(94 days)
Otosurgical prosthesis of the middle ear, implanted, in a permanent manner, in patients affected with pathologies of the middle ear.
Audio prostheses are successfully employed in case of otosclerosis, stapedo-vestibular ankylosis, outxome of otitis media, trauma, middle ear congenital malformations. Possible complication due to the use of prostheses in the middle ear include. fixation, displacement, extrusion of the prosthesis, incus necrosis, tympanic membrane perforation, perilymph fistula, labyrinthitis, otitis media, occlusion of oval and round window.
Some of the prostheses are manufactured in different lengths, some others shall be trimmed during the surgical operation. Nevertheless the length of all the prostheses should be carefully assessed by means of a microsurgical qauge (code 02.14) The implant must be carried out by a qualified surgeon.
Otosurgical prosthesis of the middle ear, implanted, in a permanent manner, in patients affected with pathologies of the middle ear.
Otosurgical prosthesis of the middle hear, are manufactured from a wide variety of materials: titanium, poliethylene (PE), stainless steel, hydroxylapatite (HA). platinum (Pt). politetrafluoroethylene (PTFE), gold, polimetilxilossano (silicon) and Nitinol, or combination of these materials.
Numerous designs are available for replacement of any or all of the bones of the ossicular chain.
The provided document is a 510(k) premarket notification for an "Audio Prosthesis" (Total/Partial Ossicular Replacement Prosthesis). It describes the device, its intended use, indications for use, and a comparison to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The document states that the device is "substantially equivalent" to legally marketed predicate devices based on having the same indications for use, technological characteristics (materials), and general design. The FDA's letter (K083780) confirms this substantial equivalence determination.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, study details (sample size, data provenance, expert qualifications, adjudication, MRMC, standalone performance), ground truth details, or training set information from this document.
The document primarily focuses on establishing substantial equivalence to existing devices rather than presenting a performance study with specific acceptance criteria.
§ 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.