(119 days)
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
| Acceptance Criteria | Reported Device Performance | Standard/Methodology |
|---|---|---|
| Aging Test | ASTM F1980-16 | |
| Light grey color | Complies (light grey color) | Visual inspection |
| No crystallization | Complies (no crystallization) | Visual inspection |
| No flocculation | Complies (no flocculation) | Visual inspection |
| Opaque | Complies (opaque) | Visual inspection |
| pH range | 8-10 | Internal testing |
| Impedance at 10Hz | 50 ± 10 Ohm | Internal testing, complies with ANSI/AAMIEC12:2000 |
| Long Term Conductivity Test | ANSI/AAMIEC12:2000/(R)2015 | |
| DC Offset voltage | Does not exceed 100mV (after 7 days testing) | Electrical testing |
| AC Impedance | Does not exceed 2000 Ohm (after 7 days testing) | Electrical testing |
| Biocompatibility | ||
| Cytotoxicity | Passed | ISO 10993-5 |
| Irritation | Passed | ISO 10993-10 |
| Sensitization | Passed | ISO 10993-10 |
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.
§ 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).