(119 days)
The RxPeakFlow is a single patient use device to measure a patient's peak expiratory flow rate in liters/minutes. This is helpful in monitoring respiratory conditions such as asthma. The device can be used anywhere the patient needs to measure their peak expiratory flow rate. It is a single patient use device intended for use for children to adults.
The RxPeakFlow is a device used to measure the peak expiratory flow of a patient. The Peak Expiratory Flow Rate is a recognized lung function value that is helpful in monitoring of respiratory conditions such as asthma. The device can be used anywhere the patient needs to measure their peak expiratory flow rate. It is a single patient use device intended for use for children to adults.
Here's a breakdown of the acceptance criteria and the study details for the RxPeakFlow Meter, based on the provided text:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (RxPeakFlow) |
|---|---|
| Range | 60-800 L/Min |
| Accuracy | +/- 10% |
| Intra-device Precision | +/- 5% |
| Inter-device Precision | +/- 5% |
Note: The document only provides the performance of the RxPeakFlow against these criteria, stating it "passed all testing and met the criteria for range, accuracy and precision of required by the American Thoracic Society's Standardization of Spirometry". It doesn't explicitly list a separate "acceptance criteria" column versus "reported device performance," but rather presented these as the requirements the device met.
2. Sample Size and Data Provenance for the Test Set
The document states that "bench testing" was performed. However, it does not provide specific details regarding:
- Sample size used for the test set (e.g., number of devices tested, number of individual measurements).
- Data provenance (e.g., country of origin, retrospective or prospective nature of the "bench testing").
3. Number of Experts and Qualifications for Ground Truth Establishment
This information is not provided in the document. Bench testing typically relies on standardized reference instruments or methods rather than human expert interpretation for ground truth.
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1, 3+1, none) are typically used when multiple human experts are involved in interpreting results, especially in imaging or diagnostic studies. Since the testing was "bench testing," and no human experts or interpretation are mentioned for establishing ground truth, information on an adjudication method is not applicable and not provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not done. The device is a "Meter, Peak Flow," which measures a physical parameter directly, rather than providing an interpretation that a human would then use to make a decision. The performance evaluation was through "bench testing," not a clinical study involving human readers.
6. Standalone Performance Study
Yes, a standalone performance study was done. The document explicitly states: "The RxPeakFlow has been tested for performance through bench testing. The device passed all testing and met the criteria for range, accuracy and precision of required by the American Thoracic Society's Standardization of Spirometry, specifically the ATS 26 flow-time waveform testing." This describes the algorithm's (or device's mechanical) performance without human intervention.
7. Type of Ground Truth Used
The ground truth used was based on standards and requirements from the American Thoracic Society's Standardization of Spirometry, specifically the ATS 26 flow-time waveform testing. This implies that the device's measurements were compared against known, standardized flow-time waveforms or reference measurements adhering to these professional guidelines.
8. Sample Size for the Training Set
The document does not provide information on a separate "training set" or its sample size. This is common for mechanical devices that are calibrated and tested against physical standards, rather than "trained" using a dataset in the way a machine learning algorithm would be.
9. How Ground Truth for the Training Set Was Established
As there is no mention of a training set in the context of machine learning, there is no information on how its ground truth was established. The device is a mechanical measurement tool rather than an AI/ML-driven diagnostic.
§ 868.1860 Peak-flow meter for spirometry.
(a)
Identification. A peak-flow meter for spirometry is a device used to measure a patient's maximum ventilatory flow rate.(b)
Classification. Class II (performance standards).