(276 days)
The GaleMed Model 3751 and Model 3752 peak flow meters are intended to measure a patient's peak expiratory flow. The Model 3751 is intended for use by adults, and the Model 3752 is intended for use by children.
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This FDA 510(k) clearance letter (K022124) for the GaleMed Peak Flow Meter, Models 3751/3752, primarily focuses on establishing substantial equivalence to a predicate device. As such, it does not contain detailed information about a study proving the device meets specific acceptance criteria in the manner of a clinical trial or performance study. The letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has the same intended use, technological characteristics, and safety and effectiveness profiles as a previously cleared device.
Therefore, many of the requested fields cannot be filled directly from the provided text.
Here is an attempt to address the prompt based solely on the provided documents 0, 1, and 2, and highlighting what is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document. The 510(k) process relies on substantial equivalence to a predicate device. Acceptance criteria would typically be related to accuracy, precision, and repeatability of peak expiratory flow measurements, likely referencing established standards for peak flow meters (e.g., ISO 23747 or ATS/ERS guidelines), but these are not present in the provided text. | Not explicitly stated in the document. The document states the device is "substantially equivalent" to legally marketed predicate devices, implying its performance is comparable to those devices. Specific performance metrics (e.g., accuracy within a certain percentage, repeatability) are not provided. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. Performance data for a test set is not provided in this 510(k) clearance.
- Data Provenance: Not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable and not provided in the context of this 510(k) submission. Establishing ground truth with experts is typically for diagnostic interpretation AI/ML devices, not for
performance of mechanical devices like peak flow meters where ground truth is typically established by instrumental measurement against a reference standard.
4. Adjudication Method for the Test Set
Not applicable and not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. An MRMC study is not relevant for a peak flow meter. This type of study is used for diagnostic systems where human readers interpret medical images or data, and the device assists in that interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This is not an AI/ML device, so "standalone algorithm performance" as typically understood does not apply. The device's performance would be assessed purely on its mechanical and measurement accuracy. Details of such a study are not provided.
7. The Type of Ground Truth Used
- Type of Ground Truth: For a peak flow meter, ground truth would typically be established by a reference spirometer or a calibrated flow generator according to recognized standards (e.g., ISO 23747). The document does not specify the method used to establish ground truth for any potential performance testing.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. This is not an AI/ML device that requires a "training set" or ground truth for training purposes.
§ 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).