(481 days)
Objective measurement device in "blocked nose" situations Deviated septums e.g. Allergic rhinitis Enlarged adenoids With the possibility of absolute and pre/post surgical or treatment comparisons.
A1 Acoustic Rhinometer
This document appears to be an FDA 510(k) clearance letter for the "A1 Acoustic Rhinometer", dated September 30, 1998. It confirms that the device is substantially equivalent to legally marketed predicate devices.
However, the provided text does not contain any information regarding specific acceptance criteria, a study proving device performance against those criteria, or details about training/test sets, ground truth establishment, or expert involvement.
The letter primarily focuses on the regulatory aspects of substantial equivalence for marketing purposes, rather than detailing the technical validation study results. Therefore, I cannot fulfill your request for a table of acceptance criteria, study details, sample sizes, or ground truth establishment based on the provided input.
To answer your request, you would need to provide the actual 510(k) submission document or a separate technical report detailing the performance testing.
§ 868.1800 Rhinoanemometer.
(a)
Identification. A rhinoanemometer is a device used to quantify the amount of nasal congestion by measuring the airflow through, and differential pressure across, a patient's nasal passages.(b)
Classification. Class II (performance standards).