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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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