(50 days)
The Mayfield MR/CT Skull Clamp is placed on the patient's skull to hold their head and neck securely in a particular position when rigid fixation is desired. The clamp is indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid fixation is necessary. In addition, the clamp is indicated for use during utilization of imaging modalities such as intraoperative CT and MR imaging, C-Am x-ray, and digital subtraction techniques.
The Mayfield® MR/CT Skull Clamp is designed to provide rigid skeletal fixation for proccdures involving all imaging modalities, intra-operative MR, CT and digital subtraction angiography. The Skull Clamp is designed for patient positioning in the prone or supine positions. The design of the Skull Clamp allows the surgeon more freedom in positioning the fixation pins. Avoidance of critical areas of the skull is made possible by a swiveling rocker arm which rotates 360°. In addition, the swiveling rocker arm can rotate 360° under full skeletal force, making final positioning after pin impingement easier. The lean body design of the Mayfield® MR/CT Skull Clamp also allows for greater exposure to the operative site.
The provided text is a 510(k) Summary for the Mayfield® MR/CT Skull Clamp. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, device performance metrics, or study details such as sample sizes, ground truth establishment, or expert involvement for a performance study.
The document is a regulatory submission for premarket notification, focusing on demonstrating that the new device is substantially equivalent to a legally marketed predicate device. This type of submission generally does not include detailed performance studies with acceptance criteria in the way described in your request, especially for non-implantable, non-diagnostic devices like a skull clamp. Instead, it focuses on demonstrating that the new device shares similar technological characteristics and intended use with the predicate, and does not raise new questions of safety and effectiveness.
Therefore, I cannot provide the requested information because it is not present in the provided text. The document concludes with the statement: "The Mayfield® MR/CT Skull Clamp is substantially equivalent to the commercially marketed predicate device and does not raise new issues of safety and effectiveness." This is the core "proof" presented in this type of regulatory filing.
§ 882.4460 Neurosurgical head holder (skull clamp).
(a)
Identification. A neurosurgical head holder (skull clamp) is a device used to clamp the patient's skull to hold head and neck in a particular position during surgical procedures.(b)
Classification. Class II (performance standards).