(43 days)
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.
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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.
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- A table of acceptance criteria and reported device performance.
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- Information on a multi-reader multi-case comparative effectiveness study or its effect size.
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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.
§ 882.5330 Preformed nonalterable cranioplasty plate.
(a)
Identification. A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constructed of a material, e.g., stainless steel or vitallium, that cannot be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).