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The Nihon Kohden TG-980P/TG-980P1 CO2 Sensor Kit is intended for medical purposes to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory status.

Along with other methods indicated by the physician for medical diagnosis, this device is intended as an indicator of patient carbon dioxide concentration during expiration. The device is intended for use by qualified medical personnel within a hospital, ambulatory care, transport, or any other clinical environment.

The TG-980P and TG-980P1, collectively referred to as TG-980P/TG-980P1, are CO2 Sensor Kits used to measure the concentration of carbon dioxide (CO2 or CO2) during patient expiration. The TG-980P/TG-980P1 is intended for use by qualified medical personnel as an aid for determining patient ventilatory status within a hospital, ambulatory care, transport, or any other clinical environment.

The TG-980P/TG-980P1 CO2 Sensor Kit comprises three main components: a CO2 sensor, an interface connector, and a sensor cable. It utilizes the mainstream measurement method to sample gas directly from the patient's airway and non-dispersive infrared (NDIR) absorption technology to measure CO2 concentration during patient expiration. CO2 gas absorbs infrared light at specific wavelengths, and the amount absorbed is directly related to CO2 concentration. The CO2 sensor is equipped with a light source that generates infrared light. The light passes through an attached Nihon Kohden accessory (except the Thermal Airflow Sensor) through which the expired air flows and is converted by photodetectors to voltage, which is used to calculate CO2 concentration. The calculated digital data is then transmitted and displayed on a connected patient monitor or other device.

The TG-980P/TG-980P1 CO2 Sensor Kit can be connected via the interface connector and used with Nihon Kohden devices for which the operator's manual specifies compatibility with the TG-980P/TG-980P1.

This FDA 510(k) clearance letter pertains to a hardware device (CO2 Sensor Kit) and not an AI/ML software. Therefore, many of the requested criteria regarding AI-specific studies (e.g., sample size for training set, number of experts for ground truth, MRMC study) are not applicable.

However, I can extract the relevant acceptance criteria and details of the non-clinical performance studies conducted for the device.

Acceptance Criteria and Device Performance (Non-AI Device)

1. A table of acceptance criteria and the reported device performance

The document provides the performance specifications for the CO2 Sensor Kit, rather than explicit "acceptance criteria" in the typical sense of a target for a specific study. The reported device performance is compared to the predicate device's performance.

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The CNS-2101 central monitor is a networked multi-patient monitoring system, that is intended to display, record and print monitored physiological data from Nihon Kohden bedside monitors, telemetry receiver and/or transmitters. The CNS-2101 does not perform any data processing on the Nihon Kohden compatible devices. When the CNS-2101 is to connect with the Nihon Kohden bedside monitors and telemetry receivers/transmitters the CNS-2101 can:

• · Admit and discharge patients on the Nihon Kohden network.
• · Display and manage compatible devices' real-time patient clinical data.
• Mimic the alarms of connected devices when a measured parameter falls outside a preset limits or when an arrhythmia is detected.
• · Review and trend data calculated by connected Nihon Kohden devices.
• · Store and transfer historical clinical data for the connected systems.
• · Print patient data.

The CNS-2101 is intended for use in professional medical facilities by trained medical personnel.

The CNS-2101 central monitor is a central monitoring device designed to support medical personnel to provide medical care to multiple patients at the same time. It acquires vital sign data from multiple monitoring devices such as bedside monitors and displays the acquired data such as ECG and pulse rate on the screen as well as informing alarms.

The CNS-2101 can communicate with other devices through a network connection. The CNS-2101 can acquire vital sign data directly from multiple monitoring devices (e.g., bedside monitors) connected to Nihon Kohen Monitoring device network or using multiple patient receivers and transmitters, or by a combination of both methods. The parameters to monitor on the central monitor can be changed as necessary by selecting a monitoring device such as a bedside monitor or transmitter and changing the parameter settings for that device.

The CNS-2101 is designed to be installed in a location outside the patient environment such as a nurse's station for central monitoring.

The provided text is a 510(k) summary for the Nihon Kohden CNS-2101 Central Monitor. This document focuses on demonstrating substantial equivalence to a predicate device through comparison of features and adherence to recognized standards. It does not present specific acceptance criteria with numeric performance values or detailed performance study results in the way typically found for AI/ML-driven devices with diagnostic or prognostic claims.

Therefore, for the information requested:

1. A table of acceptance criteria and the reported device performance: This information is not explicitly provided in the document. The document states that the device was tested according to international and FDA-recognized consensus standards to verify and validate its functionality and technical characteristics. However, specific performance metrics (e.g., sensitivity, specificity, accuracy) are not listed for the CNS-2101.

