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510(k) Data Aggregation

    K Number
    K011754
    Device Name
    EXEL SECURETOUCH PTP SYRINGE
    Manufacturer
    EXELINT INTL. CO.
    Date Cleared
    2003-01-22

    (595 days)

    Product Code
    MEG,FMF,FMI
    Regulation Number
    880.5860
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    EXEL SECURETOUCH PTP SYRINGE

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

    THIS DEVICE IS A SAFETY HYPODERMIC SYRINGE FOR INJECTION OF MEDICATION TO PATIENTS. =THIS DEVICE AIDS IN PREVENTION OF NEEDLE STICK INJURIES=

    Device Description

    EXEL SECURE TOUCH SAFETY SYRINGE

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called the "EXEL Secure Touch Safety Syringe." It does not contain information on acceptance criteria, a study proving the device meets acceptance criteria, or any of the other specific details requested in your prompt regarding artificial intelligence (AI) and its performance.

    The letter explicitly states that the device is "substantially equivalent" to legally marketed predicate devices, meaning it doesn't require a new premarket approval application (PMA). This implies that its safety and effectiveness are established through its similarity to existing, approved devices, rather than through a standalone study with performance metrics in the way your prompt describes for an AI-powered device.

    Therefore, I cannot provide the requested information from this document. The information you are looking for (acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) is typically found in a detailed clinical study report or a 510(k) summary, which is not provided in this regulatory letter.

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