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510(k) Data Aggregation

    K Number
    K182179
    Device Name
    AdvantageRib Anterior System
    Manufacturer
    SIG Medical Corp.
    Date Cleared
    2018-11-16

    (95 days)

    Product Code
    HRS,HWC
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K141241,K142823,K151173
    Why did this record match?
    Reference Devices :

    K141241

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

    The AdvantageRib Anterior System is intended for the fixation, and fusion of rib fractures and osteotomies of normal and osteoporotic bone.

    Device Description

    The AdvantageRib Anterior System is composed of commercially pure titanium locking bone plates per ASTM F67 and titanium alloy locking and non-locking screws per ASTM F1472 that provide rigid fixation in instances of fractures and osteotomies in normal and osteoporotic bone. The implant and associated screws are provided to the end user in non-sterile packaging, in a variety of sizes and lengths.

    AI/ML Overview

    I am sorry, but the provided text does not contain the acceptance criteria and study details as requested. The document is a 510(k) premarket notification letter from the FDA regarding the "AdvantageRib Anterior System." It states that clinical testing is not necessary to demonstrate substantial equivalence and refers to performance evaluation in accordance with ASTM standards and engineering/geometric analysis.

    The document does not include:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes or data provenance for a test set.
    3. Number or qualifications of experts for ground truth.
    4. Adjudication method for a test set.
    5. Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
    6. Information on a standalone (algorithm only) performance study.
    7. The type of ground truth used.
    8. Sample size for a training set.
    9. How ground truth for a training set was established.

    Instead, it focuses on demonstrating substantial equivalence to predicate devices based on intended use, materials, design features, dimensions, function, surgical technique, labeling, and adherence to specific ASTM standards (F382, F543, F2193) through engineering and geometric analysis.

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