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510(k) Data Aggregation

    K Number
    K991794
    Device Name
    ENDOSCOPIC SPINAL ACCESS SYSTEM
    Manufacturer
    ENDIUS, INC.
    Date Cleared
    1999-08-13

    (79 days)

    Product Code
    HRX
    Regulation Number
    888.1100
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    K021748,K053267,K061345,K062038
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Endius Endoscopic Access System is intended to be used for posterior endoscopic access to the lumbar spine for various endoscopic spinal procedures such as discectomy and nucleotomy.

    Device Description

    The Endoscopic Spinal Access System is a family of devices which are intended to be used to gain access and visualization to the spine in order to aid in various spinal procedures.

    AI/ML Overview

    The provided text describes a medical device submission (510(k)) for the Endius Endoscopic Spinal Access System. This document is a premarket notification for a medical device seeking clearance based on substantial equivalence to a predicate device, not a study reporting on the device's performance against specific acceptance criteria.

    As such, the document does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert involvement, or ground truth methods because it is not a clinical study report. It is a registration document for a medical device.

    Therefore, I cannot provide the requested table and study details.

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