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    K Number
    K103742
    Device Name
    ACCELL EVO3 (FORMERLY ACCELL A2I)
    Manufacturer
    INTEGRA LIFESCIENCES
    Date Cleared
    2011-03-17

    (84 days)

    Product Code
    MBP,MQV
    Regulation Number
    888.3045
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K061880,K051195
    Why did this record match?
    Device Name :

    ACCELL EVO3 (FORMERLY ACCELL A2I)

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

    Accell Evo3 is intended for filling voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure. The product is indicated for use as a bone graft extender in the spine, extremities and pelvis. Accell Evo3 may also be used as a bone void filler in the posterolateral spine, extremities and pelvis. The voids or gaps may be surgically created defects or the result of traumatic injury to the bone.

    Device Description

    Accell Evo3 is a moldable putty that contains ground, cortical de-mineralized bone marrix (DBM) in particulate and solubilized forms as well as a poloxamer reverse phase medium for proper handling. The device is packaged in a prefiled open-bore polycarbonate syringe and terminally sterilized by e-beam radiation. The DBM used to manufacture Accell Evo3 is only obtained from AATB-accredited facilities.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and the study information based on the provided text, formatted as requested:

    Acceptance Criteria and Device Performance

    The acceptance criteria are implied by the claim of "effective bone formation through fusion" and "equivalence to autograft." The device performance is the demonstration that it met these criteria.

    Acceptance Criteria (Implied)Reported Device Performance
    Effective bone formation through fusionDemonstrated effective bone formation through fusion (in posterolateral rabbit spine model)
    Equivalence to autograftRadiographic, histological, and biomechanical evidence of equivalence to autograft (in posterolateral rabbit spine model)
    Provides a favorable environment that stimulates bone growth and remodeling (Osteoconductivity)Accell Evo3 is an osteoconductive bone void filler. It creates a favorable environment for bone growth and remodeling.
    Osteoinductive potentialAssayed in vitro for bone morphogenetic protein-2, with in vitro assay validated to an in vivo (athymic mouse) osteoinductive assay.
    Biocompatible and safeDBM processing methods evaluated for viral inactivation potential, determined to provide significant viral inactivation.
    Resorption over timeDevice is resorbed over time.

    Study Information

    1. Sample sized used for the test set and the data provenance:

      • Test Set Sample Size: Not explicitly stated as a number of rabbits, but the study was conducted in a "posterolateral rabbit spine model."
      • Data Provenance: Animal study (rabbit model), likely prospective (an experimental study designed to test the device). Country of origin is not specified.

    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

      • Not specified. The assessment involved "Radiographic, histological and biomechanical evidence," suggesting evaluation by relevant experts in these fields (e.g., veterinary radiologists, histopathologists, biomechanical engineers), but their number or specific qualifications are not provided.

    3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

      • Not specified.

    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:

      • No. This was not an MRMC study comparing human readers or AI assistance. It was an animal study evaluating direct device performance.

    5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

      • N/A. This device is a bone void filler, not an algorithm.

    6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

      • The ground truth was established through radiographic, histological, and biomechanical evidence from the animal model. This combines imaging findings, tissue analysis (pathology), and functional/mechanical testing to assess bone formation and fusion.

    7. The sample size for the training set:

      • N/A. This is not an AI/machine learning device, so there is no "training set."

    8. How the ground truth for the training set was established:

      • N/A.
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