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510(k) Data Aggregation

    K Number
    K203029
    Device Name
    Auxilock Titanium Interference Screw
    Manufacturer
    Auxein Medical Private Limited
    Date Cleared
    2021-08-20

    (322 days)

    Product Code
    HWC,MBI
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K201457,K083619
    Why did this record match?
    Reference Devices :

    K201457

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

    The Auxilock Titanium Interference Screw is in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.

    Device Description

    Auxein Brand Auxilock titanium Interference screw is cannulated, tapered fastener for use in Interference fixation of ligaments and tendons in patients requiring ligament or tendon-repair.

    The device is made from a Titanium alloy, Ti-6AI-4V ELI (ASTM F136) and is available in sizes ranging from 7 to 12 mm in diameter and 20 to 35 mm in length.

    Each variant of Auxilock Titanium Interference Screw are sold both in non-sterile and sterile (EO & Gamma Sterile) conditions.

    Non-sterile version of Auxilock Titanium Interference Screw have to be sterilized before use.

    AI/ML Overview

    The provided document is a 510(k) Premarket Notification for a medical device called "Auxilock Titanium Interference Screw." It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of an AI/ML powered device.

    Therefore, the requested information about acceptance criteria, study design for AI/ML performance, sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, and standalone performance for an AI/ML device is not present in this document.

    This document pertains to a traditional orthopedic implant, a titanium screw used for ligament and tendon fixation, whose acceptance is based on:

    1. Substantial Equivalence: Comparing its characteristics (indications for use, material, performance standards, sterilization, dimensions) to an already legally marketed predicate device (Parcus Titanium Interference Screw - K083619).
    2. Mechanical Testing: Demonstrating performance through pull-out strength, torsional strength, screw-in and screw-out, and pull-out based fatigue tests.
    3. Material Compliance: Adhering to relevant ASTM material standards (ASTM F 136 and ASTM F 899-12).
    4. Biocompatibility: Testing as per EN ISO 10993-1.
    5. Sterilization and Endotoxins: LAL testing for bacterial endotoxins and packaging/shelf-life studies (EN ISO 11607-1:2009).

    Summary of Acceptance Criteria and Reported Device Performance (based on the provided document for a non-AI/ML device):

    Acceptance Criteria (for substantial equivalence)Reported Device Performance (Auxilock Titanium Interference Screw)
    Indications for UseSimilar intended use as predicate device.
    Material Standards ComplianceConforms to ASTM F 136 (Ti-6Al-4V ELI) and ASTM F 899-12.
    Performance Standards TestingComplies with ASTM F 543-17 and custom fatigue testing. Results of pull-out strength, torsional strength, screw-in and out, and pull-out based fatigue tests showed no significant differences compared to the predicate device (Parcus Medical Titanium Interference Screw).
    Sterilization MethodSupplied in Non-Sterile, Gamma Sterile, and EO Sterile conditions. Demonstrated equivalent to predicate device.
    Dimensional VerificationSame dimensions as predicate device found.
    BiocompatibilityTesting conducted as per EN ISO 10993-1.
    Bacterial EndotoxinsDetermined using LAL testing to meet endotoxin limit specifications.
    Shelf-life & PackagingPerformed accelerated and real-time studies as per EN ISO 11607-1:2009. Uses same packaging material as a previously approved reference device (K201457).

    Other requested information (not available for an AI/ML device in this document):

    • Sample sizes used for the test set and the data provenance: Not applicable to this type of device. The mechanical tests used samples of the smallest diameter screw (7mm).
    • Number of experts used to establish the ground truth...: Not applicable. Ground truth for an orthopedic screw is based on engineering specifications, material science, and mechanical testing results, not expert interpretation of AI outputs.
    • Adjudication method...: Not applicable.
    • If a multi-reader multi-case (MRMC) comparative effectiveness study was done...: Not applicable.
    • If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
    • The type of ground truth used: For this device, the "ground truth" is established through physical and mechanical property testing against defined engineering standards and comparison to a predicate device's established performance.
    • The sample size for the training set: Not applicable.
    • How the ground truth for the training set was established: Not applicable.
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