(72 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 .
Partial Ossicular Replacement Proshesis Total Ossicular Replacement Prostheses Porous Polyethylene Ossicular Replacement
This document is an FDA 510(k) clearance letter for ossicular replacement prostheses, not a study describing the acceptance criteria or performance of a device, particularly an AI-based device.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical study details from the provided text. The document is primarily administrative, confirming substantial equivalence to a predicate device and specifying indications for use.
§ 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.