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The WiTOF is a neuromuscular transmission station (nerve stimulator) that helps to pilot the neuromuscular blockade of adult patients in the operating room, recovery room or intensive care unit.

The WiTOF is a neuromuscular transmission station (nerve stimulator) that helps to pilot the neuromuscular blockade of adult patients in the operating room, recovery room or intensive care unit. It is used by health professionals (anaesthesiologists, doctors, or fully qualified nurse anaesthetists) for:

1. Objective neuromuscular transmission monitoring
2. Subjective neuromuscular transmission monitoring

The continuous monitoring of NMT blocking involves electrical nerve stimulation and the measurement of acceleration in the corresponding muscle (with a three-dimensional acceleration sensor). Based on the force of contraction resulting from the stimulation, it is possible to draw conclusions about the effectiveness of an injected neuromuscular blocking agents or the patient's curare level.

The device and all of the settings associated with it are designed for use on adult patients in hospital or health institutions so that the patient's curare level can be monitored.

The WiTOF system is composed of the station, the wireless sensor (hand), and the US AC power supply unit. The wireless sensor itself consists of the 3D accelerometer in the splint.

The WiTOF can perform several different modes of electrical stimulation in accordance with usual clinical practice:

• TOF (Train Of Four)
• PTC (Post Tetanic Count)
• ATP (Automated TOF PTC)
• DBS (Double Burst) (3,3) (3,2)
• ST (Single Twitch) 0.1 Hz and 1 Hz
• TET (Tetanus) 50 Hz and 100 Hz

The station displays the various stimulation settings, the time elapsed between stimulations, and the results for the measurements made in response to TOF, PTC, and ATP stimulations. The responses to other types of stimulation are gaged visually by the health professional. The device and stimulation settings are chosen using a display screen.

The accessories that can be used with the device include:

• Optic-serial (RS232) cable to transfer data
• Fixation clamp – regular size (10–40 mm / 0.4–1.6 inches)
• Fixation clamp – large size (20–60 mm / 0.8–2.4 inches)

The provided FDA 510(k) clearance letter for the WiTOF device does not contain the detailed performance study results, acceptance criteria, or specific data points typically found in clinical validation reports for AI/software-driven medical devices.

The document states that the software for the WiTOF device was considered of "moderate" level of concern and that "Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.'" However, it does not explicitly describe the acceptance criteria or the specific methodology/results of these tests.

Moreover, the letter explicitly states: "No animal or clinical testing was required to demonstrate the substantial equivalence of this device to its predicate, nor its safety and effectiveness." This indicates that the regulatory clearance was based on demonstrating substantial equivalence primarily through technical comparison and non-clinical performance data (electrical safety, EMC, software V&V) rather than a comparative clinical study.

Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria and the study that proves the device meets them, because this level of detail is not present in the provided 510(k) clearance letter. The letter focuses on regulatory compliance and substantial equivalence to a predicate device, not on a detailed clinical validation study as might be conducted for novel AI algorithms.

If this were an AI/ML medical device submission requiring a detailed performance study, the 510(k) summary would typically include a section describing that study with the elements you've requested (e.g., sample size, ground truth establishment, reader studies). The absence of such a section, along with the statement that no animal or clinical testing was required, confirms that these specific study details are not part of this clearance document.

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The iTOF is a neuromuscular transmission monitor for monitoring the neuromuscular block of a patient in the operating theatre, recovery room or intensive care unit.

