(24 days)
The MAYFIELD® Radiolucent Skull Pins A-2020 are intended for use with a skull clamp that is placed on the patient's skull to hold their head and neck in a particular position during surgical procedures when rigid skeletal fixation is desired and Intra-Operative CT or MR imaging is used.
The MAYFIELD® Radiolucent Skull Pins A-2020 are indicated for use in open and percutaneous craniotomies and spinal surgeries when rigid skeletal fixation is necessary and when Intra-Operative CT or MR imaging of the patient is used.
The Mayfield® Radiolucent Skull Pins are single use devices which are used with Mayfield® Skull Clamps for approaches that require rigid skeletal fixation. In preparation for surgery three Radiolucent Skull Pins are installed in a Mayfield® Skull Clamp. Two Radiolucent Skull Pins are inserted in the Rocker Arm side of the Clamp and a single Radiolucent Skull Pins is inserted on the opposite side. The Mayfield® Radiolucent Skull Pins may be used in surgical procedures when rigid fixation is desired and Intra-Operative CT or MR imaging is used.
This document is a 510(k) summary for the Mayfield® Radiolucent Skull Pins, detailing their substantial equivalence to a previously cleared device. It does not contain information about a study proving the device meets specific acceptance criteria in the context of performance metrics like accuracy, sensitivity, or specificity, which are typically associated with artificial intelligence or diagnostic devices.
The submission is for a device modification of existing skull pins, and the conclusion states: "The modified Mayfield® Radiolucent Skull Pins is substantially equivalent to the unmodified Mayfield® Radiolucent Skull Pins. The modifications do not affect the intended use, the fundamental scientific technology of the device, and do not raise new issues of safety and effectiveness."
Therefore, the requested information about acceptance criteria, device performance, study details (sample size, data provenance, experts, adjudication, MRMC, standalone performance), ground truth, and training set information is not applicable to this 510(k) submission.
This is a regulatory submission for a physical medical device (skull pins), not an AI/ML-driven diagnostic or prognostic device that would typically undergo studies to demonstrate performance metrics against a defined ground truth. The "proof" in this context is the demonstration of substantial equivalence to a predicate device, meaning it has the same intended use, technological characteristics, and raises no new questions of safety or effectiveness.
§ 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).