(45 days)
The MedNet Locator, INC., Piston Prosthesis is to be used by ear, nose and throat physicians to restore the hearing mechanism related to loss or destruction or damage to the ear ossicles due to prolonged chronic infection.
Piston Prosthesis
I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study that proves the device meets specific acceptance criteria. The documents are an FDA 510(k) clearance letter and an Indications For Use statement for a "Piston Prosthesis" by MedNet Locator, Inc. They confirm the device's substantial equivalence to a predicate device and its intended use, but they do not contain details on performance studies, acceptance criteria, or the methodology of 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.