(12 days)
Reconstruction of the sound conduction chain between the base of stapes and the tympanic membrane level by replacing the missing middle ear bones with a total implant in the sense of a tympanoplasty of type IIIC given an existing intact base of stapes with normal mobility and without luxation.
Titanium Ossicular Replacement System
The provided text is a 510(k) clearance letter from the FDA for the "Titanium Ossicular Replacement System." It indicates that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria, device performance, or any studies conducted.
Therefore, I cannot provide the requested information. The document focuses on regulatory clearance based on substantial equivalence, not on detailed performance evaluation against specific criteria or study results.
§ 874.3495 Total ossicular replacement prosthesis.
(a)
Identification. A total ossicular replacement prosthesis is a device intended to be implanted for the total functional reconstruction of the ossicular chain and facilitates the conduction of sound waves from the tympanic membrance to the inner ear. The device is made of materials such as polytetrafluoroethylene, polytetrafluoroethylene with vitreous carbon fibers composite, porous polyethylene, or from a combination of these materials.(b)
Classification. Class II.