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The Neuronaute Plus is a system intended to acquire, store, archive, and periodically transmit physiological signals from the brain using a full montage array to enable review at a physician's office, hospital, or other remote locations. It allows remote access by users via the BioSerenity Cloud.

The Neuronaute Plus and its associated software are intended to assist in the diagnosis of neurological disorders. The Neuronaute Plus and its components do not provide any diagnostic conclusions or automated alerts of an adverse clinical event about a patient's clinical condition.

The Neuronaute Plus is intended to be used by trained healthcare professionals, technicians or patients above 15 years old. In case of a patient below 15 years old, Neuronaute Plus is intended to be used by a care giver.

Adequate training is recommended for proper use of the device.

Neuronaute IceCap 2 electrodes are able to be used on patients weighing at least 10 kg and having a head circumference above 43 cm.

Neuronaute is not intended to replace direct communication with healthcare providers. The system data should not be used alone, but should be used along with all other clinical data and exams to come to a diagnosis.

The BioSerenity Cloud allows the display of signals in the diagnosis of physiological disorders through the data collected by recording.

The BioSerenity Cloud should allow the analysis and filtering of data in order to aid doctors in diagnosing neurological disorders.

The Neuronaute Plus is a non-invasive medical device which enables the acquisition, recording, storage and transmission of electrophysiological signals in order to analyze potential neurological disorders.

The system is composed of the pieces of equipment listed below, and the Neuronaute Plus components are connected through Bluetooth and Wi-Fi.

• -Neuronaute Plus (Core module): is a signal acquisition system: an electronical amplifier that records EEG, ECG, EMG, EOG and breathing signals via a connection to EEG caps which transmits the data to the Neuronaute mobile application and Cloud system.
• -Neuronaute Plus IceCap extender : is a removable interface to connect the signal acquisition system to the IceCap and IceCap2 & 2 Small.
• -Neuronaute Plus DB25 Extender : is a removable interface that can connect the signal acquisition system to any DB25-compatible EEG cap.
• -Holding band : is a wearable textile band which allows the patient to place the Neuronaute Plus close around his chest over clothes. the use of the holding band is optional.
• -Neuronaute IceCap: is a single use 21 electrode headset that connects to the Neuronaute Head Module via the IceAdapter, the DB25 cable and the Neuronaute BioAdapter, or Neuronaute Plus with its IceCap Extender. Recently, the Neuronaute Touchproof Adapter was developed to connect the IceCap electrode to Neuronaute Head module via a touchproof channel.
• Neuronaute IceCap 2 & 2 Small: recently cleared version of the IceCap dedicated to adults and pediatric patients. It connects similarly to Neuronaute and Neuronaute Plus.
• Neuronaute Mobile APP: is compatible with iOS systems. The mobile application enables the healthcare professionals to access and manage the prescribed recording sessions.
• -Bioserenity CLOUD: is a web-based information system that receives the EEG signals from the recorder through a paired Wi-Fi connection. The cloud platform enables long-term storage and display of the recorded signals. The physician, who prescribes the use of this device, should monitor its use and confirm the proper functioning of signal recording through the Neuronaute Cloud.
• -VEEG pack: it is composed of the Neuronaute N-DEO and Neuronaute N-WAY. The Neuronaute N- DEO camera enables the visualization of the patient during a recording. The IP camera provides HD resolution video sequence at 1080p, with advanced night mode and WDR technology. The Neuronaute N- WAY enables wireless connectivity (4G) for remote monitoring and data transmission to the cloud platform.

The provided text does not contain the detailed information required to fill out a table of acceptance criteria and reported device performance for a diagnostic device, nor does it describe a study that proves the device meets specific performance criteria for diagnosis with quantitative metrics like sensitivity, specificity, or accuracy.

The document is a 510(k) Premarket Notification for the Neuronaute Plus, which establishes its substantial equivalence to an existing predicate device (Neuronaute). This clearance pathway primarily focuses on demonstrating that the new device is as safe and effective as a legally marketed device, rather than proving its diagnostic performance against specific, quantitative acceptance criteria in a clinical study.

