(30 days)
The MAYFIELD® Disposable and Reusable Titanium Skull Pins are intended for use with a MAYFIELD skull clamp that is placed on the patient's skull to held their bead and neck in a particular position during surgical procedures when rigid skeletal fixation is desired and Intra-Operative MR imaging is used.
The MAYFIELD® Disposable and Reusable Titanium Skull Pins are indicated for use in open and percutaneous craniotomies and spinal surgeries when rigid skouled fir ation is necessary and when Intra-Operative MR imaging of the patient is used.
The MAYFIELD® Disposable and Reusable Titanium Skull Pins are available in two sizes, Adult and Child which are used with MAYFIELD® Skull Clamps that are applied to the patient's skull to hold their head and neck in a particular position during surgical procedures where rigid skeletal fixation is desired and intra-operative MR imaging is used.
In preparation for surgery three Titanium Skull Pins are installed in a MAYFIELD® Skull Clamp. Two Titanium Skull Pins are inserted in the Rocker Arm side of the Clamp and a single Titanium Skull Pin is inserted on the opposite side.
The MAYFIELD® Disposable and Reusable Titanium Skull Pins will be used during open and percutaneous craniotomies and spinal surgeries when rigid skeletal fixation is necessary and when Intra-Operative MR imaging of the patient is used.
This document is a 510(k) summary for MAYFIELD® Disposable and Reusable Titanium Skull Pins. It does not describe a study that uses acceptance criteria and device performance in the way typically associated with AI/ML device submissions. Instead, this is a premarket notification for a traditional medical device, demonstrating substantial equivalence to previously cleared devices.
Therefore, many of the requested fields are not applicable (N/A) in this context. The document focuses on demonstrating that the new device is as safe and effective as existing legally marketed predicate devices, primarily by comparing their intended use, technology, and materials.
Here's a breakdown of the requested information based on the provided text, indicating "N/A" where the information is not present or not relevant to this type of submission:
1. A table of acceptance criteria and the reported device performance
Since this is a submission for a traditional mechanical medical device based on substantial equivalence, specific quantitative acceptance criteria and performance metrics in the style of an AI/ML device study are not provided. The "performance" is implicitly demonstrated through comparison to predicate devices and the absence of new safety/effectiveness issues.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Material Composition: Titanium material suitability for intended use, especially with Intra-Operative MR imaging. | The device is made of Titanium, similar to the MAYFIELD® Radiolucent Disposable Skull Pins (K071458) and DORO® Titanium Pins (K063494), which are also used with Intra-Operative MR imaging. This implies suitable material properties for the intended use and MR compatibility inherent to Titanium. The submission states, "The MAYFIELD® Disposable and Reusable Titanium Skull Pins as the MAYFIELD® Radiolucent Disposable Skull Pins (K071458) and the DORO Titanium Pins (K063494) may be used in surgical procedures when Intra-Operative MR imaging of the patient is used." |
| Functionality/Intended Use: Ability to hold the patient's head and neck in a particular position during surgical procedures needing rigid skeletal fixation. | "The MAYFIELD® Disposable and Reusable Titanium Skull Pins like the predicate devices are used in a skull clamp that is placed on the patient's head to hold the patient's head and neck in a particular position during surgical procedures when rigid skeletal fixation is desired." The device is available in Adult and Child sizes, used with MAYFIELD® Skull Clamps. This indicates it performs the same function as predicates. |
| Clinical Application: Suitability for open and percutaneous craniotomies and spinal surgeries. | "The MAYFIELD® Disposable and Reusable Titanium Skull Pins like the predicate devices may be used in open and percutaneous craniatories and spinal surgeries when rigid skeletal fixation is necessary." |
| Safety and Effectiveness: Does not raise new issues of safety and effectiveness compared to predicate devices. | The conclusion explicitly states: "The MAYFIELD® Disposable and Reusable Titanium Skull Pins are 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." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not applicable (N/A). This submission is based on substantial equivalence to existing devices, not on a clinical trial with a "test set" in the context of AI/ML performance evaluation.
- Data provenance: Not applicable (N/A). No specific patient data or clinical study data is presented in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable (N/A). Ground truth generation for a test set is not part of this type of submission. The safety and effectiveness are established by demonstrating comparability to predicate devices, which are assumed to be safe and effective based on their established use.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable (N/A). No test set requiring adjudication is described.
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 (N/A). This is not an AI/ML device, and no MRMC study was conducted or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable (N/A). This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable (N/A). The concept of "ground truth" as used in AI/ML performance studies is not relevant here. The "truth" is established by the known safety and effectiveness of the existing predicate devices.
8. The sample size for the training set
- Not applicable (N/A). There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable (N/A). There is no "training set" or ground truth establishment in this context.
§ 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).