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The Smart Cable NMT Module and Accessories are indicated for monitoring the relaxation of the patient when neuromuscular blockades are administered.

The Smart Cable NMT Module and Accessories are intended to be used as a system that requires Nihon Kohden compatible electrodes and bedside monitoring systems. The Smart Cable NMT Module and Accessories are intended for use by medical personnel in clinical settings and are available by prescription only.

The Life Scope® BSM-6000 Series Bedside Monitoring Systems are intended to monitor, display, and record physiological data to provide cardiac and vital signs monitoring within a medical facility. The device is intended to produce a visual record of the electrical signals produced by the heart and monitor the electrocardiogram to generate visible and/or audible alarms when an arrhythmia exists. The device is also intended to monitor heart rate, blood oxygen saturation (SpO2), non- invasive blood pressure (NIBP), invasive blood pressure (IBP), body temperature, BIS, cardiac output (CO), oxygen concentration (FiO2), carbon dioxide concentration (CO2), EtCO2, respiratory rate and inspired anesthetic agents and anesthetic gases including N2O, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane. The device may generate an audible and/or visual alarm when a measured rate falls outside preset limits. The device may also be used to condition and transmit physiological signals via radio frequency. The device can interface to external equipment to display numerical and waveform data and alarms from the external devices. Supported external devices include CO2 monitors, BIS monitors, Anesthetic agents/gases detection system, Anesthesia machine, Ventilators, CCO monitors. TOF monitors, CCO/SvO2 Monitors, EEG monitoring device, tcPO2/tcPCO2 monitors, and external devices which output analog voltage signal. The device will be available for use by medical personnel on patients within a medical facility on all patient populations. The system requires a BSM-6000 core unit with a compatible input unit: AY Series or Life Scope® PT BSM-1700 Series.

The Life Scope® CSM-1901 Bedside Monitoring Systems are intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility. The device is intended to produce a visual record of the electrical signal produced by the heart and monitor the electrocardiogram to generate visible alarms when an arthythmia exists. The device is also intended to monitor heart rate, blood oxygen saturation (SpO2), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), body temperature, BIS, cardiac output (CO), oxygen concentration (FiO2), carbon dioxide concentration (CO2), EtCO2, respiratory rate, inspired and expired anesthetic agents and anesthetic gases including N20, halothane, isoflurane, enflurane and desflurane. The device also displays patient data from external devices such as ventilators. TOF monitors, and EEG measuring unit. The device may generate and audible and/or visual alarm when a measured rate falls outside preset limits. The device will be available for use by trained medical facility on all patient populations, including adult, neonate, infant, child, and adolescent subgroups. The system requires a CSM-1901 core unit with a compatible input unit: AY Series or Life Scope® PT BSM-1700 Series.

The Life Scope® PT BSM-1700 Series and Accessories are intended acquire and transfer electrical impulses from the patient to the main unit of the device. The BSM-1700 Series input unit monitors physiological data and may generate an audible and/or visual alarm when a measured rate falls outside preset limits when discomected from the core unit of the device. The input unit can be removed from one core unit and connected to another devices core unit. The Life Scope® PT BSM-1700 Series can be used in transport mode where data is transferred from one device to another device by using with or without WLAN technology. The input unit can acquire the following parameter signals: Electrocardiogram (ECG), Impedance respiration (Imp Resp), Non-invasive blood pressure (NIBP), Arterial oxygen saturation (SpO2), Carbon dioxide concentration (CO2), Invasive blood pressure (Temp), Cardiac Output (CO), TOF and Bispectral Index (BIS). The Data Acquisition Unit (DAU) is an optional accessory. The DAU is used to communicate between the compatible parent core unit and the input unit using connection cables. The Reys on the DAU allow operation of the bedside monitor remotely. The DAU is only compatible with the Life Scope® PT BSM-1700 Series and the AY Series Input Units.

AY Series and Accessories are intended to acquire and transfer electrical impulses from the patient to the core unit of the device. The input unit can acquire the following parameter signals: Electrocardiogram (ECG), Impedance respiration (Imp Resp), Non-invasive blood pressure (NIBP), Arterial oxygen saturation (SpO2), Carbon dioxide concentration (CO2), Invasive blood pressure (IBP), Temperature (Temp), Cardiac Output (CO), TOF and Bispectral Index (BIS). AA Series smart expansion unit adds additional MULTI sockets to an AY Series input unit and can only be used with compatible monitoring systems. The Data Acquisition Unit (DAU) is an optional accessory. The DAU is used to communicate between the compatible parent core unit and the input unit using connection cables. The keys on the DAU allow operation of the bedside monitor remotely. The DAU is only compatible with the Life Scope® PT BSM-1700 Series Input Units.

