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510(k) Data Aggregation

    K Number
    K980599
    Device Name
    NTECH ARTHROSCOPE
    Manufacturer
    N-TECH ENDOSCOPY, INC.
    Date Cleared
    1998-04-15

    (57 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    NTECH ARTHROSCOPE

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

    Operative and Diagnostic Arthroscopy for visual imiging and light transmission to the operative area.

    The Arthroscopes are limited in their use to: Wrist, Knee, Shoulder and Ankle Surgery.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for "N" Tech Arthroscopes. This document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any details related to an AI/ML-based device. It primarily confirms the substantial equivalence of the arthroscopes to a legally marketed predicate device.

    Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving device performance based on the input provided.

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