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510(k) Data Aggregation

    K Number
    K190543
    Device Name
    Cannulated Hemi Implant
    Manufacturer
    Vilex in Tennessee, Inc.
    Date Cleared
    2019-05-31

    (88 days)

    Product Code
    KWD
    Regulation Number
    888.3730
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K023684,K070052,K102401,K152454,K031859,K132496
    Why did this record match?
    Device Name :

    Cannulated Hemi Implant

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

    The Vilex CHI (cannulated hemi implant), a hemi-arthroplasty implant for the metatarsophalangeal (MTP) joint, is indicated for use in the treatment of patients with degenerative and post-traumatic arthritis in the MTP joint in the presence of good bone stock and integrity of the phalangeal base, along with the following clinical conditions: Hallux Limitus, Hallux Valgus, Hallux Rigidus, and an unstable or painful MTP joint. The Vilex cannulated metallic hemi implant is intended to be used with bone cement. The Vilex cannulated metallic hemi implant is intended for single-use only.

    Device Description

    The Vilex CHI System includes one-piece cannulated hemi-arthroplasty implants intended to resurface the metatarsal-phalangeal joint. The CHI system includes an MPJ Base and MPJ Head. These are available in standard and lesser options. These components are used for hemi arthroplasty and are not used together to create a total joint.

    AI/ML Overview

    It appears you've provided a 510(k) Premarket Notification document for a medical device: the Vilex Cannulated Hemi Implant (CHI).

    However, this document describes a joint implant, not an AI/software-as-a-medical-device (SaMD) or diagnostic imaging device. The acceptance criteria and supporting studies described in this document relate to the mechanical performance and biocompatibility of a physical implant, not the performance of an algorithm or the accuracy of a diagnostic reading.

    Therefore, the requested information about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI-driven diagnostic or image analysis device (e.g., sample size, expert ground truth, MRMC studies, standalone performance) is not present in this document.

    The performance data section (VII. Performance Data) for this implant focuses on:

    • Engineering analyses: Bending Stress, Shear Stress, Geometric Analysis, Surface Area Analysis. These are tests to ensure the physical implant is strong enough and fits correctly.

    It does not contain information relevant to AI/diagnostic device evaluation, such as:

    • A table of acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, AUC).
    • Sample sizes for a test set of diagnostic images.
    • Data provenance for diagnostic images.
    • Number of experts for ground truth of diagnostic images or their qualifications.
    • Adjudication methods for diagnostic ground truth.
    • MRMC studies to show human reader improvement with AI.
    • Standalone performance of an algorithm.
    • Type of ground truth (e.g., pathology, outcomes data) for diagnostic purposes.
    • Training set sample size for an AI model.
    • How ground truth for a training set was established for an AI model.

    In summary, this document is about a physical orthopedic implant, not an AI or diagnostic software. Therefore, it does not contain the information you are requesting about AI device evaluation methods.

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