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510(k) Data Aggregation

    K Number
    K140750
    Device Name
    SHILLA GROWTH GUIDANCE SYSTEM
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Date Cleared
    2014-07-17

    (114 days)

    Product Code
    PGM
    Regulation Number
    888.3070
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K133904
    Why did this record match?
    Reference Devices :

    K/DEN number: K133904

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

    The SHILLATM Growth Guidance System is indicated for skeletally immature patients less than 10 years of age with the potential for additional spinal growth, who require surgical treatment for correction and maintenance of the correction of severe, progressive, life-threatening early-onset deformities, including early-onset scoliosis, which are associated with or at risk of thoracic insufficiency syndrome. The SHILLA™ Growth Guidance System is intended to be removed after skeletal maturity.

    Device Description

    The SHILLA™ Growth Guidance System is intended to treat severe, progressive multi-planar spinal deformities such as early-onset scoliosis while allowing for skeletal growth. Severe, progressive early-onset scoliosis is defined as a greater than 40° Cobb angle or a rib-vertebral angle difference greater than 20°. The SHILLATM Growth Guidance System consists of a variety of shapes and sizes of steel rods, hooks, screws, CROSSLINK® Plates, and connecting components, which can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. All SHILLATM components are manufactured from medical grade stainless steel.

    AI/ML Overview

    The provided text is a 510(k) summary for the SHILLA™ Growth Guidance System, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than fulfilling specific acceptance criteria in a study to prove device performance. It doesn't detail a study with acceptance criteria in the way you've outlined.

    However, I can extract the information provided about the supporting data that was submitted to the FDA for the SHILLA™ Growth Guidance System:

    1. Table of Acceptance Criteria and Reported Device Performance:

    This document does not present a table of specific, pre-defined acceptance criteria (e.g., sensitivity, specificity, accuracy targets) and corresponding device performance values because it is a 510(k) summary. The "acceptance criteria" for a 510(k) submission revolve around demonstrating substantial equivalence to a predicate device, meaning the new device is as safe and effective as a legally marketed device.

    The reported "performance" is a general statement about clinical and mechanical equivalence:

    Acceptance Criterion (Implicit for 510(k))Reported Device Performance
    Substantial Equivalence to Predicate DeviceSurgical approaches, implant materials, surgical instruments, and sterilization methods are equivalent to the predicate CD HORIZON® Growth Rod Conversion Set.
    Equivalent Clinical OutcomesRetrospective clinical data demonstrated the SHILLA™ Growth Guidance System to be substantially equivalent to traditional growth rod systems when treating the same patient population.
    Equivalent Mechanical StrengthMechanical testing demonstrated the SHILLA™ Growth Guidance System to be substantially equivalent with regards to mechanical strength to the CD HORIZON® Growth Rod Conversion Set.
    No New Potential RisksRetrospective clinical data identified no new potential risks to patients.

    2. Sample size used for the test set and the data provenance:

    • Sample Size: Not explicitly stated. The document mentions "Retrospective clinical data for the subject device compared to traditional growth rod devices were provided." It does not specify the number of patients or cases included in this dataset.
    • Data Provenance: Retrospective clinical data. The country of origin is not specified.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

    This information is not provided. Since the clinical data is "retrospective," it likely refers to outcomes observed from standard clinical practice rather than a controlled study with a dedicated expert panel for ground truth establishment for a specific AI-assisted device.

    4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

    This information is not provided.

    5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

    This is not applicable. The SHILLA™ Growth Guidance System is a physical surgical implant system, not a software device involving human readers or AI assistance. Therefore, an MRMC study related to interpretation accuracy with or without AI is not relevant to this device.

    6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

    This is not applicable. The SHILLA™ Growth Guidance System is a physical surgical implant system, not an algorithm.

    7. The type of ground truth used:

    For the clinical data, the "ground truth" would be the observed patient outcomes (e.g., correction of deformity, continued growth, complications) obtained from standard clinical follow-up for patients treated with either the SHILLA™ system or traditional growth rods.

    8. The sample size for the training set:

    Not applicable. This device is a physical implant system, not an AI/ML algorithm that requires a training set.

    9. How the ground truth for the training set was established:

    Not applicable. As above, this device does not involve a training set for an AI/ML algorithm.

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