(324 days)
EEG adhesive conductive paste (hereafter EEG-acp) is intended for use in clinical and research EEG recordings from humans under professional guidance. EEG-acp is an electroconductive paste which should be used in combination with EEG cup electrodes on the scalp.
EEG adhesive conductive paste (hereafter EEG-acp) is intended for use in clinical and research EEG recordings from humans (from the age of 2) under professional guidance. EEG-acp is an electroconductive paste which should be used in combination with EEG cup electrodes on the scalp. It acts as a conductor between the scalp and the cup electrodes to reduce impedance between the electrode surface and the skin. The reduction in impedance facilitates better recording of the signal. It is intended to be used for up to 10 hours after application to healthy, intact skin. After drying, it is self-adhesive and can be washed off with water. The cream is provided non-sterile and in a 100g aluminum tube. It is white and has no adverse smell. Its texture is smooth and creamy directly after withdrawal from the tube, and solid after drying. EEG-acp is intended to be used as an electroconductive medium between the electrode and the patient's skin, i.e., it amplifies the electrical signal and thereby improves the electrophysiological recording. The high salt content of the cream is responsible for its conductive properties. Its impedance is -1.9 kOhm and its conductivity is 20 mS/cm.
The provided text describes the 510(k) summary for the EEG-acp device. This document is a premarket notification to the FDA to demonstrate that the device is at least as safe and effective as a legally marketed predicate device. The information details the device, its intended use, and comparative data against a predicate device.
Here's an analysis of the acceptance criteria and study proving device performance based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as typical performance metrics (e.g., sensitivity, specificity, AUC) for an AI/ML diagnostic device, because EEG-acp is an "Electroconductive Media" (a physical cream), not a diagnostic algorithm. Instead, the "acceptance criteria" for this device are established by demonstrating substantial equivalence to a legally marketed predicate device (SAC2 Electrode Cream, K192606) in terms of its physical and performance characteristics.
The table below summarizes the key comparisons made for "acceptance" of EEG-acp:
| Characteristic | Acceptance Criteria (Predicate: SAC2 Electrode Cream, K192606) | Reported Device Performance (EEG-acp, K212325) | Comparison/Outcome |
|---|---|---|---|
| Classification | Class II, Product Code GYB, 882.1275 Electroconductive Media | Class II, Product Code GYB, 882.1275 Electroconductive Media | Same |
| Indications for Use | Clinical and research EEG/EP recordings from humans; used with external electrodes as conductor to reduce impedance. | Clinical and research EEG recordings from humans (age >2); used with EEG cup electrodes on scalp as electroconductive paste to reduce impedance. | Substantially Equivalent differences noted: EEG-acp specifies "cup electrodes" (more specific than "recessed electrodes") and removes EP recordings. It also specifies use for children older than 2 years. These differences are deemed not to raise new safety/effectiveness concerns. |
| Intended Use Time | >24h, 15 min | No new questions raised. | |
| pH Range | 8-10 (alkaline) | 6-7.5 (acidic to neutral) | Difference: EEG-acp has a more skin-neutral pH. Deemed not to impact safety/effectiveness and potentially preferable for patients with skin diseases. |
| Weight | 100g per tube | 100g per tube | Same |
| Packaging | Aluminum tube | Aluminum tube | Same |
| Characteristics | Salt base, Non-irritating, Non toxic, Light-Grey color adhesive | Salt base, Non-irritating, Non toxic, White color adhesive | Difference: Color different (white vs light-grey). Deemed not to affect safety/effectiveness. |
| Additional Ingredients | None mentioned (for SAC2) | Allantoin, Bentonite, Glycerin, Lactate, Panthenol, PEG-40, Phenoxyethanol, Polyquaternium-10, Sodium Chloride, Sodium Hydroxide, Skin protection solution, Talcum, Water, Zinc oxide | Difference: EEG-acp includes components like Allantoin, Polyquaternium-10, and Panthenol for skin care/protection, aiming to reduce adverse effects. This is presented as an improvement for safety. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not describe a clinical study in humans with a "test set" in the traditional sense of an AI/ML algorithm evaluation (i.e., a dataset of patient data used to evaluate algorithm performance). Instead, the studies performed are bench testing and biocompatibility testing of the physical cream itself.
- Bench Testing:
- Impedance and Conductivity: Measured to confirm equivalence with the predicate device. The sample size for these measurements is not specified (e.g., number of cream samples, number of measurements).
- Qualitative characteristics (Color, odor, adhesiveness, time to dry): Verified to be as specified and equivalent to the predicate device. Sample size not specified.
- Shelf-life: Validated by accelerated aging testing in accordance with ASTM F1980-16. Sample size not specified (e.g., number of batches, number of samples tested over time).
- Biocompatibility Testing:
- The tests performed were:
- ISO 10993-5: Cytotoxicity in vitro Skin Irritation (Human Skin Model Test)
- ISO 10993-10: Acute Dermal Irritation/Corrosion, Irritation/Skin Sensitization, Guinea Pig Maximization Test.
- These are laboratory tests on cells/animal models, not human patient data. The sample sizes for these specific biological assays are not detailed in the summary.
- The tests performed were:
- Data Provenance: The document does not explicitly state the country of origin for the data or whether the tests were retrospective or prospective, though it implicitly describes prospective laboratory/bench testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to the evaluation of this device. As EEG-acp is an electroconductive paste, its performance is assessed through physical and chemical property measurements and biocompatibility testing, not through expert interpretation of diagnostic images or clinical outcomes. Therefore, there is no "ground truth" expert adjudication process in the context of diagnostic accuracy.
4. Adjudication Method for the Test Set
Not applicable, as there is no expert adjudication of a diagnostic performance test set.
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 applicable. This device is not an AI/ML algorithm designed to assist human readers (e.g., radiologists) in diagnostic interpretation. It is a physical medical device (conductive paste).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm. Bench tests (e.g., impedance, conductivity, shelf-life) could be considered "standalone" in the sense that they evaluate the properties of the cream itself, independent of human application for diagnosis, but this term (standalone) is typically used for AI/ML algorithms.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's acceptance is based on:
- Physical and Chemical Properties: Measured values (e.g., impedance, conductivity, pH, time to dry, color, odor, adhesiveness, consistency) are compared against scientifically established standards or performance of the predicate device.
- Biocompatibility Standards: Results from tests defined by ISO 10993-1, -5, and -10 are used as "ground truth" for safety regarding biological compatibility (cytotoxicity, irritation, sensitization).
- Shelf-life Standards: Accelerated aging tests following ASTM F1980-16 provide the "ground truth" for shelf-life performance.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of 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).