(262 days)
The Well Life Self Adhesive Electrode / CM, FA, PU and SP series are intended for use as a disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. Well Life Self Adhesive Electrode / AP, CM, FA, PU and SP series are designed and intended to be used with marketed Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation), MENS (Microcurrent Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) and PGS (Pulsed Galvanic Stimulation).
Well Life Self Adhesive Electrode / CM, FA, PU, and SP series are non-sterile, disposable laminated, flexible structures composed of the following three main construction layers: First Layer – the exterior layer which may be made of the following different type of material coated with adhesive : white fabric(CM), white foam(FA), printed plastic film(PU) or silicon pad(SP). Second Layer - Conductive plastic film. Third Layer – Biocompatible conductive hydrogel coupling media. The electrodes are designed for single-patient/multiple application use. Because of the adhesive nature of the biocompatible hydrogel, no securing materials are required to secure the device the patient's skin. The electrode has one type of connection point that can be used to connect the stimulation device to the electrodes. This connection point is compatible with all standard, marketed Neurostimulation and muscle-stimulation devices. For the electrical connection, Well Life provides two different types: 1 > Snap Series Snap connection 1.65" standard size of mail. Snap is provided to connect to the wire female snap. 2> Wire Series Lead wire assembly 4.5" ~ 6" wire with .080 in. diameter female socket connected to one side of the wire.
The provided text describes the submission for a 510(k) premarket notification for the "Well Life Self Adhesive Electrode / CM, FA, PU, and SP series." This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a novel device that requires extensive clinical studies with new acceptance criteria.
Therefore, many of the requested points regarding acceptance criteria, specific study designs, sample sizes for test and training sets, expert qualifications, and ground truth establishment are not explicitly present in this type of submission. This is typical for a 510(k) for a Class II medical device where substantial equivalence is demonstrated primarily through technological characteristics and adherence to recognized performance standards and biocompatibility tests.
Here's an analysis of what information is available from the provided text, structured as per your request, explaining why certain points are not found:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria/Standard Adhered To | Reported Device Performance/Compliance |
|---|---|---|
| Biocompatibility | Skin sensitivity testing criteria as specified in the Tripartite Biocompatibility Guidance for Medical Devices and ISO 10993-1 for skin contact. | Device uses Axelgaard gel (K983741, K000947) or other alternative biocompatibility material with ISO-10993 conformity certificate, all of which "have passed the required skin sensitivity testing criteria." |
| Electrical Performance | ANSI/AAMI EC12 (Performance Standard for Disposable ECG Electrodes) | "Conducted and completed the electrical safety testing according to the chosen performance standard, ANSI/AAMI EC12." |
| Substantial Equivalence | Demonstrated equivalence to predicate device K062675 (Gemore Technology Co., Ltd) in physical and technical characteristics. | Considered "as safe and effective as the predicate devices." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not explicitly stated for the device itself. The submission relies on the pre-existing qualification of the Axelgaard gel and the adherence to an electrical performance standard (ANSI/AAMI EC12). The sample size, provenance, and study design for proving the biocompatibility of the gel or for the electrical standard's development are not detailed in this submission. This is because the component (Axelgaard gel) itself was already cleared in other 510(k)s (K983741 and K000947).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable in this context. For a 510(k) submission based on substantial equivalence to a predicate device and adherence to industry standards, "ground truth" as established by medical experts for a diagnostic or AI device is not typically required or presented. The "ground truth" here would be the validated performance of the materials used and the adherence to technical standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable in this context. Adjudication methods are relevant for studies involving subjective interpretation of data (e.g., medical images) by multiple human readers, often used to establish a robust ground truth for AI model development or evaluation. This is not the type of study presented here.
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 study was done or is relevant. This type of study assesses the impact of AI assistance on human reader performance, which is not applicable to a self-adhesive electrode.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is an electrode, not an algorithm. Therefore, "standalone algorithm performance" is not a concept that applies.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" in this submission is indirectly established by:
- Prior regulatory clearance: The use of Axelgaard gel, which has already been proven suitable through previous 510(k) clearances (K983741 and K000947).
- Standardized testing: Compliance with the requirements of the Tripartite Biocompatibility Guidance for Medical Devices and ISO 10993-1 for skin contact and ANSI/AAMI EC12 for electrical performance. The ground truth essentially relies on the validity and acceptance of these established standards and guidelines.
8. The sample size for the training set
- Not applicable. There is no "training set" in the context of this device and submission. This device is not an AI algorithm.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set for an AI algorithm, this question is not relevant.
§ 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).