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510(k) Data Aggregation

    K Number
    K243074
    Device Name
    Spectrum Spine Lumbar Cage System
    Manufacturer
    Spectrum Spine, Inc.
    Date Cleared
    2025-04-04

    (189 days)

    Product Code
    MAX
    Regulation Number
    888.3080
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K230219,K240838,K193256,K131612,K201024,K173518,K211258
    Why did this record match?
    Reference Devices :

    K230219, K240838, K193256, K131612, K201024, K173518

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

    The Spectrum Spine Lumbar Cage System devices with roughened surface textured features, are indicated for use in skeletally mature patients with lumbar degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 – S1 whose condition requires the use of interbody fusion, confirmed by imaging studies (radiographs, CT, MRI). DDD is defined as discogenic pain with degeneration of the disc. DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had at least six months of nonoperative treatment. The Spectrum Spine Lumbar Cage System is indicated to be used with supplemental fixation cleared by the FDA for use in the lumbar spine and autograft bone, allograft bone comprised of cancellous and/or corticocancellous bone, demineralized allograft with bone marrow aspirate, or a combination thereof.

    Device Description

    The Spectrum Spine Lumbar Cage System is composed of lumbar interbody fusion devices. The Spectrum Spine Lumbar Cage System is offered in multiple footprints with varying heights and lordotic angles designed to accommodate patient anatomy. Additionally, all interbody cages are offered with a smooth finish and a rough finish. The interbody devices also contain a large graft window through the body of the device to allow for placement of bone graft and facilitate fusion. All implant components are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136. The Spectrum Spine Lumbar Cage System also includes instruments to facilitate implantation of the subject implant devices. Instruments are manufactured from medical grade stainless steel.

    AI/ML Overview

    The provided FDA 510(k) clearance letter for the Spectrum Spine Lumbar Cage System does not contain any information about a study proving the device meets acceptance criteria related to AI/ML device performance, human reader improvement with AI assistance, or the establishment of ground truth for such studies.

    The document pertains to the clearance of an intervertebral body fusion device, which is a medical implant made of titanium alloy. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" described in the document relate solely to the mechanical and physical performance of the implant itself, not to the performance of an AI/ML algorithm.

    Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving device performance in the context of AI/ML, as the provided text does not contain this information.

    Based on the provided text, here's what can be extracted regarding the "acceptance criteria" and "study" for the physical device:

    1. Table of Acceptance Criteria and Reported Device Performance (Mechanical/Physical Device):

    Acceptance Criterion (Test Type)Standard AppliedReported Device Performance Statement
    Static Axial CompressionASTM F2077-22"results have shown them to be substantially equivalent to the predicate interbody devices."
    Dynamic Axial CompressionASTM F2077-22"results have shown them to be substantially equivalent to the predicate interbody devices."
    Static Compression ShearASTM F2077-22"results have shown them to be substantially equivalent to the predicate interbody devices."
    Dynamic Compression ShearASTM F2077-22"results have shown them to be substantially equivalent to the predicate interbody devices."
    SubsidenceASTM F2267-22"results have shown them to be substantially equivalent to the predicate interbody devices."
    ExpulsionNot explicitly stated"results have shown them to be substantially equivalent to the predicate interbody devices."

    Note: The specific numerical performance values are not provided in this regulatory summary; only the conclusion of "substantial equivalence" is stated.

    2. Sample Size and Data Provenance (Mechanical/Physical Device):

    • Sample Size: Not specified in the document.
    • Data Provenance: The tests are described as "Mechanical testing... performed on the subject Spectrum Spine Lumbar Cage devices." This implies laboratory testing on physical samples, not human or patient data.

    Regarding your other points (relevant to AI/ML devices), the document provides NO information:

    • Number of experts used to establish ground truth: Not applicable/not mentioned.
    • Adjudication method: Not applicable/not mentioned.
    • MRMC comparative effectiveness study: Not applicable/not mentioned.
    • Standalone (algorithm-only) performance: Not applicable/not mentioned.
    • Type of ground truth used: Not applicable/not mentioned (for AI/ML devices).
    • Sample size for training set: Not applicable/not mentioned.
    • How ground truth for training set was established: Not applicable/not mentioned.

    In summary, the provided FDA clearance letter is for a physical medical device (spinal implant) and its mechanical properties, not an AI/ML diagnostic or therapeutic device. Therefore, the details requested for AI/ML device validation are not present in this document.

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