The Nihon Kohden Smart Cable NMT Module (NMT Module) and Accessories is an optional accessory for the Nihon Kohden bedside monitoring systems. The Smart Cable NMT Module and Accessories TOF (Train of Four) are based on EMG technology. With this system, the user can apply electrical stimulation on the ulnar nerve to detect the muscle's action potential. The reaction to the electrical impulse can be visualized on the connected monitoring system. The Smart Cable NMT Module and Accessories can assist medical personnel to quantitatively determine the level of muscle relaxation. This information can be used to determine the dose of muscle relaxants and regional anesthetics when performing anesthesia in a clinical setting. It is intended for use by medical personnel in the operating room, recovery room, or intensive care unit. NMT Module is a system comprised of NMT Module, Main Cable, Holder, and EMG Electrode. The NMT module is connected to an electrode via Main Cable. The electrode is a single-use electrode array and each array includes two stimulating electrodes, two recording electrodes, and one ground electrode The NMT module can transmit an electrical stimulation pulse to the patient and can receive EMG signals via the electrode array. The captured data from the disposable electrode is sent to the monitoring system via the Smart Cable interface connector. The various stimulation settings are also sent to the monitoring system to display. The AF-201P NMT Module is used to control the electrical stimulation and to measure the response. The operational setting is controlled via buttons on the module or a touch screen.

The Life Scope BSM-6000 Series Bedside Monitoring Systems are intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility. The device is intended to produce a visual record of the electrical signals produced by the heart and monitor the electrocardiogram to generate visible and/or audible alarms when an arrhythmia exists. The device is also intended to monitor heart rate, pulse rate, blood oxygen saturation (SpO2), non- invasive blood pressure (NIBP), invasive blood pressure (IBP), body temperature, Cardiac Output (CO), oxygen concentration (FiO2), CO2 and EtCO2, respiratory rate, BIS and inspired and expired anesthetic agents and gases including CO2, O2, N2O, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane. Anesthetic agents and gases are detected using the cleared AG-920RA Anesthetic Agent Detection System. The device can interface to external equipment to display numerical and waveform data and alarms from the external devices. Supported external devices include AG-920RA Anesthetic Agent Detection System, Ventilators, CO2 Monitors, TOF Monitors, BIS Monitors, CCO/SvO2 Monitors and continuous NIBP Monitors. The device may generate an audible and/or visual alarm when a measured rate falls outside preset limits. This device may also be used to condition and transmit physiological signals via radiofrequency. The system requires a BSM 6000 core unit with a compatible input unit: AY Series or Life Scope® PT BSM-1700 Series.

The Life Scope® CSM-1901 Bedside Monitoring Systems are systems which continuously monitors physiological information of a patient and is used in an operation room, a recovery room, general wards, ICU, CCU, HCU, NICU and an emergency room. These systems are placed near the patient and is intended to display patient's vital signs. These systems can also be connected to other external patient monitoring devices. In addition these systems can communicate patient's data to a central monitoring station via network to monitor multiple patients. The input unit is common to NK parent devices that require both a core unit and input unit. NK manufactures the input units with three (3) SpO2 options. The Life Scope® CSM-1901 Bedside Monitoring Systems have interchangeable input units that contains the MULTI socket ports. For larger monitoring systems is data acquisition unit is required to transmit data from the input unit to the core unit. The bedside monitoring systems require both a core unit and an input unit The input unit interprets the electrical impulses from the patient's body and transfers this data into the core unit. The core unit calculates the electrical impulses. Each monitor has a color display and is intended for one patient. The intended populations are all patient populations under the care of health professionals.

The provided text is a 510(k) summary for the Nihon Kohden Life Scope PT BSM-1700 Series, Data Acquisition Unit, LIFE SCOPE BSM 6000 SERIES BEDSIDE MONITORING SYSTEM, and Nihon Kohden CSM-1901 BEDSIDE MONITORING SYSTEM. It describes software modifications to enable compatibility with the Smart Cable NMT Module and Accessories, and updates to the stated Indications for Use.

The document does not contain information about an AI/algorithm-only study, a multi-reader multi-case (MRMC) comparative effectiveness study, or details on ground truth establishment for a training set. The device in question is a physiological monitor, and the software modifications are specifically related to integrating with a neuromuscular transmission (NMT) module and updating intended use statements, not for an AI/CADe (Computer-Aided Diagnosis/Detection) algorithm that would typically require such studies.

Therefore, many of the requested criteria related to AI/algorithm performance and clinical validation studies are not applicable to the information provided in this document.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the software modifications do not change the safety, performance of the predicate devices. It refers to integration testing, not a de novo performance study with specific quantifiable acceptance criteria for a new AI algorithm.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified in terms of patient data. The testing mentioned is "software unit testing, integration level testing, and system-level testing" and a "system test... based on the software requirements specification." This suggests internal product testing rather than a separate clinical test set of patient data.
• Data Provenance: Not applicable, as no external clinical data test set is described. The focus is on the integration and functional testing of the software within the device system.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. The ground truth, in this context, would be the proper functioning and integration of the software and hardware, verified through engineering and system testing, not through expert reading of medical images or data.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable. This is typically used in clinical studies for establishing ground truth for AI algorithms, which is not the subject of this 510(k).