Here's why the requested information is largely absent and what the document does provide:

1. Acceptance Criteria and Reported Device Performance (Table):

   • The document lists several non-clinical tests (electrical safety, EMC, wireless safety, PEMS, cybersecurity, biocompatibility, usability, battery safety) that the Neuronaute Plus underwent.
   • For each of these, the "acceptance criterion" is implicitly "passed" or "fulfills the requirements of the standard."
   • The "reported device performance" is simply that "all tests... are in passed status" or "the product fulfills the requirements of the standard."
   • Crucially, there are no diagnostic performance metrics (e.g., sensitivity, specificity, AUC) or corresponding acceptance criteria because the device is an EEG acquisition and display system, not an AI diagnostic algorithm that provides conclusions or automated alerts. Its "performance" is primarily about its ability to accurately acquire and display physiological signals safely and effectively, comparable to its predicate.

   Therefore, a table of acceptance criteria and reported device performance related to diagnostic accuracy (as typically seen for AI/ML devices) cannot be constructed from this document. The performance testing described is focused on safety, electrical compatibility, and usability compared to a predicate device.

   Conceptual Table (based on safety/functional tests, not diagnostic accuracy):

   Area of Test	Acceptance Criteria	Reported Device Performance
   Electrical Safety	Compliance w/IEC 60601-1, -11, -26	All tests passed; substantially equivalent to predicate.
   EMC Tests	Compliance w/IEC 60601-1-2	All tests passed; fulfills requirements of standard.
   Wireless Safety	Radio-emission safety	All tests passed; substantially equivalent to predicate.
   PEMS (Firmware)	Software safety & electrical perf.	All tests passed.
   Cybersecurity	Meets FDA guidance	Design process demonstrates safety; post-market plan.
   Biocompatibility	Compliance w/ISO 10993-1, FDA guid.	No further testing required; classified as biocompatible.
   Usability	No critical/major use errors	Validation criteria met; no critical/major use errors.
   Battery Safety	Compliance w/IEC 62133, 60601-1	All tests passed.

2. Sample Size and Data Provenance for Test Set:

   • Diagnosis/AI Performance Test Set: Not applicable. The document explicitly states: "No clinical data was needed for demonstrating substantial equivalence of the Neuronaute Plus."
   • Usability Study Test Set:
     • Sample Size:
       • User group 1 (Healthcare professionals): n=9 (Physicians, nurses, technicians)
       • User group 2 (Patients): n=15 (aged 15-30, 31-50, >50 years)
     • Data Provenance: Not specified, but generally, human factors/usability studies are prospective and often conducted in a simulated environment by the manufacturer. Country of origin is not mentioned.

3. Number of Experts and Qualifications for Ground Truth:

   • Not applicable for diagnostic ground truth as no clinical diagnostic performance study was conducted.
   • For the usability study, "trained healthcare professionals" were part of the user group, but their role was as study participants, not as ground truth experts for a diagnostic outcome.

4. Adjudication Method for Test Set:

   • Not applicable for a diagnostic test set, as no such test was conducted.
   • For the usability study, the "validation criteria are met," and "no use errors leading to critical or major risks... occurred." This implies an assessment against predefined usability metrics, likely by study administrators, but no details on an adjudication panel for "ground truth" are provided.

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

   • No. This study type is typically for assessing human reader performance with and without AI assistance for diagnostic interpretation. The Neuronaute Plus is an EEG acquisition and display system, not an AI interpretive algorithm. Its purpose is to assist in diagnosis by providing signals for a healthcare professional to review, not to provide diagnostic conclusions itself.
   • The Indications for Use clearly state: "The Neuronaute Plus and its components do not provide any diagnostic conclusions or automated alerts of an adverse clinical event about a patient's clinical condition."

6. Standalone (Algorithm Only) Performance:

   • Not applicable. The Neuronaute Plus is a hardware system with associated software for signal acquisition, storage, and display. It does not contain a standalone diagnostic algorithm that produces a diagnostic output without human intervention.

