(100 days)
The Clean Peak Flow Meter simply measures a patient's peak expiratory flow rate in liters/minutes. This is helpful in monitoring respiratory conditions such as asthma.
Targeted population:
Children scale / 50 – 380 liters/minutes Patients requiring the measurement of peak expiratory flow rate from 6 years on up to 12 years.
Adult scale / 50 - 800 liters/minutes Patients requiring the measurement of peak expiratory flow rate from 6 years on.
Environment of use: Places where a patient may require the measurement of their peak expriatory flow rate.
A peak flow meter is a device used to measure a person's peak expiratory flow rate.
Here's a summary of the acceptance criteria and the study information based on the provided text for the Clean Peak Flow Meter:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from Predicate Device) | Reported Device Performance (Clean Peak Flow Meter) |
|---|---|
| Range: 60 - 900 L/Min | Range: 50 - 800 L/Min (adult), 50 - 380 L/Min (children) |
| Accuracy: +/- 10% | Accuracy: +/- 10% |
| Intra-device Precision: +/- 5% | Intra-device Precision: +/- 5% |
| Inter-device Precision: +/- 5% | Inter-device Precision: +/- 5% |
Note: The differences highlighted indicate a slightly different measurement range for adults and a specific range for children, as well as a change in mouthpiece material. The accuracy and precision criteria remain the same and are met by the new device.
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). The document states that the Clean Peak Flow Meter was "developed in accordance with the Cardinal Health development standard operating procedures (000490 06 – Design Control)" and that "Safety test procedures demonstrate satisfaction of all safety requirements and mitigation of all identified hazards." However, no details about specific testing methodologies, number of devices tested, or the nature of the data collected during these tests are provided within the summary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The testing described primarily pertains to engineering performance characteristics of the device, not clinical performance requiring expert ground truth for interpretation.
4. Adjudication Method for the Test Set
This information is not provided in the document. As stated above, the listed tests are performance specification tests, not clinical evaluations that would typically require adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.
No, an MRMC comparative effectiveness study was not done. This type of study is typically for evaluating the impact of AI on human reader performance in diagnostic tasks, which is not applicable to a peak flow meter.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done.
Yes, in essence, the performance testing described for the Clean Peak Flow Meter is a standalone assessment of the device's accuracy and precision according to its specifications. The device itself is an analog, mechanical measuring tool; there is no AI algorithm involved. The listed performance criteria (Range, Accuracy, Intra-device Precision, Inter-device Precision) represent the device's capabilities when used as intended, without human intervention affecting its measurement output beyond the patient's breath.
7. The Type of Ground Truth Used
For the performance criteria (Range, Accuracy, Intra-device Precision, Inter-device Precision), the ground truth would typically be established by:
- Reference Standards/Calibration Devices: Highly accurate calibration equipment or standardized airflow generators are used to provide known input values against which the peak flow meter's readings are compared. This allows for validation of its accuracy and precision.
8. The Sample Size for the Training Set
This information is not applicable and therefore not provided. The Clean Peak Flow Meter is a mechanical device, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
This information is not applicable and therefore not provided, as there is no "training set" for this mechanical device.
§ 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).