LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K211322

    Validate with FDA (Live)

    Device Name
    Paratrooper Plantar Plate Repair System
    Manufacturer
    Paragon 28, Inc.
    Date Cleared
    2021-08-30

    (122 days)

    Product Code
    MBI
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K133671,K191227
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Paratrooper™ Plantar Plate Repair System is intended for fixation of tissue to tissue to tissue. Specific indications:

    Foot/ankle:

    • · Lateral Stabilization
    • · Medial Stabilization
    • · Achilles Tendon Repair
    • Metatarsal Ligament and Tendon Repair
    • · Hallux Valgus Reconstruction
    • · Digital Tendon Transfers
    • · Mid-foot Reconstruction
    • · Plantar Plate Repair
    Device Description

    The Paratrooper™ Plantar Plate Repair System includes an all-suture soft tissue fixation device. The suture implant comes in one size and is provided attached to a needle or preloaded on an inserter.

    AI/ML Overview

    The provided text describes a medical device, the Paratrooper™ Plantar Plate Repair System, and its FDA 510(k) clearance. However, it does not include information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML powered device. This document is a regulatory submission for a physical medical device, specifically a soft tissue fixation device, and not an AI or imaging diagnostic tool.

    Therefore, the requested information elements related to AI/ML device testing (such as "type of ground truth used," "sample size for the training set," "number of experts used to establish the ground truth," "adjudication method," "multi-reader multi-case study," and "standalone performance") are not applicable and cannot be extracted from this document.

    The document discusses the substantial equivalence of the Paratrooper™ Plantar Plate Repair System to a predicate device, based on:

    1. Indications for Use: The modified device has the same intended use.
    2. Technological Characteristics: Similar performance, basic design, material, sterilization, and sizes.
    3. Performance Testing: Mechanical performance testing and usability testing were conducted, along with bacterial endotoxin testing.

    There is no information in the provided text to populate the requested table or answer the specific questions related to AI/ML device acceptance criteria and study design.

    If you are looking for information about an AI/ML medical device, please provide a different document.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1