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510(k) Data Aggregation

    K Number
    K250554
    Device Name
    prodisc® L Instruments
    Manufacturer
    Centinel Spine LLC
    Date Cleared
    2025-04-25

    (59 days)

    Product Code
    QLQ
    Regulation Number
    888.4515
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K242869
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The prodisc® L Instruments are intended for the placement, positioning, and removal of the prodisc® L implants.

    Device Description

    The prodisc® L Instruments enable the Centinel prodisc® L disc to be implanted into the disc space. The purpose of this Traditional 510(k) is to seek marketing clearance for four additional prodisc® L Instruments:

    • IN1575, Hemi Chisel +3mm, 10mm
    • IN1576, Hemi Chisel +3mm, 12mm
    • IN1570, Superior Impactor, Medium
    • IN1571, Superior Impactor, Large
      These are new instruments, based on similar devices within the existing instrument set.
    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for medical instruments. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies for an AI/software device.

    The device in question, "prodisc® L Instruments," falls under the product code QLQ, which is for "Manual Instruments Designed For Use With Total Disc Replacement Devices." This indicates it is a set of physical surgical tools, not a software or AI-powered device.

    Therefore, I cannot provide the requested information because the provided document does not pertain to the evaluation of an AI or software device. The questions you've asked are typically relevant to the validation of diagnostic or predictive AI tools.

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