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The AeroChamber Plus® aVHC with Flow-Vu® IFI is intended to be used by patients who are under the care or treatment of a licensed health care provider or physician. The device is intended to be used by these patients to administer aerosolized medication from most pressurized Metered Dose Inhalers, prescribed by a physician or health care professional. The intended environments for use include the home, hospitals and clinics.

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I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that a device meets those criteria. The document is an FDA 510(k) clearance letter for the "AeroChamber Plus® aVHC with Flow-Vu® IFI" device, indicating that it has been found substantially equivalent to a legally marketed predicate device.

The letter mentions:

• The device name and its intended use (to administer aerosolized medication from Metered Dose Inhalers).
• The regulatory classification and product code.
• The date of clearance.
• General FDA regulations and requirements for marketing a medical device.

However, it does not include details on:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets or data provenance.
3. Number or qualifications of experts for ground truth.
4. Adjudication methods.
5. MRMC comparative effectiveness studies.
6. Standalone performance studies.
7. Type of ground truth used.
8. Sample size for training sets.
9. How ground truth for training sets was established.

Therefore, I cannot fulfill your request based on the provided text.

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