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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 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.

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Cardioskin is intended to aid the diagnostic evaluation for cardiac disorders by recording patient's ECG signals allowing to condition and monitor these signals. ECG data is stored, transferred and displayed for a review by a physician. Cardioskin is designed to be used by a patient to transmit multiple-lead ECG signal to enable review at a physician's office, hospital or other remote locations under medical supervision. Cardioskin target population is adults.

Cardioskin is a wireless and wearable medical device.

It enables acquisition, recording, storage, transmission and display of 3-12 leads electrocardiogram (ECG) to analyze potential cardiac pathological abnormalities from adult patients in healthcare facility, at home or clinical research environment. It is intended to be used by trained patients and healthcare professionals only.

Cardioskin is composed of a garment, Cardioskin Textile, which is a T-Shirt where textilebased electrodes made of silver yarns are knitted and only functions on Cardioskin Battery and in association with a Cardioskin Recorder.

Cardioskin functioning is coupled with a smartphone/tablet compatible with an iOS or Android system, and a mobile application, the Cardioskin App.

A web-based information system, the Cardioskin Cloud, receives the ECG signals from the Cardioskin Recorder through a paired Wi-Fi connection for its long-term storage and display the signals in the web interface. The medical expert specialist, who prescribes the use of this device, should monitor its use and confirm the proper functioning of signal recording thanks to Cardioskin Cloud.

The provided text describes the Cardioskin device, its indications for use, and a comparison to predicate devices, but it primarily focuses on regulatory approval (510(k) summary) and does not contain detailed acceptance criteria or a specific study demonstrating direct performance against those criteria.

Instead, the document mentions that "Support for the substantial equivalence of Cardioskin was provided as a result of risk management and testing which included electrical and biological safety, performance and software tests." It also states, "Testing has provided reasonable assurance of safety and effectiveness for the intended use and supports the substantial equivalence demonstration." However, it does not elaborate on what these performance tests entailed, what the acceptance criteria were, or the specific results of those tests.

Therefore, many of the requested items cannot be definitively answered from the provided text.

Here is an attempt to answer the questions based only on the information available:

1. A table of acceptance criteria and the reported device performance

   • Acceptance Criteria: Not explicitly stated in the document. The document refers to "requirements for safety, function and intended use" and compliance with specific IEC and ISO standards (IEC 60601-1, IEC 60601-1-2, ISO 14971, IEC 62304, IEC 60601-2-47). These standards imply certain performance criteria, but the specific thresholds or metrics for "acceptance" of the Cardioskin's ECG performance (e.g., accuracy of heart rate detection, signal-to-noise ratio) are not detailed.
   • Reported Device Performance: The document only makes a general statement: "The results of the verification and validation activities demonstrate that the software meets the requirements for safety, function and intended use." No specific performance metrics or quantitative results for ECG signal acquisition and analysis are provided.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • The document refers to "non-clinical and limited clinical testing" but does not specify the sample size for any test set or the data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • Not specified.

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

   • Not specified.

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 specified, and it's unlikely given the nature of an ECG recording device where the primary output is the raw data for physician review, rather than an AI interpretation tool being evaluated for reader improvement.

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

   • The device "records patient's ECG signals allowing to condition and monitor these signals. ECG data is stored, transferred and displayed for a review by a physician." This indicates a human-in-the-loop system, as the physician performs the review. There is no mention of a standalone algorithm for diagnosis.

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

   • Not specified.

8. The sample size for the training set

   • Not specified. This device is primarily for data acquisition and display, and while it has a "Cardioskin Cloud" that stores and displays signals, the document doesn't indicate extensive AI model training in the diagnostic sense that would require a large training set for a "ground truth" establishment.

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

   • Not specified.

Summary of what can be inferred or directly stated from the text regarding performance and testing:

• Type of tests conducted: Electrical and biological safety, performance (general statement), software verification and validation, electromagnetic compatibility, and compliance with specific medical device standards (IEC 60601-1, IEC 60601-1-2, ISO 14971, IEC 62304, IEC 60601-2-47).
• Biocompatibility tests: Irritation and Sensitization, based on ISO 10993 for skin contact limited to 12 hours.
• Software tests: Verification and validation according to IEC 62304:2006 and FDA Guidance "General Principles for Software Validation."
• Outcome of tests: The tests provide "reasonable assurance of safety and effectiveness for the intended use" and demonstrate that "the software meets the requirements for safety, function and intended use." Compliance with recognized standards was demonstrated.

The document primarily serves as a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices and meeting general regulatory safety and effectiveness requirements, rather than providing detailed performance study results against specific, quantified acceptance criteria for diagnostic performance.

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