(124 days)
The Custom Plastic Products Pulmonary Function Filter is intended to prevent cross-contamination between the patient and the spirometers and pulmonary function testing instruments.
The Custom Plastic Products Pulmonary Function Filter is intended to reduce cross-contamination between the patient and the spirometers and pulmonary function testing instruments.
The Custom Plastic Products Pulmonary Function Filter is a disposable barrier type filter intended to prevent contamination cross-contamination when using spirometers and pulmonary function testing instruments. The filter also prevents the transmission of harmful bacteria from the instruments to the patient.
The device consists of a plastic housing with a filtering efficiency greater than The filter is designed for inspiratory and expiratory air flow. 99%.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Lotus Pulmonary Function Filter:
It's important to note that this 510(k) summary is for a medical device (a filter), not a software or AI-driven diagnostic tool. Therefore, many of the typical acceptance criteria and study design elements found in AI/ML medical device submissions (like specificity, sensitivity, ROC analysis, MRMC studies, ground truth establishment for imaging, etc.) are not applicable here. The study focuses on the physical performance of the filter and its functional equivalence to a predicate device.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Physical Characteristics | First Article Inspections conducted on all components. | "Prior to testing, First Article Inspections were conducted on all components." (Implicitly, these were passed, as the device proceeded to further testing and submission.) |
| Material Verification | Material verification performed on all components. | "In addition, material verification was performed on all components." (Implicitly, these were passed.) |
| Filtration Efficiency | Filtering efficiency greater than 99%. | "The device consists of a plastic housing with a filtering efficiency greater than 99%." (This is a design claim, and "Bacterial Filtration Efficiency Testing were performed on the device's filter" indicates this claim was tested and presumably met.) |
| Biocompatibility | Cytotoxicity testing performed. | "Cytotoxicity... Testing were performed on the device's filter." (Implicitly, the device met biocompatibility standards, as no adverse findings are noted, and the device was deemed substantially equivalent.) |
| Functional Equivalence | Standard Force Vital Capacity (FVC) Tests using the Lotus Filter show results substantially equivalent to the predicate device (Creative Biomedics Inc. Clear Advantage Filter). | "Standard Force Vital Capacity Tests were performed using both the Lotus Filter and the predicate device. The results of testing showed that test results using the Lotus Filter were substantially equivalent to the Creative Biomedics Inc. Clear Advantage Filter." (This is the primary functional performance criterion demonstrating that the filter does not unduly impede airflow or affect spirometry results compared to an already approved device.) |
| Intended Use | Prevent cross-contamination between patient and spirometers/pulmonary function testing instruments. | The overall conclusion of "substantial equivalence" based on filtration efficiency, cytotoxicity, and functional equivalence supports the intended use. The device's design as a "disposable barrier type filter" also directly addresses this. |
Study Details:
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not explicitly state the number of filters or tests performed for the "Standard Force Vital Capacity Tests," "Cytotoxicity," or "Bacterial Filtration Efficiency Testing." It only states that these tests "were performed." For the FVC tests, it implies a comparison between the Lotus Filter and the predicate device, so at least one of each would have been tested, likely multiple instances for statistical confidence, but the exact number isn't provided.
- Data Provenance: The data appears to be prospective as it was generated by the manufacturer (Custom Plastic Products, Inc.) specifically for the 510(k) submission. There is no information on the country of origin of the data beyond it being generated by a U.S. company for FDA submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For a physical device like a filter, "ground truth" as understood in imaging or diagnostic AI (e.g., "radiologist consensus," "pathology") does not apply. The ground truth for filtration efficiency or cytotoxicity would be established by validated laboratory testing methods and controls, and for FVC, by the spirometry equipment itself, calibrated according to standards. The "experts" would be the technicians and scientists performing these laboratory tests and interpreting their results against established standards. Their specific qualifications are not detailed.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods like 2+1 or 3+1 refer to human reader consensus-building for diagnostic accuracy in scenarios like image interpretation. This is a physical device performance study, not a diagnostic accuracy study involving multiple human readers. The results of the tests (e.g., FVC values, bacterial counts, cytotoxicity scores) would be objective measurements.
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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. An MRMC study is relevant for AI systems that assist human readers in diagnostic tasks. This device is a filter, not an AI system, and the study did not involve human readers interpreting cases. It assessed the filter's physical and functional properties.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical device, not an algorithm. The "standalone" testing refers to the filter's performance in isolation (e.g., filtration efficiency) and its performance in a functional system (e.g., FVC testing with a spirometer) compared to a predicate, but there is no algorithm involved.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" here is based on objective laboratory measurements and established test standards/protocols.
- For Bacterial Filtration Efficiency, the ground truth is defined by the number of bacteria captured vs. passed, measured using standardized microbiological methods.
- For Cytotoxicity, the ground truth is determined by standardized biocompatibility testing, observing cellular reactions to extracts of the material.
- For Force Vital Capacity, the ground truth for the "accuracy" is the spirometer's readings, which are themselves calibrated and standardized, comparing the measured values with the filter to those with the predicate filter. The goal wasn't absolute accuracy against a known "true" lung capacity (which would vary by individual), but rather equivalence in measurement through the filter compared to the predicate.
- The "ground truth" here is based on objective laboratory measurements and established test standards/protocols.
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The sample size for the training set:
- Not Applicable. This device is a physical filter, not a machine learning model. Therefore, there is no "training set."
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How the ground truth for the training set was established:
- Not Applicable. As there is no training set for an AI/ML model, the concept of establishing ground truth for it does not apply.
§ 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).