(79 days)
To filter possible bacteria and viruses from the patient exhalation when performing pulmonary function testing
A disposable bacterial/viral filter used in pulmonary function testing
The provided text describes the SpiroSafe Filter, a disposable bacterial/viral filter for pulmonary function testing. The study demonstrates the device's substantial equivalence to a predicate device (PDSI KoKo Filter - K914272) based on performance criteria.
Here's a breakdown of the requested information based on the provided text:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Intended device Performance (SpiroSafe Filter) | Predicate Device Performance (PDSI KoKo Filter) |
|---|---|---|
| Bacterial Efficiency | >99% | 99.99% |
| Viral Efficiency | >99% | 99.98% |
| Resistance to Airflow | >1.5 cmH2O/L/Sec. @ 12/L/Sec. | 0.9 cmH2O/L/Sec. @ 12/L/Sec. |
| Use as bacterial/viral filter | Yes | Yes |
| Use during pulmonary function test | Yes | Yes |
| Single patient use | Yes | Yes |
| Housing material - Impact Polystyrene | Yes | Yes |
| Filter Media | Electrostat | Filtrete |
Note: While the text doesn't explicitly state "acceptance criteria", the comparison table to the predicate device implies that the performance characteristics of the predicate serve as the benchmark for substantial equivalence. The SpiroSafe Filter meets or exceeds the critical performance aspects (bacterial/viral efficiency) of the predicate. The resistance to airflow value for the predicate is 0.9, and the intended device is ">1.5", which seems to indicate the SpiroSafe filter exceeds the predicate in this metric; however, for resistance, lower is generally better. This could be a typo in the document or interpreted differently. Assuming the acceptance criteria aligns with being "comparable or better" than the predicate, the device broadly meets this.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the performance testing shown. It is simply presenting performance data.
The data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective). This appears to be a direct presentation of product specifications rather than a clinical study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. The device's performance is measured against technical specifications, not subject to expert interpretation for ground truth.
4. Adjudication Method for the Test Set
This information is not applicable as there is no mention of a human-in-the-loop assessment or expert review for adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This device is a physical filter, and the evaluation is based on its physical and filtering properties, not on diagnostic accuracy requiring human reader interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, in a sense, a "standalone" performance assessment was done. The performance metrics (bacterial efficiency, viral efficiency, resistance to airflow) are inherent to the device itself and do not involve human interaction beyond conducting the tests. The results presented are solely based on the device's intrinsic characteristics.
7. The Type of Ground Truth Used
The ground truth used is based on measured physical and performance characteristics (e.g., bacterial efficiency percentage, viral efficiency percentage, resistance to airflow in cmH2O/L/Sec.). This is analogous to laboratory testing/engineering specifications.
8. The Sample Size for the Training Set
This information is not applicable as there is no mention of a "training set" in the context of this device. The evaluation is focused on the manufactured product's specifications rather than a machine learning model.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no mention of a "training set" or a machine learning context.
§ 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).