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510(k) Data Aggregation

    K Number
    K140927
    Device Name
    UNIVERSAL NAVIGATION INSTRUMENTS
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Date Cleared
    2014-10-24

    (196 days)

    Product Code
    OLO
    Regulation Number
    882.4560
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K120867,K122211,K070106,K050438
    Why did this record match?
    Device Name :

    UNIVERSAL NAVIGATION INSTRUMENTS

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

    The Universal Navigation Instruments for EXPEDIUM® and VIPER® MIS Spine Systems are intended to assist the surgeon in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures. These are indicated for use in surgical spinal procedures, in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the pelvis or a vertebrac can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy using tracking arrays provided by the navigation manufacturer. These procedures include but are not limited to spinal fusion. These devices can be pre-calibrated and/or manually calibrated with Brainlab Navigation system, where other navigation systems require manual calibration.

    Device Description

    The Universal Navigation Instruments for EXPEDIUM® and VIPER® MIS Spine Systems are manual surgical instruments which are designed to interface with previously cleared surgical navigation systems. The instruments in this system are manually calibrated to previously cleared surgical navigation systems using manufacturers' instructions. These instruments are intended to be used in spine applications to perform general manual functions within the orthopedic surgical environment. The Universal Navigation Instruments for EXPEDIUM® and VIPER® MIS Spine Systems are intended for use with the EXPEDIUM 5.5 Spine System and VIPER 2 MIS Spine Systems components.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for "Universal Navigation Instruments for EXPEDIUM® and VIPER® MIS Spine Systems." This document is a regulatory submission for a medical device and does not contain the type of AI/algorithm performance study data you're asking for.

    The device in question is a set of manual surgical instruments designed to interface with existing surgical navigation systems. The performance data section describes benchtop testing to assess:

    • Overall accuracy compared to predicate instruments.
    • Calibration with third-party navigation software.
    • Rigidity of connections between universal clamps/arrays and the instruments.

    There is no mention of an AI algorithm, a test set, ground truth established by experts, MRMC studies, or standalone algorithm performance.

    Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI-powered device based on this document. The document describes a traditional medical device (surgical instruments) and its validation through standard engineering and benchtop testing, not an AI or software-based diagnostic/therapeutic device.

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