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510(k) Data Aggregation

    K Number
    K040598
    Device Name
    KLS MARTIN HAND PLATING SYSTEM
    Manufacturer
    KLS-MARTIN L.P.
    Date Cleared
    2004-05-13

    (66 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K961497,K992961,K011118,K032442,K944565,K944561
    Why did this record match?
    Device Name :

    KLS MARTIN HAND PLATING SYSTEM

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

    The KLS Martin Hand Plating System is used for stabilization and fixation of fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, wrist, fingers, feet, ankles and toes.

    Device Description

    The KLS Martin Hand Plating System consists of plates of various lengths and thickness from 0.6mm to 3.0mm and screws of various lengths having a diameter of 1.0mm to 2.7mm.

    AI/ML Overview

    The provided text is a 510(k) summary for the KLS Martin Hand Plating System and the FDA's response. This type of regulatory document focuses on demonstrating substantial equivalence to predicate devices for market clearance, rather than conducting new clinical studies with acceptance criteria, ground truth establishment, or multi-reader multi-case studies for AI models.

    Therefore, the input does not contain the information necessary to answer your request regarding acceptance criteria and study details for a device whose performance is being proven through a study. The document confirms that the KLS Martin Hand Plating System is substantially equivalent to existing predicate devices based on material, manufacturing processes, and intended use.

    Specifically, there is no mention of:

    1. Acceptance criteria table or reported device performance metrics. The document compares the new device to predicates based on materials, manufacturing, and intended use, not performance metrics from a study.
    2. Sample size for test set, data provenance, number of experts, qualifications of experts, or adjudication method for a study designed to prove performance.
    3. Multi-reader multi-case (MRMC) comparative effectiveness study or effect sizes for human readers with/without AI assistance.
    4. Standalone (algorithm only) performance study. The device is a physical plating system, not an AI algorithm.
    5. Type of ground truth used.
    6. Sample size for training set or how ground truth for the training set was established.

    The core of this document is a regulatory submission demonstrating substantial equivalence to legally marketed predicate devices, not providing a performance study with detailed acceptance criteria and ground truth validation as would be expected for an AI/diagnostic device.

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