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The SilkLine Soft Relining Kit is intended to be used as a denture relining, repairing, or rebasing resin.

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The provided text is a 510(k) premarket notification letter from the FDA regarding a dental device called "SilkLine Soft Relining Kit." This document does not describe acceptance criteria for a device, nor does it detail a study that proves the device meets such criteria.

The information provided is a clearance letter from the FDA indicating that the device has been found substantially equivalent to a legally marketed predicate device. This process, known as 510(k) clearance, is primarily about demonstrating equivalency to existing devices, not about establishing specific performance metrics against pre-defined acceptance criteria through a clinical study as would be detailed for a novel device or AI-powered system.

Therefore, I cannot provide the requested information as it is not present in the given text.

To address the specific points you requested:

1. A table of acceptance criteria and the reported device performance: Not available in the text.
2. Sample size used for the test set and the data provenance: Not available in the text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available in the text.
4. Adjudication method: Not available in the text.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not available in the text. This type of study is more common for diagnostic AI devices, not for a dental relining kit.
6. If a standalone performance study was done: Not available in the text.
7. The type of ground truth used: Not applicable for this type of device clearance and not mentioned.
8. The sample size for the training set: Not applicable (no AI/algorithmic training mentioned).
9. How the ground truth for the training set was established: Not applicable.

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