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Found 29 results
510(k) Data Aggregation
(124 days)
GYB
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
| Acceptance Criteria | Reported Device Performance | Study that Proves Acceptance Criteria |
|---|---|---|
| Intended Use | Jmoon Conductive Gel is intended to be used with microcurrent devices to improve skin conductivity. | Performance of the device characteristics (physical, chemical, biological) were evaluated. The conclusion states that the subject device is substantially equivalent to the predicate device for its intended use. |
| Target Population | Adults 18 years of age or older | Not explicitly tested, but matches predicate device. |
| Environment of Use | Home | Not explicitly tested, but matches predicate device. |
| Body Contact | Intact skin | Biocompatibility testing (ISO 10993-1, -5, -10, -23) |
| Conductive Material | Sodium Salt | Performance testing (conductivity) |
| Sterilization | Non-sterile | Not applicable (matches predicate) |
| Biocompatibility | Complies with ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-23 | Biocompatibility Testing (ISO 10993-5: In Vitro Cytotoxicity, ISO 10993-10: Skin Sensitization, ISO 10993-23: Irritation) |
| Chemical Safety | Non-OSHA PEL | Chemical Safety testing (not detailed, but stated as compliant) |
| pH | 5.0 ~ 7.0 | Performance testing (pH) |
| Shelf-life | 3 years | Accelerated stability testing (3 years) |
| Physical Characteristics | Meets intended specification | Performance testing (appearance, color, odor, viscosity) |
| Microbiological Growth | Meets intended specification | Performance testing (microbiological growth) |
Study Details Based on Provided Information:
- 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.
- 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.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No human interpretation requiring adjudication was involved.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-based device.
- 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).
- The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set.
- How the ground truth for the training set was established: Not applicable. No training set was used.
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(550 days)
GYB
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:
| Acceptance Criteria (Parameter) | Predicate Device (NuFACE Gel Primer - K161654) | Avologi Gel Primer (Av25) Performance | Comparison |
|---|---|---|---|
| Regulation Number | 21CFR 882.1275 | 21CFR 882.1275 | SE (Substantially Equivalent) |
| Regulation Name | Electroconductive Media | Electroconductive Media | SE |
| Regulatory Class | Class II | Class II | SE |
| Product Code | GYB | GYB | SE |
| Regulation Medical Specialty | Neurology | Neurology | SE |
| Intended Use | To be used with NuFACE microcurrent devices to improve skin conductivity. | To be used with Luminice device to improve skin conductivity. | SE |
| Use | Over-the-Counter cosmetic use | Over-the-Counter cosmetic use | SE |
| Environment of use | Home | Home | SE |
| Target population | Adults 18 years of age or older | Adults 18 years of age or older | SE |
| Where used | Topically on intact skin | Topically on intact skin | SE |
| Sterilization | Non-sterile | Non-sterile | SE |
| Color | Colorless | Colorless | SE |
| Appearance | Clear | Clear | SE |
| Odour | Odourless | Odourless | SE |
| Volume | 2 fl.oz. and 5 fl.oz. tube | 3.38 fl.oz. | Note 1 (Difference in packaging, does not affect performance) |
| Weight(g) | Not publicly available | 170 - 200 | Note 1 (Difference in packaging, does not affect performance) |
| Specific gravity | Not publicly available | 0.900 - 1.100 | SE |
| Viscosity(cps) | Not publicly available | 30000-80000 | Note 1 (Difference, does not affect performance) |
| pH | 6.0-7.0 | 5.0-7.0 | Note 1 (Difference, does not affect performance) |
| Biocompatibility | Complies with ISO 10993-5 and ISO 10993-10 | Complies with ISO 10993-5 and ISO 10993-10 (and ISO 10993-23) | SE |
| Chemical Safety | Non-OSHA PEL | Non-OSHA PEL | SE |
| Conductive material | Salt (Magnesium Sulfate) | Salt (Magnesium Sulfate) | SE |
| Impedance | Not publicly available | 154 Ω ± 10% | SE (Note 2 - acceptable based on performance study) |
| Shelf-life | Not publicly available | 3 years | Note 2 (acceptable based on real-time stability testing) |
| Conductivity (mS/cm) | 2-5 | 3.38 | Note 3 (similar to predicate, higher than some cleared devices, which is more conductive) |
| Microbiological growth (Total Aerobic Microbial Count) |
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(90 days)
GYB
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
| Test Item | Purpose of the Test | Reference Standard | Acceptance Criteria | Test Results |
|---|---|---|---|---|
