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The space chamber obtains maximum benefit from your M.D.I. It improves delivery to lungs and reduces the amount of drug deposited in the throat.

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Based on the provided text, a detailed description of acceptance criteria and a study proving device performance cannot be generated. The document is a 510(k) clearance letter from the FDA for a device called "Space Chamber™." This type of letter generally indicates that the device has been found substantially equivalent to a predicate device already on the market, but it does not contain details about specific acceptance criteria or the results of a study demonstrating performance against such criteria.

The document only states the intended use of the device: "The space chamber obtains maximum benefit from your M.D.I. It improves delivery to lungs and reduces the amount of drug deposited in the throat."

To answer your request, information about a performance study, acceptance criteria, sample sizes, ground truth establishment, expert qualifications, and adjudication methods would need to be in a separate, more detailed technical document (e.g., a summary of safety and effectiveness, clinical trial report, or engineering validation report) that typically accompanies or underpins the 510(k) submission. This letter only confirms clearance based on substantial equivalence.

Therefore, I cannot populate the table or answer the specific questions about the study details.

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