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510(k) Data Aggregation

    K Number
    K191287
    Device Name
    OptiFix AT Absorbable Fixation System with Articulating Technology – 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology – 15 Fasteners
    Manufacturer
    Davol Inc., Subsidiary of C.R. Bard
    Date Cleared
    2019-07-16

    (64 days)

    Product Code
    GDW
    Regulation Number
    878.4750
    Type
    Special
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K142873,K170278
    Why did this record match?
    Reference Devices :

    K142873

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

    The OptiFix AT Absorbable Fixation System with Articulating Technology is indicated for the approximation of soft tissue and fixation of surgical mesh to tissues during open or laparoscopic surgical procedures, such as hernia repair.

    Device Description

    The OptiFix™ AT Absorbable Fixation System with Articulating Technology, herein after referred to as "OptiFix™ AT", is a sterile (via gamma) single use device that is comprised of a deployment component and an absorbable fastener component. The device is available in either 15 or 30 preloaded fasteners. The tip of the shaft can be articulated, and the handle of the device can be rotated 360 degrees to facilitate access for fixation during surgery. The fasteners are designed with retention features and are manufactured from Poly (L-lactide and glycolide) and are dyed with D&C Violet No. 2.

    AI/ML Overview

    Here's an analysis of the provided text regarding the acceptance criteria and study proving device performance:

    1. Table of Acceptance Criteria and Reported Device Performance

    The document does not explicitly state specific quantifiable acceptance criteria (e.g., minimum tensile strength, maximum deployment force) or numerical performance metrics for the OptiFix™ AT device. Instead, it uses qualitative statements about the device meeting established requirements.

    Acceptance Criteria CategoryReported Device Performance
    BiocompatibilitySuccessfully completed testing "in accordance with the FDA Guidance" and "International Standard ISO 10993-1."
    Product Testing"Passed all the test requirements and demonstrated that the proposed device design meets product specifications and intended uses. All samples tested met the established acceptance criteria."
    Package Integrity"Completed... in accordance with the following FDA consensus standards: ISO 11607-1+A1:2014" and "ISO 11607-2:2006+A1:2014."

    2. Sample Sizes and Data Provenance

    The document does not specify the sample sizes used for the product testing (design verification and validation).

    • Test Set Sample Size: Not specified.
    • Data Provenance: Not explicitly stated, but given the nature of pre-market submissions in the US, the testing would generally occur in the US or in adherence to US/international standards. It is retrospective in the sense that the testing was completed prior to the submission.

    3. Number of Experts and Qualifications for Ground Truth Establishment

    This information is not applicable as the device is a physical medical stapling system, not an AI/software device that requires expert-established ground truth for a test set. The performance is assessed through engineering and biological testing.

    4. Adjudication Method for the Test Set

    This information is not applicable as the device is a physical medical stapling system. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or for setting ground truth in imaging/AI studies, which were not conducted for this submission.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

    No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical studies were not performed for the submission of this device nor were clinical studies performed for the predicate device." MRMC studies are typically for evaluating diagnostic devices where human readers interpret results.

    6. Standalone (Algorithm Only) Performance Study

    No, a standalone performance study was not done. This device is a physical medical staple system and does not involve an algorithm.

    7. Type of Ground Truth Used

    The concept of "ground truth" as typically used in AI/diagnostic studies (e.g., expert consensus, pathology, outcomes data) is not directly applicable here. For this physical device, the "ground truth" for verifying performance relies on:

    • Engineering Specifications: The device's design, materials, and functional performance are compared against predetermined engineering specifications and safety standards.
    • Biocompatibility Standards: Performance against established international standards (ISO 10993).
    • Packaging Standards: Performance against established international standards (ISO 11607).

    8. Sample Size for the Training Set

    This information is not applicable. This is a physical medical device, not an AI algorithm, so there is no training set in the AI sense. The manufacturing process and quality control would involve internal testing of components and assemblies that could be analogous to "training" in a broader engineering sense, but not for an "AI training set."

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

    This information is not applicable for the same reason as point 8. The "ground truth" for the design and manufacturing of such a device is established through engineering design principles, material science, applicable regulatory standards, and risk assessments.

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