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510(k) Data Aggregation

    K Number
    K150675
    Device Name
    Dorsal Spanning Plate
    Manufacturer
    SKELETAL DYNAMICS, LLC
    Date Cleared
    2015-05-12

    (57 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K093761
    Why did this record match?
    Device Name :

    Dorsal Spanning Plate

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

    The Skeletal Dynamics Dorsal Spanning Plate is intended for fixation of fractures involving the distal radius and for wrist arthrodesis.

    Device Description

    The Skeletal Dynamics Dorsal Spanning Plate consists of a bone plate designed for fracture fixation of the distal radius and wrist arthrodesis. Included in the system are titanium bone screws, k-wires, and specialized instrumentation. The system is provided non-sterile and is sterilized in the user facility. The Skeletal Dynamics Dorsal Spanning Plate is comprised of: Titanium alloy plate and screws; Stainless steel K-wires (for provisional fixation not for implantation); System specific instrumentation.

    AI/ML Overview

    I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and the study proving the device meets those criteria. The document is a 510(k) premarket notification for a medical device (Dorsal Spanning Plate) and primarily focuses on demonstrating substantial equivalence to a predicate device.

    Specifically, the text mentions:

    • Performance Testing: "Mechanical testing which established equivalency included static and dynamic testing." This indicates testing was performed but does not provide specific acceptance criteria or detailed results.
    • Conclusion: "The Skeletal Dynamics Dorsal Spanning Plate is substantially equivalent to the predicate device identified in this premarket notification." This is the overall conclusion of the 510(k) submission, based on the comparison to the predicate.

    The document does not include:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes or data provenance for a test set.
    3. Information on experts, ground truth establishment, or adjudication methods.
    4. Information on multi-reader multi-case (MRMC) studies or standalone algorithm performance.
    5. Details on training set sample size or ground truth establishment for a training set.

    Therefore, I cannot extract the requested information from the provided text.

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