Search Results
Found 3 results
510(k) Data Aggregation
(37 days)
K860210 Elefix
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.
| Acceptance Criterion (Implicitly compared to predicate) | Reported Device Performance (Relative to Predicate) |
|---|---|
| Ability to acquire, display, store, archive, and periodically transmit EEG signals | Equivalent: "The function of the system and the connection of the different elements remain the same." |
| Target population (Adults and Pediatrics 5 years and older) | Expanded: Subject device includes pediatric patients (5 years and older) due to two sizes of IceCap 2. Predicate was adults (18+). |
| Electrode material (Ag/AgCl) | Improved: Subject device uses Ag/AgCl for longer recording (up to 72h) compared to predicate's copper covered with silver (12.5h limitation due to copper migration). |
| Biocompatibility | Equivalent: "IceCap 2 / 2 Small electrodes material has been assessed by consensus standard for biocompatibility testing, as previously done with its predicate Neuronaute." |
| Electrical safety | Equivalent: Nonclinical tests demonstrated "safe" performance. |
| Performance (General) | Equivalent: Nonclinical tests demonstrated "as effective, and performs as well as the legally marketed predicate device." |
| Number of electrodes (19 EEG, 1 reference, 1 ground) | Equivalent: "Up to 21 electrodes" with the same distribution. |
| Montage (10/20 System) | Equivalent: Both use 10/20 System. |
| Head size accommodation | Improved: Subject device offers two sizes to accommodate head circumferences from 43 to 60 cm (including pediatric). Predicate had one size for "at least 90% of the population." |
| Conductive electrolyte paste | Equivalent: Both use "Elefix" paste. |
| EEG channels (Up to 24) | Equivalent: Both have up to 24 channels. |
| Data format (EDF) | Equivalent: Both use EDF. |
| Sampling Rate (250 or 500 Hz) | Equivalent: Both support 250 or 500 Hz. |
| Wireless Output (WiFi 2.4GHz, Bluetooth 2.4GHz) | Equivalent: Same wireless specifications. |
| Input dynamic range and differential offset voltage (±400mV) | Equivalent: Same specifications. |
| ADC Resolution (24 bits) | Equivalent: Same specifications. |
| ADC Common Mode Rejection Rate (CMRR) (> 105 dB) | Equivalent: Same specifications. |
| Input Impedance (> 1 Gohm) | Equivalent: Same specifications. |
| Input noise ( |
Ask a specific question about this device
(115 days)
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.
| Performance Characteristic | Acceptance Criteria (Met by adherence to standards) | Reported Device Performance (Demonstrated by testing) |
|---|---|---|
| Safety & Electrical | AAMI/ANSI ES 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-26 | Met all listed standards requirements. |
| Electromagnetic Compatibility | IEC 60601-1-2 | Met standard requirements. |
| EEG Signal Quality | IEC 60601-2-26 requirements for input noise; comparison to "EEG gold standards." | Met IEC 60601-2-26 requirements. Signal quality demonstrated (implied to be acceptable through comparison). |
| Software Verification & Validation | IEC 62304, FDA Guidance "General Principles for Software Validation" | Met all listed standards and guidance requirements. |
| Usability | IEC 62366, FDA Guidance "Applying Human Factors and Usability Engineering to Medical Devices (2016)" | Met all listed standards and guidance requirements. No new questions of safety or effectiveness identified. |
| Biocompatibility | ISO 10993-5, ISO 10993-10 (for IceCap and electrode gel paste) | Conforms to ISO 10993-5 and ISO 10993-10. |
| Input Dynamic Range & Differential Offset Voltage | IEC 60601-2-26 requirements | ±400mV (device); conforms to IEC 60601-2-26. |
| ADC Resolution | Not explicitly defined as an acceptance criterion for comparison, but described as "improved" | 24 bits |
| ADC Common Mode Rejection Rate (CMRR) | IEC 60601-2-26 requirements | > 105 dB (device); conforms to IEC 60601-2-26. |
| Input Impedance | IEC 60601-2-26 requirements | > 1 Gohm (device); conforms to IEC 60601-2-26. |
| Input Noise | IEC 60601-2-26 requirements |
Ask a specific question about this device
(198 days)
Elefix V Paste for EEG & EMG is a conductive paste used with surface electrodes to lower skin-electrode impedance. It can be used with electrodes for EEG and EMG examination.
The Elefix V Paste for EEG & EMG is the electroconductive media used with external electrodes to reduce the impedance (resistance to alternating current) of the contact between the electrode surface and the skin. The Elefix V Paste for EEG & EMG is an aqueous based material with Sodium Chloride as the conductive material combined with emulsifiers, humectants and preservatives. The Elefix V Paste for EEG & EMG has been designed to have increased stiffness and improved temperature resistance compared to its predecessor, the predicate device. These changes allow the paste to stay in place better as desired by its users. The Elefix V Paste for EEG & EMG has a neutral pH compared to the slightly alkaline pH of the predicate.
The Elefix V Paste for EEG & EMG is available in two models: ZV-401E and ZV-181E. ZV-401E is a container filled with 400 g of the paste. ZV-181E is a tube filled with 180g of the paste.
The Elefix V Paste for EEG & EMG is intended to be used by qualified medical personnel within a medical facility. It can be used with electrodes for electroencephalography (EEG) and electromyography (EMG) examination.
The document provided details for the Elefix V Paste for EEG & EMG, an electroconductive media. While the document discusses performance data and various tests conducted, it does not contain information typically associated with studies demonstrating the performance of AI/ML-driven medical devices, such as those related to effect size, human readers with or without AI assistance, or details on ground truth establishment for training sets.
Here's the information that could be extracted from the provided text, primarily related to bench testing of the device's physical properties:
1. A table of acceptance criteria and the reported device performance
| Characteristic | Acceptance Criteria (Predicate Device) | Reported Device Performance (Elefix V Paste) |
|---|---|---|
| Impedance (at 50Hz) | 1 kΩ or less | 1 kΩ or less |
| pH | 8.5 to 9.5 | 6.5 to 8.5 |
| Conductivity | 1.08 S/m | 1.04 S/m |
| Stiffness (using curdmeter) | 25 to 50 | 35 to 50 |
| Temperature Resistance | NA | Yes |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "performance testing" and "design verification and validation testing," but does not specify the sample size for these tests for pH, impedance, stiffness, or temperature resistance. The data provenance is also not specified.
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)
This information is not applicable as the tests conducted were for physical and chemical properties of a conductive paste, not for diagnostic accuracy or interpretation requiring expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the tests conducted were for physical and chemical properties and did not involve human interpretation or 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
This information is not applicable as the device is an electroconductive paste, not an AI-driven diagnostic or interpretative system. Therefore, an MRMC study related to AI assistance for human readers would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is an electroconductive paste, not a standalone algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the physical property tests, the "ground truth" or reference was based on established physical and chemical measurement standards for impedance, pH, conductivity, and stiffness. For biocompatibility, it was based on ISO 10993 standards.
8. The sample size for the training set
This information is not applicable as the device is not an AI/ML system and therefore does not have a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
This information is not applicable as the device is not an AI/ML system and therefore does not have a "training set."
Ask a specific question about this device
Page 1 of 1