LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K222380
    Device Name
    TriVerse Total Knee Replacement System
    Manufacturer
    Signature Orthopaedics Pty Ltd.
    Date Cleared
    2022-10-04

    (60 days)

    Product Code
    JWH
    Regulation Number
    888.3560
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K181530,K220737,K160159,K113550
    Why did this record match?
    Reference Devices :

    K181530, K220737, K160159

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

    The patient should be skeletally mature to receive a knee replacement. Patients should have adequate bone stock and size to support and accept the prosthesis.

    The patient's need for knee replacement should be due to one or more of the following conditions:

    • Non-inflammatory degenerative joint disease including osteoarthritis, or avascular necrosis.
    • Inflammatory degenerative joint disease including rheumatoid arthritis.
    • Functional deformity such as varus, valgus or flexion deformities.
    • Revision procedures where other treatments or devices have failed.

    Signature Orthopaedics' TriVerse Total Knee Replacement System components are indication only.

    Device Description

    The TriVerse Total Knee System is a modular total knee replacement (TKR) system consisting of a femoral component, meniscal inserts, a locking bar for the meniscal insert, a patella and a tibial baseplate with a tibial post and bolt. The femoral component and meniscal insert locking bar is manufactured from cobalt chrome. The femoral component are available as posterior stabilise and cruciate retaining variants, while meniscal inserts are available as posterior stabilised, posterior stabilised plus, cruciate retaining and anterior stabilised variants. All variants of the meniscal inserts as well as the patella components are manufactured from Vitamin-E Stabilized UHMWPE (HXLPE). The tibial post component is available as an I-Beam or Finned keel variant. The tibial base plate, bolt and post components are manufactured from titanium alloy.

    AI/ML Overview

    This document is a 510(k) premarket notification for a medical device called the "TriVerse Total Knee Replacement System." It is a submission to the FDA seeking clearance for market because the manufacturer believes it is substantially equivalent to legally marketed predicate devices.

    The document does not describe AI/ML device performance or the study that proves an AI/ML meets acceptance criteria. Instead, it focuses on the substantial equivalence of materials, design, and performance testing for a physical orthopedic implant (knee replacement system) compared to existing predicate devices.

    Therefore, I cannot extract the requested information regarding acceptance criteria and study details for an AI/ML device from this document. The provided text does not contain information about:

    1. A table of acceptance criteria and reported device performance for an AI/ML device.
    2. Sample sizes or data provenance for an AI/ML test set.
    3. Number of experts or their qualifications for establishing ground truth for an AI/ML test set.
    4. Adjudication methods for an AI/ML test set.
    5. MRMC comparative effectiveness studies for an AI/ML device, or human reader improvement with AI assistance.
    6. Standalone performance of an AI/ML algorithm.
    7. Types of ground truth used for AI/ML (expert consensus, pathology, outcomes data).
    8. Sample size for an AI/ML training set.
    9. How ground truth for an AI/ML training set was established.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1