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510(k) Data Aggregation

    K Number
    K043227
    Manufacturer
    Date Cleared
    2004-12-10

    (18 days)

    Product Code
    Regulation Number
    888.3030
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    PERIARTICULAR LOCKING PLATES, 2358 SERIES

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

    The Zimmer Periarticular Locking Plate System is indicated for temporary internal fixation and stabilization of osteotomies and fractures, including comminuted fractures, supracondylar fractures, intra-articular and extra-articular condylar fractures, fractures in osteopenic bone, nonunions, and malunions.

    Device Description

    The Zimmer Periarticular Locking Plate System is a plate and screw system intended for internal fracture fixation. The low-profile periarticular locking plate is anatomically contoured and has threaded holes which accept locking screws to create a stable, fixed angle construct.

    AI/ML Overview

    The information provided in the document focuses on regulatory clearance for a medical device (Zimmer Periarticular Locking Plate System) and does not describe acceptance criteria, a study proving the device meets those criteria, or details regarding AI/algorithm performance. The document explicitly states that "Clinical data and conclusions were not needed for this device."

    Therefore, I cannot extract the requested information as it is not present in the provided text.

    Here's why each point cannot be addressed:

    1. A table of acceptance criteria and the reported device performance: No acceptance criteria or specific performance metrics are mentioned in terms of a study outcome. The document only states that "The results of non-clinical (laboratory) performance testing demonstrate that the device is safe and effective." This is a general statement, not a detailed report of performance against specific criteria.
    2. Sample sized used for the test set and the data provenance: No test set is described. The document refers to "non-clinical (laboratory) performance testing" but provides no details on samples, sizes, or data provenance.
    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no ground truth establishment for a test set is described.
    4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable as no test set or expert adjudication is described.
    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 document is for a medical implant (bone plate system), not an AI diagnostic or assistance tool.
    6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a bone fixation plate, not an algorithm.
    7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable as no ground truth for diagnostic or interpretative purposes is mentioned. The "ground truth" for a bone plate would typically be its mechanical integrity or biological response, which is assessed via laboratory and clinical (if required) testing, not expert consensus on images.
    8. The sample size for the training set: Not applicable as this is not an AI/algorithm-based device.
    9. How the ground truth for the training set was established: Not applicable as this is not an AI/algorithm-based device.
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