(90 days)
AirWatch II Zone is a medical instrument which is intended to be used for the monitoring of asthma and other chronic respiratory diseases. The instrument measures both Peak Expiratory Flow (PEF) and Forced Expiratory Volume-One Second (FEV1). The instrument is designed for use by consumers from 5 years of age to adults.
The AirWatch II Zone is a pocket-sized, personal electronic device which monitors respiratory status by measuring peak expiratory flow (PEF) rate in liters per minute and forced expiratory volume in one second (FEV1) in liters. The AirWatch II Zone includes an LCD for displaying PEF and FEV1 information to the consumer, three control buttons, a removable mouthpiece, and an RJ-11C telephone connector which can be used to transfer data stored in the AirWatch to a remote computer.
The AirWatch II Zone is a pocket-sized, personal electronic device designed to monitor respiratory status by measuring peak expiratory flow (PEF) rate and forced expiratory volume in one second (FEV1). It includes an LCD display, control buttons, a removable mouthpiece, and an RJ-11C telephone connector for data transfer to a remote computer.
Here's an analysis of its acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Conformance to National Asthma Education Program's Statement on Technical Standards for peak flow meters | Device conforms to these standards. |
| Conformance to American Thoracic Society (ATS) 1994 Standards for accuracy | Device meets ATS 1994 Standards for accuracy. |
| Conformance to American Thoracic Society (ATS) 1994 Standards for precision | Device meets ATS 1994 Standards for precision. |
| Conformance to American Thoracic Society (ATS) 1994 Standards for linearity | Device meets ATS 1994 Standards for linearity. |
| Conformance to American Thoracic Society (ATS) 1994 Standards for back pressure | Device meets ATS 1994 Standards for back pressure. |
| Appropriate provision of information regarding PEF and FEV1 measurements | Demonstrated in the Validation/Measurement Quality Study. |
| Appropriate identification of PEF measurements of suspect quality using effort check tests | Demonstrated in the Validation/Measurement Quality Study (device includes three effort check tests and displays warning symbols when a measurement fails any test). |
| Safe and effective use by consumers under actual use conditions | Demonstrated in the Home Use Study. |
| Consumer interpretation of display readings and ability to take appropriate actions | Demonstrated in other studies (presumably part of the Home Use or User Guide studies). |
| Appropriateness of Quick Reference Guide, User Guide, physical design, and other human factors characteristics for consumers | Demonstrated in the User Guide Study and Quick Reference Guide Study. |
| Meets applicable electrical, mechanical, and environmental performance requirements stated in the Reviewers Guidance for Premarket Notification Submissions, Appendix A | Device meets all specified requirements. |
2. Sample Size and Data Provenance
- Sample Size for Test Set: 20 study subjects were used for each of the four studies: Validation/Measurement Quality Study, Home Use Study, User Guide Study, and Quick Reference Guide Study.
- Data Provenance: The document does not explicitly state the country of origin. The study appears to be prospective, as it involved "study subjects" and "testing."
3. Number of Experts and their Qualifications
The document does not provide information on the number of experts used to establish ground truth or their specific qualifications (e.g., "radiologist with 10 years of experience"). This type of detail is often omitted for devices like peak flow meters where the "ground truth" might be established by other calibrated devices or established physiological measurements, rather than expert interpretation.
4. Adjudication Method
The document does not mention an adjudication method for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. This type of study is more common for diagnostic imaging AI systems where human readers interpret medical images. The AirWatch II Zone is a direct measurement device rather than an interpretative one in the same vein as imaging diagnostics.
6. Standalone Performance Study
A standalone performance study was done for the device, specifically the "Validation/Measurement Quality Study." This study aimed to demonstrate that the device itself could:
- Appropriately provide information regarding a subject's PEF and FEV1 measurements.
- Appropriately identify PEF measurements of suspect quality.
7. Type of Ground Truth Used
For the AirWatch II Zone, the ground truth for performance assessment would likely be established using:
- Calibrated reference instruments: For accuracy and precision of PEF and FEV1 measurements (e.g., comparing the device's readings to those from a highly accurate and calibrated spirometer).
- Established physiological criteria: For the "effort check" feature, the ground truth would be based on physiological parameters that indicate a valid vs. suspect respiratory effort.
- User feedback and observation: For user interface, ease of use, and interpretability (as indicated by the Home Use, User Guide, and Quick Reference Guide studies).
The document states the device "meets the American Thoracic Society 1994 Standards for accuracy, precision, linearity, and back pressure." These standards inherently define the ground truth for those technical performance aspects.
8. Sample Size for the Training Set
The document does not mention a training set, as the AirWatch II Zone is a traditional medical device (peak flow meter) and not an AI/machine learning-based device that typically undergoes a training phase.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a training set for an AI/machine learning algorithm.
§ 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).