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510(k) Data Aggregation

    K Number
    K100707
    Device Name
    REPROCESSED PINS
    Manufacturer
    STERILMED, INC.
    Date Cleared
    2010-06-25

    (105 days)

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

    NDM

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

    The pins are intended to be used to rigidly fixate a Tracker to a single bone during computer assisted surgical procedures including hip, knee, and other trauma applications. Specifically:

    • Navigation and Ortholock Ex-Pins: The intended use of the Stryker OrthoLock Ex-Pins is to . rigidly fixate a Tracker to the bone undergoing treatment. The Stryker OrthoLock Ex-Pins are intended to be used with, but are not limited to, the OrthoLock system.
    • Anchoring Pins: The Anchoring Pins are components of the Hip, Trauma and Knee Modules of . the Stryker Navigation System and intended to be used to rigidly fixate a Tracker to a single bone.
    Device Description

    Reprocessed Pins

    AI/ML Overview

    This document is a 510(k) premarket notification decision letter from the FDA regarding "Reprocessed Pins" by SterilMed, Inc. It does not contain the detailed information required to answer your questions about acceptance criteria and study particulars for a device performance study.

    The letter confirms that the device is substantially equivalent to legally marketed predicate devices, meaning it has a similar intended use, technological characteristics, and safety and effectiveness profile. The Indications for Use are provided, stating the pins are intended to rigidly fixate a Tracker to a single bone during computer-assisted surgical procedures.

    However, the letter does not include:

    1. A table of acceptance criteria and reported device performance.
    2. Sample size used for the test set or data provenance.
    3. Number of experts and their qualifications for ground truth establishment.
    4. Adjudication method.
    5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
    6. Information about a standalone (algorithm only) performance study.
    7. The type of ground truth used.
    8. Sample size for the training set.
    9. How ground truth for the training set was established.

    These details would typically be found in the 510(k) submission itself, or in a more detailed summary of safety and effectiveness data, which is not provided in the snippet. The FDA's 510(k) decision letter focuses on regulatory approval based on substantial equivalence, rather than detailing the specifics of the underlying performance studies.

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