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510(k) Data Aggregation

    K Number
    K212547
    Device Name
    Quick-Start Screws
    Manufacturer
    Innovate Orthopaedics Limited
    Date Cleared
    2021-12-30

    (139 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K992945
    Why did this record match?
    Device Name :

    Quick-Start Screws

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

    Quick-Start Screws are indicated for interference fixation of soft tissue grafts and/or bone-tendon-bone grafts for ligament reconstruction such as anterior/posterior cruciate ligament (ACL/PCL), medial collateral (MCL), lateral collateral (LCL), posterolateral corner (PLC) and medial patellofemoral (MPFL) reconstructions.

    Device Description

    The Innovate Orthopaedics Quick-Start Screw family of products are interference screws indicated for the fixation of soft tissue or bone-tendon-bone grafts in ligament reconstruction procedures. The screw is composed of medical grade titanium alloy and is supplied sterile for single use in both standard thread and reverse thread designs.

    AI/ML Overview

    The provided text describes the performance data for the Quick-Start Screws in a 510(k) summary submitted to the FDA. Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria / TestReported Device Performance
    Biophysical Performance (Comparative)
    Ease of engagement with bone tunnel and initial insertionThe Quick-Start Screw was found to be easier to engage with the bone tunnel and initially insert than the comparative device.
    Immediate postsurgical fixation strengthThe Quick-Start Screw achieved similar immediate postsurgical fixation strength compared to the comparative device.
    ASTM Standards (Bench Testing)
    Torsional strength (ASTM F543)The Quick-Start Orthopaedic Fixation Screws meet the performance-based requirements outlined by the FDA. (Implies compliance with ASTM F543 parameters, specific values not provided in the summary.)
    Driving torque (ASTM F543)The Quick-Start Orthopaedic Fixation Screws meet the performance-based requirements outlined by the FDA. (Implies compliance with ASTM F543 parameters, specific values not provided in the summary.)
    Axial pullout strengthThe Quick-Start Orthopaedic Fixation Screws meet the performance-based requirements outlined by the FDA. (Implies compliance with relevant ASTM standards, specific values not provided in the summary.)
    Endotoxin Level (LAL Test)
    Meets acceptance criteria at 20 endotoxin units per deviceTesting demonstrates that the subject devices meet the acceptance criteria at 20 endotoxin units per device in accordance with USP for medical devices which are not in contact with cerebrospinal fluid.
    Biocompatibility (ISO 10993-1)
    Biocompatible for permanent contact (>30 days)The Quick Start Screws were determined to be biocompatible per International standard: ISO 10993-1, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing and FDA Guidance Document: Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part-1": Evaluation and Testing within a risk management process... categorized as an implant device with permanent contact (>30 days) to tissue or bone. (Implies compliance with ISO 10993-1 requirements for this category).
    Sterility (Co60 gamma irradiation)
    Sterility Assurance Level (SAL) 10-6The Quick Start screws are provided sterile (SAL 10-6) by means of Co60 gamma irradiation.
    Shelf Life
    5-year shelf lifeThe Quick Start Screws have a 5 year shelf life. (Implies testing was conducted to support this claim, though the specific study details are not provided in this summary. This would typically involve accelerated aging studies or real-time studies to demonstrate maintenance of sterility and material properties over the claimed period.)

    2. Sample Size Used for the Test Set and Data Provenance

    • Comparative Biophysical Performance Study:

      • Sample Size: 10 fresh-frozen human cadaveric knees.
      • Data Provenance: Retrospective (cadaveric tissue implies specimens were obtained from previously deceased individuals), likely from a country with cadaver donation programs. The document does not specify the country of origin.

    • ASTM Standards Testing, Endotoxin, Biocompatibility, Sterility:

      • Sample Size: Not explicitly stated for bench testing, endotoxin, biocompatibility, or sterility. These tests typically involve a statistically relevant number of samples for each specific test, but the exact count is not detailed in this summary.
      • Data Provenance: Not explicitly stated, but typically these are laboratory-based tests.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

    • This information is not provided in the given text. The studies described are primarily performance and bench testing, not image-based diagnostic studies that would require expert consensus for ground truth.

    4. Adjudication Method for the Test Set

    • This information is not applicable/not provided as the studies are primarily objective performance tests of the device itself (e.g., insertion ease, fixation strength, material properties) rather than studies that require human interpretation and adjudication of a dataset.

    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 information is not provided and is not applicable. The device is an orthopedic fixation screw, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance would not be relevant.

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

    • This information is not provided and is not applicable. The device is a physical medical implant, not an algorithm.

    7. The Type of Ground Truth Used

    • Comparative Biophysical Performance Study: The ground truth for this study was direct physical measurement and observation of the device's interaction with cadaveric bone (e.g., ease of insertion, immediate fixation strength) in comparison to a predicate device.
    • ASTM Standards Testing: The ground truth was defined by established engineering and material science standards (e.g., ASTM F543) and measured physical properties of the screw (torsional strength, driving torque, axial pullout strength).
    • Endotoxin Testing: The ground truth was the quantitative measurement of endotoxin levels against a specified USP acceptance limit.
    • Biocompatibility Testing: The ground truth was biological response assessment against the criteria outlined in ISO 10993-1.
    • Sterility Testing: The ground truth was the absence of viable microorganisms to a specified SAL (verified through standard sterility testing methods).

    8. The Sample Size for the Training Set

    • This information is not provided and is not applicable. As a physical medical device, there is no "training set" in the context of an AI/ML algorithm. The "training" for the device's design and manufacturing processes would be related to engineering iterative design and testing, not a data-driven training set.

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

    • This information is not provided and is not applicable for the reasons stated in point 8.
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