| In vitro Cytotoxicity Test | Determine if the target device extract is cytotoxic | ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | Non-cytotoxicity to L929 cells | Pass |
| Skin Sensitization Test | Evaluate skin sensitization after topical applications | ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Frequency of positive challenge results in sample extract and Negative control animals are 0%, Positive control is 100% | Pass |
| Skin Irritation Test | Evaluate skin irritation after single topical applications | ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Negligible irritation in a rabbit skin single exposure test | Pass |
| Usability Study | Study how usability will be performed | IEC 62366-1 Edition 1.0 2015-02, Medical devices - Part 1: Application of usability engineering to medical devices [Including CORRIGENDUM 1 (2016)] | The subject device can meet the usability goal of IEC 62366-1 standards | Pass |
| Shelf Life Test | Study if performance meets 2-year shelf life requirements | ASTM F1980-16: Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices; Guidance document for the "Shelf Life of Medical Devices" issued in April 1991 | All items (Exterior, Package, pH, Impedance and conductivity) tested on both before and after aging samples meet the performance required | Pass |
Additional Performance Data from Comparison to Predicate Device:
| Item | Acceptance Criteria (Predicate) | Reported Device Performance (Subject Device) |
|---|---|---|
| Impedance (at 1 MHz) | ≤ 500 Ω | ≤ 500 Ω |
| pH | 7.0 - 7.5 | 6.5 - 7.5 |
| Percent Concentration of Ingredients | Purified water: 98.25%, Carbopol: 0.5%, Glycerin: 1%, Sodium hydroxide: 0.2%, Triclosan: 0.05% | Purified water: 98.25%, Carbopol: 0.5%, Glycerin: 1%, Sodium hydroxide: 0.2%, Triclosan: 0.05% |
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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(101 days)
GYB
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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(324 days)
GYB
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:
| Characteristic | Acceptance Criteria (Predicate: SAC2 Electrode Cream, K192606) | Reported Device Performance (EEG-acp, K212325) | Comparison/Outcome |
|---|---|---|---|
| Classification | Class II, Product Code GYB, 882.1275 Electroconductive Media | Class II, Product Code GYB, 882.1275 Electroconductive Media | Same |
| Indications for Use | Clinical and research EEG/EP recordings from humans; used with external electrodes as conductor to reduce impedance. | Clinical and research EEG recordings from humans (age >2); used with EEG cup electrodes on scalp as electroconductive paste to reduce impedance. | Substantially Equivalent differences noted: EEG-acp specifies "cup electrodes" (more specific than "recessed electrodes") and removes EP recordings. It also specifies use for children older than 2 years. These differences are deemed not to raise new safety/effectiveness concerns. |
| Intended Use Time | >24h, 15 min | No new questions raised. | |
| pH Range | 8-10 (alkaline) | 6-7.5 (acidic to neutral) | Difference: EEG-acp has a more skin-neutral pH. Deemed not to impact safety/effectiveness and potentially preferable for patients with skin diseases. |
| Weight | 100g per tube | 100g per tube | Same |
| Packaging | Aluminum tube | Aluminum tube | Same |
| Characteristics | Salt base, Non-irritating, Non toxic, Light-Grey color adhesive | Salt base, Non-irritating, Non toxic, White color adhesive | Difference: Color different (white vs light-grey). Deemed not to affect safety/effectiveness. |
| Additional Ingredients | None mentioned (for SAC2) | Allantoin, Bentonite, Glycerin, Lactate, Panthenol, PEG-40, Phenoxyethanol, Polyquaternium-10, Sodium Chloride, Sodium Hydroxide, Skin protection solution, Talcum, Water, Zinc oxide | Difference: EEG-acp includes components like Allantoin, Polyquaternium-10, and Panthenol for skin care/protection, aiming to reduce adverse effects. This is presented as an improvement for safety. |
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.
- The tests performed were:
- 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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(128 days)
GYB
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:
| Acceptance Criteria (Set by Standard) | Reported Device Performance (AC Cream - Conductive paste) | Pass/Fail? |
|---|---|---|
| Biocompatibility: | Pass | |
| ISO 10993-5 (Cytotoxicity) | Yes | Pass |
| ISO 10993-10 (Irritation) | Yes | Pass |
| ISO 10993-10 (Skin Sensitization) | Yes | Pass |
| Shelf Life (Accelerated Aging - 3 years): | Pass | |
| Pale yellow color, no flocculation, bright | Exhibits pale yellow color, no flocculation, bright after 84 days (accelerated aging equivalent to 3 years) | Pass |
| Instant Impedance |
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(68 days)
GYB
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.
