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510(k) Data Aggregation

    K Number
    K192580
    Manufacturer
    Date Cleared
    2019-12-18

    (90 days)

    Product Code
    Regulation Number
    878.4493
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control Device

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

    STRATAFIX™ Spiral MONOCRYL™ Plus Bidirectional Knotless Tissue Control Device is indicated for soft tissue approximation where use of an absorbable suture is appropriate.

    Device Description

    The STRATAFIX™ Spiral MONOCRYL™ Plus Bidirectional Knotless Tissue Control Device is an antibacterial monofilament, synthetic absorbable device prepared from a copolymer of glycolide and s-caprolactone. The device contains IRGACARE®* MP (triclosan), a broad spectrum antibacterial agent, at no more than 2360 µg/m. The device is available in a dyed and undyed version. The pigment for the dyed version is D&C Violet No. 2. Poliglecaprone 25 copolymer has been found to be nonpyrogenic and elicits only a slight tissue reaction during absorption.

    The STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Bidirectional Device Design consists of barbed suture material, armed with a surgical needle on each end. The device also contains an unbarbed center transition zone that facilitation of the device use. The STRATAFIX™ Spiral MONOCRYL™ Plus Device barbs allow for tissue approximation without the need to tie surgical knots.

    AI/ML Overview

    Here's the information about the acceptance criteria and the study that proves the device meets them, based on the provided text:

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

    The document provides specific acceptance criteria for "Tensile Strength." For other characteristics, it broadly states conformance to the USP Monograph for absorbable surgical sutures, with an exception for diameter, and mentions other tests performed.

    Acceptance CriteriaReported Device Performance
    Tensile Strength
    USP Device Size 0 Minimum Knot Tensile Strength (kgf)3.90
    USP Device Size 2-0 Minimum Knot Tensile Strength (kgf)2.68
    USP Device Size 3-0 Minimum Knot Tensile Strength (kgf)1.77
    USP Device Size 4-0 Minimum Knot Tensile Strength (kgf)0.95
    EU Pharmacopoeia Device Size 3.5 Minimum Knot Tensile Strength (N)39.0
    EU Pharmacopoeia Device Size 3 Minimum Knot Tensile Strength (N)26.3
    EU Pharmacopoeia Device Size 2 Minimum Knot Tensile Strength (N)17.4
    EU Pharmacopoeia Device Size 1.5 Minimum Knot Tensile Strength (N)9.32
    Other Criteria
    Suture DiameterConforms to USP Monograph, except for diameter (actual diameter of non-barbed section is one size greater than designated size with a maximum overage of 0.1 mm)
    Needle Attachment StrengthConforms to the current USP Monograph for absorbable surgical sutures
    In Vitro Breaking StrengthConforms to the current USP Monograph for absorbable surgical sutures
    Ex Vivo Wound Closure StrengthConforms to the current USP Monograph for absorbable surgical sutures

    2. Sample sized 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 used for the test sets (e.g., number of sutures, number of measurements for each test). It also does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given that this is a 510(k) submission for a medical device and the tests are non-clinical laboratory performance tests, the data would typically be generated in a controlled laboratory environment, likely within the manufacturer's R&D facilities or contracted labs, rather than from human patients.

    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)

    This section is not applicable to the provided document. The "ground truth" for this type of device (surgical suture) is established through objective, quantifiable physical and chemical properties and performance characteristics, as defined by standard monographs (like USP and EU Pharmacopoeia) and engineering test methods. It does not rely on expert interpretation or consensus in the way, for example, an image analysis AI would.

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

    This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human evaluators and subjective assessments, particularly when establishing ground truth for AI algorithms or clinical endpoints. The studies described here are bench and ex vivo performance tests.

    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 section is not applicable. The device described is a physical surgical suture, not an AI software or a device that assists human readers in diagnostic tasks. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance would not be relevant.

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

    This section is not applicable. The device is a surgical suture, not an algorithm.

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

    The "ground truth" for the device's performance is based on established industry standards and objective physical measurements. Specifically:

    • USP Monograph for absorbable surgical sutures: This serves as the primary standard for characteristics like suture diameter (with an noted exception), needle attachment strength, in vitro breaking strength, and ex vivo wound closure strength.
    • EU Pharmacopoeia: Also referenced for device size and tensile strength.
    • Defined Tensile Strength values: Specific numeric criteria for minimum knot tensile strength are provided in Table 2, which are objective quantitative targets.

    8. The sample size for the training set

    This section is not applicable. The device is a physical product (surgical suture) and not an AI algorithm that requires a training set.

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

    This section is not applicable, as there is no AI algorithm training set involved. The "ground truth" for the performance of the suture itself is established by the methods described in point 7.

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