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510(k) Data Aggregation

    K Number
    K163355
    Device Name
    Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes
    Manufacturer
    Ad-Tech Medical Instrument Corporation
    Date Cleared
    2017-04-12

    (133 days)

    Product Code
    GZL
    Regulation Number
    882.1330
    Type
    Traditional
    Panel
    Neurology (NE)
    Reference & Predicate Devices
    K944061,K053358,K964644,K990788,K041604,K802151,K151790
    Why did this record match?
    Reference Devices :

    K944061

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

    The Ad-Tech Depth Electrodes (Depth Electrodes, Foramen Ovale Depth Electrodes, Macro Micro Depth Electrodes, Spencer Probe Depth Electrodes, Wyler Sphenoidal Depth Electrodes) are intended for temporary (

    Device Description

    The device under review is a family of Depth Electrodes. These electrodes provide sub-surface brain contact to support recording, monitoring and stimulation from user supplied equipment.

    AI/ML Overview

    This document describes the Ad-Tech Medical Instrument Corporation's Depth Electrodes (K163355) and their substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria in the context of an AI/ML medical device.

    Therefore, most of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth for an AI/ML device is not applicable to this 510(k) summary for a traditional medical device.

    However, I can extract the acceptance criteria (defined as "Summary of Requirement" in the document) and the reported performance ("Result") for the physical device testing.

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

    Acceptance Criterion (Summary of Requirement)Reported Device Performance (Result)
    Measure electrical resistance from the electrode contact to connector.Pass
    Dimensional requirements are met by manufacturing.Pass
    Stimulation at 30 $\mu$ C/cm2 does not affect the electrodes.Pass
    The optional accessory Stay Flange supports adequate Depth Electrode retention.Pass

    The following information is not applicable to this document as it pertains to an AI/ML software device, and this 510(k) is for a set of physical medical electrodes:

    1. Sample size used for the test set and the data provenance.
    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
    3. Adjudication method for the test set.
    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.
    5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done.
    6. The type of ground truth used (expert consensus, pathology, outcomes data, etc).
    7. The sample size for the training set.
    8. How the ground truth for the training set was established.

    Additional relevant information from the document:

    • Intended Use: The Ad-Tech Depth Electrodes are intended for temporary (
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