LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K980102
    Device Name
    BTI HUMERAL INTRAMEDULLARY ROD SYSTEM
    Manufacturer
    BIODYNAMIC TECHNOLOGIES, INC.
    Date Cleared
    1998-04-03

    (81 days)

    Product Code
    HSB
    Regulation Number
    888.3020
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BTI HUMERAL INTRAMEDULLARY ROD SYSTEM

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

    The BT™ Humeral Intramedullary Rod device is indicated for fractures of the humerus.

    Device Description

    BTI™ Humeral Intramedullary Rod System

    AI/ML Overview

    This looks like a 510(k) clearance letter from the FDA for a medical device (BTI™ Humeral Intramedullary Rod System). It doesn't contain the kind of detailed study information you're asking for regarding acceptance criteria, sample sizes, expert involvement, and ground truth.

    This document primarily states:

    • The device name: BTI™ Humeral Intramedullary Rod System
    • Its intended use: Fractures of the humerus
    • Its regulatory class: II
    • The FDA's determination of substantial equivalence to a predicate device.

    Therefore, I cannot provide the requested information based on the provided text.

    To answer your questions, I would need a detailed study report or clinical trial documentation, which would typically accompany a 510(k) submission but is not included in this FDA clearance letter.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1