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The Bioscope Neuromonitor Device is intended to help surgeons locate, identify, and preserve cranial motor nerves during surgery. Intra-operative monitoring and stimulation of cranial peripheral motor nerves.

Indications for Bioscope Neuromonitor Device Procedures include: thyroidectomy and parathyroidectomy, mastoidectomy.

Bioscope Neuromonitor Device is a nerve locator and monitor. The device has 3 infrastructure;

• Electronic
• Mechanic
• Software

These infrastructures are integrated with each other and work with the principle of stimulating current at 0.01-10 mA levels, conceiving EMG signals from related muscles groups. Collected signals are interpreted by the device and auditory and visual notifications will be given.

The device basically consists of stimulation and EMG subsystems. Both stimulation and EMG lines can send and collect signals from 2 channels. Depending on the operation, an EMG Endotracheal Tube or needle electrode is inserted into the muscles innervated by the relevant nerves for EMG reading. The electrode parts of the EMG tube are placed in contact with the muscles attached to the vocal cords. Needle electrodes are also inserted into the relevant muscle. Appropriate current is sent with the stimulation probe. The electrical changes in the muscles in the region and are transmitted to the device as a signal. The device gives audible and visual warnings.

Channels works on the principle of potentially stimulating the critical region through monopolar or bipolar probe connection and completing the circuit, allowing the device to make a nerve-tissue separation audibly and visually. It allows the detection of nerves such as the recurrent laryngeal nerve, which are connected to the vocal cords. The doctor brings the probe into contact with the area of potential nerve risk. The current sent to the patient through the probe causes a change in the electrical activity of the nerves and the muscles to which the nerves are connected, and this change can be detected by the device. Based on the collected data, the device gives clear audible alerts for nerve-tissue separation. The EMG signal collected from the patient is displayed as a both voltage value and latency times on the output. These values can be recorded and the interface can be used to select specific details, such as the right and left sides of the vagus, and recurrent laryngeal nerves.

The Bioscope Neuromonitor Device is intended to help surgeons locate, identify, and preserve cranial motor nerves during surgery. Intra-operative monitoring and stimulation of cranial peripheral motor nerves.
Indications for Bioscope Neuromonitor Device Procedures include: thyroidectomy and parathyroidectomy, mastoidectomy.

Here's an analysis of the acceptance criteria and study information provided:

1. Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state quantitative performance acceptance criteria (e.g., minimum sensitivity, specificity, or accuracy targets) for the Bioscope Neuromonitor Device. Instead, the acceptance criteria are implied through adherence to recognized medical device standards and the demonstration of "similar technical features" and "safety and effectiveness" compared to predicate and reference devices.

The reported device performance is primarily described as compliance with various international standards for medical electrical equipment, software life cycle processes, and specific requirements for nerve and muscle stimulators. The conclusion from nonclinical tests is that the device is "as safe, as effective, and perform as well as the legally marketed predicate device."

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

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

The provided document describes non-clinical performance testing. This type of testing typically involves laboratory-based evaluations, bench testing, and simulations to demonstrate compliance with standards and functional requirements. It does not mention clinical studies involving patient data or human subjects. Therefore, there is no information provided regarding a "test set" in the context of patient data (e.g., sample size, country of origin, retrospective/prospective).

The "test set" in this context refers to the device itself and its components undergoing various engineering, electrical, and software validation tests.

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)

As the testing described is non-clinical performance testing (bench testing, standard compliance), the concept of "ground truth" established by experts for a test set of patient cases is not applicable here. The "ground truth" in this context would be the specifications and expected performance values defined by the relevant standards and the device design. The "experts" would be the engineers, quality assurance personnel, and regulatory specialists conducting and reviewing these tests. No specific number or qualifications of such experts are mentioned beyond the general reference to "Test results demonstrate that the Bioscope Neuromonitor Device complies with the applicable standards."

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

Again, since this is non-clinical performance testing and not a clinical study involving human assessment of cases, the concept of an "adjudication method" for a test set is not applicable. Test results are typically evaluated against established technical specifications and standard requirements, not through expert consensus on case interpretations.

