(46 days)
For surgical reconstruction of the ossicular chain between the stapes footplate and ear drum where the stapes footplate is present and mobile.
S&T Total Ossicular Replacement Prosthesis
I am sorry, but based on the provided document, I cannot describe the acceptance criteria and the study that proves the device meets them. The document is an FDA 510(k) clearance letter for the "S&T Total Ossicular Replacement Prosthesis" and primarily states that the device is substantially equivalent to legally marketed predicate devices.
The letter does not include:
- A table of acceptance criteria or reported device performance.
- Details about sample sizes, data provenance, or expert qualifications for a test set.
- Information on adjudication methods.
- Any multi-reader multi-case (MRMC) comparative effectiveness study results or effect sizes.
- Standalone algorithm performance.
- The type of ground truth used.
- Training set sample size or how its ground truth was established.
This document is a regulatory approval notice, not a detailed technical report or study summary. Therefore, the requested information is not available in the provided text.
§ 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.