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510(k) Data Aggregation

    K Number
    K121509
    Device Name
    TREASURE BIPOLAR HEAD, FEMORAL HEAD, TREASURE BIPOLAR HEAD, INSERT
    Manufacturer
    TGM MEDICAL, INC.
    Date Cleared
    2012-11-05

    (168 days)

    Product Code
    KWY
    Regulation Number
    888.3390
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K922560,K102399,K111472
    Why did this record match?
    Device Name :

    TREASURE BIPOLAR HEAD, FEMORAL HEAD, TREASURE BIPOLAR HEAD, INSERT

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

    The Treasure Bipolar Head is intended for use as follows:

    • A. Fractures of the proximal femur;
    • B. Nonunions of proximal femoral neck fractures;
    • C. Aseptic necrosis of the femoral head;
    • D. Osteo-rheumatoid and post-traumatic arthritis of the hip with minimal distortion of the acetabulum;
    • E. Salvage of failed total hip arthroplasty.
      The Treasure Bipolar Head is intended for cementless use. The Treasure Bipolar Head is intended for use with the Helicon Hip System.
    Device Description

    The TGM Medical, Inc. Treasure Bipolar Head consists of a bipolar femoral head component, locking ring, and a bipolar insert component. The Treasure Bipolar Head is available either fully preassembled, or with the bipolar femoral head and locking ring preassembled and the insert separate. The bipolar femoral head component is manufactured from cobalt chrome alloy (CoCrMo, ASTM F75, ASTM F799, or ASTM F1537). The bipolar head has a highly polished spherical outer surface with a cylindrical bored internal diameter which accepts the polyethylene bipolar insert. The bipolar insert component and locking ring are manufactured from ultra-high molecular weight polyethylene (UHMWPE, ASTM F648). The bipolar insert and locking ring are designed for use with the appropriate size bipolar head component.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for the "Treasure Bipolar Head." This is a medical device submission, and the focus of such submissions is typically demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study with specific acceptance criteria in the way a clinical trial might.

    Based on the provided text, here is the information regarding acceptance criteria and the "study" (which in this context is the substantial equivalence claim):

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

    Acceptance CriteriaReported Device Performance
    Substantial Equivalence to Predicate Device: The Treasure Bipolar Head must be substantially equivalent in materials, design, packaging, sterilization, and indications for use to legally marketed predicate devices.The components of the new device (CoCr bipolar head, UHMWPE locking ring, and insert) employ identical materials, design features, packaging, and sterilization to the respective COI components (K922560, K102399, K111472) and have similar indications.
    No New Performance Data Required: No new non-clinical or clinical performance data should be required to demonstrate substantial equivalence, implying that the device performs equivalently to the predicate(s)."No new performance data was required for the Treasure Bipolar head."

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

    The document explicitly states, "No new performance data was required for the Treasure Bipolar head." Therefore, there was no "test set" in the sense of a new study involving human subjects or laboratory testing specifically for this 510(k) application. The substantial equivalence claim relies on the existing clearances and data for the predicate devices.

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

    Not applicable. No new test set requiring expert ground truth establishment was conducted for this 510(k) submission. The ground truth for the safety and effectiveness of the predicate devices would have been established during their original clearance processes.

    4. Adjudication method for the test set

    Not applicable. No new test set requiring adjudication was conducted for this 510(k) submission.

    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 device is a hip prosthesis, 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 hip prosthesis, not an algorithm.

    7. The type of ground truth used

    The "ground truth" for the substantial equivalence claim is the pre-existing FDA clearance of the predicate devices (Consensus Bipolar System K922560, Consensus TaperSet Hip System K102399, and Helicon Hip System K111472), implying that these devices were deemed safe and effective based on their original data and regulatory review. The current submission's argument is that the Treasure Bipolar Head is sufficiently similar to these predicate devices not to raise new questions of safety or effectiveness.

    8. The sample size for the training set

    Not applicable. There was no "training set" in the context of this 510(k) submission, as no new performance data or clinical study was conducted.

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

    Not applicable, as no training set was used.

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