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510(k) Data Aggregation

    K Number
    K182955
    Device Name
    EZStart Interference Screw
    Manufacturer
    ConMed Corporation
    Date Cleared
    2019-01-22

    (90 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K960962,K933352
    Predicate For
    K193491,K202569,K230595
    Why did this record match?
    Reference Devices :

    K960962

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

    EZ Start™ Interference Screws are intended for use in bone - tendon - bone graft fixation in anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL) reconstruction of the knee.

    EZ Start™ Interference Screws are used to provide bone fixation in orthopedic procedures, including bone-tendon-bone graft fixation in anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL) reconstruction of the knee.

    Device Description

    The EZStart™ Interference Screw is a dual threaded titanium interference screw with a tapered tip for easy insertion into bone. The screw is cannulated to allow a guidewire through to assist with placement of the screw into the bone tunnel. The screw is used to maintain the fixation of bone - tendon - bone grafts in orthopedic procedures. The device is Gamma Sterilized.

    AI/ML Overview

    This document does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and a study proving device performance as it relates to AI/ML devices. The provided text is a 510(k) summary for a medical device called the "EZStart™ Interference Screw," which is a physical implant for orthopedic procedures, not an AI/ML diagnostic or therapeutic device.

    Therefore, the following information cannot be extracted from the provided text:

    • A table of acceptance criteria and reported device performance in the context of AI/ML.
    • Sample size used for the test set and data provenance for an AI/ML study.
    • Number of experts used to establish ground truth and their qualifications for an AI/ML test set.
    • Adjudication method for an AI/ML test set.
    • Information on a multi-reader multi-case (MRMC) comparative effectiveness study with AI assistance.
    • Information on a standalone (algorithm only) performance study.
    • Type of ground truth used for an AI/ML study.
    • Sample size for the training set for an AI/ML model.
    • How the ground truth for the training set was established for an AI/ML model.

    However, I can provide the acceptance criteria and performance data for the physical device, the EZStart™ Interference Screw, as described in the document:

    The EZStart™ Interference Screw underwent various verification and validation tests to demonstrate its performance and substantial equivalence to a predicate device.

    1. Table of Acceptance Criteria and Reported Device Performance (as described for this physical device):

    The document lists the types of tests performed but generally states that "results met the current FDA and USP requirements" or confirmed "substantial equivalence" rather than providing specific numerical acceptance criteria or performance values for many tests. One specific quantitative criterion is mentioned for pyrogenicity.

    Test TypeAcceptance Criteria (where specified)Reported Device Performance
    Insertion TorqueImplied to meet established performance standards for the device type.Performed as intended, contributing to substantial equivalence.
    Fixation StrengthImplied to meet established performance standards for the device type.Performed as intended, contributing to substantial equivalence.
    SterilizationImplied to meet sterility assurance level (SAL) requirements.Performed as intended, contributing to substantial equivalence.
    BiocompatibilityImplied to meet ISO 10993 series standards.Performed as intended, contributing to substantial equivalence.
    Pyrogenicity< 0.5 EU/mL (FDA) and < 20 EU/device (USP)Met the current FDA and USP requirements.
    Shelf-lifeImplied to maintain intended performance and safety over the claimed shelf-life.Performed as intended, contributing to substantial equivalence.
    Post Aging FunctionalImplied to maintain functional integrity after aging.Performed as intended, contributing to substantial equivalence.
    TransportationImplied to withstand typical transport conditions without compromise.Performed as intended, contributing to substantial equivalence.
    MR SafetyImplied to meet established safety standards for MRI environments.Performed as intended, contributing to substantial equivalence.
    Device User ValidationImplied to confirm the device can be used safely and effectively by intended users.Performed as intended, contributing to substantial equivalence.
    Packaging/Labeling User ValidationImplied to confirm the packaging and labeling are clear and effective.Performed as intended, contributing to substantial equivalence.

    Summary and Conclusion: The "EZStart™ Interference Screw is either substantially equivalent or identical in design, materials, intended use, principles of operation, and technical characteristics to the predicate Concept Cannulated Interference Screw." The performance testing findings indicate that "the differences present no new issues of safety and efficacy, and the EZStart™ Interference Screw is substantially equivalent to the Concept Cannulated Interference Screw (K933352)."

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