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The Electro-Cap System is intended for use in routine clinical and research settings where rapid placement of a number of EEG electrodes is desired.

The Electro-Cap System is an EEG electrode positioning system used to quickly place the standard 20 EEG electrodes and also a large number of electrodes in a uniform and consistent manner on the head and body in order to transmit electrophysiological signals from an individual to data collection devices. The Electro-Cap is made from a spandex type material with recessed electrodes in plastic mounts attached to the cap. The standard cap covers the entire scalp and is held in place with chin straps, or with cap straps attached to a body harness. The Surgical Cap material is cut slightly different to allow the cap to fit securely over the ears to hold it in place. The spandex type material holds the electrodes securely in position during an EEG recording. Wires are attached to each electrode and exit the cap to form a cable, which is used to connect the cap to the EEG equipment, either through an adapter cable, or in some instances, directly to the equipment with the connector on the cap. The electrical activity of the brain is transferred through the Electro-Gel to the recessed electrode and then to the EEG or computer equipment for evaluation.

The Electro-Cap System is a device designed for rapid placement of EEG electrodes. The provided 510(k) summary (K112319) indicates that the device is substantially equivalent to its predicate devices, rather than performing a specific study to prove it meets acceptance criteria with quantifiable metrics. The substantial equivalence argument relies on comparing the device's technological characteristics, indications for use, and performance requirements to those of existing legally marketed predicate devices.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly define "acceptance criteria" in the format of pass/fail metrics. Instead, it compares the proposed device's characteristics and performance requirements to those of predicate devices to establish substantial equivalence. The key performance requirement is the ability to transmit electrophysiological signals with a maximum impedance of 5K/Ohms.

Note: The document focuses on demonstrating that the new device shares fundamental technological characteristics and performance requirements with devices already on the market, implying that these established characteristics represent the "acceptance criteria" for this type of device. No specific clinical trial or performance study comparing the device against a quantitative acceptance threshold is presented.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. The document describes a comparison to predicate devices to demonstrate substantial equivalence, rather than a clinical performance study with a dedicated test set. Therefore, there is no sample size for a test set or data provenance in the context of an evaluative study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. As no clinical performance study with a test set was conducted, there were no experts establishing ground truth for such a set. The "experts" involved are implicitly the regulatory bodies and the manufacturer's internal team who determined the device's characteristics and its equivalence to predicates.

4. Adjudication Method for the Test Set

Not applicable. No test set or an adjudication method for one is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor any evaluation of human reader improvement with or without AI assistance. This device is a physical EEG electrode positioning system, not an AI-powered diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. The device is a physical medical device (EEG electrode positioning system), not an algorithm or AI. Therefore, a "standalone algorithm performance" study is not relevant.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

Not applicable. The "ground truth" in this context is the established functionality and safety of the predicate devices. The new device is deemed substantially equivalent because its fundamental design, intended use, and performance requirements align with these existing, approved devices. No new ground truth for a novel claim is being established beyond this equivalence.

8. The Sample Size for the Training Set

Not applicable. There is no mention of a "training set" as this device is a physical product and not an algorithm requiring training data.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set mentioned, the establishment of ground truth for it is not relevant.

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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.

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.

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