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The GALILEO NT Line software is intended to record and display EEG, PSG, EMG and EP data acquired from the patient body through EBNeuro proprietary, FDA cleared, Acquisition Platform.(BE Plus LTM K121986, BE micro K093728, Nemus 2 system K133517.)

The device is intended to be used in the clinical and hospital environment (including the hospital room, emergency room, intensive care unit, neuro-intensive care unit) to aid the diagnosis and monitoring of potential disorders of the central and peripheral nervous system and muscles

Galileo NT Line is a software package running on a Personal Computer under Windows Operative System. This package is devoted to the complete management of various exams in the Neurodiagnostic field of application, as electroencephalography, electromyography, Evoked Potentials etc.

The product is essentially a suite of applications dedicated to the comprehensive management of neurological diagnostics in a Department of Neurophysiology, etc. ... starting from the patient's acceptance, the execution of specific tests, and finally to the production of the exam reports. The package is substantially made by a common "platform" and by various independent modules, each of which is devoted to a particular application (EEG, Video EEG, EMG, EP, ICU, etc.). All the parts of the package together with the related User Documentation are residing on the same distribution media (a DVD).

As illustrated by figure 1 below, GALILEO NT Line (simply Galileo NT in other documents of this submission) is a "software only device" that can control and acquire data from a series of (FDA cleared) Amplifier platforms developed by EBNeuro for the Neurodiagnostic field and specifically :

• 1. BE micro (K093728)
• 2. BE Plus LTM (K121986)
• 3. Nemus 2 (K133517)

For each of the above devices, Galileo NT provides the appropriate "software interface" module in order to allow the control of the Amplifier (and of all the accessories eventually provided with it, as, for example, the Evoked Potential stimulators embedded in the Nemus 1 and 2 hardware) and in order to collect the acquired data. The data, once acquired from the amplifier, are "passed" to the specialized module for successive handling as display, measure, printing, trending, archiving and so on.

The provided text is a 510(k) premarket notification for the EB Neuro Galileo NT Line software. This document primarily focuses on establishing substantial equivalence to predicate devices based on technological characteristics and intended use, rather than presenting a performance study with detailed acceptance criteria and results.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets them in the format specified (a table of acceptance criteria and reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details for testing/training).

Specifically:

• 1. A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on comparing the software's features and intended use to predicate devices, not on quantitative performance metrics with associated acceptance criteria.
• 2. Sample sized used for the test set and the data provenance: Not applicable, as a performance study of this nature is not described.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
• 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: Not applicable. This is a software package for recording and displaying physiological data, not an AI-powered diagnostic tool that assists human readers.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a software suite for managing neurodiagnostic exams, not an algorithm with standalone diagnostic performance.
• 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc.): Not applicable.
• 8. The sample size for the training set: Not applicable, as no algorithm training is described for diagnostic performance.
• 9. How the ground truth for the training set was established: Not applicable.

The document explicitly states under "Summary of Clinical Tests": "No clinical tests were performed." This further confirms that no performance study as described in your request was conducted for this 510(k) submission. The FDA clearance was based on substantial equivalence to existing devices and compliance with relevant industry standards (ISO 14971, IEC 62304, IEC 62366) for design and development, rather than a clinical performance study.

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The BE Plus LTM / GWi Amplifier is intended to be used by or under the direction of a physician for acquisition of EEG, polygraphy and polysomnography signals and transmission of these signals to a PC during recording of neurophysiology examinations.

The BE Plus LTM / GWi amplifiers system, which has 64 channels, is an amplifier system which collects the bioelectric signals from the surface of the human body trough appropriate electrodes or sensors, intensify the very low signal captured (typically the amplitude range is of the order of the uVolts), condition them (filtering), convert them in numeric form and pass these data to the "host" elaboration unit (Personal Computer or equivalent system).

For these reason this device is not intended for a "direct" use by the physician but rather by a "manufacturer" or "System Builder" (a company or a researcher) which wants to build a "complete" medical device using the "BE Plus LTM / GWi" amplifier device as the "acquiring part" of the whole system.

BE Plus LTM / GWi is therefore intended to be assembled into an electromedical system by a System Builder, who will define the specific intended use of the assembled medical device.

Here's a breakdown of the acceptance criteria and study information based on the provided 510(k) summary for the BE Plus LTM/GWi Amplifier:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided 510(k) summary for the BE Plus LTM/GWi Amplifier does not present a formal table of specific acceptance criteria with quantifiable metrics. Instead, it states that:

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size for Test Set: The document does not specify a sample size for any "test set" in the traditional sense of a clinical trial or large-scale data evaluation. The verification and validation activities described are more aligned with engineering and software testing.
• Data Provenance: Not applicable, as there isn't a "test set" of patient data described. The testing performed was non-clinical.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. This device is a physiological signal amplifier, and the testing described is primarily technical and engineering-focused (software, wireless, EMC). There is no mention of "ground truth" being established by medical experts for a clinical test set in this 510(k) summary.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set requiring expert adjudication is mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, an MRMC comparative effectiveness study was not done.
• Effect Size of Human Readers: Not applicable, as no such study was conducted. The device aims to acquire and transmit signals, not to provide diagnostic interpretations that would involve human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

While the term "standalone" isn't explicitly used as such, the non-clinical performance data section effectively describes standalone testing of the device's technical functions and software. The device itself is described as an "acquiring part" of a larger system, indicating its primary function is data capture and transmission, not interpretation requiring a human-in-the-loop for its basic operation. The focus was on verifying its technical performance and capabilities (e.g., signal acquisition, wireless connectivity, software functionality) against predefined requirements and standards, not on its diagnostic accuracy as a standalone diagnostic tool.

7. Type of Ground Truth Used:

• For the non-clinical performance data, the "ground truth" was established by engineering specifications, functional requirements, and relevant industry standards (e.g., for software, wireless, and electromagnetic compatibility). The device's performance was compared against these established technical benchmarks.

8. Sample Size for the Training Set:

Not applicable. This device is a hardware amplifier with associated software. It is not an AI/ML algorithm that requires a "training set" of data for learning or pattern recognition.

9. How Ground Truth for the Training Set Was Established:

Not applicable. As stated above, this device does not utilize a training set in the AI/ML context.

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