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510(k) Data Aggregation

    K Number
    K043209
    Device Name
    VIAGRAF DBM PASTE
    Manufacturer
    OSTEOTECH, INC.
    Date Cleared
    2005-12-05

    (381 days)

    Product Code
    MBP,MQV
    Regulation Number
    888.3045
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K020078,K040755,K020895,K041186
    Why did this record match?
    Device Name :

    VIAGRAF DBM PASTE

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

    VIAGRAF® DBM Paste is intended for use in filling bony voids or gaps of the extremities that are not intrinsic to the stability of the bony structure. The voids or gaps may be surgically created defects or defects created by traumatic injury to the bone. VIAGRAF® DBM Paste is resorbed/remodeled and is replaced by host bone during the healing process.

    Device Description

    VIAGRAF DBM Paste is an osteoconductive human bone allograft product consisting of human demineralized bone matrix (DBM) to which an inert starchbased carrier has been added. It is intended for use in filling bony voids or gaps of the extremities not intrinsic to the stability of the bony structure. VIAGRAF® DBM Paste is provided in a ready-to-use paste-like, malleable form that can be molded or manipulated by the user into various shapes. It is provided in various package sizes by volume.

    AI/ML Overview

    The provided document, K043209, does not contain detailed acceptance criteria or a comprehensive study with specific numerical performance metrics typically found for medical devices with algorithmic components. This 510(k) pertains to a demineralized bone matrix paste (VIAGRAF® DBM Paste), which is a biological product, not a software or AI-driven device. Therefore, the requested information, which is more relevant to AI/ML or diagnostic devices, is not explicitly available in this document.

    However, based on the information provided, I can infer the general nature of the performance data and its purpose:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criterion (Inferred)Reported Device Performance
    Acceptable bone formation in animal models"The results of bone formation studies in animal models demonstrated acceptable bone formation with VIAGRAF® DBM Paste."
    Relevant clinical data supporting performance"In addition, relevant clinical data exists that supports the performance of VIAGRAF® DBM Paste."
    Validation of viral inactivation process"VIAGRAF® DBM Paste is produced by a proprietary production process that has been validated to inactivate viruses including: HIV-1; hepatitis B virus (...); hepatitis C virus (...), CMV; and Polio virus."

    2. Sample size used for the test set and the data provenance

    • Sample Size: Not specified.
    • Data Provenance: The document mentions "animal models" for bone formation studies and "relevant clinical data." No specific country of origin or whether the clinical data was retrospective or prospective is mentioned.

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

    • Not applicable/Not specified. The performance evaluation for this product relies on biological outcomes (bone formation) and viral inactivation, not expert interpretation of outputs like images.

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

    • Not applicable. This concept is typically relevant for studies where human expert consensus is used to establish ground truth for a diagnostic device.

    5. 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 is not an AI/ML or diagnostic device that involves human readers interpreting results.

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

    • Not applicable. This is not an algorithmic device.

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

    • For bone formation: Biological outcomes in animal models.
    • For viral inactivation: Validation of the proprietary process against specific viruses.
    • For clinical performance: "Relevant clinical data" (assumed to be patient outcomes/follow-up data).

    8. The sample size for the training set

    • Not applicable. This is not an AI/ML device that uses a training set.

    9. How the ground truth for the training set was established

    • Not applicable.
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