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510(k) Data Aggregation

    K Number
    K152289
    Device Name
    Alians Elbow Locking Plating System
    Manufacturer
    NEWCLIP TECHNICS
    Date Cleared
    2016-08-17

    (370 days)

    Product Code
    HRS,HWC
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K000684,K011335,K974289,K993106,K143061,K120070,K120717
    Why did this record match?
    Reference Devices :

    K000684, K011335, K974289, K993106, K143061

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

    The Alians Elbow Locking Plating System is intended for the fixation of fractures and ostectornies of the distal humerus and proximal ulna in adults.

    Device Description

    The Alians Elbow Locking Plating system consists of plates and screws, designed for the fixation of fractures and osteotomies of the distal humerus and proximal ulna in adults.
    The plates and screws are manufactured from titanium alloy and are color anodized.

    The Alians Elbow Locking Plating system will be provided non-sterile for sterilization by health care professionals prior to use. A sterile version of the Alians Elbow Locking Plating System is provided in single use sterile kits, called Initial O kits, including one plate, screws and single use instrumentation necessary for the implantation.

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about an AI/ML-driven device or study parameters that would allow me to populate the requested table and describe the study proving the device meets acceptance criteria.

    The document is a 510(k) premarket notification for a medical device called the "Alians Elbow Locking Plating System," which is a metallic bone fixation appliance. It discusses the regulatory review process, device description, indications for use, and a comparison to predicate devices, including mechanical testing (non-clinical tests).

    There is no mention of:

    • Acceptance criteria for an AI/ML device
    • Device performance reported for an AI/ML device
    • Test set sample sizes, data provenance, or the number/qualifications of experts involved in establishing ground truth for AI/ML
    • Adjudication methods, MRMC studies, standalone AI performance, or types of ground truth for an AI/ML system
    • Training set sample size or how ground truth for a training set was established for an AI/ML system

    Therefore, I cannot fulfill your request for this specific document.

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