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510(k) Data Aggregation

    K Number
    K133354
    Device Name
    PERI-PROSTHETIC CABLE SYSTEM
    Manufacturer
    BIOMET, INC.
    Date Cleared
    2014-01-27

    (88 days)

    Product Code
    JDQ
    Regulation Number
    888.3010
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K982545
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Intended for use in femur and tibia fractures, prophylactic banding, trochanteric reattachment, olecranon fractures, patella fractures, ankle fractures, fixation of spiral fractures in conjunction with intramedullary nailing and screwing techniques, sternum fixation after open chest surgery and stabilization of cortical onlay strut grafts.

    Device Description

    The new Peri-Prosthetic Cabling system consists of cables, crimp lugs (cable sleeves) and associated instrumentation. The cables and crimp lugs are made of cobalt chromium alloy. All cables have a 7x7 strand construction, with the overall cable having a 1.8mm diameter.

    AI/ML Overview

    The provided text describes a medical device called the "Peri-Prosthetic Cabling System" (K133354) and its substantial equivalence to a predicate device. It details the device's technical characteristics, indications for use, and a summary of the pre-clinical data used to establish equivalence.

    Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

    Acceptance Criteria and Device Performance

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Set by Standard)Reported Device Performance (Peri-Prosthetic Cabling System)
    Tensile Strength: Requirements of ASTM F2180 (Specific values not detailed in the text, but implies a minimum threshold for cable and crimp tensile properties)."Tensile testing demonstrates that the Peri-Prosthetic Cabling System meets or exceeds the requirements of ASTM F2180." (This indicates successful compliance with the standard for tensile properties, which typically includes ultimate tensile strength, yield strength, and elongation at break).
    Crimp Pull-Out Strength: Minimum requirements for pull-out strength (Specific values not detailed, but implies a minimum force required to separate the cable from the crimp)."The crimp pull-out testing demonstrates that both the Peri-Prosthetic Cabling System and the predicate device meet the minimum requirements for pull out strength." (This shows the new device performs at least as well as the predicate and meets established safety/efficacy thresholds for crimp integrity).

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

    • Sample Size: The document does not specify the exact sample size used for the tensile and crimp pull-out testing. It only states "pre-clinical data including tensile and crimp pull-out testing."
    • Data Provenance: The data is described as "pre-clinical data." This typically implies laboratory testing conducted under controlled conditions. The country of origin of the data is not explicitly mentioned, but the submitting company is Biomet Trauma, located in Warsaw, IN, USA, so it's likely the testing was conducted in the USA or by a US-affiliated entity. The data is prospective in the sense that it was generated specifically for this submission to demonstrate substantial equivalence.

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

    This information is not applicable to this submission. The "Peri-Prosthetic Cabling System" is a mechanical medical device, not a diagnostic or AI-driven device that requires expert review for ground truth establishment. The performance is assessed through objective, quantifiable physical tests (tensile and pull-out strength) against established ASTM standards and internal minimum requirements.

    4. Adjudication method for the test set

    This information is not applicable. As discussed above, the performance is determined by objective physical measurements, not by human interpretation or adjudication.

    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

    This information is not applicable. This is a submission for a mechanical medical device, not an AI-driven diagnostic tool. Therefore, MRMC studies are not relevant.

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

    This information is not applicable. This submission is for a mechanical medical device, not an algorithm or software device.

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

    The "ground truth" for this device's performance is established by objective physical measurements (tensile forces, pull-out forces) compared against published industry standards (ASTM F2180) and internal minimum requirements. There is no "expert consensus," "pathology," or "outcomes data" in the typical sense for establishing performance of this type of device. The ground truth is the scientific and engineering validation of its material properties and mechanical integrity.

    8. The sample size for the training set

    This information is not applicable. This is a mechanical device, not a machine learning model. Therefore, there is no "training set."

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

    This information is not applicable. As there is no training set, there is no ground truth to be established for it.

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