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510(k) Data Aggregation

    K Number
    K173518
    Device Name
    Spectrum Spine Expandable Cages (SSEC)
    Manufacturer
    Spectrum Spine, LLC
    Date Cleared
    2019-03-07

    (478 days)

    Product Code
    MAX
    Regulation Number
    888.3080
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K112095,K123281,K123752,K123231,K090507
    Why did this record match?
    Device Name :

    Spectrum Spine Expandable Cages (SSEC)

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

    The Spectrum Spine Expandable Cages (SSEC) are interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).

    SSEC implants are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation.

    Device Description

    The Spectrum Spine Expandable Cages (SSEC) are lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The SSEC are provided in different shapes to accommodate a lateral surgical approach to the lumbar spine and can expand to the desired height and varying degrees of lordosis. The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. These spacers are to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. SSEC implants are manufactured from radiolucent PEEK (per ASTM 2026), titanium alloy (per ASTM F136), and tantalum markers (per ASTM F560).

    AI/ML Overview

    The provided document is a 510(k) summary for a medical device called "Spectrum Spine Expandable Cages (SSEC)". This type of regulatory submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria based on a clinical study for AI performance.

    Therefore, the document does not contain the information requested regarding acceptance criteria and study data for an AI-powered device. Specifically, it lacks:

    • A table of acceptance criteria and reported device performance for an AI
    • Sample size and data provenance for an AI test set
    • Number and qualifications of experts for AI ground truth establishment
    • Adjudication methods for AI test set
    • Multi-Reader Multi-Case (MRMC) comparative effectiveness study results
    • Standalone AI performance
    • Type of ground truth used for AI
    • Training set sample size and ground truth establishment for AI

    The information within the document pertains to mechanical and material testing of an intervertebral fusion device (implants), which are entirely different types of tests than those required for an AI-based medical device. The "Performance Data" section discusses:

    • Static Axial Compression per ASTM F2077
    • Static Compressive Shear per ASTM F2077
    • Static Subsidence per ASTM F2267 and ASTM F2077
    • Static Expulsion
    • Dynamic Axial Compression per ASTM F2077
    • Dynamic Compressive Shear per ASTM F2077

    These are all mechanical tests to ensure the physical integrity and durability of the spinal implant, not performance metrics for an AI algorithm.

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