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 comparative effectiveness study was mentioned or performed. This submission describes a conventional medical device that provides intra-operative monitoring and stimulation. It is not an AI-assisted diagnostic or interpretative device that would typically involve human readers or AI assistance for image interpretation.

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

The Bioscope Neuromonitor Device is an active medical device that provides real-time information to a surgeon during surgery. It is not an "algorithm only" device or an AI system that operates without human-in-the-loop performance. Its function is to assist the surgeon by providing auditory and visual notifications based on EMG signals. Therefore, the concept of a "standalone (algorithm only)" performance study without human interaction is not applicable to this device.

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

For the non-clinical performance testing, the "ground truth" used is the defined technical specifications, functional requirements, and the pass/fail criteria established by the international standards listed (e.g., IEC 60601-1, IEC 62304, etc.). For instance, for accuracy of current output, the ground truth would be the known, calibrated output of measurement equipment used to verify the device's output.

8. The sample size for the training set

No information about a "training set" is provided. As this is a conventional neuro-monitoring device based on electrical stimulation and EMG signal detection, it does not appear to involve machine learning or AI models that would require a training set in the typical sense. The software validation is mentioned in the context of IEC 62304, which focuses on software life cycle processes and validation, not on training an AI model.

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

Since no training set is mentioned or applicable to this type of device, there is no information on how its ground truth would have been established.

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The C2 Xplore is designed for use in the operating room to measure and display the neurophysiological signals. The system supports the application of Electromyography (EMG) for the purposes of intraoperative neuromonitoring of the peripheral nervous system. The system is not intended for monitoring life-sustaining functions.

The C2 Xplore is an electromyography (EMG) monitor for the purposes of intraoperative neuromonitoring of the peripheral nervous system. The C2 Xplore assists the surgeon in nerve identification, helping to locate and identify nerves at risk in the surgical field. The device records the EMG activity from the innervated nerves and provides visual and audible feedback for the surgeon, helping to preserve the nerve structures throughout the procedure. The device is equipped with 8 differential amplifier channels and with two independent stimulators. The C2 Xplore is operated via mechanical turning knobs and a touchscreen on the front. The audio feedback is generated by an integrated loudspeaker. The nerve monitoring provides information about the amplitude and latency of the EMG responses.

The provided text describes the C2 Xplore device, an electromyography (EMG) monitor for intraoperative neuromonitoring of the peripheral nervous system. It outlines various aspects of the device's design, intended use, and comparisons to a predicate device (C2 NerveMonitor System) and a reference device (Medtronic Xomed, Inc Nerve Integrity Monitor 3.0).

However, the document does not contain specific acceptance criteria in numerical or quantitative terms for the device's diagnostic or clinical performance (e.g., sensitivity, specificity, accuracy for nerve identification). Instead, it discusses compliance with general safety, performance, and software standards.

Therefore, I cannot create a table of "acceptance criteria and reported device performance" as defined by specific clinical metrics. The document focuses on regulatory compliance and substantial equivalence rather than a detailed performance study with clinical outcomes.

Based on the information provided, here's what can be extracted and inferred regarding acceptance criteria and performance:

1. Table of Acceptance Criteria and Reported Device Performance:

As no specific quantitative clinical acceptance criteria (e.g., sensitivity, specificity, accuracy) are provided in the document for the device's primary function of nerve identification, a direct table of "acceptance criteria and reported device performance" in that sense cannot be created.