7. Type of Ground Truth Used:

   • For diagnostic purposes, none was used or required, as per the 510(k) clearance process for this type of device (EEG acquisition/display).
   • For non-clinical tests (electrical safety, EMC, etc.), the "ground truth" is adherence to established consensus standards (e.g., IEC standards).

8. Sample Size for Training Set:

   • Not applicable. There's no mention of an AI/ML component that requires a training set for diagnostic classification or prediction. The device's software handles data acquisition, storage, transmission, and display, which are typically validated through verification and validation testing against functional requirements and standards, not through training data.

9. How Ground Truth for Training Set was Established:

   • Not applicable, as no training set for an AI/ML diagnostic algorithm is mentioned.

In summary: The provided document is a 510(k) clearance letter for an EEG acquisition and display system (Neuronaute Plus). Its "acceptance criteria" and "proof" primarily revolve around demonstrating safety, functional performance, and substantial equivalence to a predicate device through non-clinical testing and usability studies, rather than clinical diagnostic accuracy studies common for AI-powered diagnostic aids.

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Neuronaute with IceCap 2 & IceCap 2 Small is a system intended to acquire, display, store, archive, and periodically transmit EEG signals from the brain using a full montage array to enable review at a physician's office, hospital, or other remote locations. It allows remote access by users via the Neuronaute N-CLOUD which receives EEG signals from Neuronaute Head Module which sends transmissions to the cloud.

Neuronaute and its associated software are intended to assist in the diagnosis of neurological disorders. Neuronaute and its components do not provide any diagnostics conclusions or automated alerts of an adverse clinical event about a patient's clinical condition.

The device is for use by trained medical professionals for patients under medical supervision. The device is intended for use on adults and pediatrics. Neuronaute is not intended to replace direct communication with healthcare providers. The system data should not be used alone but should be used along with all other clinical data and exams to come to a diagnosis.

Neuronaute with IceCap 2 & IceCap 2 Small is a system intended to acquire, display, store, archive, and periodically transmit EEG signals from the brain using a full montage array. The system includes the Neuronaute Head Module, IceCap 2 & IceCap 2 Small electrodes, battery, Bioadapter with the IceAdapter, mobile app, and the Neuronaute N-CLOUD. The IceCap 2 and IceCap 2 Small are single-piece flexible printed circuit headsets with 21 EEG sensors (19 EEG channels, 1 reference and 1 ground), 4 skin adhesive areas and 2 connectors. The electrodes are made of Ag/AgCl sensors connected via conductive silver ink and insulated with dielectric ink. The system allows remote access by users via the Neuronaute N-CLOUD. An optional video system composed by N-way and N-Deo is available.

The provided text describes the Neuronaute with IceCap 2 & IceCap 2 Small system, an electroencephalograph device. However, it does not contain a detailed study proving the device meets specific acceptance criteria for diagnostic performance. Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Neuronaute, K202334) through a comparison of technical characteristics and non-clinical testing.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, accuracy) or report such performance for the Neuronaute with IceCap 2 & IceCap 2 Small. The comparison table focuses on technical specifications and material changes relative to the predicate device.

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

The document does not specify a sample size for a test set related to diagnostic accuracy or clinical performance. It refers to "nonclinical tests" (biocompatibility, performance, electrical safety) but does not provide details on the test subjects or data used for these. Given that a clinical study was not required, there is no clinical "test set" and thus no data provenance for such a set.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. No clinical test set with ground truth established by experts is described in the document.

4. Adjudication Method:

Not applicable. As no clinical test set requiring ground truth establishment by experts is described, no adjudication method would have been used for that purpose.

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

No. The document explicitly states: "N/A Clinical Testing was not required." Therefore, no MRMC study was conducted or reported.

6. Standalone Performance Study:

No. The document focuses on demonstrating substantial equivalence to a predicate device through technical comparisons and non-clinical testing. It does not describe a standalone performance study in terms of diagnostic accuracy or clinical outcomes. The device is intended to "assist in the diagnosis" and "should not be used alone."

7. Type of Ground Truth Used:

Not applicable for clinical performance. For the non-clinical tests (biocompatibility, performance, electrical safety), the ground truth would be based on established engineering and safety standards, but not clinical ground truth in the diagnostic sense.

