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510(k) Data Aggregation

    K Number
    K133452
    Device Name
    EMERGE MEDICAL SMALL FRAGMENT LOCKED PLATING SYSTEM
    Manufacturer
    EMERGE MEDICAL
    Date Cleared
    2014-01-08

    (57 days)

    Product Code
    HRS,HWC
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K000684,K041860
    Predicate For
    K181428
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Emerge Medical Small Fragment Locked Plating System is intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula, including osteopenic bone.

    Device Description

    The System consists of stainless steel plates (including straight, reconstruction, periarticular t-plates, humerus, one-third tubular), standard cortex screws, locking cortex screws, standard cancellous screws, and washers. The plates are available in a variety of styles and lengths with the number of holes varying depending on plate length, and include threaded locking holes and non-threaded dynamic compression slots. The screws and plates are provided non-sterile. The Emerge Medical Small Fragment Locked Plating System is intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula, including osteopenic bone.

    AI/ML Overview

    The provided document is a 510(k) premarket notification for the "Emerge Medical Small Fragment Locked Plating System," which is a metallic bone fixation device. This type of device is an orthopedic implant, not an AI/ML medical device, and therefore the concepts of acceptance criteria related to algorithmic performance, study designs like MRMC studies, ground truth establishment, and training/test sets are not applicable in this context.

    The "Performance Data" section explicitly states: "Mechanical testing performed according to ASTM F382 demonstrated that the device performs as well as or better than the predicate device. Clinical data were not needed to demonstrate substantial equivalence."

    This indicates that the regulatory clearance for this device was based on mechanical equivalency to existing predicate devices, not on the performance of a diagnostic or assistive algorithm.

    Therefore, I cannot provide the requested information about acceptance criteria for an AI/ML device, as it is not applicable to this submission.

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