LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K151998
    Device Name
    TraceIT Tissue Marker - 3mL
    Manufacturer
    AUGMENIX, INC.
    Date Cleared
    2015-08-19

    (30 days)

    Product Code
    NEU
    Regulation Number
    878.4300
    Type
    Special
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    TraceIT Tissue Marker - 3mL

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

    Not Found

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a device called "TraceIT Tissue Marker." This document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies. It is a regulatory approval letter based on substantial equivalence to predicate devices, not a detailed study report.

    Therefore, I cannot extract the requested information from the provided text. The sections of the prompt asking for specifics about acceptance criteria, study details, sample sizes, expert qualifications, and ground truth are not addressed in this type of FDA letter.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1