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510(k) Data Aggregation

    K Number
    K070033
    Device Name
    MEMOMETAL VARISATION, MODELS AV26-08, AV26-10, AV90-08 AND AV90-10
    Manufacturer
    MEMOMETAL TECHNOLOGIES
    Date Cleared
    2007-03-19

    (75 days)

    Product Code
    JDR
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    K112794,K143323,K151160
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The MEMOMETAL varisation staple is intended to be implanted for fixation of small bone fractures or for small bone reconstruction. The MEMOMETAL varisation staple is indicated for Akin type osteotomy.

    Device Description

    MEMOMETAL varisation staple is a staple with two self drilling tips. The treatment with a varisation staple allows, after possible treatment of the second ray, to correct the valgus deformation of the first ray and to recreate a square or Greek foot. Two types of staples are available depending on the bone surface

    AI/ML Overview

    This submission is for a medical device (MEMOMETAL varisation staples), not an AI/ML device. Therefore, the requested information regarding acceptance criteria and study details for an AI/ML device is not applicable. The documentation focuses on demonstrating substantial equivalence to a predicate device, as required for traditional 510(k) submissions for non-AI medical devices.

    However, I can extract the relevant performance data and the study type conducted for this medical device:

    1. Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    Material ConformanceConforms to ISO 5832-1 Implants for surgery - Metallic materials - Part 1: Wrought stainless steel (ISO 5832-1:1997).
    Functional & Mechanical PerformanceConforms to ASTM F564-02 Standard Specification and Test Methods for Metallic Bone staples.

    2. Sample Size and Data Provenance

    Not applicable. The submission is for a non-AI medical device and relies on material and mechanical standard conformance rather than clinical or algorithmic data.

    3. Number and Qualifications of Experts for Ground Truth

    Not applicable for a non-AI device.

    4. Adjudication Method

    Not applicable for a non-AI device.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

    Not applicable. This type of study is relevant to AI-assisted diagnostic devices to assess the impact of AI on human reader performance, which is not the subject of this 510(k) submission.

    6. Standalone Algorithm Performance

    Not applicable as this is a physical medical device, not an algorithm.

    7. Type of Ground Truth Used

    For this physical device, the "ground truth" is defined by established engineering standards for metallic implants and bone staples. This includes:

    • Material composition and properties: Defined by ISO 5832-1.
    • Mechanical performance (e.g., strength, fatigue): Defined by ASTM F564-02.

    8. Sample Size for Training Set

    Not applicable as there is no algorithm or training set for a physical medical device.

    9. How Ground Truth for Training Set Was Established

    Not applicable.

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