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510(k) Data Aggregation

    K Number
    K250127
    Device Name
    TSK Syringe
    Manufacturer
    TSK Laboratory, Japan
    Date Cleared
    2025-07-30

    (194 days)

    Product Code
    QNQ
    Regulation Number
    880.5860
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K210443
    Why did this record match?
    Device Name :

    TSK Syringe

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

    The TSK Syringe is a low dead volume syringe intended for use in patients that need injection and withdrawal of substances for examination, treatment, diagnosis or prevention.

    Device Description

    The TSK Syringe is a syringe intended for use with a needle to inject or withdraw substances, for general use. The TSK Syringe leaves a low volume of fluid when the plunger is fully depressed.

    There are two model numbers for the TSK Syringe. The technological differences are as follows:

    NumberSyringe Nominal Capacity (mL)
    TSY-0071P0.7
    TSY-0101Y1.0
    AI/ML Overview

    The provided text is a 510(k) Clearance Letter and 510(k) Summary for the TSK Syringe. It details the device's characteristics, indications for use, and a comparison to a predicate device. However, it does not contain the specific information required to answer your request about acceptance criteria and a study proving device performance in the context of an AI/human reader study.

    This document describes a physical medical device (syringe), not a software or AI-powered medical device that would involve AI performance metrics, human reader studies, ground truth establishment, or training/test set sample sizes in the way you've outlined.

    Therefore, I cannot provide the requested information from this document. The details about acceptance criteria and study design for AI-based performance evaluation are not present.

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