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JOVS Electric Stimulation Beauty Device is indicated for over-the-counter aesthetic use including facial and neck stimulation.

The JOVS Electric Stimulation Beauty Device is a portable, non-sterile, reusable device designed to achieve the aesthetic effect. It mainly consists of main unit, charging and disinfection base, and power cable. The device is supplied by internal rechargeable lithium battery, which can be recharged by external charger through the Type-C charging cable. The device is un-usable when charging. The device is only home environment use, which has the spring electrode head (electric stimulation) to provide the following function:

The JOVS Electric Stimulation Beauty Device is indicated for over-the-counter aesthetic use including facial and neck stimulation.

N/A

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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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The BEAGANK 4T PLUS is a handheld portable device for over-the-counter aesthetic use including facial and neck stimulation or body skin stimulation.

The BEAGANK 4T PLUS is a cosmetic device which is intended for use on the face and body skin. The device contains a rechargeable lithium ion battery and is provided with a charger. The device has four electrode metal pads on the head that deliver electrical impulses to the face and body skin and provide four different operational modes. The device operates by applying Transcutaneous Electrical Nerve Stimulation to the face and body skin. The electrodes that are positioned on the skin must be covered with a wet cotton pad. Purified water or commercially available cosmetic formulation liquid can be used as a conductive media to generate the electric pulses. Two attachments are provided with the BEAGANK 4T PLUS: Scalp attachment, Small attachment.

The provided document is a 510(k) summary for the Beagank 4T Plus device. It does not contain acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of clinical performance or diagnostic accuracy.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and compliance with safety standards. It explicitly states: "No new clinical studies have been submitted as part of this Premarket Notification."

Therefore, I cannot provide the requested information regarding acceptance criteria for clinical performance and a study proving those criteria are met, as such information is not present in the provided text.

However, I can extract information related to non-clinical performance and safety testing which serves as the basis for the FDA clearance in this case.

Here's what can be extracted:

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

Based on the "Summary of Non-Clinical / Test Data," the device performance is demonstrated by compliance with specific safety standards. The "acceptance criteria" here are essentially passing these standards.

2. Sample size used for the test set and the data provenance:
Not applicable for this type of submission. The tests are for device safety and electrical performance, typically conducted on a sample of the manufactured device. Details on the specific number of units tested and data provenance (country of origin, retrospective/prospective) are not provided in this 510(k) summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is a non-clinical safety and performance evaluation, not a clinical study involving expert ground truth for interpretation. The "ground truth" is adherence to established engineering and biocompatibility standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. This is not a clinical study.

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. The document explicitly states "No new clinical studies have been submitted." This is not an AI-assisted diagnostic device, and thus no MRMC study would be relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical electrical stimulation device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable for clinical ground truth. For the non-clinical tests, the "ground truth" is the established requirements and limits defined within the cited IEC and ISO standards.

8. The sample size for the training set:
Not applicable. There is no machine learning or AI component that would require a training set.

9. How the ground truth for the training set was established:
Not applicable.

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The Avologi Gel Primer is intended to be used with Luminice device to improve skin conductivity.

The Avologi Gel Primer 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.

This document describes the Avologi Gel Primer (Model: Av25), an electroconductive gel intended for use with the Luminice device to improve skin conductivity. The submission demonstrates substantial equivalence to the predicate device, NuFACE Gel Primer (K161654), through performance testing.

1. Table of Acceptance Criteria and Reported Device Performance:

Notes from the document:

• Note 1: Differences in pH, viscosity, and packaging do not affect device performance, and packaging compatibility has been tested. Therefore, these differences do not raise issues of safety or effectiveness.
• Note 2: Although predicate impedance and shelf life are not publicly available, the proposed device underwent 3 years of real-time stability testing and impedance testing. The impedance (154 Ω ± 10%) is acceptable, even if different from other reference devices, and does not raise issues of safety or effectiveness.
• Note 3: Conductivity is similar to the predicate and higher (more conductive) than some cleared devices, thus not raising safety or effectiveness issues.
• Note 4: Both the proposed device and predicate conducted microbiological growth tests (per USP61/62) and biocompatibility tests, indicating no adverse reactions.

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

The document describes non-clinical testing for the Avologi Gel Primer but does not specify a "test set" in the context of a clinical study or expert review for a diagnostic algorithm. The tests performed are laboratory-based and relate to the physical, chemical, and biological properties of the gel.