However, the document does detail compliance with various technical standards and internal requirements, which serve as acceptance criteria for different aspects of the device:

• Compliance with applicable guidance documents and standards (FDA guidance on premarket submissions for software, off-the-shelf software, software validation, cybersecurity).
• Rigorous development process, including software verification and validation. | "Test results demonstrate that the C2 Xplore software complies with its predetermined specifications, the applicable guidance documents and standards."
  "The software was designed and developed according to a rigorous development process, including software verification and validation."
  "The product successfully underwent the bench testing of the requirements at these levels as part of the verification and validation process." |
  | Electrical Safety | - Compliance with IEC 60601-1:2005+A1:2012 (or 2012 reprint).
• Compliance with IEC 60601-1-6:2010+AMD1:2013 (Usability).
• Compliance with IEC 60601-2-40:2016 (Electromyographs and evoked response equipment).
• Class I protection, 4000 V.
• Device type BF (Body Floating) for patient leads. | "The C2 Xplore was tested according to the following standards: [listed standards]. Test results demonstrate that the products comply with the applicable standards."
  "Class I protection 4000 V"
  "Device type BF (Body Floating)" |
  | Electromagnetic Compatibility (EMC) | - Compliance with IEC 60601-1-2:2014. | "The essential performance and safety of the C2 Xplore was tested according to the following standards: [listed standard]. Test results demonstrate that the products comply with the applicable standards." |
  | Bench Performance Testing | - Compliance with internal requirements for general device, functional, external interface, system accessory, and C2 Xplore software/firmware/OS requirements. | "The essential performance and safety of C2 Xplore was tested for performance in accordance with internal requirements."
  "The product successfully underwent the bench testing of the requirements at these levels as part of the verification and validation process." |
  | Human Factors | - Demonstration of mitigation of potential use errors.
• Safety of user interface design. | "Moreover, the testing of the influence of human factors on the device was conducted to demonstrate mitigation of potential use errors and safety of the user interface design." |
  | Overall Safety and Effectiveness | - As safe, as effective, and performs as well as, or better than, the legally marketed predicate device. | "The non-clinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device predicate."
  "The results of these activities demonstrate that the devices are as safe, effective and perform as well as or better than the predicate device." |

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

• Test Set Sample Size: Not applicable. The document states, "No additional clinical testing was performed for the C2 Xplore. Therefore, this section does not apply." The performance testing described is primarily technical bench testing and compliance with standards, not a clinical study on patient data.
• Data Provenance: Not applicable for a clinical test set. The data provenance would be from internal lab testing and compliance assessments, not patient data from a specific geographical region or retrospective/prospective study design.

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

Not applicable. As no clinical testing with patient data or medical imaging was performed, there was no need for experts to establish ground truth in a clinical context.

4. Adjudication method for the test set:

Not applicable. No clinical test set requiring expert adjudication was used.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size:

No. The document explicitly states, "No additional clinical testing was performed for the C2 Xplore." Therefore, an MRMC study comparing human readers with and without AI assistance was not conducted or reported.

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

Not applicable in the context of diagnostic AI. The C2 Xplore is a hardware device with integrated software for neuromonitoring, which inherently involves a human (surgeon) interpreting the visual and audible feedback. It is not an "algorithm only" device designed to operate independently of human intervention for its intended use of nerve identification during surgery. Its standalone performance is described through its technical specifications and compliance with safety and performance standards.

7. The type of ground truth used:

For the technical performance (EMG recording, stimulation, electrical safety, EMC, software functionality), the ground truth is established by engineering specifications, international technical standards, and validated test procedures. For example, the accuracy of voltage/current delivery, noise levels, and frequency response would be verified against known, precisely controlled inputs and expected outputs according to design specifications and relevant standards.

8. The sample size for the training set:

Not applicable. The C2 Xplore is described as an electromyography monitor and stimulator, not an AI/ML device that requires a distinct "training set" of data for learning a clinical pattern. Its software compliance involves verification and validation against predetermined specifications and guidance documents, which is a different paradigm from data-driven AI model training.

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

Not applicable, as no AI model training set is mentioned for the device.

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The Cascade IOMAX™ Intraoperative Monitor with Surgical Studio software (IOMAX) is an electroneurodiagnostic device that acquires, displays and stores physiologic data from peripheral sensory and motor nerves, muscles and the central nervous system, generated either spontaneously or elicited stimuli. The acquired data are necessary to perform somatosensory. auditory and visual evoked potentials (EPs), electroencephalography (EEG), electromyography (EMG), transcranial motor evoked potentials (TcMEPs), direct cortical stimulation, nerve conduction studies and Train of Four (TOF) analysis. SpO2 measures and displays oxygen saturation and heart rate information. The system also delivers direct nerve stimulation required for specific surgical procedures.