The iTOF is an accelerometery based Quantitative Neuromuscular Blockade Monitor that provides continuous, non-invasive neuromuscular transmission (NMT) monitoring by measuring the acceleration of muscle movement (acceleromyography) during controlled electrical stimulations. The iTOF allows medical professionals to accurately monitor and evaluate the depth of neuromuscular blockade of an adult or paediatric patient in the intensive care ward, operating theatre, or recovery room. It is used by health professionals - anaesthesiologists, doctors, or fully qualified nurse anaesthetists for objective or subjective neuromuscular transmission monitoring. The iTOF system consists of a mobile device app (User Interface Software), a Bluetooth connected nerve stimulation device (Hardware and Firmware) powered by a 9 Volt nonrechargeable battery, an Accelerometer Sensor, and Stimulation Cables. The App displays user interface elements including the various stimulation settings controls, the time elapsed between stimulations (all modes), and the results for the measurements made in response to types of stimulation chosen by the user (TOF, PTC, and DBS) (TET and TWI responses are gauged visually by the health professional). The hardware device portion of the iTOF system provides the electrical stimulation patterns via the Stimulation Cables and quantitatively measures the resulting twitch via the Accelerometer Sensor. The iTOF can perform several different modes of electrical stimulation in accordance with usual clinical practice: TOF (Train Of Four), PTC (Post Tetanic Count), DBS (Double Burst) (3.3), TWI (Single Twitch) (0.1Hz, 1 Hz, 2Hz), TET (Tetanus) (50Hz). The accessories that can be used with the device include: iTOF Splint (included).

The provided text does not contain information about specific acceptance criteria related to accuracy or performance metrics for the iTOF device. It primarily focuses on demonstrating substantial equivalence to a predicate device through functional, biocompatibility, electrical safety, wireless coexistence, software, and cybersecurity testing.

Therefore, I cannot create a table of acceptance criteria and reported device performance, nor can I provide details on sample size for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

The document indicates:

• No animal or clinical testing was required to demonstrate substantial equivalence, meaning no patient-level performance data is presented in this summary.
• Functional performance testing was performed on "output waveforms, voltage and current of different stimulation modes and simulated skin resistances." However, no specific metrics or acceptance criteria for these tests are provided.
• Software verification and validation testing was conducted, and the software was considered a "moderate" level of concern. No specific performance metrics or acceptance criteria for the software are detailed.
• The sample size for the training set and how its ground truth was established are not mentioned, as the document does not describe the development or training of any AI/ML components with performance metrics, but rather the verification and validation of software functionality.

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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.

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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 TOF3D is used to objectively monitor the level of neuromuscular transmission by measuring muscle contraction following stimulation. The TOF3D can also be used as a peripheral nerve stimulator (without the objective measuring function) for subjective monitoring. The device is intended for use for adolescents greater than 18 through 21 years of age, and adults.

The Neuromuscular Transmission Monitor TOF3D is capable to monitor the level of neuromuscular transmission (NMT) during surgery of in the intensive care unit by stimulating different nerves and measuring the response of the respective muscles to the stimulation. The different locations for monitoring are for instance the ulnar nerve/adductor pollicis muscle, the posterior tibial nerve/flexor halluces brevis muscle and the facial nerve/orbicularis oculi muscle. The Neuromuscular Transmission Monitor TOF3D uses acceleromyography (AMG) measurement for recording of evoked muscle responses. The results are shown on the LCD display of the device and shall aid qualified medical staff to maintain the proper level of neuromuscular block and to determine the level of recovery from neuromuscular block.

The provided text is a 510(k) summary for the Neuromuscular Transmission Monitor TOF3D. It describes the device, its intended use, and its substantial equivalence to a predicate device (TOF-WATCH SX).

However, the document explicitly states that no animal or clinical testing was required to demonstrate substantial equivalence (Section 5.7, "Animal and Clinical Studies"). This means there is no study described in this document that proves the device meets acceptance criteria through clinical performance metrics, effect sizes, or expert evaluations. The acceptance criteria and performance data provided are related to non-clinical testing, such as electrical safety, EMC, software verification, validation, and biocompatibility.

Therefore, I cannot provide a table of acceptance criteria and reported device performance related to clinical efficacy as requested in the prompt, nor can I answer questions about sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, or ground truth types for clinical use.

The available information about "acceptance criteria" and "device performance" in this document pertains to engineering and safety standards, not clinical effectiveness.

