(80 days)
This device is intended for monitoring PEF (Peak Expired Flow Rate) and FEV1 (Forced Expiratory Volume in one second) for patient home use. The device is designed for pediatric to adult patients.
The Microlife Electronic Peak Flow Monitor, Model PF-100, comprises a hand held microprocessor based unit, incorporating a removable micro medical digital volume transducer. The transducer consists of an acrylic tube with a freely rotating vane supported on jeweled bearings positioned between a fixed swirl plate and a cross bar. As air is passed through the transducer, a vortex is created by the swirl plate, which causes the low inertia vane to rotate. The rotation of the vane is detected by the interruption of an infrared beam which produces an electrical pulse train at the output of a phototransistor. The number of rotations is proportional to the volume of air passed through the turbine, and the rate of rotation is proportional to the flow rate. With flow rate and correspondent time, FEV1 can be calculated.
The provided document is a 510(k) summary for a medical device called the Microlife Electronic Peak Flow Monitor. This document is a premarket notification to the FDA, and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria and direct performance metrics in the way a clinical trial or algorithm validation might for a novel AI device.
Therefore, many of the requested items regarding acceptance criteria, sample sizes, expert ground truth, and AI-specific studies are not directly applicable or available in this specific document, as it predates widespread AI in medical devices and focuses on mechanical and electrical safety and performance standards for a peak flow meter.
However, I can extract information related to the device's performance based on the standards it claims to meet.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Mechanical/Flow Measurement: | |
| American Thoracic Society (ATS) recommendations for Spirometry (PEF accuracy) | "Both devices meet the American Thoracic Society (ATS) recommendations for Spirometry." |
| "meeting ATS accuracy testing using the 26 flow-time waveform and the 24 volume-time waveform." | |
| ATS recommendations for Spirometry (FEV1 accuracy) | "Both devices meet the American Thoracic Society (ATS) recommendations for Spirometry." |
| Electrical Safety: | |
| IEC 60601-1 (electrical safety) | "Product Safety Testing included successful completion of testing to the IEC 60601-1 (electrical safety) standard." |
| Electromagnetic Compatibility (EMC): | |
| IEC 60601-1-2 (electromagnetic compatibility) | "Product Safety Testing included successful completion of testing to... IEC 60601-1-2 (electromagnetic compatibility) standards." |
2. Sample size used for the test set and the data provenance
The document refers to "bench testing" and "non-clinical testing" using "ATS Standard Waveforms" and "a waveform generator." It does not specify a "sample size" in terms of human subjects or a dataset in the way an AI study would. The testing appears to involve simulated waveforms rather than real patient data. There is no information on data provenance (country of origin, retrospective/prospective) because human data was not used for this evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for the device's accuracy was established by the ATS standards themselves, which define ideal flow and volume waveforms. Experts would have developed these standards, but not specifically for this device's testing.
4. Adjudication method for the test set
Not applicable. The testing was against established technical standards and simulated waveforms, not human expert consensus.
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. This device is a peak flow meter, not an AI-powered diagnostic tool. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a standalone hardware device that measures physical parameters. It does not contain an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth used for performance validation was based on technical standards and simulated waveforms defined by the American Thoracic Society (ATS). This refers to the precise, known characteristics of the flow-time and volume-time waveforms that a spirometer should accurately capture.
8. The sample size for the training set
Not applicable. This device is not an AI/machine learning model and therefore does not have a "training set."
9. How the ground truth for the training set was established
Not applicable. As there is no training set, there is no ground truth establishment for it.
§ 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).