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510(k) Data Aggregation

    K Number
    K993873
    Device Name
    ALPHATEC EXTERNAL FIXATION SYSTEM COMPRESSION/DISTRACTION ROD
    Manufacturer
    ALPHATEC MFG., INC.
    Date Cleared
    2000-01-03

    (49 days)

    Product Code
    KTT
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ALPHATEC EXTERNAL FIXATION SYSTEM COMPRESSION/DISTRACTION ROD

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

    The Alphatec External Fixation System is indicated for limb salvage from traumatic injury; fracture treatment (i.e., long bone fracture, including the tibia, femur, humerus, radius, and ulnar bones); reconstruction of extremities with deformity and dysfunction; limb lengthening; arthrodesis; and pelvic fractures.

    Device Description

    The Alphatec External Fixation System Compression/Distraction (CD) Rod consists of a CD rod that is available in two lengths and a CD rod to rod connector. These components are designed to be used in conjunction with the Alphatec External Fixation System and the Alphatec Wire External Fixation System which were the subject of prior premarket notifications. The additional use of the CD rod with the systems listed adds the capabilities of limb lengthening during fracture fixation. The CD rod and CD rod to rod connector are manufactured from titanium alloy (Ti-6Al-4V).

    AI/ML Overview

    The provided document is a 510(k) Pre-Market Notification for the Alphatec External Fixation System Compression/Distraction Rod. This document is a regulatory submission to the FDA demonstrating that a new device is substantially equivalent to a legally marketed predicate device.

    It does NOT contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML medical device.

    Instead, it focuses on:

    • Device Description: What the device is made of and how it works.
    • Intended Use: The medical conditions the device is designed to treat.
    • Substantial Equivalence: A comparison of the device to existing, legally marketed devices to show it is as safe and effective.
    • FDA Clearance: The official letter from the FDA stating that the device is substantially equivalent.

    Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance, as these concepts are not addressed in this type of regulatory document for a mechanical medical device.

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