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510(k) Data Aggregation

    K Number
    K160978
    Device Name
    LITe BIO Delivery System
    Manufacturer
    STRYKER CORPORATION
    Date Cleared
    2016-07-08

    (92 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    Type
    Traditional
    Panel
    Hematology (HO)
    Reference & Predicate Devices
    K023074,K133328,K152532,K121124,K140710,K112773
    Why did this record match?
    Reference Devices :

    K023074, K133328, K152532

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

    The LITe® BIO Delivery System is intended to deliver autograft, allograft, or synthetic bone grafting materials to all orthopedic surgical sites.

    Device Description

    The LITe® BIO Delivery System is a manually operated hand-held device used to facilitate delivery of bone graft material to all orthopedic surgical sites. The LITe® BIO Delivery System consists of a delivery cannula, a delivery plunger, a delivery plunger tip, a loading syringe, and a delivery handle. The cannula is filled with the physician's choice of bone graft material and is then delivered to the intended surgical site.

    AI/ML Overview

    The provided text describes the 510(k) summary for the LITe® BIO Delivery System, a medical device. This document is a premarket notification for a Class II piston syringe intended to deliver bone grafting materials.

    The document does not describe a study involving an AI/Machine Learning device. It refers to a physical medical device for delivering bone graft material. Therefore, the requested information regarding acceptance criteria, performance metrics, sample sizes for test/training sets, ground truth establishment, expert adjudication, or MRMC studies for an AI/ML device is not applicable to this document.

    The "Summary of Performance Data" section lists several bench tests conducted to demonstrate the device's performance, but these are engineering performance criteria for a physical device, not an AI/ML algorithm.

    Summary of Performance Data Provided:

    The document states:
    "Testing was conducted to demonstrate performance as intended and included the following bench testing:

    • Functional testing (delivery of graft material through cannula)
    • Life cycle testing
    • Cantilever bending of cannula
    • Radial compression of cannula
    • Retention strength test of cannula
    • Connection strength test of cannula to loading funnel"

    This information aims to demonstrate that the LITe® BIO Delivery System is substantially equivalent to other currently marketed bone graft delivery systems and that its technological differences do not raise any new safety or effectiveness issues.

    Therefore, I cannot provide the requested information about acceptance criteria and studies for an AI/ML device based on this document.

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