| Parameter | Acceptance Criteria (Internal Standard / Target) | Reported Device Performance (GT5 conductive & abrasive gel) |
|---|---|---|
| Appearance | (Not explicitly defined, implied to be off-white, opaque gel) | Off-white color, opaque gel |
| Color | (Not explicitly defined, implied to be off-white) | Off-white |
| Odor | (Not explicitly defined, implied to be no adverse smell) | No adverse smell |
| pH Range | 6.5-7.5 | 6.5-7.5 |
| Impedance (at 10Hz) | 0.2 K Ohm or less | 0.2 K Ohm or less |
| Conductivity | 18.0 ± 0.5 mS/cm | 18.0 ± 0.5 mS/cm |
| Shelf-life | 3 years | 3 years (validated through accelerated aging) |
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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(280 days)
GYB
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
| Test Item | Purpose of the Test | Reference Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|---|
| In vitro Cytotoxicity Test | Determine whether the target device extract is cytotoxic under research conditions. | ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | Under the conditions of the study, the subject device extract was determined to be non-cytotoxic. | Pass |
| Skin Sensitization Test | Determine whether the non-polar and polar extracts of the target device are sensitive under research conditions. | ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Under the conditions of the study, the subject device non-polar and polar extracts were determined to be non-sensitizing. | Pass |
| Skin Irritation Test | Determine whether the non-polar and polar extracts of the target device are irritating under research conditions. | ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Under the conditions of the study, the subject device non-polar and polar extracts were determined to be non-irritating. | Pass |
| Usability Study | To study how usability will be performed in subject device in order to comply with IEC 62366-1 and IEC 60601-1-6 | IEC 60601-1-6 Edition 3.1 2013-10 (Usability) & IEC 62366-1 Edition 1.0 2015-02 (Usability Engineering), including CORRIGENDUM 1 (2016) | The subject device can meet the usability goal of IEC 60601-1-6 and IEC 62366-1 standards. | Pass |
| Shelf Life Test | To study whether the performance of subject device can meet the 2-year shelf life requirements. | ASTM F1980-16: Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices; Guidance document for the "Shelf Life of Medical Devices" issued in April 1991 | All items (Visual Inspection, pH, conductivity, Impedance and Microbiological indicators) tested on both before and after aging samples meet performance required. | Pass |
| Impedance | Not explicitly stated as a test item in the dedicated "Test Summary" table, but compared in section 7. | Not specified as a reference standard for this specific comparison. | The subject device's impedance ($500\Omega$) is "very similar" to predicate device K161715 ($527.68\Omega$) and $\leq500\Omega$ of predicate K111717. | $500\Omega$ |
| Conductivity (S/m) | Not explicitly stated as a test item in the dedicated "Test Summary" table, but compared in section 7. | Not specified. | The subject device's conductivity ($2 mS/cm$) is the same as predicate device K190050. | $2 mS/cm$ |
| pH | Not explicitly stated as a test item in the dedicated "Test Summary" table, but compared in section 7. | Not specified. | The subject device's pH (7.0 - 7.5) is "a little different" from predicate K161715 (7.15 - 7.33), but "slight" and "close to the pH value of human skin surface" and "close to 7 (neutral)". | 7.0 - 7.5 |
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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(198 days)
GYB
Elefix V Paste for EEG & EMG is a conductive paste used with surface electrodes to lower skin-electrode impedance. It can be used with electrodes for EEG and EMG examination.
The Elefix V Paste for EEG & EMG is the electroconductive media used with external electrodes to reduce the impedance (resistance to alternating current) of the contact between the electrode surface and the skin. The Elefix V Paste for EEG & EMG is an aqueous based material with Sodium Chloride as the conductive material combined with emulsifiers, humectants and preservatives. The Elefix V Paste for EEG & EMG has been designed to have increased stiffness and improved temperature resistance compared to its predecessor, the predicate device. These changes allow the paste to stay in place better as desired by its users. The Elefix V Paste for EEG & EMG has a neutral pH compared to the slightly alkaline pH of the predicate.
The Elefix V Paste for EEG & EMG is available in two models: ZV-401E and ZV-181E. ZV-401E is a container filled with 400 g of the paste. ZV-181E is a tube filled with 180g of the paste.
The Elefix V Paste for EEG & EMG is intended to be used by qualified medical personnel within a medical facility. It can be used with electrodes for electroencephalography (EEG) and electromyography (EMG) examination.
The document provided details for the Elefix V Paste for EEG & EMG, an electroconductive media. While the document discusses performance data and various tests conducted, it does not contain information typically associated with studies demonstrating the performance of AI/ML-driven medical devices, such as those related to effect size, human readers with or without AI assistance, or details on ground truth establishment for training sets.
