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510(k) Data Aggregation

    K Number
    K023388
    Device Name
    MITEK RAPIDLOC-PDS MENISCAL REPAIR SYSTEM
    Manufacturer
    MITEK WORLDWIDE
    Date Cleared
    2002-12-27

    (79 days)

    Product Code
    JDR
    Regulation Number
    888.3030
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K002406,K970119
    Why did this record match?
    Device Name :

    MITEK RAPIDLOC-PDS MENISCAL REPAIR SYSTEM

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

    The RAPIDLOC-PDS Meniscal Repair System is intended for use in the arthroscopic fixation of longitudinal vertical meniscus lesions (bucket-handle lesions) located in the vascularized area of the meniscus (red-red and red-white areas).

    Device Description

    The RAPIDLOC-PDS Meniscal Repair System consists of a two piece (polydiaxonone tophat and polylactic acid backstop) bioabsorbable meniscal tissue fixation implant mounted on a 2/0 pre-knotted PANACRYL braided long-term absorbable suture. It is applied using a cannulated needle and arthroscopic pusher.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for the Mitek RAPIDLOC-PDS Meniscal Repair System. This is a medical device, not a software algorithm or AI. Therefore, the questions related to acceptance criteria, study details for AI/software performance, ground truth, sample sizes for training/test sets, MRMC studies, and standalone algorithm performance are not applicable.

    The submission focuses on demonstrating substantial equivalence to predicate devices based on non-clinical testing and shared technological characteristics.

    Here's a summary of the relevant information provided:

    Device: Mitek RAPIDLOC-PDS Meniscal Repair System

    Device Type: Biodegradable Fixation Fastener for meniscal repair.

    Intended Use: Arthroscopic fixation of longitudinal vertical meniscus lesions (bucket-handle lesions) located in the vascularized area of the meniscus (red-red and red-white areas).

    Acceptance Criteria and Reported Device Performance:

    Acceptance Criteria (Implied)Reported Device Performance
    Substantial equivalence to predicate devices (RAPIDLOC Meniscal Repair System and Mitek "H"-Fix Meniscal Fastener)"Testing conducted to characterize performance of the RAPIDLOC-PDS Meniscal Repair System has demonstrated that it is substantially equivalent to the predicate devices and is suitable for the intended use specified."
    Similar technological characteristics, design, and configuration to predicate devices."The proposed device has similar technological characteristics and is similar in design and configuration compared to the predicate devices."
    Safety and performance acceptable for intended use."Based on 1) safety and performance data, and 2) similarities in design, operating principles, biocompatibility and sterilization method, The Mitek RAPIDLOC-PDS Meniscal Repair System has been shown to be substantially equivalent to predicate devices..."

    Study that Proves the Device Meets Acceptance Criteria:

    A "Summary of Non-clinical Test" was conducted. The document states: "Testing conducted to characterize performance of the RAPIDLOC-PDS Meniscal Repair System has demonstrated that it is substantially equivalent to the predicate devices and is suitable for the intended use specified."

    Regarding AI/Software Specific Questions:

    1. Sample size used for the test set and the data provenance: Not applicable, as this is a physical medical device, not an AI/software. No specific "test set" in the AI sense is mentioned.
    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
    3. Adjudication method for the test set: Not applicable.
    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.
    5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
    6. The type of ground truth used: Not applicable. The "ground truth" for a physical device like this would be its physical and mechanical properties, biocompatibility, and functional performance, which are assessed through non-clinical testing.
    7. The sample size for the training set: Not applicable.
    8. How the ground truth for the training set was established: Not applicable.

    Clinical Data:

    The document explicitly states: "Clinical Data: Not Applicable". This indicates that the device's substantial equivalence and suitability for its intended use were established through non-clinical testing and comparison to predicate devices, without requiring new human clinical trials for this 510(k) submission.

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