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510(k) Data Aggregation

    K Number
    K181995
    Device Name
    Chiral Surgical Pedicle Screw System
    Manufacturer
    Chiral Surgical
    Date Cleared
    2018-09-20

    (56 days)

    Product Code
    NKB
    Regulation Number
    888.3070
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K121615,K973836,K103049
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Chiral Surgical Pedicle Screw System is a posterior non-cervical pedicle screw system intended for use as an adjunct to fusion in patients with degenerative spondylolisthesis (Grade 3 and 4) with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis) of the lumbosacral spine vertebra and implants are removable after the attainment of a solid fusion. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment.

    Device Description

    The Chiral Surgical Pedicle Screw System is a top-loading multiple component, posterior spinal fixation system which consists of pedicle screws, rods, nuts, and a transverse (cross) connectors. The Chiral Surgical Pedicle Screw System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. Chiral Surgical Pedicle Screw System implant components are supplied non-sterile are single use and are fabricated from titanium alloy (Ti-6A1-4V ELI) that conforms to ASTM F136 or Cobalt Chrome that conforms to ASTM F1537. Various sizes of these implants are available.

    AI/ML Overview

    I am sorry, but the provided text from the FDA 510(k) K181995 submission for the Chiral Surgical Pedicle Screw System does not contain any information about an AI/ML-driven device or study results related to acceptance criteria for such a device.

    The document describes a traditional medical device (a pedicle screw system) and its performance data relates to mechanical properties (static axial compression, static torsion, dynamic axial compression bending) tested per ASTM F1717 standards. It assesses the substantial equivalence of the new device to predicate devices based on these mechanical tests, indications for use, and materials.

    Therefore, I cannot fulfill your request to describe acceptance criteria and study proving device performance for an AI/ML device, a test set, ground truth establishment, MRMC studies, or training set details, as this information is not present in the provided document.

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