Search Results

The Stryker® Leibinger Cranial Fixation System is intended for the fixation of a cranial bone flap after a craniotomy. The implant could be applied in the craniotomy gap as well as in burr holes.

Not Found

I am sorry, but the provided text does not contain the information required to answer your request. The document is a 510(k) summary for a medical device (Stryker Leibinger Cranial Fixation System) which focuses on its intended use and substantial equivalence to predicate devices, rather than detailed acceptance criteria or a study proving its performance against such criteria in the context of an AI-powered device.

Therefore, I cannot provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number of experts used or their qualifications.
4. Adjudication method.
5. Information on a multi-reader multi-case comparative effectiveness study or its effect size.
6. Whether a standalone performance study was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

This document pertains to regulatory clearance based on substantial equivalence to existing, already approved devices, not the detailed performance evaluation of a novel AI-driven diagnostic or therapeutic system.

Ask a specific question about this device