LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K962047
    Device Name
    TITANIUM CANNULATED TIBIAL NAIL (TI CTN)
    Manufacturer
    SYNTHES (USA)
    Date Cleared
    1996-07-24

    (57 days)

    Product Code
    JDS
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    TITANIUM CANNULATED TIBIAL NAIL (TI CTN)

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

    Both devices mentioned above are intended to stabilize fractures of the tibia. Indications include, but are not limited to, open and closed tibial shaft fractures, certain pre- and post-isthmic fractures, tibial malunions and tibial non-unions.

    Device Description

    Synthes Titanium Cannulated Tibial Nail (Ti CTN) is compared to Synthes Ti-6Al-7Nb Unreamed Tibial Nail and is an extension to Synthes Titanium Tibial Nail System.

    The Synthes Ti CTN is available in sizes ranging from 11 mm in diameter and in lengths ranging from 255 mm to 420 mm. The nail has a cannulated tube with a bend in the sagittal plane which facilitates insertion into the tibia. There are four locking holes proximally and three locking holes distally. All of the locking holes accept 4.9 mm Titanium Locking Bolts.

    The devices will be provided both sterile. The non-sterile devices must be sterilized prior to use. The following sterilization parameters are recommended:

    MethodCycleTimeTemperature
    SteamPre-Vacuum6 minutes132°C - 135°C
    SteamGravity Displacement15 minutes132°C - 135°C
    AI/ML Overview

    The provided text describes a medical device, the Synthes Titanium Cannulated Tibial Nail (Ti CTN), and its intended use. However, it does not contain any information regarding acceptance criteria, device performance studies, or details relevant to AI/algorithm performance. The document is a "Summary of Safety and Effectiveness Information" (K962047) from 1996, which predates the widespread application of AI in medical devices and focuses on comparing the new device to existing Synthes products and specifying its physical characteristics and sterilization parameters.

    Therefore, I cannot provide the requested information. The text does not include:

    1. A table of acceptance criteria and reported device performance.
    2. Sample size for test set or data provenance.
    3. Number of experts and their qualifications for ground truth.
    4. Adjudication method.
    5. Multi-reader multi-case (MRMC) comparative effectiveness study.
    6. Standalone (algorithm only) performance.
    7. Type of ground truth used.
    8. Sample size for the training set.
    9. How ground truth for the training set was established.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1