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510(k) Data Aggregation

    K Number
    K121452
    Device Name
    GRIDLOCK PLATING SYSTEM
    Manufacturer
    TRILLIANT SURGICAL LTD
    Date Cleared
    2012-08-20

    (96 days)

    Product Code
    HRS,HWC
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K091614
    Predicate For
    K123525,K130964,K160177,K172178
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Gridlock Plating System is intended for use in trauma and reconstructive procedures of the small bones in the hand/foot, ankle, and other bones appropriate for the size of the device.

    The plates and screws are intended for single use only.

    Device Description

    The Gridlock Plating System consists of various shape and size plates for the management of small bone orthopedic osteotomies, reconstruction, and trauma. Features include a low profile, limited bone contact, capability of dynamic/manual compression, and angulated-locking threaded screw holes. The system also consists of multiple locking/standard screw lengths and diameters.

    Materials:
    CP Titanium per ASTM F67 Titanium alloy per ASTM F136

    AI/ML Overview

    The provided document is limited to a 510(k) summary for the Gridlock Plating System, a medical device. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical efficacy studies typically associated with AI/ML diagnostic tools.

    Therefore, the document does not contain information relevant to AI/ML device acceptance criteria or studies proving device performance in the context you've outlined. Specifically:

    • No AI/ML components: The Gridlock Plating System is a metallic bone fixation appliance, not an AI/ML diagnostic or assistive device.
    • No acceptance criteria for AI/ML performance: The testing described (static four-point bending, dynamic bending, pull-out, torque) are mechanical performance tests for implants, not metrics like sensitivity, specificity, or accuracy relevant to AI/ML.
    • No data provenance, ground truth, expert review, MRMC studies, or training/test sets: These concepts are entirely absent because the device is a physical implant, not a software algorithm.
    • No clinical studies: The document explicitly states, "No clinical studies were performed." Substantial equivalence was based on non-clinical (mechanical) testing.

    In summary, the Gridlock Plating System is a traditional medical device, and the provided 510(k) summary does not contain any information related to the acceptance criteria or study methodologies typically associated with AI/ML-powered devices.

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