Here's the information that could be extracted from the provided text, primarily related to bench testing of the device's physical properties:
1. A table of acceptance criteria and the reported device performance
| Characteristic | Acceptance Criteria (Predicate Device) | Reported Device Performance (Elefix V Paste) |
|---|---|---|
| Impedance (at 50Hz) | 1 kΩ or less | 1 kΩ or less |
| pH | 8.5 to 9.5 | 6.5 to 8.5 |
| Conductivity | 1.08 S/m | 1.04 S/m |
| Stiffness (using curdmeter) | 25 to 50 | 35 to 50 |
| Temperature Resistance | NA | Yes |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "performance testing" and "design verification and validation testing," but does not specify the sample size for these tests for pH, impedance, stiffness, or temperature resistance. The data provenance is also not specified.
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 as the tests conducted were for physical and chemical properties of a conductive paste, not for diagnostic accuracy or interpretation requiring expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the tests conducted were for physical and chemical properties and did not involve human interpretation or 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
This information is not applicable as the device is an electroconductive paste, not an AI-driven diagnostic or interpretative system. Therefore, an MRMC study related to AI assistance for human readers would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is an electroconductive paste, not a standalone algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the physical property tests, the "ground truth" or reference was based on established physical and chemical measurement standards for impedance, pH, conductivity, and stiffness. For biocompatibility, it was based on ISO 10993 standards.
8. The sample size for the training set
This information is not applicable as the device is not an AI/ML system and therefore does not have a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
This information is not applicable as the device is not an AI/ML system and therefore does not have a "training set."
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(119 days)
GYB
SAC2 is intended for use in clinical and research EEG/EP recordings from humans. It is used with external electrodes as the conductor between the scalp and recessed electrodes to reduce impedance between the electrode surface and the skin.
SAC2 is intended for use in clinical and research EEG/EP recordings from humans. It is used with external electrodes as the conductor between the scalp and recessed electrodes to reduce impedance between the electrode surface and the skin. SAC2 is provided in an aluminum tube of 100g. It's characterized by light grey colour, no crystallization, no flocculation, no adverse smell, opaque. SAC2 function is of conductor between the electrode used and the patient's skin and of getting the impedance lower for a better recording of the signal. SAC2 is for external use with recording electrodes only. SAC2 is made of powders, Potassium Chloride and Sodium Chloride as conductors, combined with thickening agents and humectants, all in an aqueous solvent. The composition is the following: Water, Talc, Celite, Glycerol, CarboxyMethylCellulose, Sodium chloride, Potassium chloride, Phenoxyethanol, Ehylhexylglycerin The pH range is 8÷10, and Impedance at 10Hz is 50 ± 10 Ohm. The Conductivity is 20 mS/cm Shelf life of SAC2 is 3 years if stored properly in the closed aluminum tube kept away from the sunlight.
The provided text describes the 510(k) summary for the SAC2 - Electrode cream. It does not contain information about a study involving human readers or AI assistance. The performance testing section focuses on bench tests (aging, long-term conductivity) and biocompatibility, not on a clinical effectiveness study with human subjects.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance | Standard/Methodology |
|---|---|---|
| Aging Test | ASTM F1980-16 | |
| Light grey color | Complies (light grey color) | Visual inspection |
| No crystallization | Complies (no crystallization) | Visual inspection |
| No flocculation | Complies (no flocculation) | Visual inspection |
| Opaque | Complies (opaque) | Visual inspection |
| pH range | 8-10 | Internal testing |
| Impedance at 10Hz | 50 ± 10 Ohm | Internal testing, complies with ANSI/AAMIEC12:2000 |
| Long Term Conductivity Test | ANSI/AAMIEC12:2000/(R)2015 | |
| DC Offset voltage | Does not exceed 100mV (after 7 days testing) | Electrical testing |
| AC Impedance | Does not exceed 2000 Ohm (after 7 days testing) | Electrical testing |
| Biocompatibility | ||
| Cytotoxicity | Passed | ISO 10993-5 |
| Irritation | Passed | ISO 10993-10 |
| Sensitization | Passed | ISO 10993-10 |
2. Sample size used for the test set and the data provenance
Not applicable for this type of product/study. The performance tests described are bench tests on the product itself, not on data from human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for biocompatibility and bench testing is established through standardized laboratory procedures and instrument readings, not expert consensus.
4. Adjudication method for the test set
Not applicable. Adjudication is typically used in studies involving subjective interpretation (e.g., medical imaging), which is not the case for these performance tests.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, an MRMC comparative effectiveness study was not done. The document pertains to an electrode cream, not an AI software or system that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. The device is a physical electrode cream, not an algorithm.
7. The type of ground truth used
The ground truth for the performance tests (aging, long-term conductivity) was established by objective measurements against defined parameters (e.g., color, pH, impedance, DC offset voltage) and the biological responses observed in standardized biocompatibility tests (cytotoxicity, irritation, sensitization). This is based on established industry standards like ASTM F1980-16, ANSI/AAMIEC12:2000, ISO 10993-5, and ISO 10993-10.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. As noted above, this device does not involve a training set.
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