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510(k) Data Aggregation

    K Number
    K151456
    Device Name
    Small Bone Nail Implant
    Manufacturer
    VILEX IN TENNESSEE, INC
    Date Cleared
    2015-10-29

    (150 days)

    Product Code
    HSB
    Regulation Number
    888.3020
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K031438,K071944,K982953,K854338,K973812,K052614
    Why did this record match?
    Device Name :

    Small Bone Nail Implant

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

    The Tapered Small Bone Nail Implant (SBNI) is indicated for use in fractures and osteotomies of the fibula, radius, and ulna.

    Device Description

    The Vilex Small Bone Nail Implant System includes Tapered Nails (straight or bowed) and Locking Screws.

    AI/ML Overview

    This document is a 510(k) premarket notification for a medical device called the "Small Bone Nail Implant System." It is a regulatory submission to the FDA, not a study report. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria and device performance from a clinical study.

    Specifically, the document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing acceptance criteria and proving performance through a new clinical or standalone study.

    Here's why the requested information cannot be extracted from this document:

    1. Acceptance Criteria and Reported Device Performance: This document does not present acceptance criteria for a study or report specific performance metrics of the new device. Instead, it states that the device's "technological characteristics are similar to the characteristics of the predicate devices" and that "comparisons confirmed that the Small Bone Nail Implant is as safe, as effective and should perform as well as or better than the predicate devices." This is a qualitative statement of equivalence, not a quantitative measure against pre-defined acceptance criteria.

    2. Sample Size for Test Set and Data Provenance: No test set or associated data provenance is mentioned. The submission relies on comparison to predicate devices.

    3. Number of Experts for Ground Truth and Qualifications: Not applicable, as there's no diagnostic performance study involving expert ground truth.

    4. Adjudication Method: Not applicable.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No MRMC study is described. The comparison is against predicate devices in terms of design and intended use, not a human reader performance study.

    6. Standalone Performance: No standalone performance study (algorithm only) is described, as this is a physical medical implant, not an AI/software device.

    7. Type of Ground Truth Used: Not applicable, as there's no diagnostic performance study requiring ground truth.

    8. Sample Size for Training Set: Not applicable, as this is not a machine learning device.

    9. How Ground Truth for Training Set was Established: Not applicable.

    In summary, this document is a regulatory filing asserting substantial equivalence of a physical medical implant (Small Bone Nail Implant System) to existing products. It does not describe a study involving acceptance criteria, test sets, expert ground truth, or performance metrics in the way your prompt anticipates for a diagnostic or AI-driven device.

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