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510(k) Data Aggregation

    K Number
    K042295
    Device Name
    SMARTSCREW II, MODELS 232010, 232012, 232014, 232016, 232018, 232020
    Manufacturer
    LINVATEC BIOMATERIALS, LTD.
    Date Cleared
    2004-09-16

    (23 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K012001
    Why did this record match?
    Reference Devices :

    K012001

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

    SmartScrew® II is generally intended for maintenance of alignment and fixation of fractures, osteotomies, arthrodeses of cancellous bone with the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects 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aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone 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cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long 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cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects 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condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone 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    Device Description

    SmartScrew® II is generally intended for maintenance of alignment and fixation of fractures, osteotomies, arthrodeses of cancellous bone with the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, 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cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long 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cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long bones, and cancellous bone within the condylar aspects of long 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    AI/ML Overview

    This 510(k) premarket notification for the SmartScrew II is a Special 510(k), meaning it is for a modification to a previously cleared device (the SmartScrew/NuGenFX Screw, K012001). As such, the submission focuses on demonstrating that the revised device is substantially equivalent to the predicate device, especially regarding the modification, rather than proving performance against novel acceptance criteria through extensive clinical studies like a de novo device might require.

    Therefore, the provided document does not contain information about specific acceptance criteria or a detailed study proving the device meets those criteria in the way a new device would. Instead, the "study" is more accurately a comparison to the predicate device focusing on the impact of the design change.

    Here's how to address your request based on the provided text, recognizing the nature of a Special 510(k):

    Acceptance Criteria and Reported Device Performance

    The acceptance criteria for a Special 510(k) revolve around demonstrating that the modifications do not negatively impact the safety and effectiveness of the device and that it remains substantially equivalent to the predicate. The performance is assessed by comparing the new design feature (screw head) against the predicate.

    Acceptance Criteria CategoryCriteria (Implicit from Special 510(k) context)Reported Device Performance (as per submission)
    Intended UseThe device maintains the same intended use as the predicate."the same indicated use"
    Principles of OperationThe fundamental mechanism by which the device achieves its purpose remains unchanged."uses the same operating principle"
    Basic Design of ThreadThe screw thread design, crucial for fixation, is identical to the predicate."incorporates the same basic design of thread"
    Basic DimensionsOverall critical dimensions are maintained, except for the specific head modification."utilizes the same basic dimensions" (implying the functional dimensions outside the head modification are similar)
    Manufacturing ProcessThe method of production remains consistent."is manufactured by machining"
    Packaging & SterilizationThe safety and efficacy of these processes are unchanged."is packaged and sterilized using the same materials and processes"
    Shelf LifeThe stability and integrity of the device over time are not affected."has the same shelf life"
    Effect on Torsion PropertiesThe new head design should not compromise the screw's ability to withstand torsional forces during insertion."The main purposes were smaller size of screw head and improvement of installation properties without scarifying torsion properties of the screw model." (This is a claim, and generally, for a special 510(k), bench testing data would be provided to support this, even if not detailed in the summary. The summary implies that testing demonstrated no negative impact on torsion properties, or perhaps an improvement in installation without loss of torsion.)
    Material / BiocompatibilityRaw materials remain the same, ensuring continued biocompatibility."The revision of head design has no effect on... raw material"
    SterilizationSterilization methods remain the same."The revision of head design has no effect on... sterilization"
    Risk Assessment (Safety/Efficacy)No new risks are introduced, and overall safety and effectiveness are maintained.The entire submission aims to demonstrate this by showing substantial equivalence in all critical aspects. The FDA's clearance confirms this was deemed met.

    Study Information (Based on Special 510(k) Context)

    1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

      • Sample Size: Not explicitly stated. For a Special 510(k) focused on a design change like this, the "test set" would typically involve bench testing of the new screw head design and the predicate design for properties like torsional strength, insertion torque, and perhaps pull-out strength. The sample size for such bench tests would likely involve a statistically significant number of screws of each type, but this is not detailed in the summary.
      • Data Provenance: Not stated. Given the manufacturer is based in Finland, the testing would likely have been conducted in Europe or by contractors. It would be prospective bench testing designed specifically to compare the new and predicate designs.

    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

      • This is not applicable in the context of this 510(k). "Ground truth" established by experts (like radiologists for imaging devices) is relevant for diagnostic devices or those requiring subjective clinical assessment. For a mechanical fixation device undergoing a minor design change evaluated by substantial equivalence, "ground truth" is typically established through objective engineering tests (bench testing) and comparison against established performance criteria of the predicate. Engineers and biomechanical specialists would design and execute these tests.

