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The Guardian with Cascade Surgical Studio software 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 by stimuli.

Guardian can perform somatosensory, auditory, and visual evoked potentials (EPs), electroencephalography (EEG), electrocorticography (ECoG), spontaneous and triggered electromyography (EMG), transcranial motor evoked potentials (TcMEP), direct cortical stimulation (DCS), direct nerve stimulation (TEMG, DNS), nerve conduction studies (NCS), and Train of Four (TOF) analysis.

Guardian can provide remote review outside of the operating room.

Guardian 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 following functions are specifically supported individually or in combination:

Evoked Potentials (EPs): Guardian can provide electrical, auditory, and visual stimulation and measure, display, record, and store the electrical activity of the nervous system in response to the stimulations delivered.

Electroencephalography (EEG): Guardian can measure, display, record, and store electrical activity of the brain from two or more electrodes on the scalp.

Electrocorticography (ECoG): Guardian can measure, display, record, and store electrical activity directly from the brain using two or more electrodes.

Free Run Electromyography (EMG): Guardian can acquire, display, record, and store EMG activity of motor nerves.

Triggered Electromyography (TEMG): Guardian can electrically stimulate motor nerves, and display, record, and store the results.

Transcranial Motor Evoked Potentials (TcMEP): Guardian can deliver electrical transcranial stimulation, and display, record, and store the results.

Direct Cortical Stimulation (DCS): Guardian can deliver electrical stimulation to various areas of the cerebral cortex, and display, record, and store the results.

Direct Nerve Stimulation (DNS): Guardian can electrically stimulate cranial and peripheral nerves, and display, record, and store the results.

Nerve Conduction Study (NCS): Guardian can measure, display, record, and store 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): Guardian can deliver a train of four pulses, and measure, display, record, and store the results.

The Cadwell Guardian is a multi-modality intraoperative neurophysiological monitoring system with up to 80 channels of data acquisition.

The Guardian system is designed to be flexible and scalable depending on customer and procedural requirements. All systems require a Power Comm and Guardian Base, which contains an electrical Transcranial Stimulator. The user may select up to two Omni Amplifiers, two ES-10 electrical stimulators, one AVX auditory and visual stimulator, and one SMX-32 EEG amplifier that contains a low current electrical stimulator, in order to meet specific requirements.

The Guardian requires a (PC) with Windows operating system. The Guardian system uses a new version (4.0) of previously cleared Cadwell Cascade Surgical Studio software. Surgical Studio acquires, stores and reviews a wide range of intraoperative neurophysiological data, such as EMG, EEG, SSEP, BAEP, VEP, MEP and TOF, and includes Report Generation.

The provided text describes the Cadwell Guardian device, its indications for use, and a comparison to predicate devices, but it does not contain information about specific acceptance criteria or a study proving the device meets those criteria with quantitative performance metrics (like sensitivity, specificity, or accuracy) derived from a test set of data.

The document states:

• "Performance Testing: The Cadwell Guardian was tested in accordance with internal software requirements, system requirements, and usability requirements. Test results indicate that the Cadwell Guardian complies with its predetermined specifications."
• "Conclusion: Verification and validation activities were conducted to establish the performance and safety characteristics of the Cadwell Guardian. The results of these activities demonstrate that the Cadwell Guardian is as safe, as effective, and performs as well as the predicate devices. Therefore, the Cadwell Guardian is considered substantially equivalent to the predicate devices."

This indicates that internal performance testing was conducted, and the device met its specifications, leading to a determination of substantial equivalence to predicate devices. However, the details of these "predetermined specifications" or "internal software requirements" in terms of specific performance metrics are not provided in the given text. There's no mention of a clinical study or a study involving a "test set" of data for algorithm performance, human reader performance, or ground truth establishment in the way typically expected for AI/CADe device submissions.

Therefore, I cannot populate the requested tables and sections with quantitative data from the provided text. The document focuses on regulatory approval through substantial equivalence based on technical characteristics and safety standards rather than a detailed performance study against specific acceptance criteria for an AI component.

Summary of missing information based on the request:

1. Table of acceptance criteria and reported device performance: Not provided. The document states "complies with its predetermined specifications" but does not detail these specifications or measured performance.
2. Sample size used for the test set and data provenance: No information on a specific "test set" for performance evaluation, nor its size, origin (country), or whether it was retrospective/prospective.
3. Number of experts used to establish ground truth & qualifications: Not applicable, as there's no mention of a ground truth establishment process for a test set.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned. The approval is based on substantial equivalence to existing devices, not a comparative effectiveness study involving human readers with/without AI assistance.
6. Standalone (algorithm only) performance: Not mentioned, as the device is an electroneurodiagnostic system, not a standalone AI algorithm for interpretation.
7. Type of ground truth used: Not applicable, as no external ground truth establishment is described for performance evaluation.
8. Sample size for the training set: Not applicable, as the document doesn't describe an AI/ML component with a training set. The software is noted as "a new version (4.0) of previously cleared Cadwell Cascade Surgical Studio software."
9. How ground truth for the training set was established: Not applicable.

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