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510(k) Data Aggregation

    K Number
    K111212
    Device Name
    SMR SHOULDER SYSTEM- REVISION STEMS
    Manufacturer
    LIMACORPORATE S.P.A.
    Date Cleared
    2011-07-28

    (90 days)

    Product Code
    KWS,HSD
    Regulation Number
    888.3660
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K100858,K101263,K984541,K030941
    Predicate For
    K113254,K130642,K153722,K183042
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The SMR Revision Stems are indicated for the treatment of fractures or revision of a failed primary component in total or hemi-shoulder replacement.

    The components are intended for use in cemented applications according to their labeled indication.

    Total or hemi-shoulder replacement is indicated for patients suffering from disability due to:

    • Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis:
    • Inflammatory degenerative joint disease such as rheumatoid arthritis; .
    • Treatment of acute fractures of the humeral head that cannot be treated with other fracture . fixation methods
    • Cuff tear arthropathy; .
    • Revision of a failed primary component. .
    Device Description

    The SMR Revision Stems are made from Ti6Al4V (ISO 5832-3 / ASTM F1472). They are available in two versions: cemented and uncemented.

    SMR Revision cemented stems are characterized by a cylindrical shape in the distal region while the proximal part is tapered and fluted. The whole surface of the stem is polished.

    SMR Revision uncemented stems are characterized by a cylindrical shape in the distal region while the proximal part is tapered and finned. The whole surface of the stem is sand-blasted.

    Both the stems are provided with a male taper for the coupling with the humeral bodies and a safety screw is used to help initially seat the body on the stem taper. SMR Revision Stems can be used for anatomical (when coupled with trauma and election humeral bodies, cleared via K100858 and K101263) shoulder replacements.

    SMR Revision cemented stems are intended to be used with bone cement: SMR Revision uncemented stems are intended for press-fit applications.

    AI/ML Overview

    This document describes a medical device, the SMR Revision Stems, and its substantial equivalence to predicate devices, focusing on non-clinical testing. It explicitly states that clinical testing was not necessary. Therefore, many of the requested elements pertaining to acceptance criteria and clinical study performance (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are not applicable or cannot be extracted from the provided text.

    Here is the information that can be extracted:

    1. A table of acceptance criteria and the reported device performance

    Acceptance CriteriaReported Device Performance
    Mechanical Strength of Humeral StemDemonstrated ability to perform under expected clinical conditions
    Post-Fatigue Strength of Modular ConnectionsDemonstrated ability to perform under expected clinical conditions

    2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

    • Sample Size for Test Set: Not applicable. No clinical test set.
    • Data Provenance: Not applicable. Non-clinical testing was conducted, but details on data provenance (e.g., country of origin, retrospective/prospective) for this type of testing are not typically included in these summaries, nor are they provided here.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

    Not applicable. No clinical test set.

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

    Not applicable. No clinical test set.

    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. No clinical testing, and this device is a physical implant, not an AI-assisted diagnostic tool.

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

    Not applicable. This device is a physical implant, not an algorithm.

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

    For non-clinical testing, the "ground truth" would be established by engineering standards and validated testing protocols. The text states: "Where possible, standard test methods were used to allow comparison to testing of the predicate devices."

    8. The sample size for the training set

    Not applicable. No training set for an AI/algorithm is mentioned. For the non-clinical mechanical testing, "worst case components or constructs" were used, but a specific "sample size" in terms of number of units tested is not provided.

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

    Not applicable. No training set for an AI/algorithm. For non-clinical testing, the "ground truth" would be the expected performance based on relevant engineering standards and predicate device performance.

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