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This device is intended for use as a postoperative stent to maintain an opening to the frontal sinus during the first 7 to 14 days following sinus surgical procedures. The selfretaining stent provides for the ventilation and drainage of fluids from the frontal sinus and helps prevent obstruction by adhesions when used alone or with other nasal stents or packs. Indications: Any sinus surgery requiring the placement of a drainage stent for the frontal sinus.

The T-Stent is a one-piece radiopaque C-Flex thermoplastic elastomer drainage tube with T-shaped flanges at the proximal end for positioning and retention in the prepared sinus cavity.

This 510(k) premarket notification (K973273) for the Xomed T-Stent does not contain information on acceptance criteria or a study proving that the device meets such criteria.

The submission is a declaration of substantial equivalence to a predicate device (Rains stent) based on having the same intended use and similar technological characteristics, without raising new issues of safety or effectiveness. As such, it does not detail performance metrics, clinical study results, or specific acceptance criteria.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and the reported device performance: Not available.
2. Sample size used for the test set and the data provenance: Not applicable, as no performance study is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an AI algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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