2. Sample size used for the test set and the data provenance: This information is not provided. The testing described is verification and validation (V&V) against design specifications and consensus standards, not clinical performance testing with patient data in the context of diagnostic accuracy.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not applicable and therefore not provided. "Ground truth" in the context of diagnostic accuracy is not relevant to the described V&V testing of a central monitoring system.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable and therefore not provided.

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: Not applicable and therefore not provided. The CNS-2101 is a central monitoring system that displays data from other devices; it does not utilize AI to assist human readers in interpretation or diagnosis.

6. If a standalone (i.e., algorithm-only without human-in-the-loop performance) was done: Not applicable and therefore not provided. The CNS-2101 is a networked multi-patient monitoring system, not a standalone diagnostic algorithm. It displays data from already cleared bedside monitors and telemetry systems. It "does not perform any data processing on the data received from the Nihon Kohden compatible devices."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable and therefore not provided, as the testing relates to the functional performance and safety of the system rather than diagnostic accuracy against a specific condition.

8. The sample size for the training set: Not applicable and therefore not provided. The document describes a central monitoring system, not an AI/ML device that requires training data.

9. How the ground truth for the training set was established: Not applicable and therefore not provided.

Summary of available information regarding performance:

• Acceptance Criteria: Not explicitly defined with performance metrics like accuracy, sensitivity, or specificity. Instead, the acceptance criteria are implied by adherence to recognized consensus standards for medical electrical equipment, software lifecycle, risk management, usability, electromagnetic compatibility, and alarm systems.
• Study Proving Device Meets Acceptance Criteria: Non-clinical verification and validation testing was conducted on the CNS-2101 based on the following standards and guidance:
  • ISO 14971:2019 Medical devices - Application of risk management to medical devices
  • IEC 62304:2006/A1:2015 Medical device software - Software life cycle processes
  • ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 Medical electrical equipment—Part 1: General requirements for basic safety and essential performance
  • IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
  • IEC 60601-1-8: 2012 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
  • IEC 60601-2-27:2011 Medical electrical equipment--Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
  • ANSI/AAMI/IEC 62366-1:2015 Medical devices -Part 1: Application of usability engineering to medical devices.
  • Various FDA guidance documents related to software validation, cybersecurity, interoperable medical devices, off-the-shelf software, EMC, and human factors.
• Reported Device Performance: The document states that "All function in the CNS-2101 have been validated by the FDA-recognized consensus standards, therefore, the validity of the results can be ensured." It also notes that "Tests conducted within the software development cycle demonstrate that communication between the CNS-2101 and the Nihon Kohden 510(k)-cleared monitoring devices is robust and stable enough to exchange accurate physiological data in real time."

In essence, the document confirms that the CNS-2101 complies with relevant safety and performance standards for its intended function as a central monitoring system, without requiring a clinical validity study involving comparison to a "ground truth" or expert adjudication for diagnostic accuracy.

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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 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 and expired 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 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, inspired and expired anesthetic agents and anesthetic gases including N2O, 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 Beside Monitor and Accessories are intended acquire and transfer electrical impulses from the patient to the main unit of the device. The BSM-1700 Series has both an input and transport/standalone mode. 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 or when disconnected from the core unit of the input unit can be removed from one core unit and connected to another device's core unit. The Life Scope® PT BSM-1700 Series can be used in transport mode where data is transferred from one device by using with or with or without WLAN technology. In standalone mode, the device does not require a core unit. The BSM-1700 Series can acquire the following parameter signals: Electrocardiogram (ECG), Impedance respiration (Imp Resp), Non-invasive blood pressure (NBP), Arterial oxygen saturation (SpO2), Carbon dioxide concentration (CO2), Invasive blood pressure (IBP), Temperature (Temp), Cardiac Output (CO), TOF and Bispectral Index (BIS). When the BSM-1700 Series is used in transport or standalone mode, the following can be analyzed and displayed: 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), 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 keys 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 persomel 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, 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. TheNMT module can transmit an electrical stimulation pulse to the patient and can receive EMG signals via the electrode array. Thecaptured data from the disposable electrode is sent to the monitoring system via the Smart Cable interface connector. The various stimulation settings are a lso sent to the monitoring system to display. The AF-201P NMT Module is used to control the electrical stimulation and to measure theresponse. 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 cardial signs monitoring within a medical facility. The device is intended to produce a visualrecord 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 a lso intended to monitor heart rate, pulse 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 and expired a nesthetic a gents and a nesthetic gases including CO2, O2, N2O, Halothane, Isoflurane, Sevoflurane and Desflurane. Anesthetic agents and gases are detected using the cleared AG-920R A Anesthetic Agent Detection System. The device can interface to external equipment to display numerical and waveform data and a larms from the external devices. Supported external devices include AG-920RA Anestheic Agent Detection System, Ventilators, CO2 Monitors, BIS Monitors, BIS Monitors, CCO/SvO2 Monitors and continuous NIBP Monitors. The devicemay generate anaudible and or visual alarm when a measured rate falls outside preset limits. This device may also be used to condition and transmit physiological signa ls via radio frequency. 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 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 a ddition, 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-1 901 Bedside Monitoring Systems have interchangeable input units that contains the MULTI socket ports. For larger monitoring systems is data a cquisition unit is required to transmit data from the input unit to the core unit. The bedside monitoring systems require both a coreunit and an input unit interprets the electrical impulses from the patient's body and transfers this data into 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 AY Series Input unit is used with the monitoring systems platforms, when connected to the core unit of the parent device, the inputunit collects electrical impulses, and the core units calculates and displays on the core unit's screen.

