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    K Number
    K060148
    Device Name
    EBI VERTEBROPLASTY SYSTEMS
    Manufacturer
    EBI, L.P.
    Date Cleared
    2006-03-13

    (53 days)

    Product Code
    NDN
    Regulation Number
    888.3027
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K032943,K052638,K040483
    Why did this record match?
    Device Name :

    EBI VERTEBROPLASTY SYSTEMS

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

    The EBI® Vertebroplasty Systems are indicated to deliver bone cement legally cleared for use in the spine for the treatment of compression fractures of a vertebral body.

    Device Description

    Not Found

    AI/ML Overview

    This document describes the acceptance criteria and study proving the EBI® Vertebroplasty Systems meet these criteria.

    Acceptance Criteria and Device Performance

    Acceptance CriteriaReported Device Performance
    Ability to mechanically withstand insertion into a bony site."The CDO and LP27M Systems' ability to mechanically withstand insertion into a bony site" was demonstrated. "In all instances, the Vertebroplasty Systems functioned as intended and the test results obtained were as expected."
    Ability to deliver bone cement to the bony site."The CDO and LP27M Systems' ability...to deliver bone cement to the bony site" was demonstrated. "In all instances, the Vertebroplasty Systems functioned as intended and the test results obtained were as expected."
    Conformance to design specifications."Mechanical testing of the EBI® Vertebroplasty Systems was conducted which demonstrates that the CDO and LP2118 devices conform to their design specifications."
    Substantial equivalence to predicate devices (Stryker Bone Biopsy System, Abbott Spine Spinnaker System, Medtronic Sofamor Danek Equestra System)."The EBI® Vertebroplasty Systems are safe and effective as the predicate devices and have the same intended uses and similar indications, technological characteristics and principles of operation as the predicate devices. The minor technological differences between the Vertebroplasty components and the predicate devices raise no new issues of safety or effectiveness. Analysis data demonstrate that the Vertebroplasty Systems, their dimensions and materials are as safe and effective as the Stryker Bone Biopsy, Abbott Spinnaker and Medtronic Sofamor Danek Equestra systems. Thus, the Vertebroplasty Systems are substantially equivalent."

    Study Details

    1. Sample size used for the test set and the data provenance: The document mentions "Mechanical testing" of the EBI® Vertebroplasty Systems, specifically citing "CDO and LP2118 devices" and "CDO and LP27M Systems." However, specific sample sizes (e.g., number of devices tested, number of test runs) are not provided. The data provenance is not explicitly stated beyond being internal company testing ("Mechanical testing... was conducted"). It is implied to be a laboratory-based, prospective testing scenario.

    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The study involved mechanical performance testing against design specifications, not expert interpretation of outputs.

    3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This was mechanical performance testing, not a study requiring adjudication of expert opinions.

    4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This document pertains to a medical device for delivering bone cement, not an AI-based diagnostic or analysis tool involving human readers.

    5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not a software algorithm. The "standalone" performance refers to the device's mechanical function.

    6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for the mechanical testing was the predefined "design specifications" of the devices and the intended functional performance (withstanding insertion, delivering cement).

    7. The sample size for the training set: Not applicable. This is a mechanical device, not a machine learning algorithm that requires a training set.

    8. How the ground truth for the training set was established: Not applicable. As above, this is a mechanical device.

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