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    K Number
    K242814
    Device Name
    Tandry Q-Locking Plate System
    Manufacturer
    Microware Precision Co., Ltd.
    Date Cleared
    2024-11-14

    (57 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K230690,K171904,K141527
    Why did this record match?
    Device Name :

    Tandry Q-Locking Plate System

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

    The Tandry Q-Locking Plate System is intended to provide fixation during fractures, fusions, and osteotomies. The Tandry Q-Locking Plate System is indicated for the clavicle, pelvis, scapula and calcaneus, small bones including the metacarpals, wrist, metatarsals, tarsals and phalanges, and long bones including the radius, ulna, humerus, olecranon, fibula, femur, and tibia.

    Each plate is indicated for the following anatomic regions:

    • 1.5mm and 2.0mm Q-locking plates: Metacarpals, metatarsals, tarsals, and phalanges
    • 2.4mm Q-locking plates: Radius, wrist, and ulna
    • 3.5 mm Q-locking plates: Clavicle, scapula, humerus, olecranon, pelvis, fibula, calcaneus, and tibia
    • 5.0 mm Q-locking plates: Femur and tibia
    Device Description

    The Tandry Q-Locking Plate System consists of various sized plates, screws and instruments. The plates are designed to distribute for local anatomies and can accept, cortex, shaft and cancellous, locking (variable angle) screws. The screws are designed with self-tapping to promote the operation efficiency to insert the bones. Both plate and screw feature variable angle locking design.

    AI/ML Overview

    The provided document is a 510(k) premarket notification for the Tandry Q-Locking Plate System, a medical device used for bone fixation. It does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML (Artificial Intelligence/Machine Learning) device.

    The document discusses the device's indications for use, technological comparison to predicate devices, and non-clinical/clinical tests performed (biomechanical tests according to ASTM F543-17) to demonstrate substantial equivalence. These tests focus on mechanical performance, not on AI/ML performance metrics such as sensitivity, specificity, or reader improvement.

    Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI/ML device from the given text. The text does not describe an AI/ML device or its associated performance studies.

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