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510(k) Data Aggregation

    K Number
    K970846
    Device Name
    22.2/+4MM CO CR & ZIRCONIA FEMORAL HEAD
    Manufacturer
    LANDOS, INC.
    Date Cleared
    1997-06-05

    (90 days)

    Product Code
    LZO
    Regulation Number
    888.3353
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K935185
    Why did this record match?
    Device Name :

    22.2/+4MM CO CR & ZIRCONIA FEMORAL HEAD

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

    The intended use for the 22.2/-4 Femoral Head is to complete the assembly of a Ti-6Al-4V semicanus and I he mended tise for the 22.27-4 rendral to the tapen of the Morphonetic Hip, manufactures by Medinov-AMP. The indications for use are artintis, arthrosis or any joint disease at the hip level, of wromans is, failed previous surgery or joint reconstruction.

    Device Description

    The 22.2/44 Femoral Head is designed to fit on a 9/11 taper. It is 22.2mm in diameter and has a neck length of +4. It is available in zirconia or cobalt chrome alloy.

    AI/ML Overview

    This device is a physical medical device (femoral head) and not an AI/ML powered device, therefore most of the requested information is not applicable. I will provide the information that is available.

    1. Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    Substantial equivalence in burst load to the predicate device.The burst load average for both the zirconia and cobalt chrome heads is substantially equivalent to that of the predicate device.

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

    Not applicable. This is a physical device, and the testing described is mechanical, not based on data.

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

    Not applicable. Ground truth for mechanical properties is typically established through direct measurement and testing, not expert consensus in the clinical sense.

    4. Adjudication method for the test set

    Not applicable.

    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 powered device.

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

    Not applicable. This is not an AI/ML powered device.

    7. The type of ground truth used

    The ground truth used for mechanical testing like burst load is typically derived from physical measurements and destructive testing of the devices themselves, adhering to established engineering standards for medical implants.

    8. The sample size for the training set

    Not applicable. This is a physical device, and "training set" is not relevant in this context.

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

    Not applicable.

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