    3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

      • Not applicable. Adjudication methods (like 2+1 for discordant expert reads) are used in studies involving human interpretation or clinical outcomes where subjectivity might exist. For objective engineering bench tests, results are typically quantitative and directly compared, not "adjudicated."

    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:

      • Not applicable. This is a mechanical orthopedic fixation device, not an AI-powered diagnostic tool. MRMC studies are used for evaluating diagnostic performance, particularly with AI assistance in image interpretation.

    5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

      • Not applicable. This device does not involve an algorithm or AI.

    6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

      • The "ground truth" for this type of device, especially for a special 510(k), is primarily objective engineering and biomechanical data (e.g., torsional strength, insertion torque, material properties) derived from bench testing comparing the modified device to the predicate device and ensuring it meets its original performance specifications and does not introduce new risks.

    7. The sample size for the training set:

      • Not applicable. This is not a machine learning or AI device, so there is no "training set" in that sense. If referring to product development testing, materials were iterated and developed, but not as a "training set" for an algorithm.

    8. How the ground truth for the training set was established:

      • Not applicable. See point 7.
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    K Number
    K020056
    Device Name
    DUET SUTURE ANCHOR
    Manufacturer
    BIONX IMPLANTS, LTD.
    Date Cleared
    2002-06-26

    (169 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K993074,K993453,K993073,K012001,K000616,K003970,K001378,K013057,K972783,K973849,K992567,K990361,K990987,K003227,K990340,K973381,K992458,K984490,K963396,K960555,K964805,K963369,K983186,K990110,K950272,K970896,K964013,K911837,K964921
    Why did this record match?
    Reference Devices :

    K993074, K993453, K993073, K012001, K000616, K003970, K001378, K013057

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

    The Bionx Duet™ Suture Anchor is intended for use to reattach soft tissue to bone in orthopaedic surgical procedures. The device may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules, to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.

    Device Description

    Duet™ Suture Anchor is threaded, bioabsorbable suture anchor, provided as preloaded with two non-absorbable, braided, polyester #2 sutures, one of them is green and another one is white. Diameter of the anchor is 6.0mm and length 16.5mm. It is assembled with sutures with needles into single use, sterile, disposable driver and packaged into blister with a punch. The Duet™ Suture Anchor is made of poly-L/D-lactide copolymer.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for a medical device called the Duet™ Suture Anchor. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a standalone study.

    Therefore, the requested information elements related to acceptance criteria, device performance, study design (test/training sets, ground truth, expert opinions, MRMC studies) are not explicitly described in the provided text.

    Here's a breakdown of what can be extracted and what information is missing:

    1. A table of acceptance criteria and the reported device performance

    • Not explicitly provided. The document focuses on demonstrating that the Duet™ Suture Anchor has the "same intended use and principles of operation and very similar technological characteristics" as existing predicate devices. It states that "the minor technological differences between the Bionx Implants Inc. Duet™ Suture Anchor and the predicate devices do not raise any new issues of safety or effectiveness." This implies that the device is expected to perform comparably to its predicates, but no specific performance metrics or acceptance criteria are listed for the Duet™ itself.

    2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

    • Not applicable/Not provided. This document is a 510(k) submission, not a clinical study report. It does not describe a test set or data provenance in the context of device performance evaluation.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

    • Not applicable/Not provided. Ground truth establishment is not discussed in the context of device performance in this document.

    4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

    • Not applicable/Not provided. Adjudication is not mentioned as no performance study is described.

    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

    • Not applicable. This device is a bioabsorbable surgical anchor, not an AI-powered diagnostic tool. Therefore, an MRMC study is irrelevant to its evaluation.

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

    • Not applicable. This is a physical implant, not an algorithm.

    7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

    • Not applicable/Not provided. Ground truth is not discussed.

    8. The sample size for the training set

    • Not applicable/Not provided. Training sets are relevant for AI/machine learning models, which this device is not.

    9. How the ground truth for the training set was established

    • Not applicable/Not provided. Ground truth for a training set is not discussed.

    Summary of what the document does provide:

    • Intended Use: Reattachment of soft tissue to bone by arthroscopy or direct visualization.
    • Predicate Devices: A long list of existing bioabsorbable suture anchors with similar intended uses and principles of operation.
    • Material: Self-Reinforced (96/4D) PLA Copolymer, with the material provenance being previously cleared Bionx Implants Inc. devices.
    • Mechanism of action: Retains 90% strength through 20 weeks and completely resorbs over several years, allowing gradual strength loss as collagen fibers heal.
    • Conclusion: The FDA determined the device is "substantially equivalent" to legally marketed predicate devices, meaning it does not raise new issues of safety or effectiveness. This is the primary "proof" of meeting regulatory requirements for this type of submission.
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