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510(k) Data Aggregation

    K Number
    K211757
    Device Name
    Simplify Disc
    Manufacturer
    NuVasive, Inc.
    Date Cleared
    2021-08-20

    (74 days)

    Product Code
    QLQ
    Regulation Number
    888.4515
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Simplify Disc

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

    The Simplify Disc Inserter FP is intended for the placement and positioning of the Simplify Cervical Artificial Disc.

    Device Description

    The instrument set includes a number of surgical instruments designed to facilitate Simplify Cervical Artificial Disc implantation. The Simplify Disc Inserter FP enables the Simplify Disc to be held as a rigid construct in extension and to be inserted as a single unit into the disc space. The instrument set is intended to be used only with the Simplify Cervical Artificial Disc.

    The purpose of the 510(k) submission is to improve usability of the Simplify Disc Inserter with an updated version referred to as Simplify Disc Inserter FP.

    AI/ML Overview

    This document is a 510(k) summary for the Simplify Disc Inserter FP. It details the device's intended use and design modifications, but it does not contain the kind of detailed information about acceptance criteria, study design, or AI performance that you are requesting.

    The document states:

    • Performance Testing: "Testing included user testing, dimensional analysis, cleaning validation, and steam sterilization. All completed tests met the pre-determined acceptance criteria."

    However, it does not provide any specific acceptance criteria or detailed results from these tests. It also does not mention any AI component or related studies (like MRMC or standalone performance studies).

    Therefore, based on the provided text, I cannot extract the information you requested regarding:

    1. A table of acceptance criteria and the reported device performance: This information is not detailed.
    2. Sample size used for the test set and the data provenance: Not mentioned.
    3. Number of experts used to establish the ground truth and their qualifications: Not mentioned.
    4. Adjudication method: Not mentioned.
    5. MRMC comparative effectiveness study, effect size: Not applicable, as no AI component is mentioned.
    6. Standalone (algorithm only) performance: Not applicable, as no AI component is mentioned.
    7. Type of ground truth used: Not applicable, as no AI component or clinical evaluation requiring such ground truth is detailed.
    8. Sample size for the training set: Not applicable, as no AI component is mentioned.
    9. How the ground truth for the training set was established: Not applicable, as no AI component is mentioned.

    This document pertains to regulatory approval for a physical medical instrument (the Disc Inserter) and not an AI/software as a medical device (SaMD).

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