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510(k) Data Aggregation
(60 days)
Reusable and Self-Adhesive Electrodes
This product is an adhesive electrode which is intended for use as the re-usable, conductive interface between the patient's skin and the Electrical Stimulator. It is intended to be used with legally marketed Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation).
The Reusable and Self-Adhesive Electrodes are made of conductive hydrogel, fabric cloth and carbon film. They work when sticking to human skin and connecting with electrical stimulators by lead wires. During the treatment, electrical pulses are passed across the intact surface of the skin to activate the underlying nerves.
The provided document is a 510(k) premarket notification for a medical device: "Reusable and Self-Adhesive Electrodes." The primary purpose of this document is to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than to present a comprehensive study proving novel acceptance criteria for a new type of device or algorithm.
Therefore, many of the requested categories for AI/algorithm-based studies (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, effect size of AI assistance) are not applicable to this type of regulatory submission. This document details the non-clinical testing performed to show equivalence in basic device performance and biocompatibility.
Here's an analysis based on the information available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Test Performed | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Electrode Performance | Electrical Impedance Performance | Met relevant standards/specifications for conductive electrodes. | "All evaluation acceptance criteria were met" for electrode performance testing. |
| Adhesive Performance | Met relevant standards/specifications for medical adhesives. | "All evaluation acceptance criteria were met" for adhesive performance testing. | |
| Tensile Strength | Met relevant standards/specifications for device integrity. | "All evaluation acceptance criteria were met" for tensile strength testing. | |
| Biocompatibility | Cytotoxicity (ISO 10993-5) | No evidence of cytotoxic potential. | "All evaluation acceptance criteria were met" |
| Irritation (ISO 10993-10) | No evidence of irritation potential. | "All evaluation acceptance criteria were met" | |
| Sensitization (ISO 10993-10) | No evidence of sensitization potential. | "All evaluation acceptance criteria were met" | |
| Stability | Shelf life | Maintained performance characteristics for claimed shelf life. | "3 years" shelf life reported for the subject device. (Predicate: 2 years, deemed substantially equivalent). |
| Reusability | Maintained performance after multiple uses (as reusable). | Maintained performance over specified reuses. | Device is "reusable" (for single patient), performance maintained for the intended reusability. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the document. For non-clinical tests like material strength, impedance, and biocompatibility, sample sizes are typically determined by relevant ISO standards or internal quality procedures.
- Data Provenance: Not explicitly stated, but the testing would have been conducted by the manufacturer (Shaoxing DongZhi Electrical Technology Co., Ltd. in China) or a certified testing laboratory. The standard for biocompatibility is ISO 10993-1:2009. These are prospective tests conducted on manufactured device samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. These are non-clinical device performance and material safety tests, not diagnostic or interpretive tasks requiring expert consensus. The "ground truth" is established by direct measurement and adherence to defined physical and biological standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication is for human interpretation and consensus. These tests involve objective measurement against predetermined criteria.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is a medical device for electrical stimulation, not an AI diagnostic or interpretive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the non-clinical tests is established by:
- Physical measurements: For electrical impedance, adhesive strength, and tensile strength, the ground truth is the direct measurement of these properties using calibrated equipment, compared against numerical specifications derived from relevant performance standards.
- Biological assays: For biocompatibility (cytotoxicity, irritation, sensitization), the ground truth is determined by standardized laboratory assays where effects on biological systems (e.g., cell cultures, animal models) are observed and evaluated against criteria defined in ISO 10993 series.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/machine learning device.
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