(281 days)
This device is intended for monitoring PEF (Peak Expired Flow Rate) and FEV 1 (Forced Expiratory Volume in one second) for patient home use. The device is designed for pediatic to adult patients. The device is intended for monitoring respiratory conditions such as asthma.
The MSA100 Peak Flow Meter is a medical device that measures patient's maximum possible exhalation which is called "peak flow" (referred to in medical terms as PEF-Peak Expiratory Flow) and "forced expiratory volume" (commonly known as FEV1) in one second. Regular monitoring of the peak flow is useful for monitoring diseases of the airways such as asthma, C.O.P.D, or chronic bronchitis, is usually used for patient home use.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Test | Acceptance Criteria (Predicate Device) | Reported Device Performance (Proposed MSA100 Peak Flow Meter) |
|---|---|---|
| PEF Measuring Range | 50 to 900 l/min | 50 to 900 l/min |
| FEV1 Measuring Range | 0.01 to 9.99 liters | 0.01 to 9.99 liters |
| PEF Accuracy | ± 25 l/min or 12% of the reading | ± 20 l/min or ± 10% of the reading |
| FEV1 Accuracy | ± 0.1 l or ± 5% of the reading | ± 0.05 l or ± 3% of the reading |
| PEF Measuring Resolution | 1 l/min | 1 l/min |
| FEV1 Measuring Resolution | 0.01 l | 0.01 l |
| Data Safety | Data rememorized by EEPROM | Data rememorized by Flash memory |
| Memory | 240 measurements with date/time | 300 measurements with date/time |
| Power Source | 2 batteries of 1.5V, size AAA | AAA 1.5x2 alkaline batteries |
| Electrical Safety | IEC 60601-1 and IEC 60601-1-2 | IEC 60601-1 and IEC 60601-1-2 |
| Biocompatibility (In vitro cytotoxicity, irritation, sensitization) | Met acceptance criteria (implied by ISO standards) | Met acceptance criteria (ISO 10993-5: 2009; ISO 10993-10: 2010) |
| Performance Testing | ATS 2005 update | ATS 2005 update |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions that "The sponsor has performed bench tests to demonstrate the MSA100 Peak Flow Meter performs within specifications." This suggests the testing was laboratory-based rather than involving human subjects for performance evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided. The testing appears to be based on engineering and laboratory standards, not clinical ground truth established by medical experts for individual cases.
4. Adjudication method for the test set:
Not applicable. The testing described involves bench tests against specified performance metrics and adherence to international standards, not subjective expert adjudication of results.
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 measurement instrument (Peak Flow Meter) and does not involve AI or human "readers" interpreting data in a typical MRMC study context.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The device is a standalone instrument for measuring PEF and FEV1. The "algorithm only" concept doesn't directly apply as it's a physical device with embedded measurement technology (turbine transducer, photoelectric conversion). The performance described is its standalone measurement accuracy.
7. The type of ground truth used:
The ground truth used for specific performance metrics (like accuracy for PEF and FEV1) would be established by reference standards or calibrated equipment used in the bench testing. For biocompatibility and electrical safety, the ground truth is adherence to the specified ISO and IEC standards.
8. The sample size for the training set:
Not applicable. This device is a hardware measurement instrument tested against established engineering and performance standards, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of 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).