The BSM-1700 Series Bedside Monitor is a multifunctional device used as an input unit, transport/standalone monitor.
· Input unit for other monitoring systems platforms, when connected to the core unit of the parent device, the input unit collects electrical impulses, and the core units calculates and displays on the core unit's screen.
· When the patient needs to be transported, the BSM-1700 Series can be removed from the core unit, transport mode can be enabled and can be used with or without WLAN. When WLAN is enabled real time data viewing on the Nihon Kohden network or if it is disabled the BSM-1700 Series will display monitoring data and store the review data.
• When the device is removed from the coreunit it functions as a standalone or independent monitoring system.
The BSM-1700 Series has a display monitor that is disabled when connect to a core unit. Each monitor has a cobr display and is intended for one patient. When used as an inputunit with the coreunit, the system monitors a dvanced parameters. The intended populations are all patient populations under the care of health professionals. In all modes, the BSM-1700 Series uses the Smart Cable technology that is used to connect to other accessories used to collect electrical impulses. The BSM-1700 Series interprets the electrical impulses from the patient's body. When connected to a core unit, advanced calculations can be achieved. The device may generate a naudible and/or visual a larm when a measured rate falls outside preset lim its.

Here's a breakdown of the acceptance criteria and related study information, based on the provided text:

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, not necessarily a detailed clinical study report proving performance against novel acceptance criteria. In this specific case, the submission emphasizes that there are no new acceptance criteria because the device (Life Scope PT BSM-1700 Series Bedside Monitor) is being updated to include a "standalone mode," but its underlying technology and performance characteristics are unchanged from its previously cleared version (K213316). Therefore, the "study that proves the device meets the acceptance criteria" largely relies on the prior clearance and non-clinical testing for the updated mode.

1. Table of Acceptance Criteria and Reported Device Performance

Since the document explicitly states there are no new technological changes or safety/performance claims, the acceptance criteria are effectively the performance specifications of the predicate device (K213316). The reported device performance is stated to be "the same" as the predicate.

Study Proving Device Meets Acceptance Criteria

The document states:

• "The device performance and software have not changed from the original submission K213316." (Sections 2.4, 3.4, 4.4, 5.4)
• "For this submission the BSM-1700 Bedside Monitor has been updated to include the standalone mode. There are no specification changes, technological changes or safety and Performance claims. The indications for use and labeling have been updated to include the standalone mode." (Section 6)
• "The Life Scope BSM-1700 Series Bedside Monitor was subjected to tests to electromagnetic, environmental, safety, and performance testing procedures. These tests verified the operation of the device. The software validation tested the operation of the software function of the device, the results confirmed that the device performed within specifications." (Section 6.3 Safety & Performance Tests)

Given this, the "study" is primarily an affirmation that the previously cleared performance for K213316 remains valid, coupled with non-clinical verification and validation testing of the additional "standalone mode" functionality to ensure it operates within the established specifications without altering the core performance characteristics.

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

   • The document does not specify a sample size for a clinical test set in this 510(k) summary. This type of submission relies heavily on non-clinical (bench) testing to confirm performance when significant changes are not made.
   • The data provenance is implied to be from Nihon Kohden's internal testing. The submission is focused on demonstrating substantial equivalence rather than presenting a de novo clinical study with patient data. As such, the data would be laboratory-generated from testing the device.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

   • This information is not provided because no clinical study requiring expert ground truth establishment for a test set is detailed. The "ground truth" for non-clinical performance would be derived from established engineering and metrological standards and test procedures.

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

   • This is not applicable since the submission focuses on non-clinical performance and engineering validation rather than human reader studies.

4. 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, an MRMC comparative effectiveness study was not done. This device is a physiological monitor, not an AI-powered diagnostic tool, and the submission does not mention AI assistance.

