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The MA YFIELD® MR/X-Ray 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 fixation is necessary. In addition, the clamp is indicated for use during utilization of imaging modalities such as intraoperative CT and MR imaging, C-Arm X-ray, and digital subtraction techniques.

The MAYFIELD® MR/X-Ray Skull Clamp is designed to provide rigid skeletal fixation for procedures involving imaging modalities, such as intra-operative MR, CT, and digital subtraction angiography. The Skull Clamp is designed for patient positioning in the prone or supine positions. The Skull Clamp requires the use of three (3) each Skull Pins. A voidance of critical areas of the skull is made possible by a swiveling rocker arm which rotates 360°. In addition, the swiveling rocker arm can rotate 360° under full skeletal force.

The provided text is a 510(k) summary for the MAYFIELD® MR/X-Ray Skull Clamp. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria and performance data in the typical sense for an AI/CADe device.

Therefore, it is not possible to extract all the requested information, specifically regarding device performance metrics (e.g., sensitivity, specificity, AUC), sample sizes for test/training sets, expert qualifications, or details about a multi-reader multi-case study, as this information is not part of a 510(k) summary for a skull clamp. Skull clamps are mechanical devices for patient positioning and fixation, not diagnostic algorithms.

However, I can extract information related to the "acceptance criteria" in the context of a 510(k) submission, which in this case is the demonstration of substantial equivalence to a predicate device.

Here's the analysis based on the provided text:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable and not provided in the 510(k) summary. A skull clamp is a mechanical device, and its evaluation for substantial equivalence in a 510(k) primarily relies on a comparison of design, materials, and intended use with a predicate device, often supported by engineering testing rather than clinical data sets in the way AI/CADe devices are evaluated. There isn't a "test set" of patient data in this context.

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)

This information is not applicable and not provided. "Ground truth" in the context of expert consensus on medical images doesn't apply to a mechanical skull clamp.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided. Adjudication methods are relevant for subjective interpretations, primarily in medical imaging or clinical diagnoses.

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

This information is not applicable and not provided. An MRMC study is designed for evaluating diagnostic performance with and without AI/CADe assistance. This device is a mechanical skull clamp, not an AI/CADe system.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not applicable and not provided. This concept applies to AI/CADe algorithms.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

This information is not applicable and not provided. In a mechanical device comparison, the "ground truth" relates to engineering specifications, material properties, and functional performance benchmarks rather than clinical diagnostic ground truths.

8. The sample size for the training set

This information is not applicable and not provided. There is no "training set" for a mechanical device like a skull clamp in the AI/CADe sense.

9. How the ground truth for the training set was established

This information is not applicable and not provided.

Summary of the Study Proving Substantial Equivalence (as detailed in K081401):

The study described is a comparison to a predicate device for the purpose of demonstrating substantial equivalence under the 510(k) regulatory pathway.

• Predicate Device: Unmodified MAYFIELD® MR/CT Skull Clamp (K050319).
• Methodology: The submission argues that the MAYFIELD® MR/X-Ray Skull Clamp is substantially equivalent to the predicate device by showing that:
  • It has the same function (rigid skeletal fixation for procedures involving imaging modalities).
  • It has the same intended use (holding head/neck securely for craniotomies, spinal surgery, and imaging modalities like intraoperative CT, MR, C-Arm X-ray, digital subtraction).
  • The modifications (likely to accommodate X-Ray compatibility, though not explicitly detailed beyond the name change) do not affect the intended use or fundamental scientific technology.
  • The modifications do not raise new issues of safety and effectiveness.
• "Study" Data: The 510(k) summary itself serves as the primary "study" document. It relies on the comparison of features, materials (implied by MR/X-Ray compatibility), and intended use with the previously cleared predicate device. It typically would include technical specifications and potentially bench testing data (though not detailed in this summary) to support the claim of no new safety or effectiveness concerns.
• Conclusion of the "Study": The FDA reviewed the submission and concurred with the finding of substantial equivalence, allowing the device to be marketed. This indicates that the provided information (design comparison, intended use, and assertion of no new risks) met the FDA's requirements for a 510(k) clearance for this type of device.

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