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510(k) Data Aggregation

    K Number
    K201506
    Device Name
    Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical Intervertebral Body Fusion System
    Manufacturer
    Meditech Spine, LLC
    Date Cleared
    2020-09-11

    (98 days)

    Product Code
    ODP
    Regulation Number
    888.3080
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K150788,K173347,K163491
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Talos®-C Cervical Intervertebral Body Fusion Devices are indicated for intervertebral body fusion of the spine in skeletally mature patients. The Talos®-C Cervical Intervertebral Body Fusion Device or anterior cervical interbody fusion in patients with cervical disc degeneration and or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and/or pain at multiple contiguous levels from C2 - T1. The Talos®-C Cervical Intervertebral Body Fusion and with supplemental fixation. The Talos®-C Cervical Intervertebral Body Fusion Devices are designed for use with autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and or craft to faciliate fusion. Non-operative treatment with Talos®-C Cervical Intervertebral Body Fusion Devices is six (6) weeks. Talos®-C Cervical IBF Devices are to be implemented via an open anterior approach approach.

    Talos®-C Cervical IBF Devices are also to be used with supplemental fixation. Additionally, the use of Hyperlordotic angle greater than 7°) are intended to be used exclusively with anterior supplemental fixation.

    Talos®-C(HA) Cervical Intervertebral Body Fusion Devices

    The Talos®-C(HA) Cervical Intervertebral Body Fusion Devices are indicated for intervertebral body fusion of the spine in skeletally mature patients. The Talos®-C (HA) Cervical Intervertebral Body Fuss are intended for use for anterior cervical interbody fusion in patients with cervical disc degeneration and or cervical instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, myelopathy, and or pain at multiple contiguous levels from C2 - T1. The Talos®-C (HA) Cervical Intervertebral Body Fusion Devices are intended to be used with supplemental fixation. The Talos®-C (HA) Cervical Intervertebral Body Fusion Devices are designed for use with autogenous and or allogeneic bone graft comprised of cancellous bone graft to facilitate fusion. Non-operative tratment pror to treatment with Talos®-C (HA) Cervical Intervertebral Body Fusion Devices is six (6) Veeks. Talos®-C(HA) Cervices are to be implemented via an open anterior approach approach.

    Talos®-C (HA) Cervical IBF Devices are also to be used with supplemental fixation. Additionally, the use of Hyperloriotic angle greater than 7°) are intended to be used exclusively with anterior supplemental fixation.

    Device Description

    The Talos®-C Cervical Intervertebral Body Devices (Talos®-C Cervical IBF Devices) are made of the polymer, polyetheretherketone (PEEK). The devices are open devices with ridged teeth on superior and inferior ends to resist implant pullout. The Talos® C Cervical IBF Devices are rectangular devices and have curved lateral walls and rounded edges. The implants are available in a range of sizes as well as flat and lordotic angled implants to accommodate variations in patient's anatomy. In addition, titanium markers at the opposite ends are offered which allows the Talos®-C Cervical IBF Device radiological confirmation for proper positioning.

    The Talos® -C (HA) Cervical Intervertebral Body Devices (Talos®-C (HA) Cervical IBF Devices) are made of the polymer, hydroxyapatite impregnated polyetheretherketone (HA PEEK). The devices are open devices with ridged teeth on superior and inferior ends to resist implant pullout. The Talos®-C (HA) Cervical IBF Devices are rectangular devices and have curved lateral walls and rounded edges. The implants are available in a range of sizes as well as flat and lordotic angled implants to accommodate variations in patient's anatomy. In addition, titanium markers at the opposite ends are offered which allows the Talos®-C (HA) Cervical IBF Device radiological confirmation for proper positioning.

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter and summary for a medical device (Talos®-C Cervical Intervertebral Body Fusion System). It does NOT contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML-driven medical device.

    The document details the device's indications for use, technological characteristics, and non-clinical testing (mechanical tests like compression, shear, torsion, and subsidence testing, as well as Finite Element Analysis) to demonstrate substantial equivalence to predicate devices for spinal fusion.

    **Therefore, I cannot fulfill your request for:

    1. A table of acceptance criteria and reported device performance.
    2. Sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth details for an AI/ML study.**

    This submission is for a physical implantable device, not a software or AI-based diagnostic/treatment system. The "testing" mentioned refers to biomechanical performance of the implant, not performance metrics related to diagnostic accuracy or AI model output.

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