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    K Number
    K220182
    Device Name
    Aggeris™-C
    Manufacturer
    Clariance
    Date Cleared
    2022-03-30

    (68 days)

    Product Code
    KWQ
    Regulation Number
    888.3060
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K133518,K103491
    Why did this record match?
    Device Name :

    Aggeris™-C

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

    The Aggeris™-C device is intended for anterior fixation to the cervical spine from C2 to C7. The specific clinical indications include:

    1. Degenerative disc disease (defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies)
    2. Spondylolisthesis
    3. Spinal stenosis
    4. Deformities (i.e., scoliosis, kyphosis, and/or lordosis)
    5. Pseudoarthrosis
    6. Revision of previous surgery
    Device Description

    The Aggeris™-C is designed for use as a cervical plate. The device is manufactured from medical grade Titanium alloy. The device has a shape which restores the intervertebral height and lordosis. The device consists of a variety of bone screws and cervical plates provided in a variety of shapes and sizes of with rounded corners, bone screw holes, and a screw locking system. The plates are provided in a variety of lengths, allowing treatment from 1 to 5 levels. The Aggeris™-C plates, as well as the bone screws, are made from Ti alloy conforming to ASTM F136.

    AI/ML Overview

    This document describes the Clariance Aggeris™-C device, specifically a spinal intervertebral body fixation orthosis. However, the provided text does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria for software-based medical devices or AI/ML components.

    The text focuses on hardware-related regulatory submission details for a physical medical device (spinal implant), including:

    • Device name, classification, and regulation details.
    • Indications for use for a cervical plate.
    • Technological characteristics (materials, design).
    • Performance data related to biocompatibility, sterility, cleaning, and mechanical testing (static and dynamic axial compression, static torsion) of the physical implant.
    • Comparison to a predicate device for substantial equivalence, again for the physical implant.

    There is no mention of an AI/ML component, software, or any study involving human-in-the-loop performance, standalone algorithm performance, or ground truth establishment for diagnostic or predictive purposes.

    Therefore, I cannot provide the requested information based on the provided text. The questions posed in your prompt (e.g., sample size for test/training set, number of experts for ground truth, MRMC study, standalone performance) are relevant to AI/ML medical devices, not to the type of physical device and regulatory submission described here.

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