(280 days)
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.
§ 882.1275 Electroconductive media.
(a)
Identification. Electroconductive media are the conductive creams or gels used with external electrodes to reduce the impedance (resistance to alternating current) of the contact between the electrode surface and the skin.(b)
Classification. Class II (performance standards).