(110 days)
The Mayfield® Infinity 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 skull clamp is indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid fixation is necessary. The accessories provided with the skull clamp also allow it to be used where stabilization is desired instead of complete fixation.
The Mayfield® Infinity Skull clamp is designed to be a multifunctional cranial stabilization/fixation device. It's basic configuration delivers standard Mayfield Skull Clamp performance. The accessories enhance the clamp's capability and enable it to provide rigid skeletal fixation in conjunction with the Infinity Support System. The contours and length of the skull clamp uprights allow the clamp to maintain a lower profile than standard clamps. When this clamp is used to provide auxiliary skeletal fixation, the Reduced Load Torque Screw may be used for procedures that demand lower pin impingement forces. The device allows the surgeon to select the most suitable combination of components for each procedure and is designed to allow the surgeon freedom in positioning the fixation pins. Avoidance of critical areas of the skull is facilitated by a swiveling rocker arm that also rotates 360°. To simplify patient repositioning after pin impingement, the rocker may be rotated without adjustment of the impingement force imposed by the Torque Screw.
The provided text is a 510(k) summary for the Mayfield® Infinity Skull Clamp. This document focuses on demonstrating substantial equivalence to existing devices rather than presenting a study with acceptance criteria and device performance as typically seen in AI/software device submissions.
Therefore, the information required to answer the prompt (acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, training set information) is not present in the provided text.
The document states: "The Mayfield® Infinity Skull Clamp is substantially equivalent to the commercially marketed predicate device and does not raise new issues of safety and effectiveness." This indicates that the regulatory pathway chosen did not require formal performance studies against pre-defined acceptance criteria, but rather a comparison to already approved devices.
§ 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).