(49 days)
Synthes Cranial Flap Twist Clamp is intended to reattach a cranial bone flap to the surrounding Cranium after a craniotomy procedure.
Synthes Cranial Flap Twist 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 Twist Clamp is MRI safe and is for single use only.
This document is a 510(k) summary for the Synthes Cranial Flap Twist Clamp. It does not contain information about studies proving the device meets acceptance criteria, sample sizes, expert qualifications, or ground truth establishment. This is typical for Class II devices that demonstrate substantial equivalence to a predicate device rather than providing new clinical study data.
Based on the provided text, none of the requested information (acceptance criteria, device performance, study details, sample sizes, expert qualifications, ground truth, MRMC study, standalone performance, training set details) can be extracted.
The document only states the following:
- Device Name: Synthes Cranial Flap Twist 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
- Classification: Class II
- Safety Information: "The Cranial Flap Twist Clamp is MRI safe and is for single use only."
The FDA's letter (K991860) indicates that the device was found substantially equivalent to legally marketed predicate devices, meaning it does not require new clinical studies to demonstrate safety and effectiveness for its intended use, as its design, materials, and intended use are considered similar enough to an already approved device. Therefore, a clinical trial with specific acceptance criteria and performance metrics would not typically be part of a 510(k) submission for such a device.
§ 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).