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Intended for use with electric stimulation therapy devices, such as TENS and EMS. Conductive Gel is used with external electrodes to reduce the impedance of the contact between the electrode and the skin.

Conductive Gel can be used with any of dozens of stimulating devices that are legally sold, to reduce the impedance between the skin and the stimulating device. It consists of Purified water: 98.25%, Carbopol: 0.5%, Glycerin: 1%, Sodium hydroxide: 0.2% and Triclosan: 0.05%. And the Purified water used as the solvent, the Carbopol as a gel forming material, the Glycerin as a Moisturizing, the Sodium hydroxide as a Buffering and the Triclosan as a preservative. The Conductive Gel is used on intact skin surfaces. The entire surface of Conductive Gel is very conductive, smeared evenly on the stimulation device, so that the current is evenly distributed. The gel is to be generously applied to the area where an electrode will be used. The gel can be washed off the skin after use.

This document describes the validation of a "Conductive Gel" medical device. Here's a breakdown of the acceptance criteria and the study conducted to prove it:

1. Table of Acceptance Criteria and Reported Device Performance

Additional Performance Data from Comparison to Predicate Device:

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

The document does not explicitly state the exact sample sizes for each non-clinical test (cytotoxicity, sensitization, irritation, usability, shelf life). However, it refers to standard biological evaluation and aging test methods (ISO 10993-5, ISO 10993-10, IEC 62366-1, ASTM F1980-16), which inherently define sample sizes for their respective procedures, typically involving animal models for biological tests or specific numbers of units for usability/shelf life.

• Data Provenance: The studies were identified as "lab bench testing." The location of these labs or the country of origin for the data is not specified beyond the submitter's and correspondent's addresses (China). The tests are non-clinical, meaning they were not conducted on human subjects.

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

This information is not provided as the validation is based on non-clinical (lab bench) testing against established standards, not on expert consensus or human reader performance.

4. Adjudication Method for the Test Set

This information is not applicable/provided as the validation is based on objective lab bench testing against predefined acceptance criteria, not subjective interpretations requiring adjudication.

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 a conductive gel, which is a physical product, not an AI or software device that would involve human readers or comparative effectiveness studies with AI assistance.

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

Not applicable. As mentioned, this is a physical medical device (conductive gel), not an algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests is based on established scientific and regulatory standards and their defined criteria.

• For biological tests (cytotoxicity, sensitization, irritation), the ground truth is whether the device elicits a toxic or adverse biological response as determined by standardized in-vitro and in-vivo (animal) models.
• For usability, the ground truth is compliance with IEC 62366-1 usability engineering principles.
• For shelf life, the ground truth is the maintenance of specified physical and chemical properties (like pH, impedance, conductivity, exterior, package integrity) over the declared shelf life based on accelerated aging models.
• For material composition, the ground truth is the precise percentage concentration of each ingredient.
• For impedance and pH, the ground truth is the measured value compared to the specified range or limit.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, and there is no "training set" in the context of machine learning or AI.

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

Not applicable. As above, there is no training set for this type of device.

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The Conductive Gel is intended for use with TENS (transcutaneous electrical nerve stimulation) and EMS (electric muscle stimulation) therapy. The Conductive Gel is used with external electrodes to reduce the impedance of the contact between the electrode surface and the skin.

Not Found

Based on the provided text, a Conductive Gel (K221724) has received 510(k) clearance from the FDA. However, the document provided is a clearance letter, not a detailed study report. It states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices.

This type of clearance (510(k)) generally means that the manufacturer demonstrated that their new device is as safe and effective as a legally marketed predicate device, and does not typically require the submission of a new, extensive clinical study with the kind of detailed performance data and study design requested in your prompt.

Therefore, I cannot provide the information you've requested regarding acceptance criteria, device performance tables, sample sizes, ground truth establishment, or specific study methods like MRMC studies, because this type of data is not typically included or required within a 510(k) clearance letter itself, especially for a device like a conductive gel.

The clearance letter focuses on regulatory compliance and substantial equivalence to existing devices.

To answer your prompt directly with information from this document:

1. A table of acceptance criteria and the reported device performance:

• Not provided in this document. The document primarily addresses regulatory clearance based on substantial equivalence, not detailed performance metrics against specific acceptance criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not provided in this document. No "test set" or study details are discussed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not provided in this document. No ground truth establishment is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not provided in this document. No adjudication method is mentioned.

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 and not provided in this document. MRMC studies are typically for diagnostic imaging devices involving reader performance, which doesn't apply to a conductive gel.

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

• Not applicable and not provided in this document. This is not an AI/algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Not provided in this document.

8. The sample size for the training set:

• Not applicable and not provided in this document. This is not an algorithm-based device requiring a training set.

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

• Not applicable and not provided in this document.

In summary: The provided document is a 510(k) clearance letter for a Conductive Gel, indicating that it has been deemed substantially equivalent to a predicate device. This type of regulatory submission and corresponding letter does not typically contain the detailed performance study data you are asking for. For such data, one would usually need to consult the full 510(k) submission summary or a separate publication of a performance study, if one was conducted and published.

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The Conductive Gel is intended for use with TENS (transcutaneous electrical nerve stimulators) and EMS (electrical muscle stimulators). The Conductive Gel is used with external electrodes to reduce the impedance of the contact between the electrode surface and the skin.

The Conductive Gel is a colored gel used for reducing the impedance between electrodes and the skin. The gel is to be generously applied to the area under an electrode, which is to be used. The gel can be washed off the skin after use.

This submission describes a Conductive Gel and does not include a study with acceptance criteria, device performance, or human readers as described in your request. The provided text is a 510(k) summary for a medical device (conductive gel) intended for use with TENS and EMS devices.

Therefore, I cannot extract the information required concerning:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test or training sets.
• Data provenance.
• Number/qualifications of experts.
• Adjudication methods.
• MRMC comparative effectiveness study or related effect sizes.
• Standalone algorithm performance.
• Type of ground truth used.
• How ground truth was established.

This document focuses on demonstrating substantial equivalence to a predicate device (Skylark Batch #6060 Conductive Gel) rather than presenting a performance study with specific acceptance criteria that would apply to software or AI-driven devices. The "study" here is essentially the comparison to the predicate device to argue for substantial equivalence in safety and effectiveness.

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Ask a specific question about this device