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    K Number
    K223276
    Device Name
    Anchor Bolts as Accessories to Depth Electrodes
    Manufacturer
    Ad-Tech Medical Instrument Corporation
    Date Cleared
    2023-05-18

    (206 days)

    Product Code
    GZL
    Regulation Number
    882.1330
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K181544
    Why did this record match?
    Device Name :

    Anchor Bolts as Accessories to Depth Electrodes

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Ad-Tech Anchor Bolts are optional accessories for use with Depth Electrodes. The Anchor Bolts may be applied when it is desired to minimize concerns about potential cerebrospinal fluid (CSF) leakage and infection of the subdural space while stabilizing the electrode. Anchor Bolts are secured in the skull to provide an access point for Depth Electrodes.

    Device Description

    The device under review is a family of Anchor Bolts. Anchor Bolts are optional accessories to Depth Electrodes. These Anchor Bolts provide an optional access point through the skull and stabilization support for Depth Electrodes.

    AI/ML Overview

    The furnished document is an FDA 510(k) Premarket Notification stating substantial equivalence for the "Anchor Bolts as Accessories to Depth Electrodes" device. It outlines the device description, intended use, comparison with a predicate device, and performance data related to its safety in the Magnetic Resonance (MR) environment.

    However, the information provided does not describe an AI medical device or a study involving human readers or AI assistance. The performance data is solely for the physical device's safety in an MR environment, not for an AI algorithm's diagnostic or assistive performance.

    Therefore, I cannot fulfill your request as it pertains to acceptance criteria and studies for an AI medical device, multi-reader multi-case studies, or AI algorithm performance.

    The document discusses the following acceptance criteria and performance for the physical device:

    1. Table of Acceptance Criteria and Reported Device Performance

    Hazard AddressedTest Method UsedAcceptance CriterionMedical Device Configuration TestedSummary of Test Results and pass/fail (if Appropriate)
    Image Artifact (1.5T)ASTM F2119-13No Criteria, Descriptive StatementDevice with the maximum mass/linear lengthAdoption from 3.0T tests since 3.0T is the worst-case.
    Magnetically Induced Displacement Force (1.5T)ASTM F2052-15
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