(228 days)
This device is intended for monitoring PEF (Peak Expired Flow Rate) for patient home use. The device is designed for pediatric to adult patients. The simple device interface provides ease of use for pediatric patients. When the device is used to monitor lung conditions such as asthma, the user should be under the care of a licensed health care professional. A licensed health care professional's advice is required to understand the meaning and importance of the measurements reported by the device and how to decide on an appropriate treatment plan. This treatment plan will tell the patient what action to take when there are changes in their PEF measurements.
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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Microlife Electronic Peak Flow Monitor, Model PF-100:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| American Thoracic Society (ATS) recommendations for Spirometry | Device meets ATS recommendations. |
| ATS Standard for flow measuring accuracy (+/- 20 L/min) | Device is "above the ATS Standard (+/-20 L/min)" (implies meeting or exceeding). |
| IEC 60601-1 (electrical safety) | Successfully completed testing. |
| IEC 60601-1-2 (electromagnetic compatibility) | Successfully completed testing. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document explicitly states that the device was tested using "the ATS Standard Waveforms." However, it does not specify the number of waveforms or the duration of these tests. It only mentions "using the 26 flowtime waveform" in the description of the measuring principle, which might imply the type of waveform used by the ATS standard but not the sample size of tests performed.
- Data Provenance: Not specified, but given the manufacturer (Microlife Corporation) is from Taiwan and the submission is to the FDA in the USA, the testing was likely conducted by the manufacturer or a contracted lab to demonstrate compliance for US market approval. The data would be considered retrospective as it was generated specifically for the submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not Applicable. The ground truth for the performance claim (flow accuracy) was established directly by the ATS Standard Waveforms using a "waveform generator." This implies a standardized, objective set of conditions rather than expert interpretation of medical data. For electrical safety and electromagnetic compatibility, the ground truth is defined by the respective IEC standards, again not requiring human expert interpretation in the context of this submission.
- The document explicitly states "Discussion of Clinical Tests Performed: Not Applicable." This further confirms that human expert-derived ground truth from patient data was not a component of this submission's testing.
4. Adjudication Method for the Test Set
- Not Applicable. As the ground truth was established by standardized waveforms and objective technical standards (ATS, IEC), there was no need for human adjudication of results. The device's output was compared directly against the known, precise values of the generated waveforms or compliance criteria of the technical standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. The document explicitly states "Discussion of Clinical Tests Performed: Not Applicable." This type of study would involve human readers (healthcare professionals) using the device with and without AI assistance (though this device does not appear to have AI) on multiple patient cases, which was not part of the submitted evidence.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, a standalone performance assessment was conducted. The "subject device was tested to and passed the ATS Standard Waveforms using a waveform generator." This is an assessment of the device's inherent accuracy and performance characteristics in isolation, without a human operator's influence on the measurement itself (though a human activates the test and reads the result). Electrical safety and EMC testing are also standalone assessments.
7. The Type of Ground Truth Used
- Standardized Waveforms and Technical Standards:
- For performance (flow accuracy): The ATS Standard Waveforms, generated by a "waveform generator." This represents a highly controlled, objective, and reproducible standard.
- For safety and EMC: IEC 60601-1 (electrical safety) and IEC 60601-1-2 (electromagnetic compatibility). These are objective technical standards.
8. The Sample Size for the Training Set
- The document describes a physical device with a "removable micro medical digital volume transducer," not a software algorithm that would typically require a training set in the context of AI. Therefore, Not Applicable. The device's function is based on physical principles (vortex creation, vane rotation, infrared beam interruption) rather than a learned model from data.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set for this type of device, this question is not relevant.
§ 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).