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The Nicolet BraiNet is placed on the scalp to support electroencephalograph (EEG) electrode placement.

The BraiNet is used by licensed medical professionals to support placement of electroencephalograph (EEG) electrodes on the scalp. The electrodes connect to medical equipment in support of stimulation and recording. The BraiNet is provided to the user non-sterile. The BraiNet is a single patient use, disposable devices. The BraiNet is made from elastic and Velcro commercial garment grade materials.

The provided text is a 510(k) premarket notification for the Nicolet BraiNet device. It focuses on establishing substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study to prove meeting those criteria.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

Specifically, the following points from your request cannot be extracted from the provided text:

• A table of acceptance criteria and the reported device performance: This information is not present. The document concludes that the "intended use and technology...is substantially equivalent to the predicate device" and that "No new questions of safety or effectiveness are raised," but it does not provide specific performance metrics or acceptance criteria.
• Sample size used for the test set and the data provenance: Not mentioned.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
• Adjudication method for the test set: Not mentioned.
• 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 mentioned. This type of study is typically for evaluating AI-assisted diagnostic tools, which the BraiNet (an electrode cap) is not.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not mentioned. Similarly, this is not relevant for the type of device.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
• The sample size for the training set: Not mentioned.
• How the ground truth for the training set was established: Not mentioned.

The document primarily focuses on:

• Description of the Device: BraiNet, an electrode cap for EEG electrode placement.
• Intended Use: Supports EEG electrode placement.
• Technological Characteristics: Made from elastic and Velcro commercial garment grade materials.
• Predicate Device: Electro-Cap (K780045).
• Conclusion: Substantial equivalence to the predicate device.

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The Nicolet Subdural Strip Electrodes can be temporarily placed on the surface of the brain or subdural space in support of stimulating the brain or recording the brain's electrical activity.

Subdural Strip Electrodes are used by licensed medical professionals to support stimulation and recording of biopotentials from the surface of the brain or the subdural space above the surface of the brain. The electrodes connect to medical equipment in support of stimulation and recording. The electrodes are provided to the user sterile. The electrodes are single patient use, disposable devices. The electrodes are made from the same materials as the predicate devices. The electrode lead wires terminate in a safety connector, complying with the FDA Performance Standard for Lead Wires and Patient Cables, 21 CFR Part 898. These electrodes do not contain active electronics or software. The electrodes connect to the user's medical equipment.

This document describes a 510(k) premarket notification for a medical device, the Nicolet Subdural Strip Electrodes. Much of the typical information found in an AI/algorithm-based device study is not present because this is a hardware device, not a software algorithm. Therefore, many of the requested fields cannot be answered from the provided text.

Here is the information that can be extracted or deduced from the document:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. This is a hardware device submission, not a performance study for an AI/algorithm. The submission focuses on substantial equivalence to predicate devices rather than specific performance metrics against acceptance criteria.

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

Not applicable. No "test set" in the context of an algorithm's performance is mentioned as this is a hardware device.

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

Not applicable. No ground truth establishment for an algorithm's test set.

4. Adjudication method for the test set

Not applicable. No test set adjudication detailed for an algorithm.

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 hardware device. No AI component or human reader study is discussed.

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

Not applicable. This is a hardware device. No algorithm is involved.

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

Not applicable. For a hardware device being cleared via 510(k), the "ground truth" for clearance is typically demonstration of substantial equivalence to a legally marketed predicate device, often through material comparisons, manufacturing process reviews, and functional testing to ensure it meets its intended use safely and effectively, rather than a diagnostic ground truth like pathology for an AI.

8. The sample size for the training set

Not applicable. No training set for an algorithm is mentioned.

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

Not applicable. No training set for an algorithm is mentioned.

Summary of Device and 510(k) Submission:

The Nicolet Subdural Strip Electrodes are a hardware medical device intended for temporary placement on the surface of the brain or subdural space to support stimulating the brain or recording its electrical activity.

The 510(k) submission, K021144, asserts substantial equivalence to predicate devices (K970587, K923803, K850342 manufactured by Ad-Tech Medical Instrument Corp.). The basis for this claim is:

• Identical intended use: "The Nicolet Subdural Strip Electrodes can be temporally placed on the surface of the brain or subdural space in support of stimulating the brain or recording the brain's electrical activity."
• Similar technology: "The Subdural Strip Electrodes are made from the same materials as the predicate devices."
• Safety compliance: The electrode lead wires terminate in a safety connector, complying with the FDA Performance Standard for Lead Wires and Patient Cables, 21 CFR Part 898.
• Absence of active electronics or software: The device is passive and connects to existing medical equipment.

