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510(k) Data Aggregation

    K Number
    K142906
    Device Name
    APTUS Wrist 2.5 System
    Manufacturer
    MEDARTIS AG
    Date Cleared
    2015-06-09

    (246 days)

    Product Code
    HRS,HWC
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K103332,K051567,K040022,K070946
    Why did this record match?
    Device Name :

    APTUS Wrist 2.5 System

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

    APTUS® Wrist 2.5 System is intended for use in hand and forearm fractures, osteotomies and arthrodeses.

    Device Description

    APTUS Wrist 2.5 System consists of titanium locking plates. The plates are secured using previously cleared titanium screws (K103332 and K051567), both locking and non-locking. This submission includes additional lengths of non-locking screws. Plates have a low overall height, rounded edges, polished surfaces and incorporate TriLock Technology with use of TriLock (locking) screws. All plates are made from unalloyed titanium conforming to ASTM F67, and all screws are made from titanium alloy conforming to ASTM F136.

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) summary for a medical device (APTUS® Wrist 2.5 System), which describes its intended use, device description, and substantial equivalence to predicate devices. It does not contain information about acceptance criteria, device performance, study details for a diagnostic or AI-powered device, or any of the other specific points you requested (sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, or training set size).

    Therefore, I cannot provide the requested table and study description based on the information given.

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