(184 days)
The intended device simply measures a patient's peak expiratory flow rate in liters/minute. This is helpful in monitoring respiratory conditions such as asthma.
A peak flow meter is a device used to measure a person's peak expiratory flow rate.
This document describes a 510(k) premarket notification for the MicroPeak Peak Flow Meter. The following information is extracted or inferred from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the MicroPeak Peak Flow Meter are implicitly defined by its performance comparison to the Vitalograph Asmaplan+, a predicate device. The document states "The only difference is a small difference in the measurement range," implying that the MicroPeak device's performance attributes (accuracy, intra-device precision, inter-device precision) are considered acceptable if they match or are comparable to the predicate device's.
| Attribute | Acceptance Criteria (Predicate Device: Vitalograph Asmaplan+) | Reported Device Performance (MicroPeak) |
|---|---|---|
| Range | 50 - 800 L/M | 60 - 900 L/Min |
| Accuracy | +/- 10% | +/- 10% |
| Intra device Precision | +/- 5% | +/- 5% |
| Inter device Precision | +/- 5% | +/- 5% |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective or prospective). The comparison is based on the technical specifications of the device rather than a clinical study with a detailed test set.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not mention a ground truth established by experts for a test set. The validation appears to be based on engineering specifications and comparison to a predicate device.
4. Adjudication Method for the Test Set
No adjudication method is mentioned as there is no described test set involving human interpretation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. This device is a measurement tool, not an AI-assisted diagnostic tool for human readers.
6. Standalone (Algorithm Only) Performance Study
The document implicitly describes the standalone performance of the device by listing its performance attributes (range, accuracy, precision). However, it does not detail a specific standalone study design or results beyond these specifications. The device itself is a mechanical measurement tool, not an algorithm.
7. Type of Ground Truth Used
The ground truth for the device's performance appears to be based on engineering specifications and direct measurement capabilities of the device itself, compared against the known specifications of the predicate device. There is no mention of pathology, expert consensus (in the context of clinical interpretation), or outcomes data for performance validation in this submission.
8. Sample Size for the Training Set
The concept of a "training set" is not applicable as this is a mechanical peak flow meter, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
Not applicable as there is no training set mentioned.
§ 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).