LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K082619
    Device Name
    SILS PORT, MODELS SILSPT5, SILSPT12
    Manufacturer
    COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES
    Date Cleared
    2008-11-07

    (59 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K981941,K012539,K954108,K072814,K945457,K073170
    Why did this record match?
    Reference Devices :

    K981941, K012539, K954108, K072814, K945457, K073170

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

    For multiple instrument or camera access to the abdominal cavity through a single incision for performing minimally invasive laparoscopic procedures

    Device Description

    Three laparoscopic trocars and an insufflation tube bound by a flexible port.

    AI/ML Overview

    The provided text is a 510(k) summary for the SILS™ Port, a surgical trocar. It includes information about the device's intended use and performance data, but it does not contain the specific details required to answer your questions about acceptance criteria, study design, and ground truth establishment.

    The document states: "In-vitro and in-vivo testing has been performed in support of the intended use of this device." However, it does not elaborate on the specific acceptance criteria, the results of these tests, sample sizes, expert qualifications, or how ground truth was established.

    Therefore, I cannot fulfill your request for the following information based on the provided text:

    1. A table of acceptance criteria and the reported device performance: This information is not present.
    2. Sample size used for the test set and the data provenance: This information is not present.
    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present.
    4. Adjudication method for the test set: This information is not present.
    5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and the effect size: This information is not present.
    6. If a standalone study was done: While "in-vitro and in-vivo testing" is mentioned, the specific nature of these studies (e.g., standalone vs. human-in-the-loop) and their results are not detailed.
    7. The type of ground truth used: This information is not present.
    8. The sample size for the training set: This information is not present.
    9. How the ground truth for the training set was established: This information is not present.

    The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, material biocompatibility, and the general statement of performance testing, rather than a detailed breakdown of a specific clinical or performance study with acceptance criteria and ground truth methodology.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1