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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 RespArray™ patient monitor is intended to be used for monitoring, storing, of, and to generate alarms for, multiple physiological parameters of adults, pediatrics and neonates. The monitors are intended for use by trained healthcare professionals in hospital environments.
The monitor is for prescription use only.
The monitored physiological parameters include: ECG, respiration (RESP), temperature (TEMP), oxygen saturation of arterial blood (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), and carbon dioxide (CO2).
The arrhythmia detection and ST Segment analysis are intended for adult patients.
The SpO2 (NellcorTM) module is intended to be used for spot-check or continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR), in motion conditions, and in patients who are well or poorly perfused.
The MicrostreamTM capnography module is intended for continuous non-invasive monitoring of carbon dioxide concentration of the expired and inspired breath (etCO2) and respiration rate (RR).
The monitor also provides the clinician with integrated pulmonary index (IPI), apnea per hour (A/hr) and oxygen desaturation index (ODI) values. IPI is not intended for patients up to the age of one year. Allr and ODI are intended for ages 22 and up.
The monitors are not intended for MRI environments.

The RespArray patient monitor (hereinafter called RespArray) can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormity so that doctors and nurses can deal with them in time.

The provided text is a 510(k) Premarket Notification summary for the "Patient Monitor: RespArray" device. This type of submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than conducting new clinical trials for de novo clearance or PMA approval. Therefore, the details requested about acceptance criteria, specific study design (like MRMC studies, sample sizes, expert ground truth establishment for AI/algorithm performance), and training set information are not typically found in these types of submissions, as the FDA review here centers on comparing the new device's specifications and performance to an existing, already cleared device.

The document primarily highlights the device's technical specifications and how they compare to a predicate device (Edan Instruments, Inc, Patient Monitor Model X8, X10, X12 - K192514), along with compliance with relevant electrical safety, EMC, and performance standards. It explicitly states "Clinical data: Not applicable."

Given this, I will extract the information that is present in the document and indicate where the requested information is not applicable or not provided within the scope of a 510(k) submission focused on substantial equivalence.

Analysis of the Provided Document for Device Acceptance Criteria and Study Proof

The provided document is a 510(k) premarket notification. For devices cleared via a 510(k), the primary "acceptance criterion" is often substantial equivalence to a legally marketed predicate device, demonstrated through comparative testing and adherence to recognized standards. Direct, explicit "acceptance criteria" presented as quantitative performance targets with a detailed study to prove they are met (as might be seen in AI/ML clearances for algorithms with novel functionalities) are typically not included in this type of submission for a patient monitor.

The "study" that proves the device meets the acceptance criteria is primarily non-clinical performance testing (bench testing) and software verification/validation to show that the device performs as intended and is as safe and effective as its predicate.

Here's a breakdown of the requested information based on the provided document:

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

The document does not provide a table of explicit acceptance criteria/performance targets with quantitative results in the way one might expect for a new AI/ML algorithm. Instead, it demonstrates performance by stating compliance with recognized consensus standards and by comparing the subject device's specifications to those of its predicate device, showing "similar design features and performance specifications."

The closest representation of "performance" and "acceptance" is the "Predicate Device Comparison" table (pages 5-6). This table implicitly acts as the performance comparison against the predicate device that serves as the "acceptance" benchmark for substantial equivalence.

The document concludes that "the subject and predicate devices have similar design features and performance specifications. The technological differences between the subject and predicate devices do not raise different questions of safety or effectiveness."

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

The document states "Clinical data: Not applicable." Therefore, there isn't a "test set" in the sense of patient data used for clinical validation of, for example, an AI algorithm's performance. The "testing" primarily refers to non-clinical bench testing.

• Sample size: Not applicable for patient data test set. For bench testing, samples would be physical devices, components, or simulated signals, but a "sample size" in terms of patient numbers is not provided.
• Data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable, as no clinical data test set was used/provided.

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

Not applicable. Since no clinical data test set was described and "Clinical data: Not applicable" is stated, there was no need for expert ground truth establishment for a test set. This type of information would be relevant for AI/ML device clearances where human expert annotation is part of the ground truth creation.

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

Not applicable, as no clinical test set requiring adjudication of ground truth was 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. The document explicitly states "Clinical data: Not applicable." MRMC studies are typically for evaluating the impact of AI algorithms on human reader performance, which is not the scope of this 510(k) submission for a patient monitor.

