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    K Number
    K051986
    Device Name
    SYNTHES 4.5 MM LCP STRAIGHT RECONSTRUCTION PLATES
    Manufacturer
    SYNTHES (USA)
    Date Cleared
    2005-09-08

    (48 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K993077
    Why did this record match?
    Device Name :

    SYNTHES 4.5 MM LCP STRAIGHT RECONSTRUCTION PLATES

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

    The Synthes 4.5 mm LCP Straight Reconstruction Plates are intended for fixation of fractures, osteotomies and non-unions of clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in osteopenic bone.

    Device Description

    Synthes 4.5 mm LCP Straight Reconstruction Plates consist of a limited contact profile and have LCP holes. The LCP hole is a combination of Dynamic Compression (DCU) and conical threaded locking holes, which accept cortex, shaft, cancellous, and locking screws. The plates are manufactured in either stainless steel or titanium.

    AI/ML Overview

    The provided text describes Synthes 4.5 mm LCP Straight Reconstruction Plates, and references its 510(k) summary, but it does not contain information about acceptance criteria or a study proving the device meets those criteria.

    The document is a 510(k) premarket notification for a medical device. These types of submissions typically focus on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies with acceptance criteria in the format requested.

    Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria, study design, sample sizes, ground truth, or MRMC studies, as this information is not present in the provided text.

    The text primarily includes:

    • Device Name: Synthes 4.5 mm LCP Straight Reconstruction Plates
    • Classification: Class II, §888.3030 - Single/multiple component metallic bone fixation appliances and accessories
    • Predicate Device: Synthes 3.5 mm LCP Straight Reconstruction Plates
    • Device Description: Limited contact profile plates with LCP holes (combination of Dynamic Compression (DCU) and conical threaded locking holes) manufactured in stainless steel or titanium.
    • Intended Use/Indications for Use: Fixation of fractures, osteotomies, and non-unions of clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in osteopenic bone.
    • Substantial Equivalence: Claimed and affirmed by the FDA.
    • FDA Correspondence: Official letter from the FDA confirming substantial equivalence and allowing marketing.
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