(23 days)
To be used to convert liquid medication into aerosol for inhalation by patient.
Not Found
I am sorry, but the provided text does not contain the detailed information necessary to answer your request about the acceptance criteria and the study that proves the device meets them.
The documents are a 510(k) clearance letter from the FDA for the "Ezflow MAX" device and its "Indication for Use" statement. These documents confirm that the FDA has determined the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.
However, a 510(k) clearance letter does not typically include the detailed study results or acceptance criteria from the manufacturer's submission. It's a regulatory letter indicating clearance, not a summary of the underlying performance studies.
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance
- Sample sizes used for the test set and data provenance
- Number of experts and their qualifications for ground truth
- Adjudication method
- MRMC comparative effectiveness study results
- Standalone performance
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
§ 868.5630 Nebulizer.
(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).