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510(k) Data Aggregation

    K Number
    K242914
    Device Name
    Op.n Perla TL Nav
    Manufacturer
    Ecential Robotics
    Date Cleared
    2025-03-07

    (164 days)

    Product Code
    OLO
    Regulation Number
    882.4560
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Op.n Perla TL Nav

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

    Op.n™ Navigation is indicated for the positioning of compatible surgical instruments to be used by surgeons during general spinal surgery.

    The guidance is based on an intra-operative surgical plan developed with Op.n™ Navigation Software and based on intraoperative 3D images provided by a compatible imaging system.

    The device is indicated for the placement of pedicle screws, in instrument navigation mode, in vertebrae with a posterior approach in the thoracolumbar region.

    Op.n™ Navigation Software is indicated for the navigation of compatible surgical instruments to be used by surgeons.

    Device Description

    Not Found

    AI/ML Overview

    The provided text does not contain information about the acceptance criteria, device performance, study details, expert qualifications, or ground truth establishment for a specific device. The document is an FDA 510(k) clearance letter for a stereotaxic instrument called "Op.n Perla TL Nav" and "Op.n Navigation." This letter primarily addresses regulatory compliance and substantial equivalence to a predicate device, rather than detailed performance study results.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input. The requested information (table of acceptance criteria, sample sizes, expert details, adjudication methods, MRMC study, standalone performance, ground truth types, and training set details) is not present in this regulatory document.

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