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510(k) Data Aggregation

    K Number
    K151104
    Device Name
    OTELO LL
    Manufacturer
    SPINEART
    Date Cleared
    2016-01-06

    (257 days)

    Product Code
    GAD
    Regulation Number
    878.4800
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K043602
    Why did this record match?
    Device Name :

    OTELO LL

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

    The OTELO LL Retractor is intended to provide the surgeon access to the spine by dissection and traction of soft and bony tissue.

    Device Description

    The OTELO®LL Retractor System is a tubular-based retraction system, designed to provide surgeons with the freedom to retract tissue through any combination of distracting or articulating the blades. The OTELO®LL Retractor System includes instruments used to access the spine by dilating the overlying tissues, as well serving as a retracting device to maintain the access. The system can be used in conjunction with microscopes, light sources, cameras, or other visualization aids.

    AI/ML Overview

    I am sorry, but based on the provided document, I cannot fulfill your request. The document describes a 510(k) summary for a medical device called the OTELO LL Retractor, which is a manual surgical instrument. The content focuses on demonstrating substantial equivalence to a predicate device and includes pre-clinical verification and validation test results for aspects like biocompatibility, cleaning, sterilization, and mechanical performance.

    However, the provided text does not contain information about:

    • Acceptance criteria and device performance in the context of diagnostic accuracy (e.g., sensitivity, specificity, AUC)
    • Sample sizes for test sets (as it's not a diagnostic study)
    • Data provenance, number of experts, adjudication methods, or ground truth for diagnostic accuracy studies
    • Multi-reader multi-case (MRMC) comparative effectiveness studies with human readers
    • Standalone (algorithm only) performance
    • Training set details

    The "acceptance criteria" discussed in the document are related to engineering and biological performance (e.g., no cytotoxic potential, no breakage of blades, successful cleaning and sterilization) rather than diagnostic performance against clinical ground truth.

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