(134 days)
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.
Not Found
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.
§ 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).