(88 days)
M&R Disposable Electrodes are intended for single-patient/singleapplication use in TENS ("traditional" TENS, microcurrent TENS, etc.) and NMES ("traditional" NMES, interferential NMES, high-volt pulsed galvanic NMES, functional electrical stimulation (FES), etc.) applications.
M&R Disposable Electrodes are laminated, flexible structures composed of materials commonly used in this application (e.g., cloth with biocompatible adhesive, conductive rubber, and biocompatible conductive gel). The electrodes have a direct lead wire pin connection design and are compatible with all standard, marketed TENS and NMES stimulation devices.
The provided text describes a 510(k) premarket notification for M&R Disposable Electrodes. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with acceptance criteria for device performance. Therefore, the information typically requested in a study design and results section is not explicitly available in this document.
However, I can extract information related to the comparison with predicate devices, which serves as the basis for demonstrating equivalence.
Here's an analysis based on the provided text, addressing the requested points where possible, and noting where information is not applicable or available:
1. Table of Acceptance Criteria and Reported Device Performance
For a 510(k) submission like this, the "acceptance criteria" are typically met by demonstrating that the new device shares fundamental technological characteristics and has similar or identical intended use, design, and performance features to the predicate devices. The "performance" is implicitly deemed acceptable if substantial equivalence is proven.
No explicit quantitative performance metrics or acceptance criteria are presented in the document itself. The comparison table focuses on qualitative and quantitative characteristics for substantial equivalence.
| Device Characteristic | Acceptance Criteria (based on predicate equivalence) | Reported Device Performance (M&R Disposable Electrodes) |
|---|---|---|
| Intended Use | Must be substantially equivalent to predicate devices. | M&R Disposable Electrodes are intended for single-patient/single-application use in TENS ("traditional" TENS, microcurrent TENS, etc.) and NMES ("traditional" NMES, interferential NMES, high-volt pulsed galvanic NMES, functional electrical stimulation (FES), etc.) applications. This matches Medtronic and Medical Designs predicates. |
| Device Description/Technology | Must use materials commonly used in this application and have similar functional design. | M&R Disposable Electrodes are laminated, flexible structures composed of materials commonly used in this application (e.g., cloth with biocompatible adhesive, conductive rubber, and biocompatible conductive gel). They have a direct lead wire pin connection design and are compatible with all standard, marketed TENS and NMES stimulation devices. This is consistent with predicate materials and design. |
| Electrode Sizes/Shapes | Must be within clinically acceptable ranges, comparable to predicates. | 2.0 x 2.25 in. (rectangle). Additional models of various sizes will be added within size range of 2.0 x 2.0 in. (min.) and 3.0 x 6.0 in. (max.). This falls within the range of predicate sizes/shapes. |
| Electrode Construction | Must use biocompatible materials and similar functional construction. | Polyester w/ biocompatible adhesive, Conductive rubber strip, Biocompatible gel. Also, additional models will include conductive film w/ or w/o Ag/AgCl coating, lead wire assembly, male snap assembly. This is comparable to predicate constructions which use similar materials like polyester, conductive rubber strip, and biocompatible gel. |
| Lead Wire Connector Type | Must be a standard connection type compatible with existing stimulation devices. | Std. .080 in. female connection (hole in conductive rubber strip). This matches the primary connector type of the Medtronic predicate and one type from Medical Designs. |
| Labeled as Reusable or Single-Use / Disposable? | Must match the disposable nature of predicate devices. | Single-Use / Disposable. This matches both predicate devices. |
| Potential Adverse Effects | Must have similar potential adverse effects as predicate devices. | Skin irritation. This is consistent with the skin rash/irritation noted for 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)
This document does not describe a "test set" in the context of a clinical performance study. The 510(k) submission relies on a comparison to predicate devices, which are already legally marketed. There is no mention of a new clinical study with a specific sample size, data provenance, or study design.
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 applicable. No "test set" or explicit "ground truth" establishment by experts is described for this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No "test set" or adjudication method is described.
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 not an AI-enabled device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI-enabled device, and no standalone algorithm performance study is mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the context of a new clinical study. The "ground truth" for this submission is effectively the established safety and effectiveness of the legally marketed predicate devices, against which the new device is compared for substantial equivalence.
8. The sample size for the training set
Not applicable. This is not an AI-enabled device requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI-enabled device.
§ 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).