LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K211385
    Device Name
    KeriFlex® MCP and PIP Finger Joint Prostheses
    Manufacturer
    Keri Medical SA
    Date Cleared
    2022-07-27

    (449 days)

    Product Code
    KYJ
    Regulation Number
    888.3230
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K083107,K970544
    Why did this record match?
    Applicant Name (Manufacturer) :

    Keri Medical SA

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

    The KeriFlex® MCP and KeriFlex® PIP Finger Joint Prostheses are indicated for cementless replacement of the metacarpophalangeal (MCP) and interphalangeal (PIP) joints, respectively, where disabled by rheumatoid, degenerative or traumatic arthritis.

    Device Description

    The KeriFlex® Finger Joint Prostheses are flexible, one-piece, hinged silicone elastomer implants designed to be implanted across the metacarpophalangeal (MCP) or proximal interphalangeal (PIP) joints. The proximal and distal stems of the prosthesis form an angle, which mimics the approximate position of the joint when the hand is relaxed.

    The KeriFlex® Finger Joint Prostheses are single-use devices indicated for cementless replacement of the metacarpophalangeal (MCP) and interphalangeal (PIP) joints, respectively, where disabled by rheumatoid, degenerative, or traumatic arthritis. The KeriFlex® Finger Prostheses are provided sterile and are intended to be single use.

    The associated instruments include:

    • Patterns to be used prior to the bone cut to identify the resection level and to identify the definitive implant.
    • Starter (awl) to help the surgeon prepare the implantation site.
    • Rasps to help the surgeon prepare the implantation site.
    • Sterilization tray, lid, insert and rack which protect the instruments during transportation and sterilization.
    AI/ML Overview

    The provided text is a 510(k) summary for the KeriFlex® MCP and PIP Finger Joint Prostheses. It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence. However, it does not contain information about a study proving the device meets acceptance criteria related to AI/algorithm performance.

    The document states:

    • The device is a physical medical implant (finger joint prostheses).
    • The performance data listed (Fatigue Test, Material Characterization, Range of Motion) are typical engineering and biomechanical tests for an implant, not studies on AI/algorithm performance or reader improvement with AI assistance.
    • The submission aims to demonstrate substantial equivalence to predicate devices, focusing on similar technological characteristics, materials, and intended use, not on diagnostic accuracy or AI-driven improvements.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and a study proving the device meets acceptance criteria for an AI/algorithm. The information is not present in the provided text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1