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510(k) Data Aggregation

    K Number
    K052962
    Device Name
    OPTIMIZED BARB DESIGN
    Manufacturer
    SURGICAL SPECIALTIES CORP.
    Date Cleared
    2005-12-06

    (46 days)

    Product Code
    GAW
    Regulation Number
    878.5010
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K041593,K050548,K050247,K042856,K042075,K051609
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Contour Necklift Threads ™ are indicated for use in Necklift surgery. The Contour Necklift Threads TM are specifically indicated for use to fixate and Elevate the subdermis to the deep fascia of the retromastoid area.

    The Contour Midface Opposing Uni-Directional Threads™ are indicated for use in midface suspension surgery to fixate the cheek subdermis in an elevated position.

    The Contour Forehead/Browlift Thread™ is indicated for use in browplasty surgery. The Contour Forehead/Browlift Thread™ is specifically indicated for use to fixate the subdermis to the periosteum of the cranium in browplasty.

    The Featherlift™ Extended Length Aptos Thread is indicated for use in midface suspension surgery to fixate the cheek subdermis in an elevated position.

    Device Description

    The Contour Threads are a clear, nonabsorbable, sterile, surgical strand of polypropylene. The base product is USP size 2-0 polypropylene suture material. The Threads may incorporates a Uni-directional or Bi-directional barbed design. The Threads will be supplied with needles attached to both ends. The needles are made of 400 series stainless steel. The threads are supplied sterile for single use.

    AI/ML Overview

    1. Table of Acceptance Criteria and Reported Device Performance:

    Acceptance CriteriaReported Device Performance
    Biocompatibility"The Polypropylene material used for the Contour Threads is commonly used in medical applications and have been proven to be biocompatible."
    Safety and Effectiveness"Bench and animal evaluations have demonstrated the device to be safe and effective."
    Holding Tissue Force"Comparison of Holding Tissue Force in an Ex Vivo Test in pigs." (Specific results not detailed in the summary)
    Substantial Equivalence to Predicate Devices"The Contour Thread is identical to the intended use as previously submitted by Surgical Specialties Corporation. The Contour Thread barb design is the same as the Quill design approved in the 510(k) K042075 and K051609."

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

    • Test Set Sample Size: The document only mentions "Bench and animal evaluations" and "an Ex Vivo Test in pigs." It does not specify the exact sample size for these tests.
    • Data Provenance: The "Ex Vivo Test in pigs" indicates an animal model. The broad term "Bench evaluations" suggests laboratory testing. Specific country of origin is not mentioned. The studies appear to be prospective as they were conducted to support the 510(k) submission.

    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 in the document. The studies mentioned (bench, animal, ex vivo) do not typically involve human experts establishing ground truth in the same way clinical trials for diagnostic devices do.

    4. Adjudication method for the test set:

    This information is not applicable/provided. The studies described are performance tests (biocompatibility, safety, effectiveness, holding force), not studies requiring adjudication of output from a diagnostic algorithm.

    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 device is a surgical suture, not an AI-assisted diagnostic tool. Therefore, no MRMC study or AI assistance evaluation was conducted.

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

    This is not applicable. The device is a physical surgical suture, not an algorithm or AI system.

    7. The type of ground truth used:

    • For biocompatibility: Likely based on established standards and biological responses.
    • For safety and effectiveness: Likely based on observed outcomes in animal models and bench testing, adhering to pre-defined success criteria for surgical materials.
    • For holding tissue force: The "true" holding force would be the measured mechanical force in the ex vivo pig tissue test.

    8. The sample size for the training set:

    This is not applicable. The device is a physical product, not a machine learning model that requires a training set.

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

    This is not applicable, as there is no training set for this device.

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