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Synthes Cranial Flap Tube Clamp is intended to reattach a cranial bone flap to the surrounding Cranium after a craniotomy procedure.

Synthes Cranial Flap Tube Clamp consists of two clamp discs with a clamp shaft in between the discs. The disc diameters range between 8.0 mm to 20 mm. The Cranial Flap Tube Clamp is MRI safe and is for single use only.

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving device performance as typically understood for medical devices (e.g., clinical trial results, performance metrics like sensitivity/specificity, or statistical analysis).

The document is a 510(k) summary for the Synthes Cranial Flap Tube Clamp, which primarily focuses on establishing "substantial equivalence" to a predicate device. This type of submission generally relies on comparing the new device's design, materials, and intended use to a legally marketed predicate device, along with verification and validation testing (often mechanical or bench testing) to ensure it performs as intended and is safe.

The provided text only includes:

• Device Name: Synthes Cranial Flap Tube Clamp
• Intended Use: To reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure.
• Predicate Device: Aesculap's Craniofix Titanium Clamp System
• Description: Two clamp discs with a clamp shaft, MRI safe, single use.
• Regulatory Classification: Class II.
• FDA Clearance Letter: Confirming substantial equivalence based on the provided information.

Therefore, I cannot extract the requested information regarding acceptance criteria or a study proving the device meets those criteria from the given text.

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