Here's what can be extracted regarding the non-clinical acceptance criteria and "performance":

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical):

2. Sample sizes for the test set and data provenance:

• Not applicable for clinical performance studies. The testing was non-clinical (electrical safety, software, biocompatibility).

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 ground truth was established for performance testing.

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

• Not applicable, as no clinical ground truth was established for performance testing.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:

• No, explicitly stated that "No animal or clinical testing was required to demonstrate the substantial equivalence of this device to its predicate."

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

• Not applicable, as the device is a hardware monitor, not an AI algorithm.

7. The type of ground truth used:

• For non-clinical testing, the "ground truth" was compliance with established engineering and safety standards (e.g., IEC standards, FDA software guidance, ISO biocompatibility standards).

8. The sample size for the training set:

• Not applicable, as this is not an AI/ML device that requires a training set.

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

• Not applicable.

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

Not Found

I am sorry, but the provided text from the FDA document (K192958) for the TwitchView System does not contain the detailed information required to answer your request about acceptance criteria, device performance, study design, and ground truth establishment for an AI/ML device.

The document is a 510(k) clearance letter for an Electrical Peripheral Nerve Stimulator (Product Code: KOI), which is a device for quantitative monitoring of neuromuscular transmission via electromyography. It is not an AI/ML powered device, and therefore, the kind of study details you are asking for (e.g., sample size for test set, data provenance, expert adjudication, MRMC studies, standalone performance, training set details) are not relevant or present in this specific clearance.

The document primarily focuses on:

• Confirming substantial equivalence to a predicate device.
• Indications for Use.
• General controls and regulatory requirements for a Class II device.

The information you are requesting is typically found in:

• Premarket Approval (PMA) applications for novel high-risk devices, which often involve extensive clinical trial data.
• De Novo requests for novel low-to-moderate risk devices.
• Specific sections within 510(k) summaries or detailed review memoranda for AI/ML devices that explicitly describe performance studies, often in response to special controls or FDA guidance for AI/ML.

Since the provided text does not contain the requested information, I cannot fill out the table or describe the study details.

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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, battery-operated 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 provided text is a 510(k) summary for the TetraGraph Neuromuscular Transmission (NMT) Monitor. It describes the device, its intended use, and argues for its substantial equivalence to a predicate device (Datex Ohmeda S/5 NeuroMuscular Transmission Module, E-NMT).

However, the summary does not include a detailed table of acceptance criteria or the reported device performance in those terms. It generally states that "Performance testing show that TetraGraph met all the acceptance criteria for this device, and which are the same or very similar to the predicate device's specifications."

Therefore, for aspects directly requesting specific acceptance criteria and reported performance values, the information is not present in the provided document. Similarly, details about a specific study proving the device meets these criteria (like sample sizes for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone performance metrics) are not provided in the depth requested.

Here's a breakdown of the information that can be extracted or inferred based on the prompt's requirements, and what is explicitly missing:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in the document.
• Data Provenance: Not specified. The document describes "performance testing" but does not indicate if it involved human subjects, animal subjects, or purely bench testing, nor does it specify the country of origin or whether it was retrospective or prospective.

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. The document highlights functional and safety performance testing but does not mention the use of experts for establishing ground truth, as would be common in an AI/diagnostic device context. Given that this is a hardware monitoring device, the "ground truth" might be more related to established physical measurements and electrical standards, rather than expert interpretation of medical images or data.

4. Adjudication method for the test set

• Not applicable/Not specified as no expert review or human-in-the-loop diagnostic assessment is described for the performance testing.

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, an MRMC study was not done. The document explicitly states: "There was no clinical testing required to demonstrate that TetraGraph is substantial equivalent to the Datex-Ohmeda Device, as the predicate has similar technological characteristics." This implies the evaluation was primarily based on technical performance and comparison to the predicate's technical specifications, not a clinical effectiveness study involving human readers or AI assistance.

