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510(k) Data Aggregation

    K Number
    K243712
    Device Name
    WasherCap™ Mini Fixation System (Model 45)
    Manufacturer
    ABANZA TECNOMED S.L.
    Date Cleared
    2025-01-30

    (59 days)

    Product Code
    MBI
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K203495,K221135,K212197
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    WasherCap™ Mini Fixation System is intended for fixation of suture/tape (soft tissue) to bone in the shoulder, knee and hand/wrist, in skeletally mature pediatric and adult patients for the following procedures:

    • Knee:

    • Meniscal root repair: using non-absorbable UHMWPE USP 2-0 sutures or non-absorbable UHMWPE 1.4-2.2mm tapes.

    • Meniscal transplant: using non-absorbable UHMWPE USP 2-0 sutures or non-absorbable UHMWPE 1.4-2.2mm tapes.

    • ACL/PCL Repair: using non-absorbable UHMWPE USP 2-0 sutures or non-absorbable UHMWPE 1.4-2.2mm tapes.

    • ACL Reconstruction: only with WasherCap™ Mini Fixation System 4.5mm size and using 2 nonabsorbable UHMWPE 1.4mm tapes or 1 non-absorbable UHMWPE 2.2mm tape.

    • Shoulder:

    • Rotator Cuff Repair: using non-absorbable UHMWPE USP 2-0 sutures or non-absorbable UHMWPE 1.4-2.2mm tapes.

    • Hand/Wrist:

    • Triangular fibrocartilage complex (TFCC): only with WasherCap™ Mini Fixation System 3.5mm size and using non-absorbable UHMWPE USP 2-0 sutures or non-absorbable UHMWPE 1.4-2.2mm tapes.
    Device Description

    The WasherCap™ Mini Fixation System consists of an implantable device, a handled inserter, a handled screwdriver, a drill guide, a drill bit and a suture threader. The WasherCap™ Mini implantable device is pre-loaded on the handled inserter with the suture threader.

    The drill guide and the drill bit should be used to perform a drilling guided specifically to the angulation necessary to create the bone socket where the screw of the implant should be located. The suture/tape is passed through the cap with the suture threader and the screw is threaded with the handled screwdriver, setting the tension of the suture/tape.

    The WasherCap™ Mini Fixation System is provided sterile and individually packaged. All components are for single use only.

    The WasherCap™ Mini Fixation System is available in different sizes and should be implanted following the corresponding surgical procedure.

    AI/ML Overview

    This document describes the premarket notification for the WasherCap™ Mini Fixation System and does not contain the detailed information about the acceptance criteria and study proving the device meets those criteria for software-based medical devices or AI/ML components.

    The provided text pertains to a physical medical device (a bone fixation system) and its substantial equivalence to a predicate device. The performance data mentioned refers to bench testing of mechanical properties, not the performance of an AI/ML algorithm.

    Therefore, I cannot extract the requested information regarding:

    1. A table of acceptance criteria and reported device performance for an AI/ML device.
    2. Sample size and data provenance for a test set in the context of an AI/ML study.
    3. Number and qualifications of experts for ground truth establishment for an AI/ML study.
    4. Adjudication method for an AI/ML test set.
    5. MRMC comparative effectiveness study results for AI assistance.
    6. Standalone performance of an AI algorithm.
    7. Type of ground truth used for AI/ML.
    8. Sample size for the training set of an AI/ML model.
    9. How ground truth for the training set was established for an AI/ML model.

    The document explicitly states:

    • "This submission does not include any animal performance testing. It was determined that no such testing is required to demonstrate substantial equivalence." (page 8)
    • "This submission does not include any clinical performance testing. It was determined that no such testing is required to demonstrate substantial equivalence." (page 9)

    Instead, the performance data section (page 8) focuses on:

    • "Bench testing was performed on the subject device to evaluate cyclic loading and elongation, insertion, interconnection, and bone anchor pullout force."
    • "Bench testing was performed on the subject device and compared to the predicate device: cyclic loading and elongation, and bone anchor pullout force."
    • "The results of the testing met the defined acceptance criteria and were assessed against the results obtained with the predicate devices to determine substantial equivalence for design and performance."
    • "Final devices were subjected to Bacterial endotoxin testing per EP 2.6.14/USP to demonstrate that the device meets pyrogen limit specifications."

    This indicates that the "acceptance criteria" and "study" refer to mechanical and biocompatibility testing for a physical implant, not an AI/ML component.

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