Evoked Potentials (EPs): IOMAX provides electrical, auditory or visual stimulation and measures, and stores the electrical activity of the nervous system in response to the stimulation.

EEG: IOMAX measures, displays, records, and stores electrical activity of the brain from two or more electrodes on the head.

Free Run EMG: IOMAX acquires, displays, records, and stores spontaneous EMG activity of motor nerves by continually displaying a live stream of mechanically induced myotome contractions.

TcMEP: IOMAX delivers transcranial stimulation via dedicated outputs for intraoperative assessment. Cortical Stimulation: IOMAX delivers Low Current Stimulation (LCS) during surgical procedures to map various areas of the cortex.

Triggered EMG (TEMG): IOMAX electrically stimulates the motor nerves, and displays, records, and stores the resulting compound muscle action potentials in the innervated muscle.

Nerve Conduction Study (NCS): IOMAX measures, displays, records, and stores sensory and motor nerve conduction time (latency) by applying a stimulus to peripheral nerves, the spinal cord, and the central nervous system.

Train of Four (TOF) or Twitch Test: IOMAX delivers a train of four pulses and measures, and stores the compound muscle action potential amplitude fade for analysis.

SpO2: IOMAX measures and displays oxygen saturation and heart rate information. Remote Reader: IOMAX provides passive, real time remote review of intraoperative monitoring for a physician outside of the operating room.

IOMAX is used by or under the direction of a licensed physician, surgeon, or neurologist in a professional healthcare facility environment for pre-operative, intraoperative and post-operative testing.

The IOMAX is a multimodality intraoperative neuromonitoring (IONM) system. It consists of Cadwell custom hardware, a standard laptop or desktop personal computer (PC) running a standard off-the-shelf (OTS) operating system (OS), and Cadwell custom software.

The modalities recorded, measured and displayed by the IOMAX are:

• . Evoked potential (EP) in the form of:
  • Brainstem auditory (BAEP): O
  • Visual (VEP); and O
  • Somatosensory (SSEP). O
• Transcranial electrical motor evoked potential (TcMEP).
• Electromyography (EMG). ●
• Triggered EMG.
• Electroencephalogram (EEG). ●
• Nerve conduction studies.
• Train of four (TOF). ●
• SpO2 and heart rate values. ●
• Threshold mode. ●
• Cortical stimulation.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Cadwell IOMAX Intraoperative Monitor:

Acceptance Criteria and Reported Device Performance

The provided document describes the Cadwell IOMAX Intraoperative Monitor, an electroneurodiagnostic device. The acceptance criteria are broadly focused on the device's technical performance, safety, and compliance with various medical device standards. The document does not present specific quantitative acceptance criteria or reported performance values in a distinct table format. Instead, it states that "Test results indicate that the IOMAX complies with its predetermined specifications and the applicable standards." and "Clinical results indicate that the IOMAX complies with the applicable requirements of the standard."

However, we can infer the categories of acceptance criteria based on the performance testing summary. The reported device performance is generally a statement of compliance.

Study Details:

The provided document summarizes various tests rather than detailing a single "study" as one might expect for a clinical trial. However, it does outline the testing performed to demonstrate compliance.

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

   • Biocompatibility: Not explicitly stated as a "sample size" for a test set in the clinical sense. The verification was on "component materials" of accessories. Data provenance is implied to be laboratory testing of materials.
   • Software, Electrical Safety, EMC, Bench Performance: Not applicable in terms of patient sample size. These involve engineering and laboratory testing of the device itself.
   • Clinical Performance (SpO2): The document states "Clinical results indicate that the IOMAX complies with the applicable requirements of the standard [ISO 80601-2-61:2011, Medical electrical equipment – Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment]". This standard defines requirements for pulse oximeters, which would necessitate testing on human subjects. However, the specific sample size for this clinical testing is not provided in the given text. The data provenance is clinical testing against a standard. The country of origin is not specified.

