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510(k) Data Aggregation

    K Number
    K172186
    Device Name
    BioWick X Implant with Driver
    Manufacturer
    Cayenne Medical, Inc.
    Date Cleared
    2017-10-16

    (88 days)

    Product Code
    MBI
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K151068
    Why did this record match?
    Device Name :

    BioWick X Implant with Driver

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

    The Cayenne Medical, Inc. BioWick™ X Implant is intended to be used for the reattachment of soft tissue to bone in rotator cuff repairs.

    Device Description

    The BioWick™ X Implant is a sterile, manually operated, single procedure implant device for reattachment of soft tissue to bone. The implant is preloaded with floating suture and loaded on a disposable driver. The BioWick™ X implant incorporates design features that facilitate implant placement under arthroscopic, open, or limited access conditions in soft tissue to bone reattachment procedures. The BioWick™ X implant is offered in two sizes, 5.5 mm and 6.5 mm. The implant is made out of PolyEtherEtherKetone (PEEK), L-lactide/glycolide copolymer (PLGA), and Ultra High Molecular Weight Polyethylene (UHMWPE). The floating sutures are size 2 non-absorbable Ultra High Molecular Weight Polyethylene (UHMWPE) surgical sutures. The implant is either preloaded with two or three surgical sutures. The disposable driver has a working shaft length (from handle to distal tip of anchor) of 6.24 in (158mm) with an outer shaft diameter of 0.159 in (4.0mm). The driver shaft is made out of surgical grade stainless steel and the handle is made out of ABS plastic. The driver facilitates the placement of the implant into a hole tapped in the bone.

    AI/ML Overview

    The provided text is a 510(k) Summary for a medical device (BioWick™ X Implant with Driver) and does not contain information about a study proving the device meets specific acceptance criteria in the context of AI/ML or diagnostic performance. Instead, it details the substantial equivalence of the new device to a predicate device, which is a regulatory pathway for medical devices.

    Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to an AI/ML or diagnostic study.

    Based on the provided text, the following points can be extracted about the device's regulatory submission, but not in the format of AI/ML performance criteria:

    • Acceptance Criteria and Reported Device Performance: This information is not presented as "acceptance criteria" and "reported device performance" in the context of a diagnostic study. Instead, the submission focuses on demonstrating "substantial equivalence" to a predicate device (K151068 SureLock W Suture Anchor). This equivalence is based on similarities in indications for use, intended use, design features, technology, and materials.

      • Indications for Use: The BioWick™ X Implant is intended to be used for the reattachment of soft tissue to bone in rotator cuff repairs. This is identical to the predicate device.
      • Technological Differences: The subject device differs from the predicate device in terms of design features (number of floating sutures) and the offered sizes.
      • Non-clinical Testing: The device underwent non-clinical testing including being assessed as non-pyrogenic, biocompatibility testing, sterility validation, and mechanical and cadaveric usability testing. The results of these tests are implied to have met sufficient standards to demonstrate substantial equivalence, but specific numerical acceptance criteria and performance data are not detailed in this summary.

    • Sample Size for Test Set and Data Provenance: Not applicable. No diagnostic test set was used. Non-clinical testing was performed, but specific sample sizes for these tests are not provided in the summary.

    • Number of Experts and Qualifications: Not applicable. This summary does not involve expert review for diagnostic ground truth.

    • Adjudication Method: Not applicable.

    • Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No MRMC study was done, as clinical testing was not used to establish substantial equivalence.

    • Standalone Performance: Not applicable. This is not an AI/ML algorithm requiring standalone performance evaluation.

    • Type of Ground Truth Used: Not applicable in the context of AI/ML. The "ground truth" for this device's regulatory review is its comparison to an already marketed predicate device based on its design, materials, and intended use, supported by non-clinical testing.

    • Sample Size for Training Set: Not applicable. There is no training set for an AI/ML algorithm.

    • How Ground Truth for Training Set Was Established: Not applicable.

    In summary, the provided document is a regulatory submission for a medical implant, not a study evaluating the diagnostic performance of an AI/ML device. Therefore, the requested information cannot be extracted from the text.

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