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Spin Down RapidFlap is indicated for the re-attachment of the bone flap after a craniotomy.

| | Spin Down RapidFlap
modification | K971252 Sevrain
Cranial Clamp | K991029 RapidFlap
Cranial Clamp |
|--------------------------------------------|----------------------------------------------------------------------|---------------------------------------------------------------|----------------------------------------------------------------------|
| Attachment of
upper and lower
plates | Threaded stem
attachment between
the upper and lower
plates | Threaded stem
attachment between
upper and lower plates | Grooved post
connection between
the upper and lower
plates. |
| Material | CP Titanium and
Titanium 6A1 4V alloy | CP Titanium, grade 2 | Titanium 6A1 4V alloy |
| Sterility | Sterile | Non-Sterile | Sterile |

This document describes a medical device modification (Spin Down RapidFlap) and its equivalency to previously cleared devices. It does not contain information about a study proving the device meets acceptance criteria, an AI algorithm, or any associated performance metrics or ground truth establishment.

Therefore, I cannot fulfill your request as it pertains to acceptance criteria, device performance, AI study details, or ground truth. The provided text is a summary of safety and effectiveness for a 510(k) premarket notification for a traditional medical device (a cranial clamp), focusing on its materials and attachment mechanism compared to predicate devices.

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