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 in the document. The testing described is primarily technical compliance with standards, and clinical performance for SpO2 which refers to a standard directly. There is no mention of independent expert review or ground truth establishment in the traditional sense for diagnostic accuracy.

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

   • This information is not provided and is unlikely to be applicable for the types of compliance testing described here. Adjudication methods are typically used for medical image interpretation or diagnostic accuracy studies involving human readers.

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 comparative effectiveness study was done or mentioned. This device is an intraoperative monitor and stimulator; it is not an AI-powered diagnostic imaging tool that would typically involve human readers interpreting cases with or without AI assistance. Therefore, no effect size of human improvement with AI assistance is applicable or provided.

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

   • The IOMAX is an electroneurodiagnostic device that acquires and displays physiological data. Its "performance" is based on the accuracy and reliability of its measurements and stimulation. The testing described (electrical safety, EMC, bench, and clinical for SpO2) assesses the device's inherent function, which is essentially "standalone performance" in the sense that the device directly performs the measurement or stimulation. It doesn't involve an "algorithm" in the AI sense, but rather the hardware and software's ability to accurately capture and present physiological signals or deliver specific stimuli.
   • The clinical performance for SpO2 (compliance to ISO 80601-2-61) is a test of the device's standalone accuracy in measuring oxygen saturation and heart rate.

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

   • For the technical compliance tests (biocompatibility, software, electrical safety, EMC, bench performance), the "ground truth" is defined by the requirements of the specified industry standards (e.g., ISO 10993-1, ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60068, IEC 60601-2-26, IEC 60601-2-40, IEC 60601-1-6, IEC 62366). The device's output is compared against the expected performance defined by these standards.
   • For the clinical performance testing for SpO2, the ground truth would be established by a reference method or device as required by ISO 80601-2-61, which typically involves comparing the pulse oximeter's readings against arterial blood gas analysis results.

8. The sample size for the training set:

   • This information is not applicable as the device is not described as an AI/machine learning device that requires a training set in the conventional sense. The "training set" for software development would be the requirements and specifications used during its creation, rather than a dataset for statistical model training.

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

   • As the concept of a "training set" for an AI model is not applicable here, the establishment of ground truth for such a set is also not applicable. The software's "ground truth" during development would be its specified functional requirements.

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The Neuromaster G1 MEE 2000 Neural Function Measuring System is intended to monitor, record, and display the bioelectric signals produced by sensory and motor pathways in the operating room, critical care, and other areas where continuous monitoring is needed. The system measures and displays electric/auditory/visual evoked potential (EP), electroencephalography (EEG), and electromyography (EMG), skin temperature of distal portion of extremities, SpO2, and ETCO2 to provide health care professionals with information to help assess a patient's neurological status. The system is used as a nerve stimulator for surgical procedures and brain mapping during treatment of patients with seizure disorders and used for the intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency.

· EEG - The device may also measure and record the electrical activities of the patient's brain obtained by placing two or more electrodes on the head (EEG).

· EP-Electrical/ Auditory/ Visual - Continuous and/or periodic measurements of evoked potential activities are displayed and stored. The device applies an electrical stimulus to a patient through commercially available skin electrodes for the purpose of measuring the evoked response. The photic stimulator is used to generate and display a shifting pattern or to apply a brief light stimulus to a patient's eye and the auditory stimulator produces a sound stimulus for use in evoked response measurements or electroencephalogram activation.

· Free Run EMG - The Free Run EMG function identifies spontaneous EMG activity of nerves by continually displaying a live stream waveform of any mechanically induced myotome contractions.

· CoMEP - Cortical stimulation techniques for cortical mapping are used at "Low Output" for placement of electrodes during surgical procedures and for brain mapping during treatment of patients with seizure disorders.

