LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K183407
    Device Name
    Triton Cage
    Manufacturer
    Medyssey USA, Inc.
    Date Cleared
    2019-08-30

    (263 days)

    Product Code
    MAX
    Regulation Number
    888.3080
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K140348,K152475
    Why did this record match?
    Device Name :

    Triton Cage

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

    The Triton Cage is indicated for use with bone graft (autograft bone graft composed of cancellous and or corticocancellous bone graft) in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radios. Patients with previous non-fusion spinal surgery at the treated. These patients should be sketally mature and have had six months of non-operative treatment. These devices are intended for intervertebral body fusion and are intended to be used with supplemental fixation that has been cleared by the FDA for use in the lumbar spine.

    Device Description

    The Medyssey, Triton Cage is an interbody fusion device utilized to achieve fusion in the lumbar spine. The cage is manufactured from PEEK (ASTM F2026) and additively manufactured titanium alloy (ASTM F136) available in three variants (LLIF, ALIF, OLIF) and a range of sizes to accommodate different surgical approaches and anatomies.

    AI/ML Overview

    The provided text describes the 510(k) premarket notification for the Triton Cage, an intervertebral body fusion device. While it details the device's indications for use, materials, and substantial equivalence to predicate devices, it does not contain any information about a study proving the device meets specific acceptance criteria based on its performance in a clinical or imaging-based assessment where AI or human performance is evaluated.

    The "Performance Testing Summary" section only mentions mechanical testing (Static Compression, Dynamic Compression, etc.) performed on the device to demonstrate substantially equivalent performance to predicate devices in a benchtop setting, not a clinical study involving human or AI perceptual performance.

    Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or MRMC studies for this device based on the given document. The document focuses on regulatory clearance based on substantial equivalence of the physical device's characteristics and mechanical properties to previously cleared devices.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1