(267 days)
Exceleron Medical bacterial filters are single use 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.
A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit of a respiratory device. The filter is a replaceable accessory device used in oxygen concentrators, either as intake filters or final patient filters. The function of the oxygen concentrator machine is to draw room air into the machine's compressor and concentrate the oxygen content before delivering filtered, oxygen rich air to the patient. From the compressor, the filtered air proceeds to the sieve beds. The sieve beds in the oxygen concentrator machine condition the air, by removing nitrogen from the air stream, which results in a higher concentration of oxygen. The air then passes through the final patient filter before being supplied to the patient. The Exceleron Medical bacterial intake filter and the final patient filter are intended to remove air borne bacteria and other particulate debris from the air stream.
The provided document describes the acceptance criteria and the study results for the Exceleron Bacterial Filter. Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Bacterial Filtration Efficiency (BFE) at an increased challenge | 99.9% to 99.999% |
| Air Flow Resistance | Comparable to or less than predicate devices |
| Biocompatibility (Cytotoxicity, Sensitization, Intracutaneous Reactivity) | Met biocompatibility requirements |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample size for the "test set" (i.e., the number of filters tested). It mentions "Design verification testing was performed for the Exceleron Bacterial Filter," implying a set of filters were manufactured and tested.
The data provenance is not specified regarding country of origin or whether it was retrospective or prospective. It is implied these were laboratory performance bench tests conducted by the manufacturer.
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 product is a bacterial filter, not a diagnostic device requiring expert interpretation of results. Therefore, there were no experts used to establish ground truth in the context of human interpretation of medical images or data. Ground truth for performance was established through standardized physical and biological testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human interpretation of data. This is a performance bench test for a physical device, so no such adjudication method was used. The performance was measured directly through scientific methods.
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
No. This is a physical filter device, not an AI-assisted diagnostic tool.
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.)
The ground truth for the performance tests was established through:
- Quantitative measurement for Bacterial Filtration Efficiency (BFE) based on particle counts and filtration capabilities.
- Quantitative measurement for Air Flow Resistance.
- Standardized biological tests (cytotoxicity, sensitization, intracutaneous reactivity) according to ISO 10993-1 for biocompatibility.
8. The sample size for the training set
Not applicable. This is a physical device, not a machine learning model, so there is no training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for a physical device.
§ 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).