(19 days)
The MAYFIELD® Radiolucent Disposable Skull Pins 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 lutra-Operative CT or MR imaging is used.
The MAYFIELD® Radiolucent Disposable Skull Pins 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 Disposable 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 Disposable 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 a medical device called the "Mayfield® Radiolucent Disposable Skull Pins." It is a premarket notification to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device.
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device in function and intended use. | The Mayfield® Radiolucent Disposable Skull Pins are substantially equivalent in function and intended use to the unmodified Mayfield® Radiolucent Skull Pins (K021604 and K050345). The modifications do not affect the intended use, fundamental scientific technology, or raise new safety/effectiveness issues. |
2. Sample size used for the test set and the data provenance:
- Sample size: Not applicable. This submission relies on substantial equivalence to predicate devices, not new performance testing with a specific test set.
- Data provenance: Not applicable. The submission refers to prior 510(k) clearances.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No new clinical or performance study involving human experts to establish ground truth was conducted or reported in this 510(k) summary.
4. Adjudication method for the test set:
- Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a mechanical skull pin, not an AI-based diagnostic or assistive technology for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a medical device, not an algorithm.
7. The type of ground truth used:
- Not applicable. The basis for clearance is substantial equivalence (to previously cleared devices), not a new ground truth established for a novel device performance claim.
8. The sample size for the training set:
- Not applicable. No machine learning training set is relevant for this device.
9. How the ground truth for the training set was established:
- Not applicable.
§ 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).