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

The device is a patient monitor with various physiological parameter measurements and alarms. Its "performance" is inherent in its ability to accurately measure these parameters and detect events like arrhythmias. The non-clinical bench testing demonstrated its standalone performance by showing compliance with relevant standards (e.g., IEC 60601-2-27 for ECG, IEC 80601-2-30 for NIBP, ISO 80601-2-61 for pulse oximeter).

While not explicitly called "standalone algorithm performance" in the AI/ML sense, the "Performance testing-Bench" section (page 8) confirms that "Edan has conducted functional and system level testing to validate the performance of the results of the bench testing show that the subject device meets its accuracy specification and meet relevant consensus standards." This demonstrates the device's functional performance in isolation.

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

For the non-clinical bench testing, the "ground truth" would be established by:

• Reference instruments or calibrated signals (e.g., precise electrical signals for ECG, known pressure values for NIBP, calibrated gas mixtures for CO2).
• Standardized measurement protocols defined by the cited IEC/ISO standards.
• Accuracy specifications found within those standards or the device's own specifications.

There's no mention of expert consensus, pathology, or outcomes data as "ground truth" because this is a measurement and alarm device, not a diagnostic imaging AI algorithm, and no clinical data was used for validation in this submission.

8. The sample size for the training set

Not applicable. This device is a patient monitor, not an AI/ML algorithm that undergoes a distinct training phase on a dataset. The underlying algorithms for parameter measurement (e.g., NIBP oscillometric algorithm, arrhythmia detection) are established engineering designs, not typically "trained" in the machine learning sense with large datasets.

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

Not applicable, as there is no specific "training set" for an AI/ML algorithm described. The "ground truth" for the development and calibration of the monitor's measurement algorithms would have been established through engineering principles, laboratory testing with calibrated instruments, and referencing physiological models and data, but this is part of the device's fundamental design and not a separate "training set" as understood in current AI/ML contexts.

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The BeneVision N12N15/N17/N19/N22 patient monitors are intended for monitoring, displaying, storing, alarming, and transferring of multiple physiological parameters including ECG (3-lead, 5-lead or 12-lead selectable, Arrhythmia Detection, ST Segment Analysis, QT Analysis, and Heart Rate (HR)), Respiration Rate (Resp), Temperature (Temp), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), Pulmonary Artery Wedge Pressure (PAWP), Cardiac Output (C.O.), Continuous Cardiac Output (CCO), Mixed/Central Venous Oxygen Saturation (SvO2/ScvO2), Carbon Dioxide (CO2), Oxygen (O2), Anesthetic Gas (AG), Impedance Cardiograph (ICG), Bispectral Index (BIS), Respiration Mechanics (RM), Neuromuscular Transmission Monitoring (NMT), Electroencephalograph (EEG), and Regional Oxygen Saturation (rSO2). The system also provides an interpretation of resting 12-lead ECG.

All the parameters can be monitored on single adult, pediatric, and neonatal patients except for the following:

• · BIS, RM, CCO, SvO2/ScvO2, PAWP, NMT monitoring, PNP, and PNC are intended for adult and pediatric patients only. CCO using FloTrac is intended for adult patients only;
• · C.O. monitoring and A-Fib are intended for adult patients only;
• · ICG monitoring is intended for only adult patients who meet the following requirements: height: 122 to 229cm, weight: 30 to 155kg.
• · rSO2 monitoring is intended for use in individuals greater than 2.5kg.

The monitors are to be used in healthcare facilities by clinical professionals or under their guidance. They should only be used by persons who have received adequate training in their use. The BeneVision N12/N15/N17/N19/N22 monitors are not intended for helicopter transport, hospital ambulance, or home use.

The BeneVision N1 Patient Monitor is intended for monitoring, reviewing, storing, alarming, and transferring of multiple physiological parameters including ECG (3-lead, 5-lead or 12-lead selectable, Arrhythmia Detection, ST Segment Analysis, and Heart Rate (HR)), Respiration (Resp), Temperature (Temp), Pulse Oxygen Saturation (SpO₂), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), Pulmonary Artery Wedge Pressure (PAWP), Carbon Dioxide (CO2) and Oxygen (O2). The system also provides an interpretation of resting 12-lead ECG.

All the parameters can be monitored on single adult, pediatric, and neonatal patients except for the following:

• PAWP, PNP, and PNC are intended for adult and pediatric patients only;
• A-Fib is intended for adult patients only;

The BeneVision N1 monitor is to be used in healthcare facilities. It can also be used during patient transport inside and outside of the hospital environment, whereas N1 configured with WMTS technology can be used inside the hospital only. It should be used by clinical professionals or under their guidance. It should only be used by persons who have received adequate training in its use. It is not intended for home use.

