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510(k) Data Aggregation

    K Number
    K133713
    Device Name
    CHARLOTTE (TM) SNAP-OFF SCREW
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Date Cleared
    2014-03-07

    (92 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Type
    Special
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CHARLOTTE (TM) SNAP-OFF SCREW

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

    The CHARLOTTE™ Snap-Off Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:

    • Fixation of Small Bone Fragments
    • Weil osteotomy
    • Mono-cortical fixation
    • Osteotomies and fractures fixation in the foot and hand
    Device Description

    The CHARLOTTE™ Snap-Off screw is a cortical bone screw intended to aid in achieving fixation of bone fragments or bone reconstruction.
    The design features and function of the CHARLOTTE™ Snap-Off Screw are substantially equivalent to the design features previously cleared under the CHARLOTTE™ Snap-Off screw and are highlighted below:

    • Manufactured from ASTM F136 (Ti-6AI-4V ELI) .
    • . Self-drilling and self-tapping features on distal threads
    • Groove in head of screw around neck connection to drive mechanism to allow for snap off of ● drive mechanism shaft below screw head surface
      The subject screws in this Special 510(k) include a change in the tip geometry of the snap-off 2,0mm diameter screw as well as the introduction of additional screw lengths to the 2.0mm and 2.7mm diameter screws to fill in sizes not previously included. Additionally, screws that are provided sterile have been added.
    AI/ML Overview

    The provided text is for a 510(k) premarket notification for a medical device (CHARLOTTE™ Snap-Off Screw), not a study analyzing AI performance or diagnostic accuracy. Therefore, it does not contain the information required to answer your request regarding acceptance criteria, study design, expert involvement, or AI performance metrics.

    The document discusses the substantial equivalence of an updated screw design to its predicate devices based on mechanical testing, but it does not involve any diagnostic algorithms, image analysis, or human reader performance.

    To summarize, based on the provided text, I cannot extract the following information:

    1. Table of acceptance criteria and reported device performance: This document is about a physical medical device (a screw), not a diagnostic algorithm. The "performance" discussed relates to mechanical properties, not diagnostic accuracy.
    2. Sample size used for the test set and data provenance: Not applicable to this type of device submission.
    3. Number of experts used and their qualifications: Not applicable.
    4. Adjudication method: Not applicable.
    5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
    6. Standalone (algorithm only) performance: Not applicable.
    7. Type of ground truth used: Not applicable.
    8. Sample size for the training set: Not applicable.
    9. How the ground truth for the training set was established: Not applicable.
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