(161 days)
The DynamiPeak™ Peak Flow Meter is designed as a single-patient use device to measure the Peak Expiratory Flow Rate (PEFR). The device is intended for use by children to adults.
The DynamiPeak™ Peak Flow Meter is a simple mechanical device that responds to and indicates the peak expiratory flow rate (PEFR) generated by the user during a forced exhalation maneuver. The inlet of the device is placed into the user's mouth after which the maximum rate at exhalation is attempted from nearly full lungs. As this forced exhalation commences, and internal piston extends a spring as it reacts to an internal pressure spike. An indicator is pushed by the moving piston and remains at the maximum displacement position of the piston after the maneuver is terminated. This position corresponds to the PEFR and is quantified in liters per minute by reading a scale next to the indicator. The piston displacement function is logarithmic, thereby providing greater resolution of the scale at lower PEFR readings.
The provided text is for a 510(k) premarket notification for a medical device, the "DynamiPeak™ Peak Flow Meter," and its acceptance by the FDA. It does not describe a study for a device meeting acceptance criteria in the way a clinical trial or algorithm validation study would. Instead, it focuses on demonstrating substantial equivalence to predicate devices for regulatory approval.
Therefore, many of the requested elements for a study proving device acceptance criteria cannot be extracted because such a study, with distinct acceptance criteria for performance metrics, ground truth, and expert evaluation, is not presented in this document.
However, I can extract the available information related to the device and its regulatory acceptance.
Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical "acceptance criteria" that the DynamiPeak™ Peak Flow Meter had to meet from a specific performance study. Instead, the basis for acceptance is stated as substantial equivalence to predicate devices. The "reported device performance" is broadly described as functioning adequately and effectively.
| Acceptance Criteria (Inferred from Substantial Equivalence and Standards) | Reported Device Performance (from document) |
|---|---|
| General | |
| Functional Equivalence to Predicate Devices | Both devices (DynamiPeak™ and MICROPEAK) function adequately as peak flow meters (4.7.3) and have been demonstrated to function effectively in measuring patients' peak expiratory flow rates (4.7.5). |
| Meeting ATS Standardization of Spirometry Recommendations | The devices meet the recommendations of the American Thoracic Society's Standardization of Spirometry (4.7.6). |
| Design/Manufacturing Equivalence | |
| Same Design Specifications | DynamiPeak™ and MICROPEAK share the same design specifications (4.8.1). |
| Fabricated from Same Materials | DynamiPeak™ and MICROPEAK are fabricated from the same materials (4.8.1). |
| Manufactured by Same Contract Supplier | DynamiPeak™ and MICROPEAK are manufactured by the same contract manufacturing supplier (Fyne Dynamics, Ltd., UK) (4.7.1.1, 4.8.1). |
| Substantially Equivalent Components | Assembled from substantially equivalent components and raw materials (4.7.1.2, 4.7.1.3). |
| Intended Use Equivalence | |
| Same Indications for Use as Predicates | The DynamiPeak™ Peak Flow Meter has the same indications for use as the predicate devices (4.8.2). Intended as a single-patient use device to measure PEFR for children to adults (4.6, Indications for Use Statement). |
| Mechanism of Action Equivalence | |
| Simple Mechanical Device Indicating PEFR | Both DynamiPeak™ and predicate devices are simple mechanical devices that respond to and indicate the peak expiratory flow rate (PEFR) generated by a patient during a forced exhalation maneuver (4.8.3, 4.8.4). |
| Validation/Verification | |
| Undergone and Passed Equivalent Clinical Testing Criteria | Have undergone and have passed substantially equivalent clinical testing criteria (4.7.1.5). |
1. A table of acceptance criteria and the reported device performance:
(See table above)
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document states that the devices (DynamiPeak™ and MICROPEAK) "have under gone and have passed substantially equivalent clinical testing criteria" (4.7.1.5). However, no details about a specific sample size for a test set, data provenance, or retrospective/prospective nature of this "clinical testing" are provided in the document. The focus is on the equivalence of testing, not the specifics of the test itself for the DynamiPeak™ device. Given the context of a peak flow meter, this "testing" likely refers to engineering performance validation against standards rather than patient data collection.
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):
Not applicable. The document does not describe a study involving expert-established ground truth for performance. The "ground truth" for a peak flow meter would be its accurate measurement of airflow against a calibrated standard, not an expert assessment of a medical image or diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No adjudication method is described as this is not a study focused on subjective expert assessment or diagnosis.
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 mechanical peak flow meter, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This device is a standalone mechanical instrument; there is no "algorithm" in the sense of software for analysis being evaluated. Its performance is inherently "standalone" as it mechanically measures PEFR.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The document does not explicitly state the "ground truth" used for any specific testing of the DynamiPeak™ device. However, regulatory acceptance for peak flow meters typically relies on calibration against known flow rates (e.g., using a spirometer or flow simulator) to ensure accuracy, and adherence to recognized industry standards such as those from the American Thoracic Society (ATS) (4.7.6). This would be the implied "ground truth" for its function.
8. The sample size for the training set:
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. This is not a machine learning or AI device that requires a training set.
§ 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).