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

• The device itself is a "Neuromuscular Transmission Monitor" operating on electromyography (EMG) signals. Its core functionality is standalone measurement and display of physiological parameters. While it's a "monitor," meaning it presents information to a human operator, the performance testing described is of the device's ability to accurately make these measurements. The document does not describe performance tests specifically for an algorithm distinct from the device's integrated operation. Its performance is its standalone performance.

7. The type of ground truth used

• The specific type of "ground truth" for the performance testing is not explicitly detailed. However, based on the types of tests listed (electrical safety, EMC, biocompatibility, thermal, mechanical, environmental, shelf life, battery, electrode performance), the ground truth would likely be established through:
  • Engineering specifications and standards: Conformance to IEC, ISO, and ANSI/AAMI standards.
  • Reference measurements: Using calibrated equipment to measure electrical outputs, physical properties, etc.
  • Bench testing: Controlled laboratory conditions to verify functional parameters against predefined acceptable ranges.

8. The sample size for the training set

• This device is not described as an AI/machine learning device that would typically have a separate "training set" in the context of learning algorithms for diagnosis or prediction. It is a measurement device. Therefore, this concept of a training set is not applicable as described in the document.

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

• As explained in point 8, the concept of a "training set" for an AI/ML algorithm does not apply to this device as described.

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The ToFscan is a neuromuscular transmission monitor for monitoring the neuromuscular block of a patient in the operating theatre, recovery room or intensive care unit.

The ToFscan is a neuromuscular transmission (NMT) monitoring the neuromuscular block of a patient in the operating theatre, recovery room or intensive care unit. It is used by health professionals (anaesthesiologists, doctors, or fully qualified nurse anaesthetists) for:

• 1. Objective neuromuscular transmission monitoring
• 2. Subjective neuromuscular transmission monitoring
     The continuous monitoring of NMT blocking involves the stimulation of the ulnar nerve and the corresponding measurement of acceleration in the adductor muscle of the thumb (with a three-dimensional acceleration sensor). Based on the force of contraction resulting from the stimulation, it is possible to draw conclusions about the effectiveness of an injected neuromuscular blocking agents or the patient's curare level.
     The apparatus and all of the settings associated with it are designed for use on adult and paediatric patients in hospital or health institutions so that the patient's curare level can be monitored.
     The ToFscan system is composed of the monitor, the hand sensor, and the US AC power supply unit. The hand sensor itself consists of the thumb splint/3D accelerometer, the electrode clamps, and the cable which connects to the monitor.
     The ToFscan can perform several different modes of electrical stimulation in accordance with usual clinical practice:
• -TOF (Train Of Four)
• PTC (Post Tetanic Count) -
• -ATP (Automated TOF PTC)
• DBS (Double Burst) (3,3) (3,2) -
• ST (Single Twitch) 0.1 Hz and 1 Hz -
• -TET (Tetanus) 50 Hz
  The monitor displays the various stimulation settings, the time elansed between stimulations, and the results for the measurements made in response to TOF, PTC, and ATP stimulations. The responses to other types of stimulation are gaged visually by the health professional. The device and stimulation settings are chosen using a rotary knob.

The provided text is a 510(k) summary for a medical device called ToFscan, a neuromuscular transmission monitor. The summary focuses on establishing substantial equivalence to a predicate device (TOF-Watch) and includes performance data related to biocompatibility, electrical safety, EMC, and software. However, the document does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in terms of accuracy or efficacy for its intended use.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts and their qualifications for ground truth.
• Adjudication method for the test set.
• MRMC comparative effectiveness study results or effect size.
• Standalone performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

The document explicitly states: "No animal or clinical testing was required to demonstrate the substantial equivalence of this device to its predicate." This indicates that the approval was based on demonstrating similar technical specifications and intended use to an already approved device, rather than new clinical performance data proving specific efficacy or accuracy metrics against defined acceptance criteria.

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