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AC Cream - Conductive paste 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 recessed electrodes to reduce impedance between the electrode surface and the skin.

AC Cream - Conductive paste 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 recessed electrodes to reduce impedance between the electrode surface and the skin.
It's characterized by pale yellow colour, no crystallization, no flocculation, bright.
AC Cream - Conductive paste function is of conductor between the electrode used and the patient's skin and of getting the impedance lower for a better recording of the signal. AC Cream - Conductive paste is for external use with recording electrodes only.
AC Cream - Conductive paste is made of powders, Potassium Chloride and Sodium Chloride as conductors, combined with thickening agents and humectants, all in an aqueous solvent.
The composition is the following: Water, Ceteareth-20, Glycerol, Propylene Glycol, Bentonite, Sodium chloride, Potassium chloride, Calcium carbonate, Polysorbate 20, Phenoxyethanol, Ethylhexylglycerin
The pH range is 6÷8, and Impedance at 10Hz is 120± 25 Ohm.
The mean impedance after 7 days use, considering the worst values detected, is around 480 ± 10 Ohm.
The Conductivity is 20 mS/cm
Shelf life of AC Cream - Conductive paste is 3 years if stored properly in the closed packaging, kept away from the sunlight and within the limit temperature

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) summary for AC Cream - Conductive paste:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Test Set Description: The summary describes performance testing for biocompatibility, accelerated aging (shelf life), and long-term conductivity.
• Sample Size: The exact sample size for each test (e.g., number of units tested for aging, number of samples for biocompatibility) is not explicitly stated in the provided text.
• Data Provenance: The document indicates that the performance testing was "conducted on AC Cream - Conductive paste." This implies the testing was performed internally by Spes Medica S.r.l. or by a contract lab on their behalf. There is no information regarding the country of origin of the data or whether the tests were retrospective or prospective since it concerns product qualification.

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 this type of device (electroconductive paste) or the described studies. The studies are bench tests and biocompatibility tests against established standards. Ground truth, in the sense of expert consensus on diagnostic interpretations, is not relevant here. The "ground truth" for these tests is the quantitative measurement against predefined physical and biological acceptance limits from international standards (ISO, ANSI/AAMI).

4. Adjudication method for the test set:

This information is not applicable as the tests performed are objective physical and biological measurements against specific numerical or qualitative (e.g., "no flocculation") criteria. There is no subjective interpretation that would require an adjudication method.

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:

No, an MRMC comparative effectiveness study was not done. This device is an electroconductive paste, not an AI or imaging diagnostic device that would involve human readers or AI assistance.

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

No, a standalone algorithm performance study was not done. This device is a physical product (conductive paste), not an algorithm or software.

7. The type of ground truth used:

The ground truth used for the performance testing is based on:

• International Standards: ISO 10993-5, ISO 10993-10, and ANSI/AAMI EC12:2000/(R)2015. These standards define the acceptable limits and methodologies for testing biocompatibility and electrical performance parameters for electroconductive media.
• Physical/Chemical Properties: Measured values for color, crystallization, flocculation, brightness, pH, impedance, and conductivity.

8. The sample size for the training set:

This information is not applicable. This device is not an AI/machine learning product and therefore does not have a "training set" in that context. The device's formulation was likely developed through R&D, but this is not a "training set" in the context of typical AI device submissions.

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

This information is not applicable, as there is no "training set" in the AI/ML context for this device. The formulation and properties were established through product development, material science principles, and internal quality control, with the goal of meeting the performance requirements eventually tested against the standards mentioned above.

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