(212 days)
This device is intended to monitor a patient's Peak Expiratory Flow (PEF) and Forced Expiratory Volume in one second (FEV 1) at home. The device is designed for adults and children over 5 years of age with caregiver supervision. The device is intended for monitoring respiratory conditions such as asthma.
Smart Peak Flow Meter (Model: B1) is a new type of hand-held pulmonary function testing device that measures peak expiratory flow (PEF) and forced expiratory Volume in 1 second (FEV1). Regular measurement is beneficial to the controlling of pulmonary disease such as asthma. The accuracy meets American Thoracic Society (ATS) Standard 2005 Revision.
The Smart Peak Flow Meter (Model: B1) is mainly composed of the main unit and removable mouthpiece. The use of B1 is very simple, user can master it quickly after reading the product user manual. It adopts mouth blowing method. After mouthpiece installation and powering on, keep breath steady, take a deep breath, hold the breath while put the mouthpiece into mouth, then exhale quickly and forcefully, taking as much time as possible. The results will be shown on the display screen and smart phone App. The mouthpiece should be removed regularly for cleaning.
The device can store 100 sets of data which can be transmitted to smart phone App through Bluetooth transmission mode for permanent storage. User can check the previous measurement records on the smart phone App.
The provided text describes the acceptance criteria and a study for the Smart Peak Flow Meter (Model: B1).
1. A table of acceptance criteria and the reported device performance
| Criteria | Acceptance Criteria (from ATS 2005 Standard) | Reported Device Performance |
|---|---|---|
| PEF Accuracy | ±10% or ±18 L/min (whichever is greater) | Meets the requirements in the standards (ATS 2005) |
| FEV1 Accuracy | ±3% or ±0.05 L (whichever is greater) | Meets the requirements in the standards (ATS 2005) |
| Intra-instrument Repeatability | Not explicitly stated, but implied to meet ATS 2005 | Meets the requirements in the standards (ATS 2005) |
| Inter-instrument Repeatability | Not explicitly stated, but implied to meet ATS 2005 | Meets the requirements in the standards (ATS 2005) |
| Flow Resistance | Not explicitly stated, but implied to meet ATS 2005 | Meets the requirements in the standards (ATS 2005) |
| Software Functionality | Software functions as specified in software requirement specifications | Software validation demonstrated functionality |
| Biocompatibility | Conformance to ISO 10993-1 | Passed tests as per ISO 10993-1 |
| Electrical Safety | Conformance to IEC 60601-1 and IEC 60601-1-11 | Passed tests as per IEC 60601-1 and IEC 60601-1-11 |
| EMC | Conformance to IEC 60601-1-2 | Passed test as per IEC 60601-1-2 |
| Wireless Functionality | Compliance with FDA's guidance for RF Wireless Technology | Complies with FDA's guidance |
| Human Factors | Ease of use, safety, and effectiveness for intended users | 100% of participants completed critical tasks with ease and confidence; device and application are as safe and effective as predicate device |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Performance Test (Accuracy, Repeatability, Flow Resistance): The document states "All of the tested parameters meet the requirements in the standards," but it does not specify the sample size used for the performance testing.
- Human Factor Engineering Study:
- Sample Size: 20 participants
- Data Provenance: Not specified, but likely a prospective study conducted for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The document refers to conformance with the American Thoracic Society (ATS) Standard 2005 Revision for performance testing. For such standards, the "ground truth" is typically defined by the standard's specifications and measurement methods using reference equipment. No information is provided about human expert involvement in establishing a ground truth for the performance test itself. For the human factors study, the "ground truth" would be the observed user interaction and satisfaction, not expert medical opinion.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The performance testing relies on comparison to standardized measurements against the ATS 2005 standard, not human adjudication of medical findings. The Human Factor study measures user performance and feedback, not a diagnostic outcome requiring adjudication.
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
Not applicable. The device is a "Smart Peak Flow Meter" for spirometry, which directly measures physiological parameters (PEF and FEV1). It does not involve "human readers" or AI assistance in interpreting images or data in a way that an MRMC study would be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The primary performance tests (accuracy, repeatability, flow resistance) are effectively standalone tests of the device's measurement capabilities against a standard. The human factors study evaluates the user interface and overall device usability for human users, making it a human-in-the-loop evaluation for that aspect. However, the core measurement functionality is standalone.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the performance tests (PEF and FEV1 accuracy) is based on the American Thoracic Society (ATS) Standard 2005 Revision. This standard defines the acceptable range and methodology for measuring these physiological parameters, likely involving calibrated reference equipment.
8. The sample size for the training set
Not applicable. The device is a measurement device for spirometry, not a machine learning or AI-driven diagnostic tool that requires a "training set" in the conventional sense.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" in the context of this 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).