• Biocompatibility Testing:
  • In vitro Cytotoxicity Test: Used L929 cells. (Details on sample size of cells not provided, but standard for in vitro assays).
  • Intracutaneous Reactivity Test: Performed in a rabbit model. (Specific number of rabbits not provided, but "a rabbit" implies at least one).
  • Skin Sensitization Test: Performed in a guinea pig model. (Specific number of guinea pigs not provided, but "the guinea pig" implies at least one).
• Shelf-life testing: Real-time stability testing for 3 years. (Details on number of samples or batches tested not provided).
• Physical property testing: Includes microbiological growth, packaging compatibility, conductivity, and stability testing. (Details on specific sample sizes for these tests are not provided).

Data Provenance: The tests are described as non-clinical testing, implying they were conducted in a laboratory setting by the manufacturer or a contracted lab. The document does not specify the country of origin for these tests. It is retrospective in nature, summarizing completed tests.

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

This information is not applicable (N/A) as the submission is for an electroconductive gel and its substantial equivalence and does not involve an AI device requiring expert-established ground truth for a diagnostic test set. The "ground truth" here is established through scientific laboratory testing results against established standards (e.g., ISO, USP).

4. Adjudication method for the test set:

This information is not applicable (N/A) for the same reasons as above. No expert adjudication method (like 2+1, 3+1) was used as there's no diagnostic output from an AI algorithm being evaluated.

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:

This information is not applicable (N/A). The device is an electroconductive gel, not an AI-powered diagnostic tool. Therefore, no MRMC study or evaluation of human reader improvement with AI assistance was conducted.

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

This information is not applicable (N/A). The device is a physical product (gel), not an algorithm or AI system.

7. The type of ground truth used:

The ground truth for the performance of the Avologi Gel Primer is established through objective laboratory testing against recognized standards (e.g., ISO 10993 standards for biocompatibility, USP 61/62 for microbiological growth, and internal specifications for physical properties like pH, viscosity, impedance, and conductivity). The comparison is primarily against the predicate device's characteristics and general requirements for electroconductive media.

8. The sample size for the training set:

This information is not applicable (N/A). The device is a physical product and does not involve AI model training.

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

This information is not applicable (N/A) for the same reasons as above.

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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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EEG adhesive conductive paste (hereafter EEG-acp) is intended for use in clinical and research EEG recordings from humans under professional guidance. EEG-acp is an electroconductive paste which should be used in combination with EEG cup electrodes on the scalp.

EEG adhesive conductive paste (hereafter EEG-acp) is intended for use in clinical and research EEG recordings from humans (from the age of 2) under professional guidance. EEG-acp is an electroconductive paste which should be used in combination with EEG cup electrodes on the scalp. It acts as a conductor between the scalp and the cup electrodes to reduce impedance between the electrode surface and the skin. The reduction in impedance facilitates better recording of the signal. It is intended to be used for up to 10 hours after application to healthy, intact skin. After drying, it is self-adhesive and can be washed off with water. The cream is provided non-sterile and in a 100g aluminum tube. It is white and has no adverse smell. Its texture is smooth and creamy directly after withdrawal from the tube, and solid after drying. EEG-acp is intended to be used as an electroconductive medium between the electrode and the patient's skin, i.e., it amplifies the electrical signal and thereby improves the electrophysiological recording. The high salt content of the cream is responsible for its conductive properties. Its impedance is -1.9 kOhm and its conductivity is 20 mS/cm.

The provided text describes the 510(k) summary for the EEG-acp device. This document is a premarket notification to the FDA to demonstrate that the device is at least as safe and effective as a legally marketed predicate device. The information details the device, its intended use, and comparative data against a predicate device.

Here's an analysis of the acceptance criteria and study proving device performance based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as typical performance metrics (e.g., sensitivity, specificity, AUC) for an AI/ML diagnostic device, because EEG-acp is an "Electroconductive Media" (a physical cream), not a diagnostic algorithm. Instead, the "acceptance criteria" for this device are established by demonstrating substantial equivalence to a legally marketed predicate device (SAC2 Electrode Cream, K192606) in terms of its physical and performance characteristics.

The table below summarizes the key comparisons made for "acceptance" of EEG-acp:

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

The document does not describe a clinical study in humans with a "test set" in the traditional sense of an AI/ML algorithm evaluation (i.e., a dataset of patient data used to evaluate algorithm performance). Instead, the studies performed are bench testing and biocompatibility testing of the physical cream itself.