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

   • The term "standalone" in the provided document refers to a mode of operation for the BSM-1700 device, where it functions independently without being connected to a core unit. It does not refer to a standalone performance study of an algorithm.
   • However, the performance tests described in Section 6.3 were likely conducted in a "standalone" fashion for the device's functional parameters, meaning the device itself was tested to ensure its outputs (e.g., heart rate, SpO2 accuracy) met specifications. The submission highlights that "The device performance and software have not changed from the original submission K213316," implying that the standalone performance requirements were met by the previous device and confirmed for this update.

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

   • For the non-clinical testing, the ground truth would be based on calibrated reference standards and established measurement methodologies for physiological parameters (e.g., known electrical signals for ECG, certified NIBP simulators, calibrated temperature baths, etc.).
   • No clinical ground truth (like pathology or outcomes data) is described in this submission, as it's not a clinical study.

7. The sample size for the training set:

   • This information is not provided. Medical devices like this (physiological monitors) typically undergo engineering development, verification, and validation testing rather than a "training set" in the machine learning sense. Any underlying algorithms (e.g., for signal processing, arrhythmia detection) would have been developed and validated during earlier stages or for previous clearances.

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

   • Not applicable for this type of device and submission. If any algorithms involved "training," the ground truth would have been established using rigorously collected physiological data and expert annotation/labeling, but this detail is not present in the 510(k) summary.

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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 Life Scope® G5 and Nihon Kohden Life Scope® G7 Bedside Monitoring System 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 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, BIS, cardiac output (CO), oxygen concentration (02), carbon dioxide concentration (CO2), EtCO2, respiratory rate, inspired and expired anesthetic agents and anesthetic gases including N20, halothane, isoflurane, enflurane, sevoflurane, and desflurane. The device also displays patient data from external devices such as ventilators, TOF modules, CCO/SvO2 monitors, and EEG measuring units.

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

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

A-fib detection, ST measurement and QTc/QRSd monitoring are intended for adult patients only. Arrhythmia detection function is intended for child, adolescent, and adult patients.

The Nihon Kohden Life Scope® G5 and Life Scope® G7 Bedside Monitoring System are an LCD touchscreen bedside monitoring system. These bedside monitors are installed near the patient and are intended to display the patient's vital signs such as ECG (basic and 12 lead), NIBP, temperature, SpO2, respiration, and CO2 and generate alarms from the bedside monitor. Additional parameters can be measured such as arrhythmia detection, ST elevation, and Train of Four (TOF) measuring parameters. Apnea and arrhythmia can also be monitored. The configuration of the bedside monitor can be adapted by the health care professionals to meet the clinical setting requirements.

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 bedside monitor is designed so the operator can directly touch the screen from the operator position. Other optional accessories can also be used with the bedside monitor to add other parameters, allowing it to be used in a wide range of sites, such as operating rooms and intensive care units (ICU). The bedside monitor can also be connected to a network to communicate with central monitors and other Nihon Kohden devices.

The Life Scope® G5 Bedside Monitoring System consists of two models, those models are offered in two sizes:

• CSM-1501 bedside monitoring with core unit (CU) model CU-151R: 12.1-inch . display
• CSM-1502 bedside monitoring with core unit (CU) model CU-152R: 15.6-inch . displav

The Life Scope G7 Bedside Monitoring System consists of two models, those models are offered in two sizes:

• CSM-1701 bedside monitoring with core unit (CU) model CU-171R: 15.6-inch . displav
• CSM-1702 bedside monitoring with core unit (CU) model CU-172R: 19.0-inch . display

The Life Scope G7 Bedside Monitoring System consists of an input unit and a data acquisition unit with either the CU-171R or the CU-172R core unit.

Here is an analysis of the acceptance criteria and supporting study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on establishing substantial equivalence to a predicate device rather than defining specific performance-based acceptance criteria for novel claims. The acceptance criteria are implicitly derived from the predicate device's specifications and compliance with recognized standards. Therefore, the "reported device performance" is essentially a statement of "identical" or "below" (meaning lower capacity/resolution but deemed not to affect safety/effectiveness) compared to the predicate.

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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 comprised of:

• · AF-201P NMT Module with Smart Cable
• Disposable Electrodes
• Main cable
• · Holder (optional)

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-3000 Series 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 signals produced by the heart and monitor the electrocardiogram to generate audible and/or visible 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 (O2), carbon dioxide concentration (CO2), EtCO2, respiratory rate, and inspired and expired anesthetic gases including N20. 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, rSO2 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 Life Scope BSM-6000 Series 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 signals produced by the heart and monitor the electrocardiogram to generate audible and/or visible alarms when an arrhythmia exists.

