(44 days)
For surgical reconstruction of the sound conduction chain between the stapes and the ear drum, where the stapes is intact and mobile, by replacement of the missing ossicles with a partial implant.
S&T Partial Ossicular Replacement Prosthesis
This document is a 510(k) premarket notification for a medical device (S&T Partial Ossicular Replacement Prosthesis), indicating FDA clearance for marketing. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The information requested in the prompt (acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is typically found in clinical study reports, scientific publications, or detailed sections of a premarket application. This specific FDA letter and its linked "Statement of Indications for Use" only confirm that the device is substantially equivalent to legally marketed predicate devices and can be marketed.
Therefore, I cannot fulfill your request based on the provided text. The document does not contain the necessary details to describe the acceptance criteria and the study that proves the device meets them.
§ 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.