The FDA reviewed the submission and determined that the device is substantially equivalent to legally marketed predicate devices, meaning it does not raise new questions of safety or effectiveness. This clearance allows Nicolet Biomedical to market the device.

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The SNAP device is intended to monitor a patient's EEG. A derived EEG measure, the SNAP Index, indicates the patient's brain activity level. The SNAP device is used under the guidance and interpretation of a licensed medical professional.

The SNAP device records and displays a processed EEG parameter called the SNAP Index, records and displays a time based trend of the SNAP Index and displays a real time EEG signal. The SNAP system has four significant components:

1. A Visor SNAP module, which is inserted into the springboard slot of a Handspring Visor handheld computer.
2. A disposable, single patient use SNAP Electrode for acquiring the EEG signal.
3. A patient cable which connects the Visor SNAP module to the patient electrode.
4. SNAP personal computer application software, which is provided for use on personal computers operating with Microsoft Windows® operating systems.

The provided document is a 510(k) premarket notification for the Nicolet Biomedical SNAP EEG Monitor. This type of regulatory filing is focused on demonstrating substantial equivalence to existing predicate devices, rather than establishing new safety and effectiveness through extensive clinical trials with pre-defined acceptance criteria and statistical performance measures.

Therefore, the document does not contain the information requested regarding:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, or standalone performance for a specific study proving it meets acceptance criteria.
• Type of ground truth used for such a study.
• Training set sample size or how its ground truth was established.

Instead, the document states:

• Intended Use: The SNAP device is intended to monitor a patient's EEG. A derived EEG measure, the SNAP Index, indicates the patient's brain activity level. The SNAP device is a prescription device used under the guidance and interpretation of a licensed medical professional. This is consistent with the classification 21 CFR 882.1400, Electroencephalograph.
• Technological Equivalence: "The technology of the SNAP device is equivalent to other EEG monitoring devices. The EEG signal is acquired in analog format, digitized and presented to the user for interpretation. The SNAP device includes an EEG trended parameter of the power spectrum of the EEG signal, SNAP Index."
• Conclusion of Substantial Equivalence: "The indications, intended use and technology of the SNAP device is substantially equivalent to the predicate devices. No new questions of safety or effectiveness are raised." The predicate devices listed are the ASPECT Medical Inc. A-1050 EEG Monitor (K952347) and the Nicolet Biomedical Bravo Endeavor Multi-Modality System (K991054).

The FDA's letter explicitly confirms "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices."

In summary, the provided text does not describe a study to prove acceptance criteria for device performance, but rather lays out the basis for substantial equivalence to predicates, which is the regulatory pathway taken.

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The Nicolet Electrocautery Detector is an accessory device supporting muting of external audible outputs when electrocautery interference is detected.

The Nicolet Electrocautery Detector interfaces between the auditory signal output from a nerve monitor and the nerve monitor's external speaker. The Electrocautery Detector automatically mutes the nerve monitor speaker when electrocautery interference is detected.

The Nicolet Electrocautery Detector is an accessory device designed to mute external audible outputs from a nerve monitor when electrocautery interference is detected. The device's performance is compared to a predicate device, the XOMED NIM-2 XL.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided summary does not contain information regarding a specific "test set" in the context of clinical trials or performance testing with human subjects. The comparison is based on device specifications and features, not a study involving a particular sample size of cases or patients. The data provenance is derived from the technical specifications and design of the Nicolet Electrocautery Detector and its predicate device. This is a comparison of product specifications, not a clinical study.

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

Since there is no mention of a "test set" for a clinical study or performance evaluation with human data, there is no information on the number of experts or their qualifications used to establish ground truth.

4. Adjudication Method for the Test Set

As there is no mention of a "test set" involving expert review of cases, there is no information on an adjudication method.

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

The document does not describe an MRMC comparative effectiveness study. This device is an accessory for a nerve monitor, designed to automatically mute auditory signals, not an AI-based diagnostic tool requiring human reader interpretation or improvement. Therefore, there is no information on an effect size for human reader improvement with or without AI assistance.

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

The document does not describe a standalone algorithm performance study. The device functions as an accessory that performs an automated action (muting) based on detecting electrocautery interference. The "performance" is implicitly evaluated by comparing its technical specifications (like recovery time and detection method) to those of the predicate device.

