Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K972008
    Date Cleared
    1997-09-19

    (112 days)

    Product Code
    Regulation Number
    878.4400
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Select - Sutter Electrosurgical Forceps and Electrodes are reusable Electrosurgical Forceps and Electrodes which have applications in laparoscopic, general, Neurologic and Thoracic applications in laparosoppid are designed to provide surgeons with an electrosurgical technique for coagulation. The accessories provide a method for aiding in electrosurgical rie accessories provice a migues and medical literature relative procedures. Surgical techniques and medical to tache consulted procedered. Complications, and hazards are to be consulted proceded the performance of any surgical procedures.

    Device Description

    The Select-Sutter Electrosurgical Instruments are reusable surgical instruments which have applications in but not limited to; laparoscopic, general, neurologic and thoracic procedures The Forcens and Hierrories are designed to provide surgeons with an electrosurgical technique for coagulation.

    AI/ML Overview

    The provided text is a 510(k) premarket notification for an electrosurgical cutting and coagulation device. It primarily details the device's classification, material composition, intended uses, and lists various types of testing that "will be completed, reviewed and approved prior to release and distribution of this product."

    However, it does not contain the results of these tests, nor does it define specific acceptance criteria against which device performance is measured. The document states that testing will be conducted, implying that at the time of this filing, the comprehensive performance data and their comparison to acceptance criteria were not yet available.

    Therefore, I cannot provide the requested information from the given text. Specifically:

    1. A table of acceptance criteria and the reported device performance: Not available. The document lists types of tests but not criteria or results.
    2. Sample sized used for the test set and the data provenance: Not available.
    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no study results are presented.
    4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
    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: Not applicable. This device is an electrosurgical instrument, not an AI-assisted diagnostic tool.
    6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm-based device.
    7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
    8. The sample size for the training set: Not applicable.
    9. How the ground truth for the training set was established: Not applicable.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1