(90 days)
Self-adhesive electrode is intended for single use, conductive adhesive interface between the patient's skin and the electrical stimulation devices. Some common types of the stimulation devices include, but are not limit to, TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). The electrode is for OTC (Over-The -Counter) or Prescription use, for single patient use only.
Self-adhesive electrode is available in Lead wire type and snap type. Both types are composed of a non-woven fabric, a double side adhesive tape, conducting film, hydrogel and plastic film. The construction difference is the lead wire or snap. It functions as a passive device by carrying an electrical signal from a stimulation device through the device cable and electrode lead wire or snap to the user skin.
The provided document is a 510(k) summary for a "Self-adhesive Electrode" device. It outlines the device's technical characteristics and compares them to a predicate device to establish substantial equivalence. However, it does not describe a study that establishes acceptance criteria and then proves the device meets those criteria in the way typically expected for a diagnostic or AI-driven medical device.
This document focuses on establishing substantial equivalence for a Class II medical device, which generally means demonstrating that the new device is as safe and effective as a legally marketed predicate device. This often involves performance testing against recognized standards rather than extensive clinical studies with acceptance criteria based on diagnostic accuracy.
Given the nature of this submission (a 510(k) for a cutaneous electrode), the "acceptance criteria" are primarily based on meeting established electrical, physical, and biocompatibility standards relevant to such devices, rather than clinical performance metrics like sensitivity or specificity for a diagnostic claim.
Here's a breakdown of the requested information based on the provided text, with acknowledgments of what is not present because it's largely irrelevant for this type of device and submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard / Test) | Reported Device Performance (Subject Device) |
|---|---|
| Electrical impedance | Less than 3KΩ |
| Current uniformity | Current deviation index less than 5% |
| Adhesive performance / Maximum duration use | 30 minutes maximum duration use |
| Biocompatibility (Cytotoxicity) | Passed per ISO 10993-5 (or series) |
| Biocompatibility (Skin Irritation) | Passed per ISO 10993-10 (or series) |
| Biocompatibility (Skin Sensitization) | Passed per ISO 10993-10 (or series) |
| Shelf life | Verified per ASTM F 1980-07 |
| Size | As per specification in Section 4.2 |
2. Sample size used for the test set and the data provenance
- The document does not specify sample sizes for non-clinical performance tests (electrical impedance, current uniformity, adhesion). These are typically bench tests, and exact sample numbers are not detailed in this summary.
- Biocompatibility tests (cytotoxicity, skin irritation, sensitization) are conducted on samples of the device materials, but specific sample numbers (e.g., number of animals or cell cultures) are not provided in this summary.
- Shelf life verification involves testing samples over time, but the specific sample size is not mentioned.
- Data provenance is not explicitly stated in terms of country of origin for the test data, nor is it classified as retrospective or prospective for these non-clinical tests. These are internal engineering and lab tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This question is not applicable in the context of this device and submission. The "ground truth" for non-clinical performance tests (like electrical impedance or adhesion) is determined by the measurement standard itself (e.g., a multimeter reading, adherence force). For biocompatibility, the "ground truth" is adherence to established biological response criteria laid out in the ISO standards, evaluated by qualified lab personnel, but not "experts" establishing a diagnostic ground truth in the sense of clinical decision-making.
4. Adjudication method for the test set
- This question is not applicable. Adjudication methods (like 2+1, 3+1) are relevant for studies involving human interpretation or clinical outcomes, typically for diagnostic devices where there might be inter-reader variability. For the performance and biocompatibility tests described here, the results are objectively measured against defined criteria within recognized standards.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, especially those incorporating AI, to assess the impact of AI assistance on human performance. The "Self-adhesive Electrode" is a passive component for electrical stimulation and does not involve AI or human interpretation in its intended use.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No, a standalone performance evaluation of an algorithm was not done. As stated, this device is a passive electrode and does not contain any algorithms or AI components.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the performance tests: The "ground truth" is defined by the measurement standards and specifications (e.g., impedance values in ohms, percentage of current deviation, adhesion time, physical dimensions).
- For biocompatibility tests: The "ground truth" is defined by the assessment criteria within the ISO 10993 series standards (e.g., lack of cytotoxicity, skin irritation, or sensitization exceeding defined thresholds).
- There is no clinical "ground truth" (like pathology or outcomes data) established for this device, as it's not a diagnostic device.
8. The sample size for the training set
- This question is not applicable. The device is an electrode, not an AI model or a device requiring a "training set" in the machine learning sense. The manufacturer doesn't mention any AI components in the device description or testing.
9. How the ground truth for the training set was established
- This question is not applicable, as there is no training set for an AI model.
§ 882.1320 Cutaneous electrode.
(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).