(13 days)
Porous Media oxygen concentrator 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, patient care facility, etc.
Room air is drawn into the compressor through the bacterial intake filter. From the compressor, 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 a higher concentration of oxygen. The air then passes through the final filter before being supplied to the patient.
This 510(k) summary describes Replacement Oxygen Concentrator Filters manufactured by Porous Media. The submission focuses on demonstrating substantial equivalence to existing predicate devices.
Here's an analysis of the acceptance criteria and study information provided, framed around a typical AI/medical device study structure, even though this submission is for physical filters and not an AI device. I will address each point from your request using the provided text.
1. A table of acceptance criteria and the reported device performance
For these oxygen concentrator filters, "acceptance criteria" are primarily based on demonstrating identical technical specifications and intended use to legally marketed predicate devices. The "reported device performance" is the direct assertion of these identical specifications. The submission is a comparison study, not a performance study against predefined thresholds for a novel device.
| Acceptance Criteria (Predicate Specification) | Porous Media Device Performance |
|---|---|
| Intended Use | Identical |
| Filtration Efficiency (e.g., 99.999% BFE, 99.99% @ 0.3 µm, 99.97% @ 0.3 µm) | Identical |
| Filter Material (e.g., Glass microfiber, Polyester) | Identical |
| Housing Material (e.g., Polystyrene, Nylon 6/6, Polypropylene) | Identical |
| Air Flow Resistance (e.g., 4.0 inH2O @ 100 scfh, 35.0 inH2O @ 4.50 scfm, 3.0 cmH2O @ 100 slpm) | Identical |
| Maximum Flow Rate (e.g., 100 LPM) | Identical |
| Connections (e.g., Male 22mm ISO, 3/8" FNPT, 1/4"-18 FNPT, 3/8" Hose Barbs, 1/8" Hose Barbs, 22mm ISO Male/Female) | Identical |
| Part Number (corresponds to specific predicate) | Specific Porous Media Part Number (e.g., DBF24) |
| Compatibility with Oxygen Concentrator Models | Identical (e.g. DeVilbiss 303 Series, Respironics Millennium Series, Invacare Platinum Series) |
The study essentially proves the device meets the "acceptance criteria" by showing a feature-by-feature match with the predicate devices, thereby establishing substantial equivalence, which is the primary regulatory pathway for 510(k) devices. There is no independent performance study detailed here, as the performance is assumed to be equivalent to the predicate.
The following points are typically relevant for AI/algorithm-based medical devices. Since this submission is for physical filters, these specific questions regarding AI algorithms and ground truth methods are not directly applicable to the provided text. I will address them by stating their non-applicability or reinterpreting them in the context of a physical device.
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: This submission is for physical filters. There is no "test set" in the context of an AI algorithm evaluation. The "data" here refers to the specifications of the predicate devices and the filters themselves. The comparison is against published and known specifications of existing, approved devices. No specific "sample size" of devices was tested for this submission beyond the comparison to the existing designs. The data provenance is essentially from the design and manufacturing specifications of both the predicate devices and the Porous Media filters. No geographical or retrospective/prospective distinction is relevant here.
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: There is no "ground truth" in the AI sense for these physical filters. The "ground truth" for the comparison is the published, legally established specifications of the predicate oxygen concentrator filters, which are accepted by the FDA. The experts involved would likely be engineers, quality control specialists, and regulatory affairs personnel from Porous Media and potentially consultants verifying the comparison, but not "experts establishing ground truth" in a diagnostic sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: No adjudication method is described or required for comparing physical device specifications. The comparison is a direct, objective matching of technical parameters.
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 submission for physical filters, not an AI-assisted diagnostic device. Therefore, no MRMC study, human readers, or AI assistance is involved.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This is for physical filters, not an independent algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable (in the AI sense): For this submission, the "ground truth" is the established technical specifications and performance characteristics of the legally marketed predicate devices, as approved by the FDA in their original 510(k) clearances. This is a regulatory "ground truth" rather than a clinical one.
8. The sample size for the training set
- Not Applicable: There is no "training set" as this is not an AI device.
9. How the ground truth for the training set was established
- Not Applicable: As there is no AI training set, there is no ground truth establishment for it.
§ 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).