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510(k) Data Aggregation

    K Number
    K980123
    Device Name
    CARTER-THOMASON NEEDLE-POINT SUTURE PASSER INSTRUMENT SET
    Manufacturer
    LOUISVILLE LABORATORIES, INC.
    Date Cleared
    1998-03-09

    (54 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 :

    CARTER-THOMASON NEEDLE-POINT SUTURE PASSER INSTRUMENT SET

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

    The Needle-Point Suture Passer is indicated to pass suture through soft tissues of the body during endoscopic/laparoscopic surgery.

    Device Description

    Needle-Point Suture Passer Instrument Set

    AI/ML Overview

    I am sorry, but the provided text does not contain the detailed information necessary to describe the acceptance criteria and the study that proves the device meets those criteria. The document is an FDA 510(k) clearance letter for a medical device (Carter-Thomason Needle-Point Suture Passer Instrument Set), confirming its substantial equivalence to a predicate device.

    While it mentions the device's intended use ("to pass suture through soft tissues of the body during endoscopic/laparoscopic surgery"), it does not include any specifics regarding:

    • Acceptance criteria: No performance metrics or thresholds are listed.
    • Device performance data: No study results, sensitivity, specificity, accuracy, or other performance indicators are provided.
    • Sample sizes: No information about test sets, training sets, or data provenance.
    • Ground truth establishment: No details on experts, adjudication methods, or the type of ground truth used.
    • Comparative effectiveness studies (MRMC) or standalone algorithm performance: These concepts are not applicable to the type of device described (a surgical instrument, not an AI/software device).

    The document is a regulatory approval, not a technical report detailing the device's validation study. Therefore, I cannot populate the requested table or answer the specific questions based on the given input.

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