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The Electrode Store™ Sterile Cutaneous Electrode is indicated for use as a recording (active/reference) or stimulating electrode during electromyography (EMG), including nerve conduction studies (NCS) and evoked potential (EP) recordings. It is provided packaged and labeled as a sterile device for single patient use.

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I am sorry, but the provided text does not contain the information requested in the prompt regarding acceptance criteria and a study proving a device meets them. The document is a 510(k) clearance letter from the FDA for "Sensory Nerve Electrodes-Two Finger Rings, Stimulator Probe Electrodes-Facial" and "Sterile Cutaneous Electrode."

It mentions:

• Device Names: Sensory Nerve Electrodes-Two Finger Rings, Stimulator Probe Electrodes-Facial, and The Electrode Store™ Sterile Cutaneous Electrode.
• Regulation Number and Name: 21 CFR 882.1320, Cutaneous Electrode
• Regulatory Class: II
• Product Code: GXY
• Indications for Use: The Electrode Store™ Sterile Cutaneous Electrode is indicated for use as a recording (active/reference) or stimulating electrode during electromyography (EMG), including nerve conduction studies (NCS) and evoked potential (EP) recordings. It is provided packaged and labeled as a sterile device for single patient use.

However, it does not provide details about:

1. A table of acceptance criteria or reported device performance.
2. Sample sizes or data provenance for any test set.
3. Number or qualifications of experts for establishing ground truth.
4. Adjudication methods.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document is primarily an FDA clearance letter confirming substantial equivalence to a predicate device, not a detailed study report.

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