LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K190375
    Device Name
    Parcus ATLAS
    Manufacturer
    Parcus Medical, LLC
    Date Cleared
    2019-04-24

    (64 days)

    Product Code
    MBI
    Regulation Number
    888.3040
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K122805,K152711
    Why did this record match?
    Device Name :

    Parcus ATLAS

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

    The Parcus ATLAS is indicated for CMC Arthroplasty.

    Device Description

    The Parcus ATLAS is designed for use in CMC arthroplasty. The ATLAS is comprised of medical grade titanium, PEEK-OPTIMA™ from Invibio™, and UHMWPE. The ATLAS is provided sterile.

    AI/ML Overview

    The documents provided do not contain information related to software or AI/ML-driven devices. The submission (K190375) describes a mechanical medical device, the Parcus ATLAS, which is indicated for CMC (Carpometacarpal) arthroplasty. This device is composed of titanium, PEEK-OPTIMA™, and UHMWPE.

    Therefore, the requested information regarding acceptance criteria and studies proving the device meets those criteria, specifically concerning AI/ML performance metrics, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, cannot be extracted from this text. The provided text primarily focuses on substantial equivalence to predicate devices, material composition, manufacturing, sterilization, and basic mechanical performance testing (tensile loading).

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1