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510(k) Data Aggregation

    K Number
    K172843
    Device Name
    TwitchView System
    Manufacturer
    Blink Device Corporation
    Date Cleared
    2018-03-29

    (191 days)

    Product Code
    KOI
    Regulation Number
    868.2775
    Type
    Traditional
    Panel
    Anesthesiology (AN)
    Reference & Predicate Devices
    K132533,K102084,K972698
    Why did this record match?
    Reference Devices :

    K132533, K102084

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

    The TwitchView System is used for the quantitative monitoring of neuromuscular transmission by means of electromyography.

    Device Description

    The TwitchView System has been designed to provide a quantitative neuromuscular transmission monitor with a modernized user interface and a single-use electrode array that is placed on the hand of the patient. The degree of neuromuscular block is measured with the TwitchView System by stimulating a peripheral nerve (the ulnar nerve at the wrist), and by evaluating the response of the hand via electromyography. The TwitchView System consists of three components: 1. TwitchView Monitor, 2. TwitchView Charging Station, 3. Single-Use Electrode Array.

    AI/ML Overview

    The provided text is related to a 510(k) premarket notification for the "TwitchView System," a medical device used for monitoring neuromuscular transmission. However, the document does not contain the specific information requested about acceptance criteria and a study proving the device meets those criteria, particularly in the context of an AI/ML-driven device.

    This document describes technical aspects, regulatory compliance (IEC standards, biocompatibility, electrical safety, etc.), and a comparison to predicate devices, but it does not mention any AI or machine learning components, nor does it describe a study involving a test set, expert ground truth, multi-reader multi-case studies, or standalone algorithm performance. The device primarily relies on electromyography (EMG) measurements and nerve stimulation, which are well-established non-AI technologies in medical monitoring.

    Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets those criteria, specifically concerning AI/ML performance, because the provided text does not contain this information.

    The document focuses on demonstrating substantial equivalence to predicate devices based on:

    • Intended Use: Quantitative monitoring of neuromuscular transmission.
    • Technological Characteristics: Stimulating a peripheral nerve with constant current and measuring muscle response. The key difference from the predicate (TOF Watch) is the use of electromyography (TwitchView) versus accelerometry (TOF Watch) for muscle response detection, with the document stating these methods are clinically equivalent.
    • Performance Standards & Testing: Compliance with IEC 60601-2-40 (for electromyographs and evoked response equipment), PART 898 (for electrode lead wires and patient cables), biocompatibility, software verification/validation, electrical safety, EMC, and various bench performance tests (stimulation accuracy, EMG accuracy, battery life, etc.).

    There is no mention of an AI/ML component, and thus no related acceptance criteria, test sets, or validation studies for AI performance.

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