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Neuro-IOM system with Neuro-IOM.NET software is a medical device intended for intraoperative neurophysiologic monitoring: the device provides information to assess a patient's neurophysiological status.

The system allows to monitor the functional integrity and/or mapping of central and peripheral nervous system including motor and sensory pathways.

It is provided in III different configurations:

I. 32/B

II. 32/S

III. 16/S

The system ensures the following IOM modalities: free-run EMG (electromyography), direct nerve stimulation including pedicle screw test, SSEP (somatosensory evoked potentials), MEP (motor evoked potentials), EEG (electroencephalography), AEP (auditory evoked potentials), VEP (visual evoked potentials), direct cortical stimulation. Also the train-of-four (TOF) stimulation is performed.

The system is not intended to measure the vital signs. It records the data to be interpreted by the neuromonitoring specialist.

Neuro-IOM system with Neuro-IOM.NET software is a medical device intended for intraoperative neurophysiologic monitoring: the device provides information to assess a patient's neurophysiological status.

The system allows to monitor the functional integrity and/or mapping of central and peripheral nervous system including motor and sensory pathways. It is provided in III different configurations:

I.32/B 32/8 II. III. ાર્ભદ્ર

The system ensures the following IOM modalities: free-run EMG (electromyography), direct nerve stimulation including pedicle screw test, SSEP (somatosensory evoked potentials), MEP (motor evoked potentials), EEG (electroencephalography), AEP (auditory evoked potentials), VEP (visual evoked potentials, direct cortical stimulation. Also, the train-of-four (TOF) stimulation is performed.

The system is not intended to measure the vital signs. It records the data to be interpreted by the neuromonitoring specialist.

The systems can be used in operating rooms, intensive care units of different health care facilities (including clinics, hospitals, health centers, ambulance centers, etc.), specialized medical facilities (including prevention centers, medicine centers for emergency, military and medical expertise centers), research and educational medical and biological facilities where the neuromonitoring is required, only by qualified operators who have received training on these devices.

The provided text is an FDA 510(k) summary for the Neuro-IOM system. It details the device's technical specifications and compares them to a predicate device (Xltek Protektor 32) to demonstrate substantial equivalence, rather than providing the results of a specific clinical study with defined acceptance criteria and human reader performance.

Therefore, many of the requested details about acceptance criteria, clinical study design, sample sizes, expert ground truth, and MRMC studies are not present in this document because they are not typically required for a 510(k) clearance based on substantial equivalence for this type of device. The focus is on demonstrating that the new device is as safe and effective as a legally marketed predicate through non-clinical testing and comparison of specifications.

However, I can extract the information that is available and note what is not provided.

Acceptance Criteria and Device Performance:

The document does not present specific "acceptance criteria" for a clinical performance study in the typical sense of metrics like sensitivity, specificity, accuracy, or AUC. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to the predicate device, primarily through comparison of technical specifications and non-clinical performance testing (biocompatibility, electrical safety, EMC, performance tests, and software verification/validation).

The "reported device performance" is demonstrated by showing that the Neuro-IOM system's technical attributes are either identical or sufficiently similar to the predicate device, or where differences exist, they do not adversely affect safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

As noted, there isn't a direct table of clinical acceptance criteria and performance metrics. Instead, the document provides detailed comparison tables between the subject device (Neuro-IOM system) and the predicate device (Xltek Protektor 32) across various attributes. The acceptance is implied if the differences are found to not adversely affect safety and effectiveness.

Here's a summary of the technical performance comparison, which serves as the basis for the "acceptance" of substantial equivalence:

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

• Sample Size: This document does not describe a clinical study with a "test set" sample size in terms of patient data. The evaluation for 510(k) clearance was based on non-clinical testing (e.g., electrical safety, EMC, performance tests, software verification/validation) and comparison to a predicate device.
• Data Provenance: Not applicable as no clinical patient data set was used for performance evaluation described here. The company, Neurosoft Ltd, is based in the Russian Federation.

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

• Not applicable. There was no clinical "test set" and thus no ground truth established by experts for that purpose. The ground truth for this submission is implicitly the established safety and effectiveness of the predicate device and the adherence to relevant medical device standards.

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

• Not applicable. There was no clinical "test set" requiring adjudication.

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. This device is an intraoperative neurophysiological monitoring system, not an AI-powered diagnostic imaging tool that would typically undergo such a study. The product description does not indicate AI assistance that would augment human reader performance in interpreting findings beyond displaying physiological data.

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

• The device functions as a physiological monitoring system that "records the data to be interpreted by the neuromonitoring specialist." It is not a standalone diagnostic algorithm that operates without human interpretation. Its performance is demonstrated through its hardware and software specifications for signal acquisition and display, similar to the predicate device.

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

• The "ground truth" for this 510(k) submission is the demonstrated safety and effectiveness of the predicate device (Xltek Protektor 32) and compliance with relevant industry standards (e.g., AAMI/ANSI ES 60601-1, IEC 60601-1-2, IEC 62366-1, ISO 10993 series). The testing focused on functional equivalence and safety conformance, not diagnostic accuracy against a clinical ground truth.

8. The sample size for the training set:

• Not applicable. This document is a 510(k) summary for a physiological monitoring device, not an AI/ML device that requires a training set of data.

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

• Not applicable, as there was no training set.

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