8. Sample Size for the Training Set:

Not applicable. The document does not describe any machine learning or AI component that would require a "training set" in the context of diagnostic performance studies. The device is an EEG acquisition system and associated software, not an AI diagnostic tool.

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

Not applicable, as no training set for AI/ML is mentioned.

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Neuronaute is a system intended to acquire, display, store, archive, and periodically transmit EEG signals from the brain using a full montage array to enable review at a physician's office, hospital, or other remote locations. It allows remote access by users via the Neuronaute N-CLOUD which receives EEG signals from Neuronaute Head Module which sends transmissions to the cloud. Neuronaute and its associated software are intended to assist in the diagnosis of neurological disorders. Neuronaute and its components do not provide any diagnostics conclusions or automated alerts of an adverse clinical event about a patient's clinical condition.

The device is for use by trained medical professionals for patients under medical supervision. The device is intended for use on adults (ages 18 and above). Neuronaute is not intended to replace direct communication with healthcare providers. The system data should not be used alone, but should be used along with all other clinical data and exams to come to a diagnosis.

Neuronaute allows up to 24 channels EEG monitoring. It includes the following components: Neuronaute Head Module, Neuronaute High Capacity Battery Module, Neuronaute BioAdapter, Neuronaute Mobile App, Neuronaute N-CLOUD, Neuronaute N-DEO, Neuronaute N-WAY, Neuronaute IceCap.

The provided text describes the Neuronaute device, an electroencephalograph (EEG) system, and its substantial equivalence to a predicate device (AE-120A EEG Head Set, K183529) for FDA clearance. However, it does not contain a specific study demonstrating that the device meets numerically defined acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, accuracy for a particular condition). Instead, the submission focuses on demonstrating substantial equivalence through non-clinical performance testing against recognized standards.

Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are not applicable or cannot be extracted from this document, as a clinical performance study with such metrics was not submitted.

Here's a breakdown of the information that can be extracted or inferred:

1. Table of Acceptance Criteria and Reported Device Performance

As a clinical performance study with specific diagnostic metrics (like sensitivity, specificity, or accuracy) was not submitted, there isn't a table of acceptance criteria for diagnostic performance against specific disease states. Instead, the acceptance is based on meeting technical and safety standards, and demonstrating signal quality, all of which are considered "performance" in this context.

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

• Sample Size (Test Set): Not applicable. No clinical performance testing with a patient test set was submitted for diagnostic accuracy. The testing performed was non-clinical (bench, software V&V, usability).
• Data Provenance: Not applicable. No clinical patient data was submitted for performance testing.

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

• Number of Experts: Not applicable. No clinical performance testing with expert-established ground truth was submitted.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. No clinical performance testing requiring adjudication was submitted.

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

• MRMC Study: No. The device "Neuronaute" is an EEG data acquisition, display, storage, and transmission system. It is explicitly stated that "Neuronaute and its components do not provide any diagnostics conclusions or automated alerts of an adverse clinical event about a patient's clinical condition." Therefore, it does not include AI for diagnostic assistance, and an MRMC study comparing human readers with and without AI assistance is not relevant to this device's current claims.

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

• Standalone Performance: No. As noted above, the device does not provide diagnostic conclusions or automated alerts, implying no standalone diagnostic algorithm. Its primary function is to collect and transmit EEG signals for review by a physician.

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

• Type of Ground Truth: Not applicable for diagnostic performance. For the technical performance aspects (e.g., signal quality, electrical safety), the "ground truth" would be the specifications and requirements of the referenced industry standards (e.g., IEC 60601-2-26) or "EEG gold standards" referenced in the text.

8. The sample size for the training set

• Sample Size (Training Set): Not applicable. As the device does not provide diagnostic conclusions or automated alerts, it does not appear to involve a machine learning model that would require a patient-based training set for diagnostic classification.

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

• Ground Truth for Training Set: Not applicable. See explanation for #8.

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The Neuronaute is a medical, wireless and mobile equipment, which allows acquisition, record, storage, transmission and displaying of electroencephalogram (EEG) from adult patients.

