(125 days)
Intended to perform spirometry and may be used in hospitals and medical offices or at other locations including homes. The accessory is a Bacterial/Viral Filter designed for single patient use. For use on both adult and pediatric patients.
The Ergofilter™ SP1 filter is a bacterial and viral filter with an anatomical mouthpiece, for spirometers. The filter is a single use, non-sterile filter. A new filter must be used for each new patient and for each new spirometry examination. Operating principle of Filtrete™ 3M™ filtration medium: The filtering medium is manufactured by the 3M company in a clean room; it uses an electrostatic process which attracts small mass particles, while having a very small resistance to arr flow; the density and thickness of the filtration medium itself provides an increased filtration capacity.
The provided text describes the Ergofilter™ SP1, a bacterial/viral filter accessory for spirometers, and its comparison to a predicate device. Below is an analysis of its acceptance criteria and the study used to demonstrate its performance, based only on the provided text.
Based on the provided document, the device did not undergo a standalone, human-in-the-loop, or MRMC study. The comparison is primarily based on bench testing of the filter's physical and performance characteristics against a predicate device. No clinical study details (sample size, ground truth, expert qualifications) are provided.
1. Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (from predicate device) | Reported Device Performance (Ergofilter™ SP1) |
|---|---|---|
| Airflow resistance | $\leq 0.862 cm H_2O/L/Sec$ at 14 L/Sec | $0.60 cm H_2O/L/Sec$ at 12 L/Sec (Note: Different flow rate, but lower resistance suggests meeting the spirit) |
| Dead volume | Not explicitly stated as an "acceptance criteria," but predicate has 60 ml | 65 ml |
| % of bacterial removal efficiency | >99.7% | >99.9% |
2. Sample size used for the test set and data provenance
The document indicates "bench" and "filter effectiveness" testing, but no specific sample sizes for these tests are provided. No details on data provenance (e.g., country of origin, retrospective/prospective) are given for these tests. The document also mentions "clinical testing data," but no specifics about this data are available within the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
No information is provided regarding the number or qualifications of experts used to establish ground truth for any tests.
4. Adjudication method for the test set
No adjudication method is described. The assessment appears to be based on direct measurement of physical properties and performance characteristics.
5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done
No, there is no indication that an MRMC comparative effectiveness study was done. The comparison is between the new device and a predicate device based on technical specifications and performance metrics, not human reader performance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device is a physical filter, not an algorithm. Therefore, the concept of "standalone performance" in the context of an algorithm does not apply. The performance metrics reported (airflow resistance, bacterial removal efficiency, dead volume) represent the standalone performance of the physical filter itself.
7. The type of ground truth used
The ground truth for the performance metrics (airflow resistance, bacterial removal efficiency, dead volume) would be the measured physical properties and filtration capabilities under controlled laboratory conditions, likely following standardized test methodologies, though these specific methodologies are not detailed in the provided text.
8. The sample size for the training set
The concept of a "training set" is not applicable as this is a physical medical device (filter), not a machine learning algorithm.
9. How the ground truth for the training set was established
Not applicable (see point 8).
§ 868.1840 Diagnostic spirometer.
(a)
Identification. A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.(b)
Classification. Class II (performance standards).