Search Results

SAC2 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.

SAC2 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. SAC2 is provided in an aluminum tube of 100g. It's characterized by light grey colour, no crystallization, no flocculation, no adverse smell, opaque. SAC2 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. SAC2 is for external use with recording electrodes only. SAC2 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, Talc, Celite, Glycerol, CarboxyMethylCellulose, Sodium chloride, Potassium chloride, Phenoxyethanol, Ehylhexylglycerin The pH range is 8÷10, and Impedance at 10Hz is 50 ± 10 Ohm. The Conductivity is 20 mS/cm Shelf life of SAC2 is 3 years if stored properly in the closed aluminum tube kept away from the sunlight.

The provided text describes the 510(k) summary for the SAC2 - Electrode cream. It does not contain information about a study involving human readers or AI assistance. The performance testing section focuses on bench tests (aging, long-term conductivity) and biocompatibility, not on a clinical effectiveness study with human subjects.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable for this type of product/study. The performance tests described are bench tests on the product itself, not on data from human subjects.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth for biocompatibility and bench testing is established through standardized laboratory procedures and instrument readings, not expert consensus.

4. Adjudication method for the test set

Not applicable. Adjudication is typically used in studies involving subjective interpretation (e.g., medical imaging), which is not the case for these performance tests.

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. The document pertains to an electrode cream, not an AI software or system that assists human readers.

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. The device is a physical electrode cream, not an algorithm.

7. The type of ground truth used

The ground truth for the performance tests (aging, long-term conductivity) was established by objective measurements against defined parameters (e.g., color, pH, impedance, DC offset voltage) and the biological responses observed in standardized biocompatibility tests (cytotoxicity, irritation, sensitization). This is based on established industry standards like ASTM F1980-16, ANSI/AAMIEC12:2000, ISO 10993-5, and ISO 10993-10.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

Not applicable. As noted above, this device does not involve a training set.

Ask a specific question about this device