(28 days)
The Alliance Tech Medical, Inc. All Flow Pulmonary Function Filter is designed as a disposable and single-use, bi-directional filter for use in reducing possible bacterial and/or viral cross contamination of spirometers and pulmonary function testing instruments, associated valves and hoses, from aerosols and particulates, which may be present in a patient's exhaled gas. The device is indicated for diagnostic applications.
The All Flow Pulmonary Function Filter, manufactured by Alliance Tech Medical, Inc., is a see barrier type, bi-directional filter fabricated from a plastic resin that is a filtering medium. The customer packaged and non-sterile. Fabricated with a filtering medium that is highly effective in reducing the numbers of both bacterial and viral contaminates that may be present in a patient's exhaled gas, the device's design also minimizes the resistance to air flow. The product is intended to protect both the patient and pulmonary function instruments from potential transmission of pathogens by droplets and aerosols.
The device consists of two molded plastic housings enclosing a disk of filter media. To avoid confusion, the patient housing side is made from a white opaque of miller the and the machine housings are fabricated from the same plastic but with different colors. The colored end fits the machine and the white opaque end is for the patient side; therefore making clear definition as to which end is used for the patient and the machine.
The provided text is a 510(k) submission for the "All Flow Pulmonary Function Filter" and details its performance against certain criteria. It is not a study involving AI or human readers, but rather a submission for a medical device. Therefore, many of the requested points related to AI studies (like sample sizes for test/training sets, ground truth establishment for AI, expert qualifications, adjudication, MRMC studies, or standalone algorithm performance) are not applicable to this document.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (from context of predicate devices/standards) | Reported Device Performance (All Flow Pulmonary Function Filter) |
|---|---|---|
| Bacterial Filtration Efficiency (BFE) | Implied to be high (as predicates are effective). Specific quantitative criteria not explicitly stated as a target, but the context of "reducing cross-contamination" and meeting standards implies high efficiency. | > 99.99% (at an increased challenge) |
| Viral Filtration Efficiency (VFE) | Implied to be high (as predicates are effective). Specific quantitative criteria not explicitly stated as a target, but the context of "reducing cross-contamination" and meeting standards implies high efficiency. | > 99.99% (at an increased challenge) |
| Airflow Resistance | Meets recommendations of American Thoracic Society's Standardization of Spirometry. Specific quantitative criteria are implied by the standard but not explicitly listed in the document. | Average of 2.625 cm H₂O½SLPM at 720 L (approx. 0.23 cm H2O/L/sec). The document states this "meets the recommendations of the American Thoracic Society's Standardization of Spirometry." |
| Filter Dead Space | Not explicitly stated as an acceptance criterion in this document, but characteristics like this are typically considered in device design for pulmonary function testing. | Approximately 35 mL |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. The document states "Data provided in this submission indicate that the basic functional characteristics..." but does not detail the sample size for the BFE, VFE, or airflow resistance testing.
- Data Provenance: Not specified. The country of origin of the testing data is not mentioned, nor whether the tests were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a submission for a non-AI medical device (a filter), not a study involving expert assessment of data for ground truth. The "ground truth" here is the physical performance of the device as measured by scientific testing, not subjective expert evaluation of medical images or conditions.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no human adjudication required for the performance testing of this filter device.
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 document is not an MRMC comparative effectiveness study and does not involve AI assistance for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This document is about a physical medical device (a filter), not an algorithm or AI.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance is established through objective, laboratory-based physical and microbiological testing. Specifically:
- BFE/VFE: Determined by challenging the filter with known bacterial/viral concentrations and measuring the reduction.
- Airflow resistance: Measured using standardized instrumentation against known flow rates.
- Filter dead space: Measured physically.
The ultimate "ground truth" for substantial equivalence is the comparison of these objective performance metrics to those of legally marketed predicate devices and established medical standards (like the American Thoracic Society's recommendations).
8. The sample size for the training set
Not applicable. This is a submission for a physical medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device submission.
§ 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).