7. The Type of Ground Truth Used

The "ground truth" in this context is the technical specifications and functional design of the device and its predicate. The assessment is made by comparing these attributes, particularly the method of electrocautery detection and muting, and key performance parameters like recovery time. There is no mention of ground truth established by expert consensus, pathology, or outcomes data in a clinical trial setting.

8. The Sample Size for the Training Set

The provided document does not mention a "training set". This type of device, an electro-mechanical accessory, is not typically developed using machine learning or AI models that require a training set of data. Its functionality is based on detecting physical RF energy.

9. How the Ground Truth for the Training Set was Established

Since there is no mention of a training set, there is no information on how ground truth for a training set was established.

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Concentric, Monopolar, Hook Wire and Hypodermic EMG Electrodes are intended for use with recording, monitoring and stimulation/recording equipment for the stimulation/recording of biopotential signals including electromyograph (EMG) and nerve potential signals.

EMG electrodes are applied in the study of biopotentials such as electromyograph (EMG), nerve conduction and stimulation/response. Electrodes are invasive as they are placed in contact with nerve or muscle tissue.

The electrodes consist of a needle with a connector/lead wire attached. The connector/lead wires terminate in a safety connector that cannot be connected to an AC power outlet.

The electrodes provide the patient contact device. The electrodes connect to the user's recording, monitoring and stimulation/response equipment. The electrodes are used under the supervision of a physician.

The EMG electrodes consist of a needle with a connector or lead wire attached. The connector or lead wires terminate in a safety connector that cannot be connected to an AC power outlet. The EMG Electrodes are provided sterile and for single patient use.

This document is a 510(k) summary for Sterile EMG Electrodes by Nicolet Biomedical Incorporated. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria or a study proving device performance against such criteria.

Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence to predicate devices, which is a regulatory pathway that typically does not involve new clinical performance studies or specific acceptance criteria for performance metrics like sensitivity, specificity, or accuracy.

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The BioRehab System is used for electromyography (EMG) biofeedback support of relaxation and muscle reeducation. The BioRehab System may be used by licensed medical practitioners to support their methods of muscle relaxation and reeducation/rehabilitation. The BioRehab System can be used in hospital, physician office, clinics, long-term patient care facilities, home and other therapy locations.

The BioRehab System consists of an EMG amplifier, computer and software. Under the care and guidance of a physician or therapist, the BioRehab System supports relaxation and muscle reeducation by the application of electromyography (EMG) biofeedback. The BioRehab System supports patient game playing under EMG control. The patient consciously controls the EMG signal level from the therapist's selected muscle groups.

This document is a 510(k) premarket notification for the Nicolet Biomedical BioRehab System, a biofeedback device. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving the device meets specific acceptance criteria through a study with defined performance metrics. Therefore, the information requested in your prompt regarding acceptance criteria and a study to prove it is not typically found or required in a 510(k) submission like this one.

Here's why and what information can be extracted/inferred:

• 510(k) Submissions Focus on Substantial Equivalence: The primary goal of a 510(k) is to demonstrate that the new device is as safe and effective as a legally marketed predicate device. It does not usually involve extensive clinical trials or performance studies with predefined acceptance criteria in the same way a Premarket Approval (PMA) application would.
• "Summary of Safety and Effectiveness" vs. "Performance Study": The document explicitly states "Summary of Safety and Effectiveness". This summarization points towards a comparison with predicate devices, not a de novo study with acceptance criteria.

Therefore, I cannot populate the table or answer most of your numbered questions directly from the provided text because this type of study was not performed or reported in this 510(k) submission.

However, I can extract information related to the device and its intended use:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as this is a 510(k) submission for substantial equivalence. The "acceptance criteria" here implicitly is that the device is as safe and effective as the predicate devices.
• Reported Device Performance: The document states:
  • "The BioRehab System applies EMG signal detection and amplification to support relaxation and muscle reeducation therapy."
  • "The EMG signal output of the BioRehab system is qualitative not quantitative."
  • "Under control of the therapist, an EMG signal threshold is set for the patient to support control of the computer cursor."
  • "The control of the computer cursor supports patient game playing on the computer."
  • Conclusion: "The characteristics of the BioRehab System are substantially equivalent to the predicate devices. No new questions of safety or effectiveness are raised."