The device is also intended to monitor heart rate, plood 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 and expired anesthetic agents and anesthetic gases including N20, 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, rSO2 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 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, 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 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.

The 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-3000 Series Bedside Monitoring System 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 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 (O2), 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, EEG monitoring device, tcPO2 monitors, rSO2 monitors and external devices with output analog voltage signal 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 radio frequency.

The Life Scope BSM-6000 Series Bedside Monitoring System 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 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 Nihon Kohden CSM-1901Series 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.

The provided text describes the acceptance criteria and study data for the Smart Cable NMT Module and Accessories, as well as the Life Scope BSM-3000, BSM-6000, and CSM-1901 Bedside Monitors. However, the document is a 510(k) summary for substantial equivalence, which primarily focuses on comparing the new device to existing predicate devices and demonstrating that it is as safe and effective. It does not contain an explicit table of acceptance criteria and reported device performance in the format typically used for a detailed study report.

Instead, the document states that various tests were performed and that the devices "met all the acceptance criteria" or "performed within specifications." It also notes that "No clinical tests have been submitted, referenced or relied on in the premarket notification submission for a determination of substantial equivalence." This implies that the acceptance criteria for performance were likely derived from industry standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-40, ANSI/AAMI EC12:2000), internal company specifications, and comparison to predicate devices, rather than from a standalone clinical study with an explicit set of primary and secondary endpoints and predefined performance metrics.

Therefore, many of the requested details such as sample size for the test set, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment from actual patient data (for algorithm training/testing) are not present in this 510(k) summary. This is typical for a 510(k) submission where substantial equivalence is demonstrated through non-clinical performance and engineering validation rather than through new clinical studies, especially for devices where modifications are minor or where performance can be adequately assessed through bench testing and comparisons to established technological characteristics of predicates.

Below is an attempt to address the request based on the information available in the provided text, while also explicitly stating what information is not provided.

Acceptance Criteria and Device Performance (Based on available information):

The document does not present a formal table of acceptance criteria with corresponding device performance results for each specific metric. Instead, it broadly states that the devices underwent various non-clinical tests and met the acceptance criteria. The acceptance criteria were primarily based on compliance with relevant industry standards and comparison to the performance specifications of predicate devices.

Summary of Device Performance and Acceptance (Inferred from the document):

Details Regarding the Study/Testing:

1. A table of acceptance criteria and the reported device performance:

   • As noted above, a formal table is not provided. The document states that various tests (electrical safety, EMC, software V&V, operational performance, environmental performance, biocompatibility, shelf life, electrode performance for NMT module; and software integration, EMC, environmental, safety for Bedside Monitors) were conducted and that the devices "met all the acceptance criteria" or "performed within specifications." The specific quantitative pass/fail thresholds for each test are not detailed in this summary.

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

   • Sample Size: Not explicitly stated for any of the performance tests (e.g., how many devices were tested, how many signal samples were used for performance evaluation).
   • Data Provenance: The tests are described as non-clinical (bench testing, software validation). There is no indication of patient data being used for device performance validation as part of this 510(k) submission. The document explicitly states: "No clinical tests have been submitted, referenced or relied on in the premarket notification submission for a determination of substantial equivalence."

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

   • Not applicable as no clinical study or expert-adjudicated ground truth dataset is described for device performance validation. The ground truth for engineering and performance tests would be defined by the measurement standards and validation protocols themselves (e.g., a calibrated instrument reading as ground truth for a measurement accuracy test).

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

   • Not applicable as no clinical study or expert adjudication process for a test set is described.

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 MRMC study was done, as explicitly stated: "No clinical tests have been submitted, referenced or relied on in the premarket notification submission." The device is a monitor, not an AI-assisted diagnostic tool that would typically involve human reader improvement studies.

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

   • Performance validation was conducted via non-clinical testing against specifications and standards, which generally assesses the algorithm's (or device's) performance in isolation under controlled conditions (e.g., accuracy of readings, alarm thresholds). Specific "standalone performance" metrics (like sensitivity/specificity for a diagnostic algorithm) are not detailed as the device is a measurement and monitoring system.

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

   • For the non-clinical tests described, the "ground truth" would be the known inputs or reference values from calibrated test equipment, as per engineering and quality assurance standards. No medical "ground truth" (e.g., expert consensus, pathology, outcomes data) from patients was used for device verification or validation in this submission.

8. The sample size for the training set:

   • Not applicable. The document describes a medical device (monitor) with firmware/software, not an AI/ML algorithm that would typically require a distinct training set (beyond standard software development and testing).

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

   • Not applicable, as there is no specific "training set" described for an AI/ML algorithm.

