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510(k) Data Aggregation

    K Number
    K200987
    Device Name
    LTJ Screws and Washer
    Manufacturer
    AzurMeds inc.
    Date Cleared
    2020-09-22

    (160 days)

    Product Code
    HWC,HTN
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K124027
    Predicate For
    K210268
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The LTJ Screws (3.75mm solid and 4.5mm cannulated) are intended to be used in skeletally mature patient as stand-alone bone screws for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation, appropriate for the size of the device. Optional washers are available for the 3.75 solid screws.

    Device Description

    The LTJ Screws are partially threaded solid headless 3.75 mm screws and partially threaded cannulated headed 4.5 mm screws provided in various length ranging from 26 mm to 50 mm. They are provided in Stainless Steel Alloy compliant with ASTM F138. The headless implants can be associated to an LTJ diameter 8 mm Washer provided in Stainless Steel Alloy compliant with ASTM F138. It is essential to handle and insert implants with LTJ instruments specifically designed for this purpose.

    AI/ML Overview

    This document is a 510(k) summary for a medical device called "LTJ Screws and Washer." It describes the device, its intended use, and a comparison to a predicate device to establish substantial equivalence.

    Based on the provided text, there is no acceptance criteria or study data related to device performance in terms of clinical outcomes or diagnostic accuracy involving human readers or AI systems. The performance data section refers exclusively to mechanical testing of the screws and not to any AI or human-assisted diagnostic performance.

    Therefore, most of the requested information cannot be extracted from this document, as it pertains to a different type of device (a bone fixation fastener) and a different type of evaluation (mechanical properties rather than diagnostic accuracy).

    Here's what can be extracted based on the primary focus of the request:

    1. Table of Acceptance Criteria and Reported Device Performance:

    Acceptance Criteria CategoryAcceptance Criteria (from text)Reported Device Performance (from text)
    Mechanical Testing (Torque Strength)Measured according to ASTM F543Demonstrated adequacy for intended use.
    Mechanical Testing (Insertion/Removal Torque)Measured according to ASTM F543Demonstrated adequacy for intended use.
    Mechanical Testing (Pullout Strength)Measured according to ASTM F543Demonstrated adequacy for intended use.

    2. - 7. (Information regarding AI/human reader studies, ground truth, sample sizes for test/training sets, adjudication, etc.):

    This information is not applicable to the provided document. The document describes a metallic bone fixation fastener (LTJ Screws and Washer), which is a physical implant, not a diagnostic AI device or a device requiring human reader interpretation for its primary function. The "performance data" mentioned refers to mechanical testing of the physical screws to ensure they meet engineering standards for their intended use in bone fixation, not to the performance of any AI algorithm or human diagnostician.

    8. Sample size for the training set: Not applicable and not mentioned.
    9. How the ground truth for the training set was established: Not applicable and not mentioned.

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