• Bench Testing:
  • Impedance and Conductivity: Measured to confirm equivalence with the predicate device. The sample size for these measurements is not specified (e.g., number of cream samples, number of measurements).
  • Qualitative characteristics (Color, odor, adhesiveness, time to dry): Verified to be as specified and equivalent to the predicate device. Sample size not specified.
  • Shelf-life: Validated by accelerated aging testing in accordance with ASTM F1980-16. Sample size not specified (e.g., number of batches, number of samples tested over time).
• Biocompatibility Testing:
  • The tests performed were:
    • ISO 10993-5: Cytotoxicity in vitro Skin Irritation (Human Skin Model Test)
    • ISO 10993-10: Acute Dermal Irritation/Corrosion, Irritation/Skin Sensitization, Guinea Pig Maximization Test.
  • These are laboratory tests on cells/animal models, not human patient data. The sample sizes for these specific biological assays are not detailed in the summary.
• Data Provenance: The document does not explicitly state the country of origin for the data or whether the tests were retrospective or prospective, though it implicitly describes prospective laboratory/bench testing.

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

This information is not applicable to the evaluation of this device. As EEG-acp is an electroconductive paste, its performance is assessed through physical and chemical property measurements and biocompatibility testing, not through expert interpretation of diagnostic images or clinical outcomes. Therefore, there is no "ground truth" expert adjudication process in the context of diagnostic accuracy.

4. Adjudication Method for the Test Set

Not applicable, as there is no expert adjudication of a diagnostic performance test set.

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 not an AI/ML algorithm designed to assist human readers (e.g., radiologists) in diagnostic interpretation. It is a physical medical device (conductive paste).

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

Not applicable. This is not an algorithm. Bench tests (e.g., impedance, conductivity, shelf-life) could be considered "standalone" in the sense that they evaluate the properties of the cream itself, independent of human application for diagnosis, but this term (standalone) is typically used for AI/ML algorithms.

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

The "ground truth" for this device's acceptance is based on:

• Physical and Chemical Properties: Measured values (e.g., impedance, conductivity, pH, time to dry, color, odor, adhesiveness, consistency) are compared against scientifically established standards or performance of the predicate device.
• Biocompatibility Standards: Results from tests defined by ISO 10993-1, -5, and -10 are used as "ground truth" for safety regarding biological compatibility (cytotoxicity, irritation, sensitization).
• Shelf-life Standards: Accelerated aging tests following ASTM F1980-16 provide the "ground truth" for shelf-life performance.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML algorithm 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 this type of device.

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AC Cream - Conductive paste 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.

AC Cream - Conductive paste 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.
It's characterized by pale yellow colour, no crystallization, no flocculation, bright.
AC Cream - Conductive paste 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. AC Cream - Conductive paste is for external use with recording electrodes only.
AC Cream - Conductive paste 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, Ceteareth-20, Glycerol, Propylene Glycol, Bentonite, Sodium chloride, Potassium chloride, Calcium carbonate, Polysorbate 20, Phenoxyethanol, Ethylhexylglycerin
The pH range is 6÷8, and Impedance at 10Hz is 120± 25 Ohm.
The mean impedance after 7 days use, considering the worst values detected, is around 480 ± 10 Ohm.
The Conductivity is 20 mS/cm
Shelf life of AC Cream - Conductive paste is 3 years if stored properly in the closed packaging, kept away from the sunlight and within the limit temperature

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) summary for AC Cream - Conductive paste:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test Set Description: The summary describes performance testing for biocompatibility, accelerated aging (shelf life), and long-term conductivity.
• Sample Size: The exact sample size for each test (e.g., number of units tested for aging, number of samples for biocompatibility) is not explicitly stated in the provided text.
• Data Provenance: The document indicates that the performance testing was "conducted on AC Cream - Conductive paste." This implies the testing was performed internally by Spes Medica S.r.l. or by a contract lab on their behalf. There is no information regarding the country of origin of the data or whether the tests were retrospective or prospective since it concerns product qualification.

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

This information is not applicable to this type of device (electroconductive paste) or the described studies. The studies are bench tests and biocompatibility tests against established standards. Ground truth, in the sense of expert consensus on diagnostic interpretations, is not relevant here. The "ground truth" for these tests is the quantitative measurement against predefined physical and biological acceptance limits from international standards (ISO, ANSI/AAMI).

4. Adjudication method for the test set:

This information is not applicable as the tests performed are objective physical and biological measurements against specific numerical or qualitative (e.g., "no flocculation") criteria. There is no subjective interpretation that would require an adjudication method.

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. This device is an electroconductive paste, not an AI or imaging diagnostic device that would involve human readers or AI assistance.

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. This device is a physical product (conductive paste), not an algorithm or software.

