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The Foil is intended for use by surgeons only where indicated for plastic and reconstructive surgery. The most widespread and standard use presently is for repair of orbital floor blow-out fractures in the eye. Its use is detailed in articles by Orkan Stasior, M.D., Merrill J. Reeh and James Tsujimura, M.D., J. Emery, M.D., G. von Noorden, M.D., and Donald Schlernitzauer, M.D. The foil is also used in Tympanoplasty in the middle ear as reference in...(the) article by James L. Sheehy, M.D. It has also been used to separate nerves and tendons from surrounding tissue to prevent adhesions during healing and then removed after healing is complete. It has been used to repair or replace dura matter in the skull, and in heavier thicknesses it has been attched to bones to give added strength where necessary.

Sterile SupraFOIL Smooth Nylon Foil Sheets

I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria.

The document is an FDA 510(k) clearance letter for a medical device called "Sterile SupraFOIL Smooth Nylon Foil Sheets". It states that the device is "substantially equivalent" to a legally marketed predicate device, meaning it doesn't require a new efficacy study.

Therefore, the text does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets, data provenance, number of experts, or adjudication methods for establishing ground truth.
3. Information about multi-reader multi-case comparative effectiveness studies or standalone algorithm performance.
4. Details on the type of ground truth used or the sample size and ground truth establishment for a training set.

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