It can be used with patients in health care facility (data acquisition and reporting) or clinical research environment.

The Neuronaute requires operation by a trained healthcare professional.

The Neuronaute only acquires and displays physiological signals, no claims are being made for analysis of the acquired signals with respect to the accuracy, precision and reliability.

The Neuronaute is a wearable and wireless equipment, which allows acquisition, recording, storage, transmission and displaying of electroencephalogram (EEG).

The Neuronaute is composed of a textile cap where twenty-one titanium dry electrodes are attached. An electronic box is attached to the cap (EEG recording) associated to batteries. The system operates on battery power only.

The system is connected to a device (i.e. smart phone or a digital tablet) loaded with a separate stand-alone software program ("app"). The app works with a cloud backend service, which allows the user management and authentication, the data storage for application recordings and access to this data via a web-based interface, the devices management and authentication, the recording scheduling, the download of the latest firmware version.

The acquired signals are saved in a universal data format (European Data Format, EDF) that is intended to be visualized by a Physician through the web-based interface.

Here's an analysis of the acceptance criteria and supporting study for the Neuronaute device, based on the provided FDA 510(k) summary:

The Neuronaute device is an electroencephalograph (EEG) system intended for acquiring, recording, storing, transmitting, and displaying EEG from adult patients. The acceptance criteria and supporting studies focus on demonstrating that the Neuronaute performs similarly to or better than predicate devices, and meets relevant electrical, software, and biocompatibility standards.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list "acceptance criteria" with numerical targets and then "reported device performance" in a separate section. Instead, the "Performance Data" and "Technological Characteristics" sections describe testing conducted and the device's measured specifications, often compared directly to predicate devices to demonstrate substantial equivalence. I will synthesize the relevant information into a table, focusing on direct and inferable criteria for signal quality and electrical characteristics.

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

• Physiological Tests (Impedance, Alpha Rhythm):
  • Impedance tests: 24 subjects.
  • Alpha Rhythm tests: 26 healthy adult subjects.
• EEG signal testing for comparison with Rythmlink Disc Electrodes: The document doesn't explicitly state the number of subjects for this comparison, but it implies a test was conducted.
• Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given the mention of "healthy adult subjects," it implies a prospective clinical or research study was conducted internally or with a clinical partner.

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

The document does not describe the use of experts to establish ground truth for the physiological or comparative EEG signal quality tests. The "gold standard" comparison for EEG signal quality refers to a predicate device (Rythmlink Disc Electrodes), not expert interpretation of data. The physiological tests (Alpha Rhythm, Impedance) likely relied on objective measurements and established physiological markers rather than expert consensus for ground truth.

4. Adjudication Method for the Test Set:

Not applicable, as no expert-based ground truth establishment or adjudication process is described for the tests mentioned. The assessment of signal quality and electrical performance appears to be based on direct measurement and comparison to predefined technical specifications and predicate device performance.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The Neuronaute is described as a device that only acquires and displays physiological signals, with "no claims being made for analysis of the acquired signals with respect to the accuracy, precision and reliability." This means the device does not provide AI-assisted interpretations to be compared against human readers. Its function is data acquisition and display.

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

A standalone algorithm performance study was not done, as the Neuronaute explicitly states it makes "no claims ... for analysis of the acquired signals." The "software" (firmware, mobile app, cloud) focuses on verification and validation of its functionality in acquiring, recording, storing, transmitting, and displaying data reliably and safely.

7. Type of Ground Truth Used:

• For EEG signal quality comparison: The "gold standard" was another cleared EEG electrode, Rythmlink Disc Electrodes (K061148). This serves as a technical ground truth for comparison of electrical and signal performance.
• For physiological tests (Alpha Rhythm, Impedance): The ground truth is based on established physiological phenomena (e.g., normal presence of alpha modulation, expected impedance levels) and objective measurements.

8. Sample Size for the Training Set:

The document does not mention any "training set" as it is not an AI/ML device that performs analysis or interpretation. The software validation is for the functionality of data handling and display, not for learning from data.

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

Not applicable, as there is no training set for an AI/ML algorithm.

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