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Jmoon Conductive Gel is intended to be used with microcurrent devices to improve skin conductivity.

The Jmoon Conductive Gel is a clear, viscous and chloride-free formulation. The gel is to be applied to the area under an electrode to reduce the impedance of the contact interface between the electrode surface and the skin.

The provided FDA 510(k) clearance letter and summary for the Jmoon Conductive Gel do not contain any information regarding clinical studies with human participants or the use of AI/algorithms. The document primarily focuses on the device's substantial equivalence to a predicate device based on its physical, chemical, and biological characteristics, as well as biocompatibility and shelf-life testing.

Therefore, many of the requested categories cannot be populated from the provided text.

Here's a breakdown of the available information:

Acceptance Criteria and Reported Device Performance

Study Details Based on Provided Information:

1. Sample size used for the test set and the data provenance: Not applicable. The studies mentioned (biocompatibility, shelf-life, performance testing) refer to laboratory-based evaluations of the gel's properties, not clinical studies with a test set of human subjects or images.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This information is relevant for studies involving human interpretation or clinical outcomes, which are not present in this document.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No human interpretation requiring adjudication was involved.
4. 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. The device is a conductive gel, not an AI-based diagnostic or assistive tool.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-based device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device would be established through laboratory standards and validated test methods for chemical, physical, and biological properties, as well as regulatory standards for biocompatibility (e.g., ISO 10993 series).
7. The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set.
8. How the ground truth for the training set was established: Not applicable. No training set was used.

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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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DR-HO'S Electro Therapy 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.

DR-HO'S Electro Therapy 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 DR-HO'S Electro Therapy Conductive Gel is used on intact skin surfaces. The entire surface of DR-HO'S Electro Therapy Conductive Gel is very conductive, sprayed 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.

Your request asks for information about the acceptance criteria and study proving a medical device meets these criteria, based on the provided text.

The provided text is a 510(k) summary for DR-HO'S Electro Therapy Conductive Gel. This type of submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than conducting a full clinical trial to prove de novo improved effectiveness or benefit. Therefore, the "study that proves the device meets the acceptance criteria" in this context refers to the bench testing conducted to demonstrate safety and performance equivalence to established standards and predicate devices.

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

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

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

• The document does not specify the sample sizes used for any of the individual bench tests (In vitro Cytotoxicity, Skin Sensitization, Skin Irritation, Usability, Shelf Life).
• Data provenance (country of origin, retrospective/prospective) is not stated. These are laboratory bench tests and typically do not involve human subject data provenance in the same way clinical studies do. The tests were performed to specific ISO and ASTM standards.

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)

• This document describes performance based on bench testing against international standards (ISO, ASTM, IEC), not clinical studies requiring expert ground truth for interpretation of patient data. Therefore, there were no "experts used to establish the ground truth for the test set" in the context of clinical reads, nor are their qualifications mentioned, as this is not applicable here. The "ground truth" for these tests is the defined acceptance criteria within the standards themselves.

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

• Adjudication methods like "2+1" or "3+1" are relevant for clinical studies where multiple readers interpret images or data and discrepancies need to be resolved. This document reports laboratory bench tests, not clinical studies with multiple readers. Therefore, no adjudication method is mentioned or applicable.

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 MRMC comparative effectiveness study was done. This is a 510(k) submission for a conductive gel, which is a Class II medical device. The submission focuses on demonstrating substantial equivalence in terms of safety and basic performance characteristics (biocompatibility, shelf-life, electrical properties) with existing predicate devices, rather than proving a comparative effectiveness outcome with human readers or AI assistance.

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

• This device is a conductive gel. It is a physical product, not an algorithm or AI. Therefore, no standalone algorithm performance study was conducted. The "performance" refers to its physical and chemical properties and biocompatibility.

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

• For the bench tests, the "ground truth" is defined by the specific requirements and endpoints set forth in the referenced international standards (ISO 10993-5, ISO 10993-10, IEC 60601-1-6, IEC 62366-1, ASTM F1980-16). For example, for cytotoxicity, the "ground truth" is whether the extract caused cell death as measured by the standard's methodology. For impedance, it's a measurable electrical property.

