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510(k) Data Aggregation

    K Number
    K080353
    Device Name
    LTM-T SURGICAL MESH
    Manufacturer
    LIFECELL CORP.
    Date Cleared
    2008-04-03

    (52 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K070560,K071065
    Why did this record match?
    Device Name :

    LTM-T SURGICAL MESH

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

    The LifeCell Tissue Matrix (LTM) Surgical Mesh is intended for the reinforcement of soft tissue repaired by sutures or suture anchors during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Indications for use also include the repair of body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome.

    The device is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Sutures, used to repair the tear, and sutures or bone anchors used to attach the tissue to the bone, provide biomechanical strength for the tendon repair.

    LTM is intended for single patient, one time use only.

    Device Description

    The LTM is a surgical mesh that is derived from porcine skin. The LTM device consists of a terminally sterilized sheet of the processed porcine dermal matrix provided in prescribed geometric configurations and thicknesses, and packaged in double pouch configuration.

    AI/ML Overview

    The provided text describes a 510(k) summary for the LTM Surgical Mesh. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study design with specific performance metrics as one would find for a novel device or software.

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

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

    Acceptance CriteriaReported Device Performance
    Biocompatibility: Device is suitable for contact with living tissue without causing adverse reactions.The data indicate that the device is biocompatible.
    Viral Inactivation: Manufacturing process effectively inactivates viral components that may be present in the starting material.The manufacturing process is capable of inactivating any viral components that may come with the starting material.
    Biomechanical Strength & Suture Retention: The material possesses sufficient strength and suture retention for its intended use (reinforcement of soft tissue in tendon repair and body wall defects).The biomechanical data show that the LTM matrix possesses sufficient strength and suture retention for the intended use.
    Substantial Equivalence: LTM Surgical Mesh is as safe and effective as legally marketed predicate devices.LTM is substantially equivalent to LifeCell Corp.'s LTM Surgical Mesh (K070560) and Pegasus Biologics, Inc.'s OrthADAPT™ (K071065).

    2. Sample size used for the test set and the data provenance

    The document does not specify a "test set" in the context of a dataset for an AI device. Instead, it refers to different types of testing:

    • Biocompatibility testing: Not specified.
    • Animal testing: Not specified.
    • Viral inactivation testing: Not specified.
    • Biomechanical testing: Not specified.

    The text does not mention the country of origin of data or whether it was retrospective or prospective, as these are details commonly associated with clinical studies for AI/software devices. The studies mentioned here are performance and safety tests for a biological medical device.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

    This information is not applicable and is not provided. The ground truth for this device's performance is established through laboratory and animal testing, not expert interpretation of data points.

    4. Adjudication method for the test set

    This information is not applicable and is not provided. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human readers or expert panels for diagnostic tasks, which is not the nature of the testing described here for a surgical mesh.

    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

    No such study was conducted or mentioned. This type of study is relevant for AI-powered diagnostic or assistive devices, not for a surgical mesh.

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

    This concept is not applicable to the LTM Surgical Mesh, which is a physical device, not an algorithm.

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

    The "ground truth" for this device's performance is based on:

    • Biocompatibility standards: Likely established through standardized in-vitro and in-vivo tests.
    • Viral inactivation protocols: Based on validated methods to demonstrate removal or inactivation of viruses.
    • Biomechanical engineering principles: Measured properties like tensile strength and suture retention, compared against established requirements for the intended application.

    8. The sample size for the training set

    This information is not applicable as the LTM Surgical Mesh is a physical product, not an AI/software device that requires a training set.

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

    This information is not applicable.

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