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510(k) Data Aggregation

    K Number
    K152149
    Device Name
    VersaOne Bladed Trocar 5mm
    Manufacturer
    COVIDIEN
    Date Cleared
    2016-01-22

    (172 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Type
    Special
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K062326,K112349
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    indicated for use in a variety of gynecologic, general, thoracic, and urologic endoscopic procedures to create and maintain a port of entry.

    Device Description

    VersaOne™ Bladed Trocar is available in diameter 5mm, cannula fixation and smooth, and length standard and short. VersaOne™ Bladed Trocar consists of an obturator component with a bladed tip and a cannula assembly. The devices are supplied sterile single-use.

    AI/ML Overview

    This FDA 510(k) summary is for a medical device (VersaOne™ Bladed Trocar), which means its "acceptance criteria" and "performance" are related to mechanical and biological safety and efficacy, not AI algorithm performance metrics like sensitivity/specificity.

    Therefore, the requested information elements related to AI algorithm studies (such as sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance with AI, and type of ground truth) are not applicable to this document.

    The document describes material and performance testing against specifications, rather than a clinical study evaluating diagnostic or prognostic algorithmic performance.

    Here's an interpretation of the document in the context of the requested table, focusing on what is available:

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

    Acceptance Criteria (What the device must achieve)Reported Device Performance (What the device achieved)
    Biocompatibility: Complies with ISO 10993-1 standard.Acceptable results demonstrated VersaOne™ Bladed Trocar complies with ISO 10993-1 standard.
    Performance: Performs to specifications.Results from performance testing demonstrated the proposed VersaOne™ Bladed Trocar perform to specifications.
    Comparability: Comparable to predicate devices (K062326 and K112349).Results from performance testing demonstrated the proposed VersaOne™ Bladed Trocar is comparable to predicate devices K062326 and K112349.
    Functionality: Bladed tip cuts tissues, shield covers blade upon entry, seal system prevents loss of Pneumoperitoneum, cannula bevel reduces penetration forces, stopcock for insufflation/desufflation.Implicitly met: The device description outlines these functional characteristics, and performance testing confirmed it performs to specifications, implying these functions were successful.

    The study that proves the device meets the acceptance criteria is referred to as "performance testing" and "biocompatibility evaluation."

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

    • Not Applicable: This document describes a medical device's mechanical and material performance testing, not a clinical study involving human data or AI algorithms. The "test set" would refer to the physical devices tested. The number of devices tested is not specified, nor is their "provenance" in the context of country of origin for clinical data.

    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)

    • Not Applicable: "Ground truth" in this context would refer to established engineering and biocompatibility standards (e.g., ISO 10993-1). The "experts" would be the personnel conducting the testing and evaluating the results against these standards, but their number or specific qualifications are not detailed in this summary, as it is standard practice in medical device testing.

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

    • Not Applicable: This refers to clinical data adjudication, which is not relevant to medical device performance testing.

    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 applies to AI-assisted diagnostic or screening tools. This device is a surgical trocar.

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

    • Not Applicable: This applies to AI algorithms.

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

    • Type of Ground Truth: The ground truth for this device's performance is based on established engineering specifications, material science standards (e.g., ISO 10993-1 for biocompatibility), and comparability to predicate devices as demonstrated through physical and mechanical testing.

    8. The sample size for the training set

    • Not Applicable: This applies to AI algorithms.

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

    • Not Applicable: This applies to AI algorithms.
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