8. The sample size for the training set

• This document describes bench testing and a 510(k) submission based on substantial equivalence, not an AI or machine learning model that would require a "training set." Therefore, no training set sample size is mentioned or applicable.

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

• As there is no training set for this type of device and submission, this question is not applicable.

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Tech Dots are intended for use in clinical and research EEG/EP recordings from humans. They are used with external electrodes as the conductor between the scalp and recessed electrodes to reduce impedance between the electrode surface and the skin

Tech Dots are conductive gel dots to be used with external electrodes as the conductor between skin and electrode and to reduce impedance between the electrode surface and the skin. A single Tech Dot has a 11 ± 1 mm diameter, 2.5 ± 0.5 mm high, and weights 0.14 ± 0.01 g. It's characterized by clear colour, no crystallization, no flocculation, no adverse smell, brightness. Tech Dots 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. Tech Dots are for use with external electrodes only. Tech Dot is made of Potassium Chloride as conductor, combined with thickening agents and humectants, all in an aqueous solvent. The composition is the following: Water, Glycerol (vegetable origin), Polyacrylate co-polymer (proprietary), Potassium chloride. The pH range is 4.1 ± 0.1, and Impedance at 10Hz is 80 ± 10 Ohm. The Conductivity is 2 mS/cm. Shelf life of TechDots is 3 years if stored properly in sealed aluminum pouch and at the limits of temperature indicated on the labeling.

This document is a 510(k) premarket notification for a medical device called "Tech Dots - Conductive gel," submitted by Spes Medica S.r.l. to the FDA. The submission aims to demonstrate that Tech Dots are substantially equivalent to a legally marketed predicate device (Electro-Gel, K111717).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for "Tech Dots - Conductive gel" are primarily established through demonstrating substantial equivalence to the predicate device and meeting relevant performance standards for electroconductive media. The reported performance is based on internal testing.

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

The document details performance testing (Biocompatibility and Bench Testing) for the Tech Dots device itself, rather than a clinical study involving human subjects or image data for AI.

• Sample Size for Testing: The specific sample sizes for tests like aging, pH, impedance, and long-term conductivity are not explicitly stated in the provided text (e.g., "how many units were tested"). It mentions "Spes Medica Tech Dots are tested internally for pH, impedance on a regular basis," implying ongoing quality control, but not a specific sample size for a formal study dataset. For biocompatibility, it indicates the gel "Gel" as 'Component Name' being tested.
• Data Provenance: The studies are described as "Performance Testing was performed on device characteristics of Spes Medica Tech Dots," and "Spes Medica Tech Dots are tested internally." This implies the data is prospective (generated for this submission/validation) and produced by the manufacturer (Spes Medica S.r.l.) in Italy.

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

This document describes the validation of a conductive gel, not an AI-powered diagnostic device that requires expert-established ground truth from medical images. Therefore, the concept of "experts" establishing "ground truth" for a test set (e.g., radiologists for disease presence) is not applicable here. The "ground truth" for the device's performance is established by technical specifications and recognized industry standards (e.g., ISO 10993, ANSI/AAMIEC12). The "experts" involved would be the engineers and quality assurance personnel at Spes Medica S.r.l. who conducted the tests and verified compliance with these standards. Their specific qualifications are not detailed beyond "Quality Assurance and Regulatory Affairs" for the Official Correspondent.

4. Adjudication Method for the Test Set

Not applicable. As this is not an AI device or a clinical study requiring human interpretation of medical data, there is no need for an adjudication method. The test results are objective measurements against defined standards.

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 is not an AI device, and therefore no MRMC study or assessment of human reader improvement with AI assistance was conducted or needed.

