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Cutaneous (Bar) Electrode is intended for non-invasive use as a recording (active/reference) or stimulating electrode during electromyographic (EMG), Nerve Conduction Studies(NCS), and Evoked Potentials (EP) recordings.

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This document is a 510(k) clearance letter from the FDA for several electrodes (cutaneous, digital ring, cutaneous disc, and cutaneous ground electrodes). It does not contain information about acceptance criteria or a study proving that a device meets those criteria. The letter confirms that the devices are substantially equivalent to previously marketed devices and can therefore be marketed.

Therefore, I cannot provide the requested information based on the input text. The provided document is a regulatory clearance, not a technical report detailing performance criteria or study results.

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Cutaneous Ground Electrode is intended for non-invasive use as a recording (active/reference) electrode during electromyographic (EMG) recordings.

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The provided text is a 510(k) premarket notification letter from the FDA regarding several electrodes. It does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML medical device. The document is for a traditional medical device (electrodes) and predates widespread AI/ML applications in healthcare.

Therefore, I cannot provide the requested information.

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Digital Ring Electrode is intended for non-invasive use as a recording electrode during electromyographic (EMG) recordings.

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I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter and an "Intended Use Statement" for a Digital Ring Electrode. It confirms that the device is substantially equivalent to a predicate device and can be marketed.

However, it does not include details about:

• Acceptance criteria and reported device performance in a table format.
• Specific studies, sample sizes, data provenance, ground truth establishment, or expert qualifications.
• Information on MRMC comparative effectiveness studies or standalone algorithm performance.

The document discusses regulatory clearance, but not the technical study details you've asked for.

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Cutaneous (Disc) Electrode is intended for non-invasive use as a recording (active/reference) electrode during electromyographic (EMG) recordings.

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This document is a 510(k) premarket notification decision letter from the FDA to Neuro Supplies, Inc. for several types of cutaneous electrodes. It states that the devices are substantially equivalent to legally marketed predicate devices.

Crucially, this document is an FDA clearance letter, not a study report or clinical trial documentation. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications.

The letter is a regulatory approval notice, indicating that the devices (Cutaneous (Bar) Electrode, Cutaneous Ground Electrode, Digital Ring Electrode, and Cutaneous (Disc) Electrode) can be marketed. It confirms that the FDA has determined these devices are substantially equivalent to previously approved devices based on the information provided in the 510(k) submission.

Therefore, I cannot provide the requested information because it is not present in the provided text. The prompt asks for details that would typically be found in a clinical study report or a detailed technical submission, neither of which is this document.

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