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K Number
K142238
Device Name
MAYFIELD Skull Clamp
Manufacturer
INTEGRA LIFESCIENCES CORPORATION
Date Cleared
2014-11-24

(103 days)

Product Code
HBL
Regulation Number
882.4460
Type
Traditional
Panel
NE
Reference & Predicate Devices
K120633
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The MAYFIELD 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.

Device Description

The MAYFIELD Skull Clamp is a cranial stabilization device, designed to provide rigid skeletal fixation. The MAYFIELD Skull Clamp supports a 2-pin rocker arm, which allows for 360° rotation under full impingement force. The device has the means for skull pin force

AI/ML Overview

The provided text describes the MAYFIELD Skull Clamp, its indications for use, and nonclinical tests conducted to demonstrate its performance. However, it does not contain information about an AI-powered device, acceptance criteria or a study proving its performance for such a tool.

Therefore, the following information cannot be extracted from the given text:

  • A table of acceptance criteria and the reported device performance (for an AI device).
  • Sample size used for the test set and the data provenance.
  • Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
  • Adjudication method for the test set.
  • If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of how much human readers improve with AI vs without AI assistance.
  • If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
  • The type of ground truth used (expert consensus, pathology, outcomes data, etc).
  • The sample size for the training set.
  • How the ground truth for the training set was established.

The document is a 510(k) summary for a medical device that is a neurosurgical head holder (skull clamp), not an AI diagnostic or treatment device. The tests discussed are physical performance tests for a mechanical device.

§ 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).