(37 days)
Smart One is intended for home use by patients to monitor PEF (Peak Expiratory Flow) and FEVI (Forced Expiratory Volume in one second). The device is designed for children greater than five years of age, adolescent and adult subjects.
Smart One is a pocket-sized system for monitoring the following respiratory parameters: PEF (Peak Expiratory Flow) and FEV1 (Forced Expiratory Volume in 1 sec). For each of these two parameters, the result is a number shown on the smartphone screen. PEF is also associated with a three zone monitoring system that, according to the result, may be green, yellow or red. Smart One is made up of two elements - the device and a Mobile Medical Application for smartphones (or tablets) that communicate via Bluetooth Smart 4.0.
The provided text describes specific performance tests for the Smart One device, particularly focusing on non-clinical testing. Here's a breakdown based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Accuracy of measured parameters per ATS standards (specifically "Standardization of Spirometry - 2005" document) | "Accuracies of measured parameters are within the limits of the ATS standards." |
| Electrical safety | Device is in compliance with IEC 60601-1:2005. |
| Electromagnetic compatibility (EMC) | Device is in compliance with IEC 60601-1-2:2007. |
| Mechanical durability | Testing was completed. |
| Temperature/humidity | Testing was completed. |
| Wireless transmission integrity | Testing was performed. |
| Wireless coexistence | Testing was performed. |
| Biocompatibility (cytotoxicity, irritation, sensitization) | Materials are biocompatible, tested according to ISO 10993-1:2009. |
| Software verification and validation | Testing was conducted and documentation provided as per FDA guidance. |
| Bluetooth SIG qualification | SmartOne has been qualified. |
| Data transmission integrity (Bluetooth) | Thoroughly tested. |
2. Sample size used for the test set and the data provenance
- Test set sample size: Not explicitly stated for each test beyond mentioning "a Pulmonary Waveform Generator" for the performance test.
- Data provenance: The performance test was conducted "in MIR facilities" using a Pulmonary Waveform Generator. Other tests (electrical safety, EMC, mechanical durability, temperature/humidity, wireless transmission, biocompatibility, software V&V) are generally bench tests or internal company evaluations.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable / Not specified. The tests described are primarily engineering and performance bench tests against established standards (e.g., ATS, IEC, ISO) rather than clinical evaluations requiring expert human interpretation of medical data. The ground truth for these tests would be the controlled outputs of the Pulmonary Waveform Generator or the specified limits within the engineering standards.
4. Adjudication method for the test set
- Not applicable / Not specified. As the tests are objective engineering and performance evaluations against predefined standards, an adjudication method for human interpretation is not relevant.
5. 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
- No. This document does not describe an MRMC comparative effectiveness study. The device is a peak flow meter for spirometry, a diagnostic tool measuring physiological parameters, not an AI-driven image interpretation or diagnostic aid that would typically involve human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, effectively. The performance tests described (e.g., "A performance test has been carried out on the bench according to the American Thoracic Society (ATS) Document 'Standardization of Spirometry - 2005' ... using a Pulmonary Waveform Generator.") are standalone evaluations of the device's accuracy in measuring PEF and FEV1. The device itself (including its internal algorithms) is being evaluated against known, controlled inputs from the waveform generator. The mobile medical application primarily displays and compares the device's output rather than performing the core measurement algorithm.
7. The type of ground truth used
- Standardized references and objective measurements:
- For accuracy of PEF and FEV1: The "Standardization of Spirometry - 2005" document from the American Thoracic Society (ATS) and a "Pulmonary Waveform Generator" which provides known, controlled respiratory flow patterns.
- For electrical safety and EMC: IEC 60601-1:2005 and IEC 60601-1-2:2007 standards.
- For biocompatibility: ISO 10993-1:2009.
- For software: FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
8. The sample size for the training set
- Not applicable / Not specified. This document describes a medical device (a peak flow meter) which is based on physical measurement principles (turbine flow meter, infrared interruption) rather than a machine learning or AI algorithm that would require a distinct "training set" in the context of deep learning. The "training" here would be the engineering calibration and firmware development of the device based on physics and physiological principles.
9. How the ground truth for the training set was established
- Not applicable / Not specified. See point 8. The device operates on established physical principles for flow measurement. Its "training" or calibration would involve ensuring the sensor accurately translates physical airflow into digital values that conform to spirometry standards, likely using highly accurate reference instruments and controlled flow sources, rather than a "ground truth" derived from expert labeling of a dataset for machine learning.
§ 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).