The following numbered items cannot be answered from the provided text for the reasons explained above:

2. Sample sizes used for the test set and the data provenance: Not applicable to a 510(k) predicated on substantial equivalence without specific performance studies 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 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 device is a biofeedback system, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. The device is used "Under the care and guidance of a physician or therapist" and involves "patient game playing under EMG control," indicating a human-in-the-loop system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a 510(k) for substantial equivalence.
8. The sample size for the training set: Not applicable, as this is not a machine learning device or a study describing a training set.
9. How the ground truth for the training set was established: Not applicable.

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The Bravo Multi-Modality System is intended to record and display EEG, EP, EMG and TCD data in the clinic and hospital (including the hospital room, operating room, emergency room, intensive care unit, neuro intensive care unit, critical care unit, etc.), and to import and display data from third-party monitoring devices such as vital signs monitors. It is intended to aid the diagnosis and monitoring of potential disorders of the central and peripheral nervous system and muscles.

The Bravo Multi-Modality System is a personal computer-based digital data recorder for continuously monitoring various types of neurological information, including: (i) neuroelectric and neuromuscular data pertaining to the patient's central and peripheral nervous system and muscles, and (ii) neurovascular data pertaining to blood flow in the patient's brain and related blood vessels. The intended use of this device is to record and display EEG, EMG, EP and TCD signals; and to import and display data from third-party monitoring devices, such as vital signs monitors. EEG signals are passively recorded using electrically-conductive electrodes that are placed in electrical contact with the patient's skin or nervous system. EMG and EP signals are recorded using electrically-conductive electrodes that are placed in electrical contact with the patient's skin, nervous system or muscles. EMG signals are passively recorded, while EP signals are evoked using a light source, a sound source, or an electrical stimulator. TCD signals are actively recorded using a non-invasive ultrasound transducer that emits and records ultrasound energy. The ultrasound energy is applied externally to the skin, passes through the skin and body tissues, reflects off blood molecules moving in the blood stream, passes back through the body tissues and skin, and returns to the transducer. Movement of the blood molecules causes a frequency or "Doppler" shift in the returned ultrasound energy, which is detected and converted into a signal representing the velocity of the blood from which the ultrasound energy was reflected. Third-party monitoring devices, such as vital signs monitors, acquire and display a variety of physiological data from the patient. Importing and displaying such data is done by taking an output signal directly from such monitoring devices without any additional connections to the patient. Data obtained from the monitoring device is then displayed, analyzed or stored by the Bravo Multi-Modality System independently of how the third-party device handles the data.

The provided document does not contain acceptance criteria or detailed study results for the Bravo Multi-Modality System.

Instead, the document is a 510(k) summary and a subsequent FDA substantial equivalence letter for the device. It focuses on demonstrating equivalence to predicate devices rather than presenting performance data against defined acceptance criteria.

Here's a breakdown of why the requested information is not available in the provided text:

• Acceptance Criteria and Reported Device Performance (Table): The document states only that "nonclinical tests consist of various tests to verify program function" and that "tests are ongoing, but indicate that the performing as expected." It then says "Test results are summarized below" but no summary or table of results is present in the provided text.
• Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set): The document explicitly states: "Clinical tests will be used to validate the device's performance under simulated or actual use conditions. Because each of the individual modalities was derived from an existing from an existing the decided data will be a primary validation tool. To provided for an existing and to vill be ev the device will be evaluated at different health care sites to solicit can annound with the mainting valiation, which in the studion, which is and and to was over of ovaluated at different health care sites to solicit common". This fragmented sentence indicates that clinical validation will be used, suggesting that detailed clinical study results (including specifics like sample sizes, ground truth establishment, expert qualifications, etc.) are either not yet finalized or not part of this 510(k) summary. The emphasis is on the fact that the modalities are "derived from an existing" (predicate) device, implying that the performance is expected to be similar, rather than requiring extensive new performance studies for substantial equivalence.

In summary, the provided text serves as a regulatory submission for substantial equivalence based on technological similarity to existing devices, and it does not detail specific acceptance criteria or the results of a primary study proving device performance against such criteria.

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The Satellite is intended to acquire EEG data from patients that are stationary or ambulatory, regardless of whether they are inside or outside a medical-care facility.

