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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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The Electrode Store™ Surface Electrodes for Electroencephalography are intended for non-invasive use as recording electrodes in studies of physiological signals. These devices are indicated for use with adult or pediatric patients during electroencephalography, including biofeedback, sleep studies and evoked potential recordings.

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This document is an FDA 510(k) clearance letter for a medical device: "Surface Electrode for Electroencephalography." It confirms that the device is substantially equivalent to a predicate device already on the market.

Based on the provided text, there is no information about acceptance criteria or the study that proves the device meets specific performance criteria.

The document is purely a regulatory clearance. It does not contain details about:

• A table of acceptance criteria and reported device performance.
• Sample sizes or data provenance for a test set.
• Number or qualifications of experts used for ground truth.
• Adjudication methods.
• MRMC comparative effectiveness studies.
• Standalone algorithm performance studies.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

The FDA 510(k) clearance process focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring a detailed study proving performance against specific acceptance criteria in the same way a novel high-risk device might. The "evidence" typically provided in a 510(k) submission to show substantial equivalence usually includes:

• Comparison of technological characteristics.
• Comparison of indications for use.
• Performance data (e.g., bench testing, electrical safety, biocompatibility) to show that any differences in technological characteristics do not raise new questions of safety or effectiveness.

However, the specific content of such studies is not included in this clearance letter. The letter simply states that the FDA "reviewed your Section 510(k) premarket notification" and "determined the device is substantially equivalent."

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The Electrode Store™ Subdermal Needle Electrode for Electroencephalography (EEG) is intended for single-use, subdermal application to record physiological signals or to apply electrical stimulation. It is indicated for use with adult or pediatric patients as a recording or stimulating electrode during electroencephalography.

Subdermal Needle Electrode for Electroencephalograpy

I am sorry, but the provided text from the U.S. Food and Drug Administration (FDA) correspondence and the "Indications for Use Statement" for the "Subdermal Needle Electrode for Electroencephalography" does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or comparative effectiveness with AI.

The documents are solely related to the 510(k) premarket notification process, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, not on detailed performance studies or AI integration.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.

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The Electrode Store™ Surface Cutaneous Electrode for EMG is indicated for non-invasive use as recording (active/reference) or stimulating electrode during electromyography (EMG), including nerve conduction studies (NCS) and evoked potential (EP) recordings.

Not Found

This looks like a 510(k) clearance letter for a medical device and not a study. The document confirms that "The Electrode Store™ Surface (Cutaneous) Electrode for EMG" is substantially equivalent to legally marketed predicate devices.

Therefore, the specific information requested about acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment is not available in this document. This letter is a regulatory compliance document, not a clinical study report. It does not contain data or design information regarding a clinical investigation to assess performance against specific acceptance criteria.

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