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510(k) Data Aggregation

    K Number
    K070994
    Device Name
    EAGLE + ANTERIOR CERVICAL PLATE SYSTEM
    Manufacturer
    DEPUY SPINE, INC.
    Date Cleared
    2007-05-09

    (30 days)

    Product Code
    KWQ
    Regulation Number
    888.3060
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K040197
    Why did this record match?
    Device Name :

    EAGLE + ANTERIOR CERVICAL PLATE SYSTEM

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

    The EAGLE™ + Anterior Cervical Plate System is intended for anterior cervical intervertebral body fixation. This system is indicated for patients in which stability is desired following anterior cervical fusion for the indications listed below. The intended levels for treatment range from C2 to T1.

    Indications include symptomatic cervical spondylosis, trauma, fracture, posttraumatic kyphosis or lordosis, tumor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), re-operation for failed fusion, or instability following surgery for the above indications.

    Device Description

    The EAGLE + Anterior Cervical Plate System consists of an assortment of plates and screws. The EAGLE + Anterior Cervical Plate System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.

    AI/ML Overview

    The provided document describes the EAGLE™ + Anterior Cervical Plate System, a medical device. It does not contain information about software or AI, and therefore, does not include acceptance criteria for algorithm performance, a study proving such criteria are met, or details related to AI/algorithm performance.

    The document is a 510(k) summary for a spinal implant system. It discusses:

    • Device Description: The EAGLE + Anterior Cervical Plate System consists of plates and screws manufactured from ASTM F-136 implant grade titanium alloy. It also includes Class 1 manual surgical instruments.
    • Intended Use/Indications for Use: The system is for anterior cervical intervertebral body fixation for patients needing stability after anterior cervical fusion, for levels C2 to T1. Indications include symptomatic cervical spondylosis, trauma, fracture, post-traumatic kyphosis or lordosis, tumor, degenerative disc disease, re-operation for failed fusion, or instability following surgery for these indications.
    • Predicate Device: The EAGLE™ Anterior Cervical Plate System (K040197).
    • Performance Data: The document states "Performance data were submitted to characterize the EAGLE + Anterior Cervical Plate System," but it does not detail what that performance data is or what acceptance criteria were used or met. It's highly probable that this performance data would relate to mechanical testing (e.g., fatigue, static strength) suitable for a spinal implant, rather than diagnostic accuracy or algorithmic performance.

    Therefore, for your specific questions regarding acceptance criteria for an algorithm/AI and related studies, the provided text does not offer any relevant information.

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