Search Results

The TetraGraph Neuromuscular Transmission (NMT) Monitor is indicated for monitoring the relaxation of the patient when neuromuscular blockade is administered.

The TetraGraph Neuromuscular Transmission (NMT) Monitor (TetraGraph) is a portable, batteryoperated EMG-based neuromuscular transmission monitor for use perioperative and in recovery and critical care environments following or during the application of Neuromuscular block. TetraGraph undertakes this function by electrical stimulation of the peripheral nerve and directly measuring the evoked response of the muscles (Muscle Action Potential (MAP)), thus providing a quantitative and automatic measurement of muscle response to a stimulus using electromyography (EMG). The TetraGraph is a prescription-only medical device and is indicated for use in hospitals. TetraGraph consists of the following main components: TetraGraph Monitor, TetraSens Electrode, TetraSens Pediatric Electrode (new accessory), Philips Interface (new and optional accessory), and Pole clamp kit (optional accessory).

The provided text describes the 510(k) premarket notification for the Senzime AB TetraGraph Neuromuscular Transmission Monitor, specifically for the addition of new accessories: the TetraSens Pediatric electrode and the Philips Interface. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device (TetraGraph Neuromuscular Transmission Monitor, K190795).

Based on the provided document, here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance results in a clear, summarized format. Instead, it refers to generalized performance testing.

However, it implicitly states that performance testing was conducted for the TetraGraph with the new TetraSens Pediatric electrodes and that "all of the acceptance criteria for this device" were met. These criteria are noted to be "the same or very similar to the predicate device's specifications."

The types of performance testing mentioned are:

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

The document does not specify the sample sizes used for any of the performance tests mentioned (biocompatibility, electrode testing, EMG detection, tensile strength, shelf life, software, electrical, EMC).

The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. It implies internal testing conducted by the manufacturer or their designated testing facilities.

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 provided in the document. The tests described are largely bench-top and engineering performance tests, which typically do not involve experts to establish ground truth in the same way clinical studies or image-based diagnostics would.

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

This information is not applicable/not provided as the tests described are technical performance tests rather than clinical evaluations requiring adjudication of subjective 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:

This type of study is not applicable and was not conducted. The device is a neuromuscular transmission monitor, not an AI-assisted diagnostic tool that aids human readers. The document explicitly states: "There was no clinical testing required to demonstrate that TetraGraph with the new TetraSens Pediatric electrodes is substantial equivalent to the predicate device as the predicate has similar technological characteristics."

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

The device itself is a measurement and monitoring device, an "algorithm only" or "standalone" performance would refer to its accuracy and reliability in measuring neuromuscular transmission. The performance testing (EMG evoked response detection, compliance with standards) serves this purpose by demonstrating the technical capabilities of the device in isolation, even though it's used by humans. The document confirms that "performance testing made for the device" was completed and met acceptance criteria.

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

For the described performance tests, the "ground truth" would be established by:

• Scientific Standards: For biocompatibility (ISO 10993-1) and electrode testing (ANSI/AAMI EC12: 2000), the ground truth is defined by the requirements and test methods outlined in these international and national standards.
• Engineering Specifications: For EMG evoked response detection, electrode tensile strength, and other performance tests, the ground truth is based on the device's design specifications and expected technical performance against which the measured results are compared.

8. The sample size for the training set:

This information is not applicable/not provided. The TetraGraph is a measurement device and the data provided does not suggest it uses machine learning or AI models that require a "training set" in the conventional sense. The submission focuses on hardware accessories and their technical performance.

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

This information is not applicable/not provided for the same reasons as in point 8.

Ask a specific question about this device

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.

Ask a specific question about this device