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510(k) Data Aggregation

    K Number
    K203381
    Device Name
    Dynanail Mini Hybrid
    Manufacturer
    MedShape Inc
    Date Cleared
    2021-01-15

    (59 days)

    Product Code
    HWC,JDS
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K182677
    Why did this record match?
    Device Name :

    Dynanail Mini Hybrid

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

    The DynaNail Mini™ Fusion System is indicated for fracture fixation, osteotomies, reconstruction procedures, non-unions, and fusions of large bones in the foot and ankle.

    Device Description

    The proposed DynaNail Mini Hybrid™ is part of the DynaNail Mini™ Fusion System. The proposed implant is sterile, single use titanium device with an additional internal Nitinol compressive element for use in midfoot and hindfoot reconstruction. A titanium outer body provides bending and torsional rigidity to the arthrodesis construct, while the internal Nitinol compressive element sustains compression across the joints post-operatively. The DynaNail Mini Hybrid™ is available in multiple diameters and lengths to accommodate variations in patient anatomy. The DynaNail Mini Hybrid™ is implanted with a driver/ deployment frame and fixation screws. The fixation screws are single use titanium headless screws. These are available in various lengths to accommodate the anatomical fixation required. The system includes instruments for implantation.

    AI/ML Overview

    The provided text describes a medical device, the DynaNail Mini HybridTM, and its 510(k) premarket notification to the FDA. The information focuses on the device's characteristics, intended use, and comparison to a predicate device to establish substantial equivalence.

    Based on the provided text, the device is a Smooth or threaded metallic bone fixation fastener / Orthopedic Nail. The acceptance criteria and the study that proves the device meets them are described in the context of establishing substantial equivalence to a predicate device, not in the typical sense of AI/algorithm performance.

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

    1. A table of acceptance criteria and the reported device performance
    Acceptance Criteria (Performance Tests)Reported Device Performance
    Static Torsion test per ASTM F543Test results and analysis demonstrate substantial equivalent performance to the predicate device.
    Static Axial Strain test per ASTM F2516Test results and analysis demonstrate substantial equivalent performance to the predicate device.
    Fatigue Strain test per ASTM E606Test results and analysis demonstrate substantial equivalent performance to the predicate device.
    Pyrogenicity testing per ANSI/AAMI ST72 (worst-case largest DynaNail™ system)Confirms the most loaded device scenario meets the limit of 20EU.
    Bacterial endotoxin testing (BET) per ANSI/AAMI ST-72:2011 (R2016)Confirms the most loaded device scenario meets the limit of 20EU.

    1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
      The document does not specify the sample sizes for the mechanical tests (Static Torsion, Static Axial Strain, Fatigue Strain, Pyrogenicity, BET). These tests are typically performed on a limited number of device samples, not patient data. The provenance of this data is from engineering analysis and laboratory testing, not patient-derived data from specific countries or study designs (retrospective/prospective).

    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
      Not applicable (N/A). The evaluation is based on engineering and material performance specifications of the device itself, not on expert interpretations of medical images or patient outcomes.

    3. Adjudication method (e.g. 2+1, 3+1, none) for the test set
      N/A. This concept is for clinical trials or diagnostic performance studies involving human interpretation. The reported studies are mechanical and biocompatibility tests.

    4. 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
      N/A. This is a medical device (bone fixation fastener), not an AI diagnostic or assistance tool. Therefore, MRMC studies are not relevant.

    5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
      N/A. This is a hardware medical device, not an algorithm.

    6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
      The "ground truth" for the device's performance is established by validated engineering standards (ASTM F543, ASTM F2516, ASTM E606) and biocompatibility standards (ANSI/AAMI ST72). The ground truth for performance is the ability of the device to meet the specified performance criteria set by these standards, demonstrating substantial equivalence to the predicate device.

    7. The sample size for the training set
      N/A. This medical device does not involve a "training set" in the context of machine learning or AI.

    8. How the ground truth for the training set was established
      N/A. As there is no training set, this question is not applicable.

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