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510(k) Data Aggregation

    K Number
    K140431
    Device Name
    PEDILOC FRAGMENT SYSTEM
    Manufacturer
    ORTHOPEDIATRICS, CORP.
    Date Cleared
    2014-07-29

    (159 days)

    Product Code
    HRS,HTN,HWC,KTT
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K111086,K083286,K082949,K000684
    Why did this record match?
    Device Name :

    PEDILOC FRAGMENT SYSTEM

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

    OrthoPediatrics' PediLoc Fragment System is intended to provide temporary internal fixation and stabilization of long bones, short (small) bones, pelvis, and scapula. This includes fractures, osteotomies, mal-unions, and non-unions in all pediatric subgroups (except neonates), and small stature adults.

    Device Description

    The OrthoPediatrics' PediLoc Fragment System combines implants and instruments in one convenient and comprehensive system. This System provides immediate stability and temporary fixation of bones during the healing process with conventional plating technology and fixation techniques.

    AI/ML Overview

    This document describes the acceptance criteria and the study conducted for the OrthoPediatrics' PediLoc Fragment System, as presented in the provided 510(k) summary.

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategorySpecific CriteriaReported Device PerformanceStudy Type
    Technological CharacteristicsFundamental scientific principles, intended use, material, general design, and sizes are the same as or similar to predicate devices.The device's fundamental scientific principles, intended use, material, and general design, and sizes are reported to be the same as, or similar to, the predicate devices.Comparison with Predicate Devices
    Mechanical PerformancePerforms as well as or better than predicate devices.Performed as well as or better than the predicate devices.Nonclinical (Bench) Testing
    Static TestingMeets established static performance standards.Demonstrated satisfactory performance as per ASTM Standards.Nonclinical (Bench) Testing
    Dynamic TestingMeets established dynamic performance standards.Demonstrated satisfactory performance as per ASTM Standards.Nonclinical (Bench) Testing
    FEA AnalysisResults are comparable or superior to predicate devices.FEA analysis along with comparisons demonstrated satisfactory performance.Nonclinical (FEA Analysis)
    Dimensional ComparisonDimensions are comparable and supported by engineering rational.Dimensional comparison review and analysis with engineering rational provided supportive data.Nonclinical (Dimensional Review)

    2. Sample Size Used for the Test Set and Data Provenance

    The provided 510(k) summary does not mention a "test set" in the context of clinical data or human subject studies. The nonclinical testing performed involved mechanical laboratory (bench) testing, FEA analysis, and dimensional comparisons. Therefore, there is no information about a sample size for a test set or data provenance in terms of country of origin or retrospective/prospective nature for human data.

    3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

    There is no mention of experts or a ground truth establishment process for a human-related test set. The study detailed is entirely nonclinical (bench testing and analysis).

    4. Adjudication Method for the Test Set

    Not applicable, as there was no test set involving human data or expert review.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

    No, an MRMC comparative effectiveness study was not done. The study presented is nonclinical and focuses on the physical and mechanical properties of the device compared to predicate devices.

    6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

    Not applicable. This device is a physical medical implant (fragment system), not a software algorithm or AI-driven system. Therefore, the concept of "standalone performance" in the context of algorithms does not apply.

    7. The Type of Ground Truth Used

    For the nonclinical studies, the "ground truth" was established based on:

    • ASTM Standards: Recognized industry standards for mechanical testing of medical devices.
    • Predicate Device Performance: The established performance characteristics of legally marketed predicate devices.
    • Engineering Rational: Principles of engineering analysis and design for comparison of dimensions and performance.

    8. The Sample Size for the Training Set

    Not applicable. The device is not an AI/ML algorithm or system that requires a "training set" of data.

    9. How the Ground Truth for the Training Set Was Established

    Not applicable, as there was no training set for an algorithm.

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