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The N10, N12, N15, N10MPro, N12MPro, NM15Pro Multi-parameter Patient Monitors are intended for monitoring, displaying, reviewing, storing, alarming and transferring of multiple physiological parameters including ECG (3-lead, 5-lead, 12-lead selectable), Arrhythmia Analysis, ST Segment Analysis, QT Analysis, Heart Rate (HR) and Heart-Rate-Variability(HRV)), interpretations of resting 12-lead ECG, Respiration rate(Resp), Temperature(Temp), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), Pulmonary Artery Wedge Pressure (PAWP), Cardiac Output (C.O.), Carbon Dioxide (CO2). The N10MPro, N12MPro, NM15Pro Multi-parameter Patient Monitors are also intended for monitoring, displaying, reviewing, storing, alarming and transferring of physiological parameters including Masimo Rainbow SpO2, Anesthesia gas (AG), oxygen (O2) respiratory gas monitoring, Bispectral Index (BIS), Respiration Mechanics (RM) and Neuromuscular Transmission Monitoring (NMT). All the parameters can be monitored on single adult, pediatric, and neonatal patient except for the following:

• Arrhythmia analysis is intended to use on adult patients only and is not intended and shall not be used on pediatric and neonatal population.
• NIBP measurement continual mode is not applicable to neonates.
• When using COMEN SpO2, the monitor is intended to be used on adult patient only.
• PAWP is intended for adult and pediatric patients only.
• C.O. measurement is intended for adult patients only.
• BIS monitoring is intended for adult patients only.
• RM is intended for adult and pediatric patients only.
• NMT monitoring is intended for adult and pediatric patients only.

The monitors are to be used in healthcare facilities by healthcare professionals or under their guidance.

The Multi-parameter Patient monitors are not intended for emergency and transport use, aircraft environment or home use.

The monitors are not intend for use as apnea monitors.

The monitors are not intended for use in MRI or CT environments.

The monitors are not used on patients who have a demonstrated need for cardiac monitoring known arrhythmias of VT, Accelerated Idioventricular rhythm and Torsades de Pointes.

There are six (6) models under evaluation, namely N10, N12, N15, N10MPro, N12MPro, N15MPro. All models share the same intended condition of use, the same intended patient population and operator profile, biological safety characteristic and principle of operation. All these models are the same on electric and electrical circuit and components, mechanical construction, software and alarm system. The only difference lies on the screen and configuration of with/without plug-in module slot and the number of battery packs.

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

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.

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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