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510(k) Data Aggregation

    K Number
    K223654
    Device Name
    Medussa-PL Cage
    Manufacturer
    Medyssey USA, Inc.
    Date Cleared
    2022-12-28

    (22 days)

    Product Code
    MAX
    Regulation Number
    888.3080
    Type
    Special
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K170341,K110067
    Why did this record match?
    Reference Devices :

    K170341,K110067

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

    The Medussa-PL Cage 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. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone.

    Device Description

    The Medussa-PL Cage is an interbody fusion device utilized to facilitate the fusion process in the lumbar spine. The Medussa-PL Cage is additively manufactured from Titanium Alloy (Ti-6Al-4V) according to the ASTM F3001 and is available in a range of sizes to accommodate different patient anatomies, and pathologies.

    AI/ML Overview

    I am sorry, but based on the provided text, I cannot provide the requested information. The document is a 510(k) clearance letter for a medical device (Medussa-PL Cage) and does not contain details about:

    1. Acceptance criteria and reported device performance: The document mentions "engineering analysis and the performance testing result" but does not provide specific acceptance criteria or quantitative performance data.
    2. Study design details: There is no mention of sample sizes, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, or standalone algorithm performance.
    3. Ground truth information: While it states the device is for Degenerative Disc Disease (DDD) confirmed by "patient history and radiographic studies," it doesn't elaborate on how ground truth was established for any assessment studies, nor does it specify training set details.

    The document primarily focuses on establishing substantial equivalence to a predicate device based on general similarities in design, materials, function, and indications for use, rather than presenting a detailed clinical or performance study with quantified acceptance criteria.

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