(54 days)
The MAYFIELD® Infinity XR2 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 skeletal fixation is necessary.
In addition, the clamp is indicated for use during utilization of imaging modalities such as intra-operative CT imaging, C-Arm x-ray, and digital subtraction techniques.
The MAYFIELD® Infinity XR2 Skull Clamp is designed to be a multifunctional, cranial stabilization/fixation device. Its basic configuration delivers standard MAYFIELD Skull Clamp performance, that is, provide rigid skeletal fixation in conjunction with various Olamp porteRase Units. The MAYFIELD® Infinity XR2 Skull Clamp is suitable for Digital Subtraction Angiography (DSA), Fluoroscopy and CT imaging modalities.
With the use of the optional removable Force Applicator, the user can temporarily detach this component of the clamp prior to scanning; thereby removing a potential source of imaging artifact. Interchangeable components allow the surgeon to tailor the skull clamp and the cranial stabilization equipment to the requirements of their patient's surgical procedure and the use of image-guided surgery systems.
The MAYFIELD® Infinity XR2 Skull Clamp is designed to allow the surgeon freedom in positioning the skull pins for fixation. Avoidance of critical areas of the skull is facilitated by a two-pin rocker arm that swivels 360º degrees. To simplify patient repositioning after pin impingement, the rocker arm can be rotated without adjustment of the Torque Screw force on the single-pin side of the clamp.
The provided text is a 510(k) summary for the MAYFIELD® Infinity XR2 Skull Clamp. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and study results for device performance in the way that would typically be described for an AI/ML medical device.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, ground truth, and MRMC studies for an AI/ML device is not applicable to this document.
The document states that:
- Substantial Equivalence: The MAYFIELD® Infinity XR2 Skull Clamp is substantially equivalent in function and intended use to the MAYFIELD® MR/CT Skull Clamp (K050319) and the MAYFIELD® Infinity Skull Clamp (K051440).
- Basis for Substantial Equivalence: "The MAYFIELD® Infinity XR2 Skull Clamp is similar to the predicate devices in the intended use, the fundamental scientific technology of the device, and does not raise new issues of safety and effectiveness."
No specific performance acceptance criteria or a dedicated study proving device performance (in the context of an AI/ML device) are described because the regulatory pathway chosen (510(k)) relies on demonstrating equivalence to existing, legally marketed 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).