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

Not applicable. This is not an algorithm or software device. Its performance is inherent to its physical and chemical properties as a conductive gel.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth used for validating "Tech Dots - Conductive gel" is based on:

• Performance Standards: Recognized international and national standards for medical devices and electroconductive media (e.g., ISO 10993 for biocompatibility, ANSI/AAMIEC12 for electrical performance/impedance).
• Predicate Device Characteristics: The established characteristics and cleared performance of the legally marketed predicate device (Electro-Gel, K111717) serve as a comparative ground truth for demonstrating substantial equivalence of intended use and technological characteristics.
• Defined Chemical and Physical Specifications: Internal specifications for pH, conductivity, viscosity, appearance, etc., which are then verified through laboratory testing.

8. The Sample Size for the Training Set

Not applicable. This is not an AI device that requires a "training set."

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

Not applicable. As there is no training set for an AI model, there is no ground truth established for it.

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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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FOR USE WITH TENS (TRANSCUTANEOUS ELECTRICAL NERVE STIMULATORS) AND EMS (ELECTRICAL MUSCLE STIMULATORS). CONDUCTIVE GEL IS USED WITH EXTERNAL ELECTRODES TO REDUCE THE IMPEDACE OF THE CONTACT BETWEEN THE ELECTRODE SURFACE AND THE SKIN.

BATCH #6060 CONDUCTIVE GEL

The document provided is a 510(k) clearance letter for the "BATCH #6060 Conductive Gel." This type of document from the FDA primarily focuses on establishing substantial equivalence to a predicate device, rather than presenting detailed performance studies with acceptance criteria and specific statistical results.

Therefore, the information required to fully answer your request regarding acceptance criteria and the study that proves the device meets them is not available in the provided text.

Here's a breakdown of why and what information is present:

Why the requested information is not available:

• Nature of 510(k) Clearance: A 510(k) submission typically demonstrates that a new device is "substantially equivalent" to a legally marketed predicate device. This often involves demonstrating similar technological characteristics and performance, but it doesn't necessarily require extensive, standalone clinical studies with pre-defined acceptance criteria in the same way a PMA (Premarket Approval) would. For simple, lower-risk devices like conductive gels, performance data might be limited to bench testing (e.g., conductivity, impedance reduction, biocompatibility) and comparisons to the predicate device's known performance, rather than complex human-in-the-loop or multi-reader studies.
• Document Content: The provided text is the FDA's clearance letter, not the original 510(k) submission itself. The clearance letter confirms that the FDA reviewed the submission and found the device substantially equivalent. It summarizes the regulatory decision but does not detail the specific performance data or study methodologies presented by the manufacturer in their submission.

Specific Points from your Request and why they cannot be answered from the text:

1. Table of acceptance criteria and the reported device performance: Not present. The letter states the device is for use with TENS and EMS and "is used with external electrodes to reduce the impedance of the contact between the electrode surface and the skin." However, no numerical performance targets (acceptance criteria) or specific performance results (e.g., "impedance reduced by X%," "conductivity of Y S/m") are mentioned.
2. Sample size used for the test set and the data provenance: Not present. No details about any test sets, sample sizes, or data origin for performance evaluation are provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not present. This type of detail is relevant for diagnostic or image-based AI devices, not for a conductive gel. No ground truth establishment is described.
4. Adjudication method: Not applicable/Not present for the same reason as above.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable/Not present. This is relevant for diagnostic devices where human readers interpret data, often in radiology or pathology. A conductive gel does not involve human interpretation in this manner.
6. Standalone (algorithm only without human-in-the-loop performance) study: Not applicable/Not present. This applies to AI algorithms. No algorithm is part of this device.
7. Type of ground truth used: Not applicable/Not present.
8. Sample size for the training set: Not applicable/Not present. This applies to AI/machine learning models.
9. How the ground truth for the training set was established: Not applicable/Not present.

In summary, the provided document confirms the regulatory clearance of a conductive gel but does not contain the detailed performance study information, acceptance criteria, or ground truth establishment methods typically found in scientific publications or specific sections of a 510(k) submission that describe performance testing.

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