The Satellite is a portable, battery-powered, digital electroencephalographic (EEG) data recorder that is designed to be carried in a hip belt worn by the patient. The intended use of this device is to record the patient's EBG while the patient is ambulatory or at home. Recorded EEG data is stored in a removable hard disk drive, which the medical practitioner can then remove from the data recorder and connect to a standard personal computer. The personal computer is then used to review and analyze the EEG data, generate reports, and provide longer-term storage for the EEG data. The personal computer also performs various system utility functions on the data recorder, such as programming the user-selectable parameters, and measuring the electrical impedance of the EEG electrode connections. A battery pack and charger also accompany the data recorder. These items are designed so the battery pack cannot be recharged while it is powering the data recorder, so the data recorder (which may be attached to the patient) cannot be connected to the AC-powered charger. The device is intended to complement Nicolet's existing line of EEG systems, including the Voyageur digital EEG system (K921927B) and BMSI long-term EEG monitoring system (K891405A). Neither of these devices currently provides the capability for ambulatory or athome EEG data recording, however, both will record and playback EEG data that is similar to the data recorded by the Satellite.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Nicolet Satellite device:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific, quantifiable acceptance criteria (e.g., "sensitivity > X", "specificity > Y", "accuracy > Z%"). Instead, the acceptance criteria are implicitly defined by the claim of substantial equivalence to predicate devices. The performance is reported in qualitative terms relating to this equivalence.

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

• Sample Size for Non-Clinical Tests: Not explicitly stated as a number. The text mentions "EEG test data derived from actual human EEG recordings, and included examples of actual seizures, spikes, seizure-like artifacts, and non-seizure waveforms." This implies a set of diverse, pre-recorded human EEG data but doesn't quantify the number of cases or recordings.
• Sample Size for Clinical Tests: Not explicitly stated. The text notes that "clinical tests were performed to solicit comments from actual users and to assess the performance of the device under actual-use conditions." This suggests a qualitative assessment with an unspecified number of users/patients.
• Data Provenance: The text does not specify the country of origin. The test data for non-clinical evaluation was "derived from actual human EEG recordings." For clinical tests, the data was from "actual-use conditions," implying real patients. Both appear to be prospective data collection (for the specific purpose of testing the Satellite), but for the non-clinical tests, the "actual human EEG recordings" could have been retrospective archival data used prospectively for testing. However, this is not clarified.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The summary states that the device is "intended to involve competent human intervention" and that "clinical judgment and experience must be used to check and interpret the system's output." This implies that the 'ground truth' for evaluating the device's ability to record and present data for seizure, spike, and waveform identification would ultimately be based on the interpretation of qualified medical professionals (e.g., neurologists or neurologists specializing in electrophysiology), but this is not explicitly stated as how ground truth was established for the specific test set.

4. Adjudication Method for the Test Set

Not specified. Given the nature of the device (a data recorder, not an interpretive AI), direct adjudication methods like 2+1 or 3+1 typically used for diagnostic interpretations are less relevant. The evaluation focused on the device's ability to faithfully record various EEG phenomena for subsequent human interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC comparative effectiveness study was not conducted. The comparison was primarily against the specifications and characteristics of predicate devices, not through a direct comparative study with human readers using or not using the device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop) Performance Was Done

Yes, in essence. The primary evaluation described is a standalone performance test of the device as an EEG data recorder. The device records data, and its performance is judged on its ability to capture and store that data accurately, making it available for human review. It is explicitly stated that the device "is intended to involve competent human intervention before any impact on human health occurs (i.e., clinical judgment and experience must be used to check and interpret the system's output)." This confirms that the device itself is not providing a diagnosis or interpretation algorithm that would be judged in a standalone fashion against a ground truth diagnosis. Its "performance" is its ability to record and present the data.

7. The Type of Ground Truth Used

The ground truth for the non-clinical tests appears to be based on expert consensus/identification within the "actual human EEG recordings". The test data included "examples of actual seizures, spikes, seizure-like artifacts, and non-seizure waveforms." The 'ground truth' here is the presence of these known phenomena within the source recordings, and the device's ability to accurately capture and represent them. This isn't pathology or outcomes data, but rather a recognized pattern within electrophysiology as interpreted by experts.

8. The Sample Size for the Training Set

Not applicable/provided. The Nicolet Satellite is an EEG data recording device, not an AI/machine learning algorithm that requires a training set in the conventional sense. Its function is to accurately capture analog electrical signals and convert them into a digital format for storage and later review. It does not learn or make diagnostic interpretations.

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

Not applicable. As noted above, the device does not use a training set as it is not an AI/ML system.

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