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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, digital subtraction techniques, and MR imaging.

The MAYFIELD Infinity Skull Clamp is a cranial stabilization device, designed to provide rigid skeletal fixation. 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.

The MA YFIELD Infinity XR2 Skull Clamp has not been modified since its clearance to market by United States Food and Drug Administration (FDA) on April 20, 2009 under K090506.

The proposed MAYFIELD Infinity XR2 Skull Clamp is identical in every way to the currently marketed MAYFIELD Infinity XR2 Skull Clamp except for revised labeling which includes information regarding the safe use of this device when used in an MR environment and updated cleaning/decontamination instructions.

Below is an analysis of the provided 510(k) summary for the MAYFIELD® Infinity XR2 Skull Clamp. This device is a traditional medical device (a skull clamp), not an AI/ML powered device, so many of the requested categories related to AI performance, ground truth, and training sets are not applicable or cannot be extracted from this document type.

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) summary is for a traditional medical device (skull clamp), not an AI/ML-powered device. Therefore, the "acceptance criteria" discussed are typically related to mechanical performance, materials, and safety, especially in an MR environment, rather than metrics like accuracy, sensitivity, or specificity common in AI/ML performance.

Note: The document states that the device is "identical in every way to the currently marketed MAYFIELD Infinity XR2 Skull Clamp except for revised labeling which includes information regarding the safe use of this device when used in an MR environment and updated cleaning/decontamination instructions." This implies that the core mechanical performance (load range, fixation strength, etc.) was previously established for the predicate device (K090506) and is assumed to be met here due to identical design. The new testing focuses specifically on MR safety.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: Not explicitly stated in terms of number of devices or number of tests for the MR environment testing. Typically, for bench testing like this, a sufficient number of samples (e.g., 3-5) would be tested to demonstrate reproducibility.
• Data Provenance: The testing was "bench testing" performed by the manufacturer, Integra LifeSciences Corporation. There is no information on country of origin of data as it's not patient-derived data, and it is prospective in the sense that it was conducted specifically for this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable. The ground truth for magnetic attraction in an MR environment is established by physical measurement using established ASTM standards (ASTM F2052), not by expert consensus or interpretation.

4. Adjudication Method for the Test Set

Not applicable. This is objective bench testing against a standard, not a subjective assessment requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This is not an AI/ML device that assists human readers with interpretation. It is a physical device (skull clamp).

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

For the MR environment testing, the ground truth was based on objective physical measurements and adherence to the requirements of the ASTM F2052 standard ("Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment").

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This is a physical medical device, not an AI/ML algorithm.

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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.

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