· TcMEP - Transcranial electrical stimulation techniques for motor evoked potentials (TcMEP) are used at "TcMEP Output" for the intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency."

· Nerve conduction study - The device is intended to measure and display nerve conduction time by applying a stimulus to a patient's peripheral nerve. This device includes the stimulator and the electronic processing equipment for measuring and displaying the nerve conduction time.

• SpO2 - When the SpO2 adapter and finger and toe probe for SpO2 measurement are used. oxygen saturation information is automatically measured and displayed.

· EtCO2 - When the CO2 adapter and sensor for EtCO2 measurement are used, endtidal carbon dioxide of respiratory gas information is automatically measured and displayed.

• Skin temperature - When the skin temperature sensor for skin temperature measurement is used, skin temperature information is automatically measured and displayed.

· Remote reader – The remote reader function provides real time remote access to the system for a monitoring physician outside of the operating room.

The device is intended for use by medical personnel within a hospital, laboratory, clinic or nursing home setting or outside of a medical facility under direct supervision of a medical professional.

The device is available for use on any patient as determined by the medical professional including adults and children of all ages.

The Neuromaster G1 MEE2000 Neural Function Measuring System is a compact and multi-functional system for continuous monitoring of brain and neural pathways intraoperatively and in critical care areas. The system measures and displays electric/auditory/visual evoked potential (EP), electroencephalography (EEG), and electromyography (EMG), skin temperature of distal portion of the extremities, SpO2 and ETCO2. The system also measures and displays nerve conduction time by applying a stimulus to a patient's peripheral nerve. The system includes the stimulator and the electronic processing equipment for measuring and displaying the nerve conduction time.

The system uses electrical stimulus, visual stimulus, or sound stimulus in evoked responses measurements (EP). Continuous and/or periodic measurements of evoked potential activities are displayed and stored. The system applies an electrical stimulus to a patient through skin electrodes for the purpose of measuring the evoked response. The photic stimulator is used to generate and display a shifting light pattern or to apply a brief light stimulus for use in evoked response measurements or electroencephalogram activation. The system may measure and record the electrical activities of the patient's brain obtained by placing two or more electrodes on the head (EEG).

The system can be used as a nerve stimulator for surgical procedures and brain mapping during treatment of patients with seizure disorders and used for intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency.

The system can be connected to SpO2 and ETCO2 sensors to display the patient's oxygen saturation values as measured by pulse oximetry and CO2 values respectively throughout the procedure.

The acquired waveforms are displayed in cascaded format and measurement data may be displayed on the trend graph with waveform annotations (events). The acquired waveforms with the measurement data can be saved to a large capacity storage media. The data can be printed directly on paper, printed to portable document format (pdf), and/or archived to other locations.

The Neuromaster G1 MEE2000 System consists of at minimum a main unit (DC-200B), an amp unit (JB-232B), one breakout box (JB-210B), four stimulation pods [JS-201B(A), JS-202B (B), JS-203B (C), JS-204B (D)], and a computer (CC-201BK) with specific software. There are several standard and optional accessories such as cables, connectors, SpO2 probes, ETCO2 sensors, and various types of electrodes and leads.

Here's a breakdown of the acceptance criteria and study information for the Neuromaster G1 MEE2000 Neural Function Measuring System, as derived from the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than setting novel acceptance criteria and explicitly defining the new device's performance against them. Instead, the performance characteristics of the Neuromaster G1 MEE2000 System are presented in comparison to its predicate device (Neuromaster MEE1000 System) and other reference predicates. The "acceptance criteria" here are implicitly the performance specifications of the predicate devices, which the new device aims to meet or exceed where noted.

I will present a selection of key characteristics to illustrate this comparison format. Please note that the document contains a very extensive table (Table 3) outlining numerous characteristics; this is a summary of some of the most relevant ones to demonstrate the device's technical specifications and how they align with or improve upon predicates.

Table: Acceptance Criteria (Predicate Performance) and Reported Device Performance (Neuromaster G1 MEE2000)

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