(199 days)
Electro-Gel is intended for use in clinical and research EEG/EP recordings from humans. It is used with external electrodes as the conductor between the scalp and the (recessed) electrodes. It also reduces impedance (resistance to alternating current) between the electrode surface and the skin.
Electro-Gel is the conductor between the scalp and the (recessed) electrodes. It also reduces impedance (resistance to alternating current) between the electrode surface and the skin. The electrical activity of the brain is transferred to the electrode and then to the EEG or computer equipment. Electro-Gel is for use with external electrodes only. Electro-Gel is an off white color, water-miscible conductive gel consisting of Sodium Chloride as the conductor combined with thickening agents, emulsifiers, humectants and preservatives all in an aqueous solvent. The pH range is 4.5 to 6.0 pH, Viscosity range is 575 to 615 cp. and Impedance 0.5K/Ohms or less. Direct contact with the Electro-Gel should not exceed 8 hours in any single recording session. The Electro-Gel is available in the following jar sizes: 16 ounce and 128 ounce. Shelf life is 1 year if stored properly, i.e. kept with containers tightly closed and at room temperature.
Here's an analysis of the provided text, focusing on the acceptance criteria and study data for the Electro-Gel device:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for Electro-Gel are primarily based on its physical properties and biocompatibility. The reported device performance demonstrates compliance with these criteria.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Physical Properties | pH range | 4.5 to 6.0 pH |
| Viscosity range | 575 to 615 cp. | |
| Impedance | 0.5K/Ohms or less | |
| Shelf life | 1 year (if stored properly: containers tightly closed, room temperature) | |
| Composition | Conductive material | Salt (NaCl) |
| Thickening agent | Aragum, Glycerine (note: changed from Tragacanth, Glycerine in prior version) | |
| Preservative | Methylparaben and Propylparaben | |
| Biocompatibility | Cytotoxicity (ISO 10993-5, -12) | Passed (Agar Diffusion Test) |
| Primary Skin Irritation (ISO 10993-10, -12) | Passed (Primary Skin Irritation Test-ISO Direct Contact) | |
| Sensitization (ISO 10993-10, -12) | Passed (Buehler Sensitization Test) | |
| Sterilization Status | Provided Non-Sterile | Provided Non-Sterile |
| Chemical Safety | No OSHA PEL (Permissible Exposure Limit) requirements | No OSHA PEL* |
| Intended Use | Use with external electrodes as conductor between scalp and electrodes, reducing impedance for EEG/EP recordings in humans. | The device's stated intended use aligns with the functional performance (conductivity and impedance reduction) and safety (biocompatibility) demonstrated. The device is used with external electrodes as the conductor between skin and electrode to reduce impedance between the electrode surface and the skin. Test results for pH, viscosity and impedance are regularly monitored internally. The non-clinical tests (biocompatibility tests) confirmed its safety and effectiveness relative to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a sample size for a "test set" in the traditional sense of a clinical or performance study with patient data. The testing described for the device is primarily non-clinical:
- Biocompatibility Tests: These tests (Agar Diffusion Test for cytotoxicity, Primary Skin Irritation Test, Buehler Sensitization Test) were conducted by Toxikon Corporation, an FDA/USDA Registered lab, in compliance with 21CFR, Part 58 (Good Laboratory Practice for Non-Clinical Laboratory Studies). The document does not specify the number of samples or subjects (e.g., animals for irritation/sensitization, cell cultures for cytotoxicity) used in these tests. These are standard laboratory tests, so the "provenance" is a certified testing facility adhering to GLP.
- Internal Testing: pH, impedance, and viscosity are tested internally on a regular basis. No sample sizes are provided for these internal quality control checks. The data provenance is internal quality control.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable to the provided document. The submission is for an electrode gel, and the "test set" described consists of non-clinical, laboratory-based evaluations of physical properties and biocompatibility. There is no mention of a clinical study or a need for expert consensus on a "ground truth" derived from patient data for this type of device.
4. Adjudication Method for the Test Set
This information is not applicable. Since there's no clinical "test set" involving human interpretation or subjective assessment, an adjudication method like 2+1 or 3+1 is not relevant. The biocompatibility tests have objective outcomes (pass/fail based on established assay criteria) and are interpreted by the testing laboratory.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic algorithms or imaging interpretation devices where human performance is significantly impacted by and compared with AI assistance. The Electro-Gel is a medical device (electrode gel) and not an AI-powered diagnostic tool. Therefore, there's no "AI" component, no human readers, and no effect size on how human readers improve with AI vs. without AI.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone (algorithm only) performance study was not done. The device is an electrode gel, not an algorithm or software. Its performance is measured through its physical and chemical properties and biocompatibility, not as an "algorithm" operating independently.
7. Type of Ground Truth Used
The "ground truth" for evaluating Electro-Gel is based on:
- Established physical and chemical standards: The pH, viscosity, and impedance ranges are established specifications for such gels, likely derived from industry standards and functional requirements.
- Biocompatibility standards: ISO 10993 standards define the acceptable "ground truth" for cytotoxicity, irritation, and sensitization. The device's performance is compared against these internationally recognized biological evaluation criteria for medical devices.
- Comparison to predicate devices: The primary method for demonstrating safety and effectiveness is substantial equivalence to legally marketed predicate devices. The "ground truth" here is the established safety and efficacy profile of these comparable products.
8. Sample Size for the Training Set
This information is not applicable. The Electro-Gel is a physical product (an electrode gel), not a machine learning model or algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no training set for this device.
§ 882.1275 Electroconductive media.
(a)
Identification. Electroconductive media are the conductive creams or gels used with external electrodes to reduce the impedance (resistance to alternating current) of the contact between the electrode surface and the skin.(b)
Classification. Class II (performance standards).