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Elefix V Paste for EEG & EMG is a conductive paste used with surface electrodes to lower skin-electrode impedance. It can be used with electrodes for EEG and EMG examination.

The Elefix V Paste for EEG & EMG is the electroconductive media used with external electrodes to reduce the impedance (resistance to alternating current) of the contact between the electrode surface and the skin. The Elefix V Paste for EEG & EMG is an aqueous based material with Sodium Chloride as the conductive material combined with emulsifiers, humectants and preservatives. The Elefix V Paste for EEG & EMG has been designed to have increased stiffness and improved temperature resistance compared to its predecessor, the predicate device. These changes allow the paste to stay in place better as desired by its users. The Elefix V Paste for EEG & EMG has a neutral pH compared to the slightly alkaline pH of the predicate.

The Elefix V Paste for EEG & EMG is available in two models: ZV-401E and ZV-181E. ZV-401E is a container filled with 400 g of the paste. ZV-181E is a tube filled with 180g of the paste.

The Elefix V Paste for EEG & EMG is intended to be used by qualified medical personnel within a medical facility. It can be used with electrodes for electroencephalography (EEG) and electromyography (EMG) examination.

The document provided details for the Elefix V Paste for EEG & EMG, an electroconductive media. While the document discusses performance data and various tests conducted, it does not contain information typically associated with studies demonstrating the performance of AI/ML-driven medical devices, such as those related to effect size, human readers with or without AI assistance, or details on ground truth establishment for training sets.

Here's the information that could be extracted from the provided text, primarily related to bench testing of the device's physical properties:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "performance testing" and "design verification and validation testing," but does not specify the sample size for these tests for pH, impedance, stiffness, or temperature resistance. The data provenance is also not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as the tests conducted were for physical and chemical properties of a conductive paste, not for diagnostic accuracy or interpretation requiring expert consensus.

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

This information is not applicable as the tests conducted were for physical and chemical properties and did not involve human interpretation or adjudication.

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

This information is not applicable as the device is an electroconductive paste, not an AI-driven diagnostic or interpretative system. Therefore, an MRMC study related to AI assistance for human readers would not be relevant.

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

This information is not applicable as the device is an electroconductive paste, not a standalone algorithm.

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

For the physical property tests, the "ground truth" or reference was based on established physical and chemical measurement standards for impedance, pH, conductivity, and stiffness. For biocompatibility, it was based on ISO 10993 standards.

8. The sample size for the training set

This information is not applicable as the device is not an AI/ML system and therefore does not have a "training set" in the context of machine learning.

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

This information is not applicable as the device is not an AI/ML system and therefore does not have a "training set."

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The SVM-7200 series Vital Signs Monitor is intended for monitoring of physiologic parameters, including non-invasive blood pressure (systolic, and mean arterial pressure), pulse rate, non-invasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and temperature, and neonatal patients in hospital environments when used by clinical physicians or appropriate medical staff under the direction of physicians.

The SVM-7200 series Vital Signs Monitor is intended to be used by clinicians, doctors, nurses, and medically qualified personnel for measuring noninvasive blood pressure (NIBP), noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), body temperature (TEMP) of one patient at a time. The monitors can be used in the specialized health care environment such as hospitals, clinics, special medical facilities, independent surgery centers, multitherapy facilities and wards. Adults, children and neonates can be monitored using this device. The SVM-7200 series monitors have an eight-inch TFT color display and two modes: spot check and continuous mode. The monitor can operate with either a wired or wireless LAN connection.

The NIHON KOHDEN SVM-7200 series Vital Signs Monitor obtained FDA clearance (K190468) based on its substantial equivalence to predicate devices, leveraging previously validated clinical accuracy data for its sub-systems.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly present a table of quantitative acceptance criteria for device performance (e.g., specific accuracy ranges for SpO2, NIBP, Temperature). Instead, the acceptance criteria are implicitly met by demonstrating compliance with various recognized standards and by leveraging clinical accuracy data from previously cleared sub-systems.

The reported device performance for the SVM-7200 series (referring to accuracy) is based on the validation of its constituent clinical sub-systems, not on new, standalone performance studies for the integrated SVM-7200 itself.

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

The document states: "New clinical accuracy validation testing was not necessary as these subsystems along with their accessories have been previously validated and cleared. This 510(k) leverages the previous clinical accuracy data from the predicates..."

Therefore, there is no new sample size for a test set conducted specifically for the SVM-7200 series for clinical accuracy. The "test set" in this context refers to the data used in the original validation studies of the individual sub-systems (Masimo SpO2, Nellcor SpO2, Nihon Kohden SpO2, Covidien TEMP, Exergen TEMP, Nihon Kohden NIBP). The document does not provide details on the sample sizes or data provenance (e.g., country of origin, retrospective/prospective) of these historical studies.

