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    K Number
    K171351
    Device Name
    Posterior Spine Truss System (PSTS) Interbody Fusion Device
    Manufacturer
    4Web, Inc.
    Date Cleared
    2017-09-08

    (122 days)

    Product Code
    MAX
    Regulation Number
    888.3080
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K143258,K142112,K160924
    Why did this record match?
    Device Name :

    Posterior Spine Truss System (PSTS) Interbody Fusion Device

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

    The Posterior Spine Truss System (PSTS) Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation and must be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s)

    Device Description

    The device is an open architecture truss design mathematically formulated to provide structural support with open space throughout the implant for bone growth and fusion. The 4WEB additive manufacturing process provides a hierarchical surface roughness. The implant is made from Ti6Al4V alloy. The device is available in a variety of sizes and lordotic angles to accommodate the patient's anatomy.

    AI/ML Overview

    The provided FDA 510(k) K171351 document describes a medical device, the Posterior Spine Truss System (PSTS) Interbody Fusion Device, but does not contain information about the acceptance criteria or a study proving that the device meets those criteria in the context of AI/ML or diagnostic performance.

    This document is a marketing clearance notification for a physical medical implant, not a software device or an AI/ML diagnostic tool. Therefore, the questions related to sample size for test/training sets, experts, ground truth, MRMC studies, or standalone algorithm performance are not applicable to this submission.

    The "Performance Standards" section refers to mechanical and material performance testing for the implant itself, not diagnostic accuracy or AI performance. The tests listed (ASTM F2077, F2267, F2119, F2052, F2213, F2182) are standard tests for intervertebral body fusion devices, assessing physical properties like static/dynamic compression, shear, torsion, subsidence, and MR compatibility. These are not related to diagnostic accuracy or AI performance metrics.

    In summary, this document does not provide the information requested regarding acceptance criteria and studies for an AI/ML-driven device.

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