LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K073274
    Device Name
    SPINAL SPHERE SYSTEM
    Manufacturer
    LIFE SPINE
    Date Cleared
    2008-03-17

    (117 days)

    Product Code
    NVR
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K051320,K060415
    Why did this record match?
    Device Name :

    SPINAL SPHERE SYSTEM

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

    The Spinal Sphere System is intended to be inserted between the vertebral bodies into the disc space from L3 to S1 to help provide stabilization and to help promote intervertebral body fusion. Properly used, this internal fixation device is intended and designed solely for holding bone parts in alignment while they heal. The Spinal Sphere System is intended to be used with bone graft. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. It is not intended for use in motion-sparing, non-fusion procedures.

    Device Description

    The Spinal Sphere System consists of spheres manufactured from either CoCrMo or PEEK-OPTIMA. The device may be implanted from L3 to S1 to provide temporary stabilization in order to help promote fusion. The spheres are available in a variety of sizes.

    AI/ML Overview

    I apologize, but I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

    The provided documents are a 510(k) summary and an FDA clearance letter for the "Spinal Sphere System" by Life Spine. These documents relate to the regulatory clearance of a medical device, specifically demonstrating substantial equivalence to a predicate device.

    They do not contain information about:

    1. Acceptance criteria in terms of specific performance metrics for a software or AI device.
    2. A study proving device meets acceptance criteria with details such as sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies.
    3. Performance metrics (e.g., sensitivity, specificity, accuracy) that would populate a table of acceptance criteria and reported performance for an AI/software device.

    The context of the provided text is for a physical orthopedic implant (spinal spheres), not a diagnostic AI/software device. The FDA clearance is based on demonstrating the new device is "substantially equivalent" to an existing, legally marketed device, primarily in terms of intended use, design, function, and materials, rather than a performance study against specific AI-related acceptance criteria.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1