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510(k) Data Aggregation

    K Number
    K243624
    Device Name
    Acu-Sinch Knotless Mini
    Manufacturer
    Acumed LLC
    Date Cleared
    2025-01-23

    (59 days)

    Product Code
    HTN
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K140328
    Why did this record match?
    Device Name :

    Acu-Sinch Knotless Mini

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

    Acu-Sinch Knotless Mini, when used for fixation of bone-to-bone or soft-tissue to bone, is intended as a fixation post, distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, Acu-Sinch Knotless Mini is indicated for Carpal Metacarpal (CMC) joint arthroplasty as an adjunct in the healing process of hematoma distraction arthroplasty by providing stablization at the base of the first and second metacarpal when the trapezium has been excised due to osteoarthritis.

    Device Description

    The Acu-Sinch Knotless Mini is intended to provide fixation during the healing process of a trapeziectomy. Acu-Sinch Knotless Mini consists of two buttons, a suture strand, and instruments to aid in insertion. The buttons are manufactured from titanium alloy conforming to ASTM FI 36 (Ti-6AL-4V ELI). The suture is manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE). The devices are sterile and for single use.

    AI/ML Overview

    The provided document is a 510(k) premarket notification for a medical device called Acu-Sinch Knotless Mini. It describes the device's indications for use, technological characteristics, and a summary of non-clinical tests conducted to demonstrate substantial equivalence to a predicate device.

    Here's an analysis of the acceptance criteria and study information:

    1. Table of Acceptance Criteria and Reported Device Performance

    The document does not explicitly present a table of acceptance criteria with specific numerical values for metrics like sensitivity, specificity, or accuracy, as would be common for diagnostic AI/ML devices. Instead, the acceptance criteria are framed in terms of substantial equivalence to a predicate device (Arthrex CMC Mini Tightrope). The key performance criteria evaluated through non-clinical testing are static and dynamic fatigue, and MRI compatibility.

    Acceptance Criteria CategorySpecific Criteria/GoalReported Device Performance
    Mechanical PerformanceDevice performs statistically equivalent to the predicate device in static and dynamic fatigue testing.Acu-Sinch Knotless Mini performed as well as, or better than the predicate device. (This indicates it met or exceeded the performance of the predicate in these tests).
    MRI CompatibilityDevice meets safety requirements for image artifact, magnetically induced displacement force, radio frequency induced heating, and magnetically induced torque in the Magnetic Resonance Environment, per relevant ASTM standards.Tests conducted in accordance with ASTM F2052, ASTM F2119, ASTM F2182, and ASTM F2213 were performed. The document states these tests were conducted, implying compliance with the standards, but does not state specific numerical results or explicitly say "passed" for each. However, the overall conclusion that the device is "safe and effective for the indication" implies these tests were successful.
    BiocompatibilityEndotoxin levels meet requirement of
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