(27 days)
Ossicular replacement prostheses are indicated for the function of the ossicular chain when a conductive hearing loss is present. Indications include: Chronic middle ear disease, Otosclerosis, Congenital fixation of the stapes, Secondary surgical intervention to correct for a significant and persistent conductive hearing loss from prior otologic surgery, Surgically correctible injury to the middle ear from trauma
Not Found
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) clearance letter for "Stapes Prostheses," which declares the device substantially equivalent to legally marketed predicate devices. It outlines the indications for use but does not contain details about performance studies, sample sizes, ground truth establishment, or expert involvement in such studies.
§ 874.3450 Partial ossicular replacement prosthesis.
(a)
Identification. A partial ossicular replacement prosthesis is a device intended to be implanted for the functional reconstruction of segments of the ossicular chain and facilitates the conduction of sound wave from the tympanic membrane to the inner ear. The device is made of materials such as stainless steel, tantalum, polytetrafluoroethylene, polyethylene, polytetrafluoroethylene with carbon fibers composite, absorbable gelatin material, porous polyethylene, or from a combination of these materials.(b)
Classification. Class II.