(90 days)
The intended use of the AG EDGE is to convert liquid medication into a fine mist that can be drawn into the lungs to treat respiratory conditions for adult and pediatric patients who have been prescribed inhalation therapy or medication.
The AG EDGE is indicated only for use with nebulizer provided and viceversa.
The AG EDGE is transportable equipment intended for home health care use. The AG EDGE is not intended as a life sustaining or life support device.
Not Found
I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is a 510(k) premarket notification letter from the FDA regarding the "AG EDGE" nebulizer, determining its substantial equivalence to legally marketed predicate devices.
The text focuses on regulatory aspects such as:
- The FDA's review and determination of substantial equivalence.
- The device's classification (Class II).
- General controls provisions of the Act (annual registration, listing, good manufacturing practice, labeling, prohibitions against misbranding and adulteration).
- Contact information for further guidance.
- Indications for Use.
It does not contain details about:
- Specific acceptance criteria for performance.
- Any study design, methodology, or results related to device performance against such criteria.
- Sample sizes for test or training sets.
- Ground truth establishment, number or qualifications of experts, or adjudication methods.
- MRMC comparative effectiveness studies or standalone algorithm performance.
Therefore, I cannot provide the requested table or details about a study from the given input.
§ 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).