The subject BeneVision N Series Patient Monitors includes six monitors:

• . BeneVision N12 Patient Monitor
• BeneVision N15 Patient Monitor
• BeneVision N17 Patient Monitor ●
• BeneVision N19 Patient Monitor ●
• BeneVision N22 Patient Monitor ●
• BeneVision N1 Patient Monitor

Mindray's BeneVision N Series Patient Monitors provide a flexible software and hardware platform to meet the clinical needs of patient monitoring.

This document is a 510(k) Summary for the Mindray BeneVision N Series Patient Monitors, which focuses on demonstrating substantial equivalence to a previously cleared predicate device (K202405).

The information provided primarily details the device's technical specifications and comparisons to a predicate device, rather than a full study proving the device meets acceptance criteria for a specific medical condition or AI diagnostic output.

Therefore, I cannot fully answer all parts of your request as the document does not contain the detailed clinical study results (like sample sizes for test sets, number of experts for ground truth, adjudication methods, MRMC studies, or specific AI performance metrics) that would typically be found for a device requiring those types of studies (e.g., an AI-powered diagnostic tool).

However, I can extract the relevant information regarding the device's functional and technical performance as demonstrated in this 510(k) submission.

Here's a breakdown of what can be inferred and what is missing:

Acceptance Criteria and Reported Device Performance

The "acceptance criteria" in this context are related to meeting the performance specifications of the predicate device and relevant consensus standards. The "reported device performance" is demonstrated through functional and system-level testing, ensuring the device meets its accuracy specifications for the various physiological parameters it monitors.

Table of "Acceptance Criteria" (Implied Specifications) and "Reported Device Performance" (Conformance):

Detailed Study Information (Based on Document Content):

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

   • The document states that "functional and system level testing" and "bench testing" were conducted.
   • However, no specific sample sizes for test sets (e.g., number of patients, number of data recordings) are provided for any of the performance evaluations.
   • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The tests described are generic "bench testing" to ensure compliance with technical specifications and standards, not clinical studies.

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

   • Not applicable / Not provided. This document describes engineering and bench testing against pre-defined technical specifications and industry standards for physiological measurement accuracy. It does not describe a clinical study involving human experts establishing ground truth for diagnostic interpretation (e.g., for an AI algorithm interpreting medical images).

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

   • Not applicable / Not provided. Same reason as above.

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. This device is a patient monitor. It detects physiological parameters and provides alarms, and some interpretations of ECG (e.g., 12-lead ECG interpretation, arrhythmia detection). It is not an AI-assisted diagnostic device in the sense of image interpretation for which MRMC studies are typically performed. The document details that "optimized auditory ALARM SIGNALS" and "alarm highlight" were added, suggesting improvements to the human-device interface, but not a formal MRMC study on diagnostic improvement.

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

   • The document implies that algorithms for ECG (Mindray or Mortara algorithm for arrhythmia and ST-segment analysis) are embedded in the device. The listed accuracy specifications for these measurements (e.g., HR, ST, QT) reflect the standalone performance of these measurement algorithms and sensors against established benchmarks. However, a formal "standalone study" with detailed methodology, distinct from the general bench testing, is not specifically described or provided with separate results. The performance data listed (e.g., accuracy for HR, ST, QT) serves as the "standalone" performance verification for these integrated functionalities.

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

   • For physiological measurements (ECG, SpO2, NIBP, etc.), the "ground truth" would typically refer to reference measurement devices or calibrated simulators used during bench testing to verify the accuracy of the monitor's readings against a known, accurate value.
   • For the ECG interpretation (e.g., 12-lead ECG interpretation, arrhythmia detection), the ground truth for the algorithms would have been established during their development and previous clearance processes (Mindray or Mortara algorithms). This document focuses on demonstrating that the integration and revised features maintain that established accuracy rather than re-proving the core algorithms.

7. The sample size for the training set:

   • Not provided. This document pertains to the 510(k) clearance of updates to an existing patient monitor series. It does not detail the development or training of new AI/ML algorithms, which would typically involve substantial training datasets. The ECG algorithms (Mindray or Mortara) were presumably "trained" (or developed and validated) previously as part of their initial predicate clearances.

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

   • Not provided. (See point 7). For existing algorithms like Mortara or Mindray ECG algorithms, ground truth for their original development would likely have been established using large, diverse ECG databases with expert cardiologist interpretations and/or correlation with clinical outcomes where relevant. This particular 510(k) document is concerned with demonstrating equivalence and continued performance with minor changes, not the original algorithm development.

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