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

Since no new clinical accuracy studies were conducted specifically for the SVM-7200 series, this information is not provided in the document. The ground truth for the leveraged clinical accuracy data from the sub-systems would have been established during their original validation studies, but details on experts and their qualifications are not included here.

4. Adjudication Method for the Test Set:

This information is not provided as no new clinical accuracy studies were performed for the SVM-7200 series in this submission.

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:

This device is a vital signs monitor, not an AI-assisted diagnostic tool that would involve "human readers" interpreting images or data. Therefore, an MRMC comparative effectiveness study is not applicable and was not performed.

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

The device performance, particularly for its various measurement sub-systems (NIBP, SpO2, Temp), is essentially "standalone" in the sense that the algorithms embedded within these components calculate the physiological parameters. The document confirms that "New clinical accuracy validation testing was not necessary as these subsystems along with their accessories have been previously validated and cleared." This implies that the algorithms for calculating these vital signs had their standalone performance validated in previous 510(k) submissions. The SVM-7200 (the subject device) integrates these already validated standalone sub-systems.

7. The Type of Ground Truth Used:

The ground truth for the clinical accuracy of the individual sub-systems (NIBP, SpO2, Temperature) would have been established using reference methods or clinically accepted gold standards during their original validation studies. For example:

• SpO2: Co-oximetry for arterial blood gas analysis would typically be the ground truth.
• NIBP: Invasive arterial blood pressure measurement or auscultatory methods would be common ground truths.
• Temperature: Rectal temperature, or other highly accurate core body temperature measurements, are typically used.

The document does not detail the specific ground truth methods for the (already cleared) sub-systems, but it implicitly relies on their validation against such standards.

8. The Sample Size for the Training Set:

The SVM-7200 is not described as utilizing machine learning or AI models that require "training sets" in the conventional sense. Its sub-systems (NIBP, SpO2, Temp) are based on established algorithms and hardware. Therefore, information regarding a "training set sample size" is not applicable/provided.

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

As no training set is discussed or implied for this device in the context of machine learning, this information is not applicable/provided.

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The AE-120A EEG Head Set is intended to amplify, capture, and wirelessly transmit electrical activity of the brain for review by a trained medical professional using the previously cleared and validated Nihon Kohden electroencephalograph systems (EEG-1200A series and EEG-9100) to assist in the diagnosis of neurological disorders. The AE-120A EEG Head Set and its associated EEG Software do not provide any diagnostic conclusion or automated alerts of an adverse clinical event about a patient's condition.

The device is intended for use by trained medical professionals in a medical facility such as a physician's office, laboratory, or clinic. The device is intended for use on adults (ages 18 and above). (Rx Only)

The Nihon Kohden AE-120A EEG Head Set is a battery powered (2 AA, LR6 alkaline disposable) wireless EEG head set which facilitates the placement of disposable EEG electrodes on the patient's scalp. The AE-120A EEG Head Set with the electrodes is then attached to the patient's head using the head set's chin, top, and rear straps.

With the head set turned on and secured in place, the head set acquires and amplifies electrical activity via EEG electrodes placed in contact with the patient's scalp. The captured waveforms from these signals are transmitted wirelessly via Bluetooth to a Nihon Kohden specified electroencephalograph through the AE-120A EEG Head Set and receiver.

The head set outputs the collected brain electrical activity to the computer component of the electroencephalograph system where a medical professional can review and interpret the information.

The AE-120A EEG Head Set has 8 channels for measurement along with one reference and one Z electrode. The electrodes are fixed into position with the head set to approximate the 10-20 electrode positions.

The AE-120A EEG Head Set is designed to work with the Nihon Kohden EEG-1200A series and EEG-9100, cleared in K080546 and K011204, respectively. The associated system software is used to facilitate the communication and display of the information from the head set.

The provided text describes a 510(k) premarket notification for the Nihon Kohden AE-120A EEG Head Set. This submission focuses on demonstrating substantial equivalence to a predicate device, primarily through performance testing and comparison of technological characteristics, rather than a clinical study evaluating diagnostic accuracy or human-in-the-loop improvement. Therefore, many aspects of a traditional clinical study (e.g., sample size for test set, adjudication methods, MRMC studies, effect size of human readers, ground truth establishment) are not relevant or described in this type of submission.

The document details performance testing related to electrical safety, biocompatibility, and electrode performance, but not a study to prove improved diagnostic accuracy for neurological disorders.