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No. The document explicitly states: "No clinical tests have been submitted, referenced or relied on in this premarket notification submission for a determination of substantial equivalence." This device is not an AI-assisted diagnostic or therapeutic tool; it's a physiological monitor with updated software for compatibility.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• No. This is not an AI algorithm requiring standalone performance evaluation. The "software modification" refers to updates enabling the NMT module to work with the monitoring system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For the software and system functionality: The ground truth is the predefined technical specifications and expected behavior of the device and its integrated components. This is verified through "software unit testing, integration level testing, and system-level testing."

8. The sample size for the training set:

• Not applicable. There's no machine learning model or AI algorithm described that would require a "training set."

9. How the ground truth for the training set was established:

• Not applicable for the same reason as above.

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The Nihon Kohden CSM-1901 Bedside Monitor is intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility. The device is intended to produce a visual record of the electrical signal produced by the heart and monitor the electrocardiogram to generate visible alarms when an arrhythmia exists. The device is also intended to monitor heart rate, blood oxygen saturation (SpO2), noninvasive blood pressure (NIBP), invasive blood pressure (IBP), body temperature, BIS, cardiac output (CO), oxygen concentration (FiO2), carbon dioxide concentration (CO2), EtCO2, respiratory rate, inspired and expired anesthetic agents and anesthetic gases including N20, halothane, enflurane, enflurane and desflurane. The device also displays patient data from external devices such as ventilators, TOF monitors, and EEG measuring unit.

The device may generate and audible and/or visual alarm when a measured rate falls outside preset limits.

The device will be available for use by trained medical facility on all patient populations, including adult, neonate, infant, child, and adolescent subgroups.

The Bedside monitor CSM-1901 is a device which continuously monitors physiological information of a patient and is used in an operation room, a recovery room, general wards, ICU, CCU, HCU, NICU and an emergency room. This bedside monitor is placed near the patient and is intended to display patient's vital signs. This device can also be connected to other external patient monitoring devices. In addition, this device can communicate patient's data to a central monitoring station via network to monitor multiple patients.

Here's an analysis of the provided text regarding the Nihon Kohden CSM-1901 Bedside Monitor, focusing on acceptance criteria and study details.

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It primarily details compliance with recognized standards and internal testing protocols. It does not contain specific, detailed acceptance criteria in quantitative terms (e.g., sensitivity, specificity for arrhythmia detection) or a robust clinical study with detailed performance metrics like one might find for a novel AI device or a PMA submission. Therefore, some sections below will indicate that the information is not present in the provided document.

Acceptance Criteria and Reported Device Performance

Missing Specific Quantitative Acceptance Criteria: The document does not provide specific quantitative acceptance criteria for the performance of arrhythmia detection (e.g., minimum sensitivity or specificity targets for specific arrhythmia types), or for the accuracy and precision of physiological measurements against a gold standard. The performance is generally stated as "functions as intended" or "complies with standards."

Study Details

1. Sample Size Used for the Test Set and Data Provenance:

   • Test Set Sample Size: The document does not specify a distinct "test set" in terms of patient data or physiological recordings used for clinical performance evaluation. The testing described is primarily in the context of engineering verification and validation (software, electrical safety, EMC, etc.).
   • Data Provenance: Not applicable, as no specific patient data test set is described.

2. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:

   • Not applicable. The document describes engineering and systems testing, not a clinical trial involving expert-labeled ground truth.

3. Adjudication Method for the Test Set:

   • Not applicable. No clinical test set with adjudicated ground truth is described.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, a MRMC comparative effectiveness study was not done (or at least not reported in this 510(k) summary). The device is a "bedside monitor" with integrated detection algorithms, not an AI-assisted diagnostic tool that augments human interpretation in a comparative reader study context.
   • Effect Size of Human Readers Improve with AI vs. Without AI Assistance: Not applicable, as no such study was conducted or reported.

5. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

   • Yes, in essence, standalone performance was assessed though not in the form of a detailed clinical "study" with specific performance metrics for individual algorithms. The device's integrated arrhythmia detection and physiological measurement algorithms are designed to operate independently to generate alarms and display data. The testing mentioned (software unit testing, integration testing, system verification, system validation) would cover the standalone functionality of these algorithms and systems against their specifications. However, specific performance metrics (e.g., for arrhythmia detection accuracy against a recognized benchmark dataset like MIT-BIH) are not
     detailed in this summary.

6. Type of Ground Truth Used:

   • For the engineering and systems testing, the "ground truth" would be established by:
     • Defined specifications: Software units and system functions were tested against their intended design and functional requirements.
     • Standardized test signals/simulators: Electrical and EMC tests, and possibly some physiological parameter accuracy checks, would use calibrated test equipment and signals representing known conditions.
     • Compliance to standards: The ground truth for safety and performance would be the requirements laid out in the cited IEC and ANSI/AAMI standards.
     • Predicate device comparison: Functional equivalence was likely established by comparing the new device's behavior to the predicate device under similar test conditions.

7. Sample Size for the Training Set:

   • Not applicable. The document does not describe the use of machine learning or AI in a way that requires a "training set" for model development. This seems to be a traditional medical device employing established signal processing and rule-based algorithms. Therefore, there's no mention of a training set.

8. How the Ground Truth for the Training Set was Established:

   • Not applicable, as no training set is mentioned for AI/ML model development.

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