(337 days)
Disposable Non-invasive EEG Sensor is applied directly to the patient's skin to enable recordings of electrophysiological (such as EEG) signals.
Disposable Non-invasive EEG Sensor is a sensor assembly with pre-gelled electroencephalogram (EEG) electrodes. The Sensor is applied to the skin of the patient to record electrophysiological (such as EEG) signals. It is a low impedance, single patient use, non-sterile disposable electrode sensor that is designed for application to areas including forehead, temporal, above eyebrow and mastoid process. The Sensor is designed to provide ease of use and electrode placement accuracy. It is used in conjunction with a monitor with an EEG module.
The sensor design is constructed using FPC (Flexible Printed Circuit Board) and medical foam. Place the foam plate and conductive gel on the FPC board. The bottom of the foam is covered with medical grade pressure sensitive adhesive for skin adhesion. A printed circuit board, which is part of the FPC board and printed with conductive silver chloride, is pasted on the other side of the foam. The flexible foam wrapped with conductive gel is used to contact the skin. When the flexible foam contacts the skin, the conductive gel will connect the skin with the FPC board to form a conductive bridge. The silver/silver chloride circuit provides signal continuity from each electrode to the monitor. The FPC board is attached to site like forehead and transmits EEG signals.
The company, Shenzhen Med-link Electronics Tech Co., Ltd., is seeking 510(k) clearance for their Disposable Non-invasive EEG Sensor. The device is a non-sterile, single-patient use electrode sensor designed to record electrophysiological (EEG) signals. The indications for use state that the sensor is "applied directly to the patient's skin to enable recordings of electrophysiological (such as EEG) signals."
Here's an analysis of the provided information regarding acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria / Performance Aspect | Predicate Device Standards | Proposed Device Performance |
|---|---|---|
| Electrical Safety | Adherence to 60601-1 standards (GE Entropy Sensor) | Complies with ANSI/AAMI ES60601-1 |
| Performance | Complies with ANSI/AAMI EC12 | Complies with ANSI/AAMI EC12 |
| Biocompatibility | Adherence to ISO10993-5, ISO 10993-10 (GE Entropy Sensor) | All patient-contacting materials evaluated by ISO10993-5, ISO 10993-10 |
| Package Integrity & Functional Performance | Not explicitly stated for predicates | Completed on subject device following Accelerated aging test to support proposed shelf life. |
2. Sample size used for the test set and the data provenance:
The document mentions "bench testing," "electrical safety and performance tests," "biocompatibility tests," and "package integrity and functional performance testing." However, specific sample sizes for these tests are not provided in the summary. The provenance of the data (country of origin, retrospective/prospective) is also not explicitly stated beyond the manufacturer being in China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable to the data provided. The studies described are bench tests and engineering performance evaluations of a physical medical device (EEG sensor), not studies that require expert-established ground truth for diagnostic accuracy or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable as the described tests are technical performance evaluations, not studies involving 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 is not applicable. The device is an EEG sensor, a hardware component for recording signals, not an AI-powered diagnostic tool requiring human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This is not applicable. The device is a sensor, not an algorithm. The performance tests are focused on the hardware's ability to accurately record signals and meet safety standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the tests performed is based on established industry standards and regulatory requirements for electrical safety, performance, biocompatibility, and material properties. For example, ANSI/AAMI ES60601-1 for electrical safety, ANSI/AAMI EC12 for EEG electrode performance, and ISO10993 series for biocompatibility.
8. The sample size for the training set:
This is not applicable. The device is a hardware sensor, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
This is not applicable as there is no training set for this device.
§ 882.1320 Cutaneous electrode.
(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).