7. The type of ground truth used:

The ground truth used for the performance testing is based on:

• International Standards: ISO 10993-5, ISO 10993-10, and ANSI/AAMI EC12:2000/(R)2015. These standards define the acceptable limits and methodologies for testing biocompatibility and electrical performance parameters for electroconductive media.
• Physical/Chemical Properties: Measured values for color, crystallization, flocculation, brightness, pH, impedance, and conductivity.

8. The sample size for the training set:

This information is not applicable. This device is not an AI/machine learning product and therefore does not have a "training set" in that context. The device's formulation was likely developed through R&D, but this is not a "training set" in the context of typical AI device submissions.

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

This information is not applicable, as there is no "training set" in the AI/ML context for this device. The formulation and properties were established through product development, material science principles, and internal quality control, with the goal of meeting the performance requirements eventually tested against the standards mentioned above.

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GT5 conductive & abrasive gel is intended for use in clinical and research EEG/EP recordings from humans. It can be not only used as skin-prep gel to abrade the skin surface lightly in order to reduce impedance to alternating current) efficiently, but also used as the conductor between the scalp and the external electrodes to reduce impedance between the electrode surface and the skin. GT5 conductive & abrasive gel is not intended for use with stimulating electrodes.

GT5 conductive & abrasive gel is intended for use in clinical and research EEG/EP recordings from humans. It can be not only used as skin-prep gel to abrade the skin surface lightly in order to reduce impedance (resistance to alternating current) efficiently, but also used as the conductor between the scalp and the external electrodes to reduce impedance between the electrode surface and the skin. The electrical activity of the brain is transferred to the electrode and then to EEG instruments and computer equipment. GT5 conductive & abrasive gel is for use with external electrodes only.

GT5 conductive & abrasive gel is an off-white color, opaque, no adverse smell gel with sodium chloride as the conductive material combined with thickening agents, emulsifiers, humectants, preservatives and abrasive particles. With the abrasive particles in the gel, the gel can be also used as skin preparation by being applied to the skin surface to rub the skin lightly in order to reduce skin impedance efficiently and increase signal quality recorded with EEG electrodes.

The composition of GT5 conductive & abrasive gel is as follows:

Glycerin, Sodium chloride, Water, Methylparaben, Sodium Carboxymethyl cellulose, Alkyl indican, Aluminum Oxide.

The pH range is 6.5-7.5, and the impedance at 10Hz is 0.2K Ohm or less. The conductivity is 18±0.5 mS/cm. GT5 conductive & abrasive gel is available in the following sizes: a pre-filled syringe of 20g, a tube of 100g, a bottle container of 473g, a bottle container of 946g. Shelf life is 3 years if stored properly, i.e. kept with containers tightly closed and at room temperature.

The provided text describes the regulatory submission for the GT5 conductive & abrasive gel. It is a Class II medical device (electroconductive media) and the submission (A 510(K) premarket notification) attests to its substantial equivalence to previously cleared predicate devices.

The document does not contain information about a study proving the device meets acceptance criteria in the context of an AI/ML algorithm's performance. Instead, it details the acceptance criteria for the physical and chemical properties of the gel and internal performance testing to demonstrate these criteria are met. Therefore, many of the requested elements for an AI/ML algorithm study cannot be populated from the provided text.

Here's an attempt to answer the questions based on the provided text, with clear indications where information is not available or not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here refer to the physical and chemical properties of the conductive gel, not the performance of an AI/ML diagnostic algorithm.

2. Sample size used for the test set and the data provenance:
This information is not applicable and not provided. The testing relates to the physical and chemical properties of the gel, not a data-driven AI/ML test set. The shelf-life testing involved "accelerated aging," but the sample size of tested units is not specified. All testing appears to be internal ("tested internally").

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 information is not applicable and not provided. "Ground truth" in this context would refer to established chemical and physical standards or measurements, not expert radiographic reads.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable and not provided. Adjudication methods are typically employed in clinical studies involving human interpretation or consensus for ground truth, not for physical property testing of a gel.

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:
This information is not applicable. The device is a conductive and abrasive gel, not an AI-powered diagnostic tool, so no MRMC study would be performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The device is a conductive and abrasive gel, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the physical and chemical properties of the gel would be established by standard analytical chemistry and materials science methodologies, such as:

• pH measurement: Using a calibrated pH meter.
• Impedance/Conductivity measurement: Using appropriate electrical testing equipment validated against known standards.
• Appearance/Color/Odor: Visual and olfactory inspection against a defined standard or reference.
• Shelf-life: Stability testing over time (accelerated aging).

8. The sample size for the training set:
This information is not applicable and not provided. There is no AI/ML model involved requiring a training set.

9. How the ground truth for the training set was established:
This information is not applicable. There is no AI/ML model involved.

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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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