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510(k) Data Aggregation

    K Number
    K992250
    Device Name
    CORE AUDIBLE TROCAR II
    Manufacturer
    CORE DYNAMICS, INC.
    Date Cleared
    1999-09-24

    (80 days)

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

    CORE DYNAMICS, INC.

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

    The CORE Audible Trocar II has applications in gynecological laparoscopy, laparoscopic cholecystectomy and thoracic procedures.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a device called "Core Audible Trocar II". This document confirms that the device is substantially equivalent to a legally marketed predicate device and can be marketed.

    However, this letter does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any details typically found in a clinical study report or performance evaluation.

    Therefore, I cannot fulfill your request for:

    1. A table of acceptance criteria and reported device performance.
    2. Sample size used for the test set and data provenance.
    3. Number of experts and their qualifications.
    4. Adjudication method.
    5. MRMC comparative effectiveness study details.
    6. Standalone performance study details.
    7. Type of ground truth used.
    8. Sample size for the training set.
    9. How ground truth for the training set was established.

    This document is purely a regulatory clearance notice, not a scientific study report.

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    K Number
    K992190
    Device Name
    CORE POUCH
    Manufacturer
    CORE DYNAMICS, INC.
    Date Cleared
    1999-09-01

    (64 days)

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

    CORE DYNAMICS, INC.

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

    The CORE Pouch is used when the surgeon desires to collect and remove tissue during laparoscopic procedures.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA regarding a medical device called "Core Pouch" and a research proposal on computer vision, neither of which contains information about acceptance criteria or a study proving device performance as requested. The document does not describe any specific performance characteristics, clinical studies, or acceptance criteria for the "Core Pouch" device. It primarily states that the device is substantially equivalent to legally marketed predicate devices.

    Therefore, I cannot provide the requested table or detailed study information based on the input given.

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    K Number
    K955490
    Device Name
    LAPAROSCOPIC KNITTER
    Manufacturer
    CORE DYNAMICS, INC.
    Date Cleared
    1996-01-22

    (80 days)

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

    CORE DYNAMICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

    Ask a specific question about this device

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