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510(k) Data Aggregation

    K Number
    K203228
    Device Name
    DART-FIRE EDGE Cannulated Screw System
    Manufacturer
    Wright Medical
    Date Cleared
    2021-05-11

    (190 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K080850,K183696,K082320
    Why did this record match?
    Device Name :

    DART-FIRE EDGE Cannulated Screw System

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

    The DART-FIRE EDGE Cannulated Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of foot and ankle bones appropriate for the device. Screws gre intended for single use only.

    Device Description

    The DART-FIRE EDGE Cannulated Screw System contains partially and fully threaded, cannulated screws offered in a variety of diameters and lengths. The screws are manufactured from titanium alloy (ASTM F136).

    AI/ML Overview

    Here's a summary of the acceptance criteria and study information based on the provided document:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criterion (Type of Test)Reported Device Performance
    Insertion TorqueDemonstrated substantial equivalence to predicate device
    Removal TorqueDemonstrated substantial equivalence to predicate device
    Pull Out StrengthDemonstrated substantial equivalence to predicate device
    Ultimate TorqueDemonstrated substantial equivalence to predicate device
    Yield Torque Strength (per ASTM F543)Demonstrated substantial equivalence to predicate device
    RF Heating (per ASTM F2182 for MR Safety)Demonstrated substantial equivalence to predicate device
    Image Artifact (per ASTM F2182 for MR Safety)Demonstrated substantial equivalence to predicate device
    Induced Force (per ASTM F2052 for MR Safety)Demonstrated substantial equivalence to predicate device
    Induced Torques (per ASTM F2052 for MR Safety)Demonstrated substantial equivalence to predicate device

    2. Sample Size for Test Set and Data Provenance

    Not applicable. The study was non-clinical and involved performance testing of the device itself rather than a test set of data.

    3. Number of Experts Used to Establish Ground Truth and Qualifications

    Not applicable. This was a non-clinical study based on engineering performance tests.

    4. Adjudication Method for Test Set

    Not applicable. There was no test set requiring expert adjudication.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

    Not applicable. This was a non-clinical study for a bone fixation device, not an AI-assisted diagnostic tool.

    6. Standalone (Algorithm Only) Performance

    Not applicable. This device is a physical medical implant, not an algorithm. The performance described is for the device's physical properties.

    7. Type of Ground Truth Used

    The ground truth or benchmark for performance was the performance of the legally marketed predicate device (K082320: Wright Compression Screws, K080850: DARCO Headless Compression Screw, K183696: PERFORM Reverse). The study aimed to demonstrate "substantial equivalence" to these devices through various mechanical and MR Safety tests.

    8. Sample Size for Training Set

    Not applicable. This was a non-clinical study for a physical device, not an AI model.

    9. How Ground Truth for Training Set Was Established

    Not applicable. There was no training set in the context of this device.

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