LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    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
    Predicate For
    N/A
    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<45° deflectionThe device with maximum massAdoption from 3.0T tests since 3.0T is the worst-case.
    Magnetically Induced Torque (1.5T)ASTM F2213-17, Low friction surface method<45° rotationThe device with maximum massAdoption from 3.0T tests since 3.0T is the worst-case.
    RF Induced Heating (1.5T)ASTM F2182-19e2<6°CBased on ISO10974 methodology; devices with different lengths, electrode designs, and insertion depths.Under the condition defined in the labeling, the MR induced heating will be less than <6°C
    Image artifact (3.0T)ASTM F2119-13No Criteria, Descriptive StatementDevice with the maximum mass/linear lengthImage distortion of 19 mm from the edge of the device
    Magnetically Induced Displacement Force (3.0T)ASTM F2052-15<45° deflectionThe device with maximum masspass
    Magnetically Induced Torque (3.0T)ASTM F2213-17, Low friction surface method<45° rotationThe device with maximum masspass
    RF Induced Heating (3.0T)ASTM F2182-19e2<6°CBased on ISO10974 methodology; devices with different lengths, electrode designs, and insertion depths.Under the condition defined in the labeling, the MR induced heating will be less than <6°C

    The following information, as requested in your prompt, is not applicable or not available in the provided text because the document is not about an AI/software device:

    1. Sample size used for the test set and the data provenance: Not applicable. This is not a study on an algorithm's performance on a dataset of patient data. It is testing on physical device configurations.
    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI algorithm is not established here.
    3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
    4. 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: Not applicable.
    5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
    6. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
    7. The sample size for the training set: Not applicable.
    8. How the ground truth for the training set was established: Not applicable.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1