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510(k) Data Aggregation

    K Number
    K992324
    Device Name
    FUNNEL TROCAR
    Manufacturer
    PATTON MEDICAL CORP.
    Date Cleared
    1999-08-19

    (38 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K943976,K901407,K911813,K950457,K953409,K953903
    Predicate For
    K080161
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Funnel Trocar™ is an access device for laparoscopic procedures. The new instrument creates and maintains a passageway for laparoscopic instruments during a variety of general, gynecologic, thoracic, and urological procedures.

    Device Description

    The Funnel Trocar™ is a disposable single patient use device fabricated from surgical grade stainless steel, and biocompatible medical grade polymers. The device is available in a variety of diameters (5mm. 7/8mm. 12mm) and lengths (55mm. 70mm, and 100mm). The Funnel Trocar™ is supplied with either a shielded cutting obturator (trocar). The cannula is equipped with a luer fitting to provide access for insufflation of the operative area. The cannula is available with or without stability threads.

    AI/ML Overview

    The provided text is a 510(k) summary for the Funnel Trocar™ and the FDA's clearance letter. This type of document focuses on establishing substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a study with the elements you've requested for AI/software devices.

    Therefore, most of the information regarding detailed study design, sample sizes, ground truth establishment, expert qualifications, and MRMC studies will not be present in this document. The Funnel Trocar™ is a physical surgical device, not an AI or software-based medical device.

    Here's a breakdown based on the information available and the nature of the device:

    1. A table of acceptance criteria and the reported device performance

    Acceptance CriteriaReported Device Performance
    Not explicit in this document. The primary "acceptance criterion" for 510(k) clearance is demonstrating substantial equivalence to a legally marketed predicate device. This is typically achieved by comparing design, materials, intended use, and performance characteristics (e.g., mechanical strength, sterility, biocompatibility if applicable) to the predicate.The FDA determined the Funnel Trocar™ is substantially equivalent to the predicate devices listed (Sabre Ultimate Shielded Trocar System K943976 and various Core Dynamics, Inc. Laparoscopic Trocars K901407, K911813, K950457, K953409, K953903).

    2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

    This information is not provided in the 510(k) summary. For physical devices, testing typically involves mechanical, material, and biocompatibility tests rather than clinical studies with "test sets" in the context of AI/software. If such tests were performed, the details would be in supporting documentation not included in this summary.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

    This is not applicable and not provided. This concept relates to ground truth establishment for analytical or diagnostic software, which is not relevant to a physical surgical trocar.

    4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

    This is not applicable and not provided. Similarly, this is a concept used for human review in studies, especially for diagnostic accuracy, and is not relevant to the clearance of a physical surgical instrument like a trocar.

    5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

    This is not applicable for this device. An MRMC study is designed for evaluating diagnostic algorithms, typically AI or software, and is not relevant to a physical surgical trocar.

    6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

    This is not applicable for this device. This refers to the performance of an AI algorithm independently, which is not what the Funnel Trocar™ is.

    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

    This is not applicable and not provided. For physical devices, "ground truth" would relate to engineering specifications, material properties, and functionality testing, not a diagnostic outcome. The "truth" for substantial equivalence is met by demonstrating the device performs as intended and is as safe and effective as its predicates.

    8. The sample size for the training set

    This is not applicable and not provided. "Training set" refers to data used to train AI/machine learning models, which is not involved in the development or clearance of this physical medical device.

    9. How the ground truth for the training set was established

    This is not applicable and not provided for the same reasons as point 8.

    In summary: The provided document is a 510(k) premarket notification for a physical medical device. The focus is on demonstrating substantial equivalence to already legally marketed devices, not on proving performance through clinical studies with the highly specific criteria you've outlined for AI/software devices. Therefore, most of your requested information is not relevant or present in this context.

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