(117 days)
Aluna is intended for monitoring FEV1 (Forced exhalation in the first second) and PEF (Peak Expired Flow Rate) for home use. The device is designed for children 5 years of age or older, adolescent and adult subjects. Additionally, the device may be used by clinicians for in-office monitoring.
Aluna is a small hand-held peak flow meter that captures lung health information and makes it available through a mobile application. Aluna is intended for monitoring FEV1 (Forced Expiratory Volume in one second) and PEF (Peak Expiratory Flow) for over-the-counter use. Aluna is designed for use by pediatric to adult users. Aluna is not recommended for children under 5 years of age. Additionally, the device may be used by clinicians for in-office monitoring.
Here's an analysis of the provided text to extract the acceptance criteria and study information for the Aluna device:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Aluna) | Reported Device Performance (Aluna) |
|---|---|---|
| FEV1 Accuracy | ± 3% or 0.05 L, whichever is greater | Meets criteria |
| PEF Accuracy | ± 10% or 0.3 L/s, whichever is greater | Meets criteria |
Note: The document states that the technological differences (rechargeable battery, cloud data storage, game function) "have undergone testing to ensure the device is as safe and effective as the predicate" and that "non-clinical performance bench testing including FEV1/PEF measurement accuracy and repeatability per 2005 American Thoracic Society document ATS/ERS Task Force: Standardization of Lung Function Testing" was performed. While the specific numerical performance results are not explicitly listed in a separate "reported performance" column, the conclusion section states that "performance characteristics for the proposed Aluna are assessed to be substantially equivalent to the predicate device," implying that the device met these stated accuracy criteria.
2. Sample Size Used for the Test Set and Data Provenance
The provided FDA 510(k) summary does not specify the sample sizes used for the FEV1/PEF measurement accuracy and repeatability testing. It only mentions that these tests were performed as "non-clinical performance bench testing."
Regarding data provenance, the document does not explicitly state the country of origin or if the data was retrospective or prospective. Given it's a bench test, the data would be generated in a controlled laboratory environment.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish ground truth for the test set. For FEV1/PEF accuracy testing, the "ground truth" is typically established by comparing the device's readings against a highly accurate standard spirometer calibrated to known volumes and flows, or established physical simulators that produce precise airflow patterns. This is a technical measurement, not an expert interpretive judgment.
4. Adjudication Method for the Test Set
Not applicable. The accuracy testing described is a technical comparison against a standard, not an interpretive task requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The Aluna device is a peak-flow meter, which measures physiological parameters. Its effectiveness is assessed through accuracy and repeatability against established standards, not through human reader interpretation of images or data. Therefore, a study comparing human readers with and without AI assistance is not relevant to this type of device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance assessment was done. The FEV1/PEF measurement accuracy and repeatability testing assesses the algorithm's ability to accurately measure lung function parameters by itself, without human intervention in the measurement process (though a human operates the device).
7. The Type of Ground Truth Used
For the FEV1/PEV measurement accuracy and repeatability testing, the ground truth would be established by:
- Highly accurate standard spirometry equipment or flow/volume simulators: These devices are precisely calibrated and serve as the reference standard against which the Aluna device's measurements are compared. The "2005 American Thoracic Society document ATS/ERS Task Force: Standardization of Lung Function Testing" explicitly details the methods and standards for this type of testing, which involves comparing the device's output to known, accurate flow and volume signals.
8. The Sample Size for the Training Set
The document does not provide information on a "training set" sample size. The Aluna is a medical device for measuring physical parameters, not an AI model that learns from a dataset in the traditional sense (e.g., machine learning for image classification). While there might be internal algorithms for signal processing or data analysis within the device, the summary does not detail the development or validation of such algorithms using a distinct training set. The emphasis is on the device's performance against established physical measurement standards.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as a traditional "training set" and associated ground truth establishment (as seen in AI/ML contexts) are not described for this device in the provided document. The device's performance is validated through specific bench testing against established physical and physiological measurement standards.
§ 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).