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510(k) Data Aggregation

    K Number
    K200140
    Device Name
    Silhouette Instalift
    Manufacturer
    Silhouette Lift Inc.
    Date Cleared
    2020-03-27

    (66 days)

    Product Code
    GAM
    Regulation Number
    878.4493
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K163676,K142061
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Silhouette Instalift device is indicated for use in mid-face suspension surgery to temporarily fixate the cheek sub dermis in an elevated position.

    Device Description

    Silhouette Instalift Sutures are absorbable, sterile sutures. It is manufactured from a USP size 3-0 Poly/Glycolide/I-lactide suture material and an implantable grade of bioabsorbable PLGA resin (100% Poly (L-lactideco-glycolide) (co-monomer ratio: L-Lactide =82mol%: glycolide=18mol%). The 30 centimeter suture (+- 10 %) (SMS 28-PLG-3.0.1- NA), 27.5 centimeter suture (+- 10 %) (SMS 29-PLG-3.0.1-NA) or 26.8 centimeter suture (+- 10 %) (SMS 30-PLG-3.0.1-NA) are attached to two 12 centimeter straight stainless steel needles. All products are supplied sterile (EO) for single use only. Silhouette Instaliff Sutures elicit a minimal acute inflammatory reaction in tissue that is followed by gradual encapsulation.

    AI/ML Overview

    The provided text is a 510(k) summary for a medical device called Silhouette Instalift. It primarily discusses a change to the device's labeling and asserts substantial equivalence to a previously cleared device. It does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria.

    The document states:

    • "No changes have been made to the intended use or fundamental scientific technology and therefore the supporting information on sterilization, biocompatibility, and clinical data remain unchanged from the original application."
    • "The only modification made to the predicate device is the modification to the labelling of the device."

    Therefore, I cannot provide the requested information such as acceptance criteria, reported device performance, sample sizes for test/training sets, data provenance, number or qualifications of experts, adjudication methods, MRMC study results, standalone performance, or ground truth details, because this information is explicitly stated as unchanged from the original application and is not provided in this specific 510(k) summary document.

    To obtain this information, one would need to refer to the original 510(k) applications (K142061 and K163676) mentioned in this document.

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