ELECTROMED REUSABLE NEUROSTIMULATION ELECTRODES

• K Number: K030800
• Device Name: ELECTROMED REUSABLE NEUROSTIMULATION ELECTRODES
• Manufacturer: ELETROMED, INC.
• Date Cleared: 2003-06-11 ( 90 days)
• Product Code: GXY
• Regulation Number: 882.1320
• Type: Traditional
• Panel: NE
• Reference & Predicate Devices: K963125 , K932849

Intended Use

Electromed Reusable Neurostimulation Electrodes are intended for use as the disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. Electromed Reusable Electrodes are designed and intended to be used with marketed, Electrical Stimulators i.e. TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) of PGF (Pulsed Galvanic Stimulation).

Device Description

Electrodes, cutaneous

AI/ML Overview

The provided text describes Electromed Reusable Neurostimulation Electrodes and states that no clinical testing was applicable or performed to demonstrate performance against acceptance criteria. Therefore, the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies cannot be extracted from the provided document.

The document focuses on demonstrating substantial equivalence to predicate devices through technological and labeling comparisons, and bench testing, rather than presenting a performance study with detailed acceptance criteria.

Here's a breakdown of why each requested point cannot be answered:

1. A table of acceptance criteria and the reported device performance: Not available. The document states "Bench testing demonstrated that the characteristics of Electromed are substantially equivalent to that of the predicate device," but no specific performance metrics or acceptance criteria are listed.
2. Sample size used for the test set and the data provenance: Not applicable, as no clinical performance study was conducted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not 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: Not applicable. This device is an electrode and does not involve AI or human reader interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is an electrode and does not involve an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The conclusion from testing explicitly states: "The Electromed is substantially equivalent in electrical output to the predicate device and any differences between the devices do not pose new questions of safety." This indicates the review was based on equivalence rather than meeting specific performance criteria demonstrated by a clinical study.

Regulation Number and Section

§ 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).