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510(k) Data Aggregation

    K Number
    K163104
    Device Name
    Terrace™ Anterior Cervical Plate System
    Manufacturer
    CoreLink, LLC
    Date Cleared
    2017-06-21

    (226 days)

    Product Code
    KWQ
    Regulation Number
    888.3060
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K121514,K102820,K100614,K130202,K133475
    Why did this record match?
    Device Name :

    Terrace™ Anterior Cervical Plate System

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

    The CoreLink TERRACE™ Anterior Cervical Plate System is intended for anterior fixation of the cervical spine. Indications for use include the temporary stabilization of the anterior spine during the evolution of cervical fusions in patients with degenerative disc disease (DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, and/or failed previous fusions. The intended levels for treatment range from C2 – T1.

    Device Description

    The Terrace™ Anterior Cervical Plate System is indicated for one through five levels of fixation and are provided in multiple sizes to accommodate a variety of patient anatomies. Screws are provided in multiple sizes to accommodate a variety of patient anatomies. Implants are manufactured from Ti-6Al-4V ELI conforming to ASTM F136 and nitinol conforming to ASTM F2063. Implants are provided non-sterile with instructions for sterilization.

    AI/ML Overview

    The provided document describes the Terrace™ Anterior Cervical Plate System, a medical device, and its submission for FDA clearance (K163104). This document focuses on demonstrating substantial equivalence to predicate devices based on non-clinical performance data, primarily mechanical testing.

    Here's an analysis of the requested information based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Test Standard)Reported Device Performance (Summary)
    Static axial compression bending per ASTM F1717-14Results sufficient for intended use; substantially equivalent to predicate devices.
    Static torsion per ASTM F1717-14Results sufficient for intended use; substantially equivalent to predicate devices.
    Dynamic axial compression bending fatigue per ASTM F1717-14Results sufficient for intended use; substantially equivalent to predicate devices.
    Corrosion testing per ASTM F2129Results sufficient for intended use; substantially equivalent to predicate devices.

    2. Sample Size Used for the Test Set and Data Provenance

    The document does not provide specific sample sizes (e.g., number of devices or constructs tested) for the mechanical tests. It also does not specify the provenance of the data in terms of country of origin or whether it was retrospective or prospective, as these are non-clinical (benchtop) tests.

    3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

    Not applicable. This device's evaluation is based on non-clinical mechanical testing, not clinical data requiring expert review for ground truth.

    4. Adjudication Method for the Test Set

    Not applicable. This evaluation is based on non-clinical mechanical testing, not clinical data requiring adjudication.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

    No. The document presents non-clinical (benchtop) mechanical testing results, not clinical studies involving human readers or comparative effectiveness with AI.

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

    No. This document does not pertain to an AI-powered device or algorithm. It concerns a physical medical implant.

    7. The Type of Ground Truth Used

    The "ground truth" for this type of evaluation is effectively established by the ASTM test standards (ASTM F1717-14 and ASTM F2129) themselves, which define acceptable methodologies and performance metrics for spinal implants. The device's performance is compared against these standards and to predicate devices to demonstrate substantial equivalence.

    8. The Sample Size for the Training Set

    Not applicable. This device is not an AI/ML algorithm that requires a training set. The evaluation is based on mechanical testing.

    9. How the Ground Truth for the Training Set Was Established

    Not applicable. This device is not an AI/ML algorithm that requires a training set.

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