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510(k) Data Aggregation

    K Number
    K192013
    Device Name
    VERTICALE® Cervical System
    Manufacturer
    Silony Medical GmbH
    Date Cleared
    2020-04-07

    (253 days)

    Product Code
    NKG,KWP
    Regulation Number
    888.3075
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K151885
    Why did this record match?
    Device Name :

    VERTICALE**®** Cervical System

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

    The VERTICALE Cervical System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction (occiput-C2), the cervical spine (C1 to C7) and the thoracic spine (T1-T3):

    • traumatic spinal fractures and /or traumatic dislocations
    • instability or deformity
    • failed previous fusions (e.g. pseudoarthrosis)
    • tumors involving the cervical/thoracic spine
    • degenerative disease, including intractable radiculopathy and/or arm pain of discogenic origin as confirmed by radiographic studies, and
    • degenerative disease of the facets with instability
    Device Description

    The VERTICALE Cervical System is a posterior double rod fixation system for immobilization and stabilization of the spinal seqments of the craniocervical junction (occiput-C2), cervical spine (C1-C7), and thoracic spine (T1-T3).
    The system may only be used in the field of human medicine and consists of polyaxial screws, favored anqle polyaxial (FA) screws, rods, occiput plates, connectors and the related instrumentation.
    The VERTICALE Cervical System will be used in patients with occiput cervical and upper cervical spine instabilities.
    The implants of the VERTICALE Cervical System are manufactured from titanium alloy conforming to ASTM F136 / ISO 5832-3. They are delivered in a sterile condition and can be used without any further preparations. The implants are packaged in accordance with EN ISO 11607 Part 1+2 and sterilized with gamma irradiation at a minimum dose of 25 kGy.
    Implants delivered by the manufacturer in a sterile condition may not be sterilized. They are intended for single use.

    AI/ML Overview

    I am sorry, but based on the provided text, I cannot find the specific information regarding the acceptance criteria, reported device performance, sample sizes, data provenance, expert details, adjudication methods, MRMC study, standalone performance, or ground truth details for a device that relies on AI.

    The document you provided is an FDA 510(k) clearance letter for the VERTICALE® Cervical System, which is a posterior double rod fixation system for spinal immobilization. This device is a traditional medical implant, not an AI/ML-driven device. The document primarily discusses:

    • Substantial Equivalence: Comparing the device to a predicate device (Mountaineer OCT Spinal System) based on indications for use, principles of operation, technological characteristics, materials, and performance testing.
    • Non-Clinical Performance Data: It lists mechanical performance tests (e.g., ASTM F1717-18, ASTM F2706-18, ASTM F1798-13), biocompatibility (ISO 10993-1), cleaning and sterilization (ISO 11137), and shelf-life testing. These are standard tests for medical implants.
    • Clinical Performance Data: States explicitly, "There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device."

    Therefore, the requested information about acceptance criteria, study details, expert qualifications, and ground truth for an AI/ML device is not present in this document.

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