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.

Device Description

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.

AI/ML Overview

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

Acceptance Criteria (for 510(k) Substantial Equivalence)	Reported Device Performance
Criterion: Device is substantially equivalent in function to a legally marketed predicate device.	Reported Performance: "The MAYFIELD® MR/X-Ray Skull Clamp is substantially equivalent in function and intended use to the unmodified MAYFIELD® MR/CT Skull Clamp which has been cleared to market under Premarket Notification 510(k) K050319."
Criterion: Device has the same intended use as the predicate device.	Reported Performance: The indications for use are described and are considered equivalent to the predicate device. The conclusion states, "The modifications do not affect the intended use..."
Criterion: Device has the same fundamental scientific technology as the predicate device.	Reported Performance: The conclusion states, "...the fundamental scientific technology of the device [is not affected]..."
Criterion: Device does not raise new issues of safety and effectiveness.	Reported Performance: The conclusion states, "...and do 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)

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.

Summary

{0}------------------------------------------------

MAYFIELD® MR/X-Ray Skull Clamp 510(k) Summary K081401

Submitter's name and address:

Integra LifeSciences Corporation 4900 Charlemar Drive, Building A Cincinnati, Ohio 45227 USA

Contact person and telephone number:

Helder A. Sousa Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536 (609) 936-6850

Date prepared: May 16, 2008

Name of device:

Proprietary Name:	MAYFIELD® MR/X-Ray Skull Clamp
Common Name:	Skull Clamp
Classification Name:	Neurological Head Holder

Substantial Equivalence:

The MAYFIELD® MR/X-Ray Skull Clamp is substantially equivalent in function and intended use to the unmodified MAYFIELD® MR/CT Skull Clamp which has been cleared to market under Premarket Notification 510(k) K050319.

Indications Use:

The MAYFIELD® 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.

Device Description:

Conclusion:

The modified MAYFIELD® MR/X-Ray Skull Clamp is substantially equivalent to the unmodified MAYFIELD® MR/CT Skull Clamp (K050319). 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.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.

OCT 0 8 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Integra LifeSciences Corporation % Helda A. Sousa Regulatory Affairs Project Manager 311 Enterprise Drive Plainsboro, New Jersey 08536

Re: K081401

Trade/Device Name: MA YFIELD® MR/X-Ray Skull Clamp Regulation Number: 21 CFR 882.4460 Regulation Name: Neurosurgical head holder (skull clamp) Regulatory Class: II Product Code: HBL Dated: September 5, 2008 Received: September 8, 2008

Dear Helda A. Sousa:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{2}------------------------------------------------

Page 2 - Helda A. Sousa

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark H. Wilkerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Indications for Use

K081401 510(k) Number (if known):

Device Name: MAYFIELD® MR/X-Ray Skull Clamp

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R.P. Ogden for mkm

(Division Sign-C Division of General, Restorative, and Neurological Devices

510(k) Number K081401

Page 1 of 1

B-001

Regulation Number and Section

§ 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).