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510(k) Data Aggregation

    K Number
    K242201
    Device Name
    HyperSuture White/Green Extension Line
    Manufacturer
    Threadstone LLC
    Date Cleared
    2025-03-27

    (244 days)

    Product Code
    GAT
    Regulation Number
    878.5000
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K230311
    Why did this record match?
    Applicant Name (Manufacturer) :

    Threadstone LLC

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

    HyperSuture™ White/Green Extension Line sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular surgery, and the use of allograft tissues for orthopedic procedures.

    Device Description

    HyperSuture™ White/Green Extension Line cables are non-absorbable, sterile, surgical sutures composed of multiple multifilament strands of ultra-high molecular weight polyethylene (UHMWPE) braided together to form the implant. The sutures are intended to be used for general soft tissue approximation and/or ligation, including use in cardiovascular surgery, and allograft tissues for orthopedic procedures. HyperSuture™ White/Green Extension Line cables are available in USP #2-0. USP #2. and USP #5 and tapes are available in 0.8mm (USP 2-0 equivalent), 1.5mm (USP 2 equivalent) and 2.0mm (USP 5 equivalent). Both HyperSuture™ White/Green Extension Line cables and tapes are available in white/green, 36 inches or 40 inches in length, and with or without pre-attached AISI 302 stainless steel needles.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for a medical device called "HyperSuture™ White/Green Extension Line." This document is a clearance letter from the FDA, indicating that the device is substantially equivalent to a previously cleared predicate device.

    The information given is typical for a 510(k) submission for a physical medical device (suture) and does not contain the details typically found in a study proving an AI/software as a medical device (SaMD) meets acceptance criteria. Therefore, I am unable to construct the requested table and provide information on many of the points (sample size, expert ground truth, MRMC study, etc.) because the provided document is not about an AI/SaMD.

    This document focuses on the physical and material properties of the suture (e.g., tensile strength, diameter, needle attachment, material composition, biocompatibility) and its substantial equivalence to a predicate suture. It does not mention any AI or algorithm component.

    Therefore, I cannot fulfill the request as it pertains to an AI/SaMD and the provided text describes a traditional medical device.

    If you have a document describing the study and acceptance criteria for an AI/Software as a Medical Device (SaMD), please provide that text for analysis.

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