Here's an analysis of the provided information, focusing on what is described in the 510(k) summary:

1. A table of acceptance criteria and the reported device performance

The document describes several performance tests and their outcomes, which can be interpreted as demonstrating the device meets implicit acceptance criteria for safety and performance in its intended function. Explicit acceptance criteria values are stated for electrode performance testing.

2. Sample sized used for the test set and the data provenance

• Electrode Performance Test: "Twelve (12) electrode pairs were tested." The data provenance is not specified (e.g., country of origin, retrospective/prospective).
• Other tests (Software, Electrical Safety, Biocompatibility): These refer to verification and validation activities against standards and internal requirements, not studies on patient data. Thus, there isn't a "test set sample size" in the clinical sense.

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

This information is not provided because the submission describes device performance testing (e.g., electrical, mechanical, software functionality) rather than a clinical study requiring expert-established ground truth for diagnostic accuracy. The device "assists in the diagnosis of neurological disorders" for "review by a trained medical professional" but does not provide diagnostic conclusions or automated alerts itself.

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

Not applicable. There was no clinical test set requiring adjudication of diagnostic outcomes.

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 such study was conducted or described. This device is an EEG headset that amplifies, captures, and transmits raw electrical brain activity. It does not incorporate AI for interpretation or diagnostic assistance, nor does it claim to improve human reader performance.

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

Not applicable. The device's function is to acquire and transmit data for human review. It does not have a standalone diagnostic algorithm.

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

For the performance tests described:

• Electrode Performance: Ground truth was based on measurements against the specified criteria of the ANSI AAMI EC12:2000 standard, as measured by testing equipment.
• Biocompatibility: Ground truth was established by adherence to ISO 10993 series standards, verified through laboratory testing.
• Software, Electrical Safety & EMC: Ground truth was established by adherence to recognized national and international standards (e.g., IEC 60601 series, FDA guidances) through testing and verification/validation processes.

No clinical ground truth (e.g., expert consensus on neurological disorders, pathology, patient outcomes) was necessary for this 510(k) submission, as the device doesn't provide a diagnostic output.

8. The sample size for the training set

Not applicable. This device does not use machine learning or AI that would require a "training set" of data.

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

Not applicable, as there is no training set for this device.

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The OLG-3800A CO2 monitor is intended to monitor respiratory rate, CO2 partial pressure and EtCO2. The device is also intended to monitor pulse rate and SpO2.

The device may generate an audible and/or visible alarm when a measured physiological rate falls outside preset limits, or when a technical error is detected.

The devices are intended to be used by qualified medical facility, such as hospital or clinic, on all patient populations including adult, neonate, infant, child, and adolescent subgroups.

The Nihon Kohden OLG-3800A is a compact CO2 monitor with a 7-inch display and is designed so the operator can directly touch the screen from the operator position. The CO2 monitor displays the patient's vital signs (CO2, RR, SpO2, PR) on the screen and generates an alarm according to the setting. Alarms are indicated with a screen message, sound, blinking or lighting of the alarm indicator. The device is used with commercially available sensors for intubated and non-intubated patients. The CO2 monitor is intended to be used in an ER, OR, ICU, CCU or general ward on all patient populations, depending on the accessories used with the device. The OLG-3800A is AC and/or battery operated.

When the operation mode is set to Network mode, the CO2 monitor can connect to a Nihon Kohden monitoring system network and communicate with the central monitor and bedside monitor on the network.

A new optional accessory, single-use adult cap-ONE Biteblock YG-227T can be used together with OLG-3800. YG-227T is inserted between the patient's teeth to prevent closure of the patient's jaws. It connects to a specified Nihon Kohden CO2 sensor kit to measure the partial pressure of the expired CO2 of a patient. Also, it allows oxygen (including an oxygen-air mixture) to be provided to the patient during endoscopy.

This document describes the Nihon Kohden CO2 Monitor, Model OLG-3800A, and its substantial equivalence to predicate devices. However, it does not contain a typical study design with the elements requested (acceptance criteria, device performance, sample size, ground truth, expert involvement, etc.) for an AI/ML-based medical device. Instead, it details the device's technical specifications, indications for use, and compliance with various international standards for medical electrical equipment and a brief section on performance testing.

Therefore, many of the requested fields cannot be directly extracted from the provided text because they are not applicable to the type of regulatory submission (a 510(k) for a hardware medical device with standard electrical and performance testing against a predicate device, not an AI/ML algorithm requiring a clinical validation study with human readers or standalone performance metrics).

However, I can extract information related to the device's stated performance and compliance with relevant standards, which serve as its "acceptance criteria" in this context.

Here's the information that can be extracted or inferred based on the provided document:

1. A table of acceptance criteria (from standards) and the reported device performance:

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