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510(k) Data Aggregation

    K Number
    K210286
    Device Name
    Cure 2.0 Anterior Cervical Plate (ACP) System
    Manufacturer
    Meditech Spine, LLC
    Date Cleared
    2021-03-18

    (44 days)

    Product Code
    KWQ
    Regulation Number
    888.3060
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K160604
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Cure™ 2.0 Anterior Cervical Plate (ACP) System is intended for anterior screw fixation to the C2 to C7 levels of the cervical spine. The system is indicated for use in skeletally mature patients for temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radies), Spondylolisthesis, Trauma (i.e., fractures or dislocations), Deformity (defined as kyphosis, lordosis), Pseudarthrosis, and Failed previous fusions.

    Device Description

    Cure™ 2.0 Anterior Cervical Plate (ACP) System is composed of plates in a wide range of sizes to coincide with the surgical approach and screws that are available in multiple lengths and diameters.

    Cure™ 2.0 Anterior Cervical Plate (ACP) System is manufactured from Grade 23 Titanium (Ti-6Al-4V ELI); manufactured according to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications.

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) summary for a medical device (Cure™ 2.0 Anterior Cervical Plate (ACP) System). This type of document focuses on establishing substantial equivalence to a predicate device based on technological characteristics and non-clinical testing.

    The information you requested, such as acceptance criteria, reported device performance (with specific metrics like sensitivity, specificity, or accuracy), details about test sets (sample size, data provenance), ground truth establishment (number of experts, qualifications, adjudication), MRMC studies, standalone algorithm performance, and training set details, are typically found in studies for AI/ML-enabled devices or diagnostic software.

    The Cure™ 2.0 Anterior Cervical Plate (ACP) System is a physical implant, and its clearance is based on mechanical testing (ASTM F1717) to ensure it performs equivalently to an existing device. Therefore, the requested information about AI/ML device performance metrics and study design elements is not applicable to this document.

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