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510(k) Data Aggregation

    K Number
    K183472
    Device Name
    DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio – MR Conditional
    Manufacturer
    Synthes (USA) Products LLC
    Date Cleared
    2019-03-13

    (89 days)

    Product Code
    FTM,GAQ
    Regulation Number
    878.3300
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K051879,K040364,K952677,K832283,K022665,K041333,K042606
    Why did this record match?
    Device Name :

    DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio – MR Conditional

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

    The DePuy Synthes Porous Polyethylene Implants are intended for use in non-load bearing applications in craniofacial reconstruction, cosmetic surgery, and repair of craniofacial trauma.
    The DePuy Synthes Titanium Wire is indicated for use in soft tissue approximation and/or ligation, canthoplasty, canthopexy and/or canthal tendon repair.
    The DePuy Synthes Titanium Wire With Barb is indicated for use in soft tissue approximation and/or ligation, canthoplasty, canthopexy and/or canthal tendon repair.

    Device Description

    The DePuy Synthes Porous Polyethylene Implants consist of porous/smooth implant sheets with or without titanium.
    The DePuy Synthes Titanium Wire is a nonabsorbable, monofilament, sterile surgical wire composed of commercially pure titanium wire is available in a length of 500mm with different gauge sizes, and is available with or without a permanently attached stainless steel needle.
    The DePuy Synthes Titanium Wire with Barb is a nonabsorbable, monofilament, sterile surgical wire with an attached barb. The 28 gauge titanium wire with barb is available in a length of 538mm, and has a permanently attached stainless steel needle.

    AI/ML Overview

    The provided text describes the 510(k) premarket notification for the DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio, focusing on their MR Conditional labeling. It primarily details non-clinical performance testing rather than a clinical study evaluating diagnostic accuracy or algorithmic performance with human readers.

    Here's a breakdown of the requested information based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategoryStandard/MethodSpecific Criteria/PurposeReported Device Performance
    MR Conditional SafetyMagnetically Induced Displacement ForceASTM F2052-14Assessed in MR environment
    Magnetically Induced TorqueASTM F2213-06Assessed in MR environment
    Radio Frequency (RF) HeatingASTM F2182-11aAssessed in MR environment
    Image ArtifactsASTM F2119-07Assessed in MR environment

    Conclusion: The non-clinical performance data demonstrated that the subject devices, when exposed to the MR environment under specific MR conditions of use, did not raise new questions of safety or efficacy.

    2. Sample Size Used for the Test Set and the Data Provenance

    The document does not detail a "test set" in the context of clinical or algorithmic performance. The testing described is non-clinical performance testing on the devices themselves to assess their safety in an MR environment. Therefore, information about human data provenance, sample size of a test set, etc., is not applicable to this type of study.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

    Not Applicable. As this is non-clinical performance testing for MR safety, there is no "test set" that requires expert ground truth establishment in the traditional sense of medical image analysis or diagnosis. The "ground truth" here is the physical interaction of the device with the MR environment as measured by standardized tests.

    4. Adjudication Method for the Test Set

    Not Applicable. There is no "test set" requiring adjudication by experts. The performance is measured against established engineering standards for MR safety.

    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

    No. The document describes non-clinical performance testing for MR safety of physical implants and wires. It does not involve any AI, human readers, or a comparative effectiveness study.

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

    No. The document describes non-clinical performance testing of physical medical devices, not an algorithm.

    7. The Type of Ground Truth Used

    The ground truth used for this submission is based on established engineering and safety standards (ASTM standards) for assessing the behavior of medical devices in a Magnetic Resonance (MR) environment. This includes:

    • ASTM F2052-14 for magnetically induced displacement force.
    • ASTM F2213-06 for magnetically induced torque.
    • ASTM F2182-11a for radio frequency (RF) heating.
    • ASTM F2119-07 for image artifacts.

    8. The Sample Size for the Training Set

    Not Applicable. This is not an AI/algorithm study involving a training set. The descriptions are for non-clinical performance testing of physical devices.

    9. How the Ground Truth for the Training Set Was Established

    Not Applicable. As there is no training set for an algorithm, there is no ground truth established in this context.

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