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The NCS Electrode System 2000 is for electromyographic recording, stimulating, and referencing in motor, sensory nerve conduction, and volitional electromyography.

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The provided text is a 510(k) clearance letter from the FDA for a device called "TECA NCS Electrode System 2000." This document primarily addresses the regulatory approval process and states that the device is substantially equivalent to a predicate device.

Crucially, this document does NOT contain information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

The 510(k) process focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than detailed performance study results that would typically be found in a clinical trial report or a comprehensive technical specification.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and the study proving the device meets them based on the provided text. The document confirms the device's clearance for marketing but does not delve into the detailed performance data that you are asking for.

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The disposable hypodermic monopolar needles are FOR SINGLE USE ONLY in electromyography (EMG) in situations wherein it is desired to insert an electrode, in the form of a probe, into a patient to locate a particular muscle and then inject a medication into that muscle. The hypodermic needle with an open lumen is designed for muscle stimulation, motor unit action potential recording and drug delivery. Once the physician is satisfied with the location, he/she injects a drug therein via the lumen of the needle.

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The provided text is a 510(k) premarket notification letter from the FDA to TECA Corporation regarding their Disposable Monopolar Needle Electrodes and MyoJect Disposable Needle Electrodes. This document does not contain information about acceptance criteria, device performance, study designs, sample sizes, expert qualifications, or ground truth establishment.

Instead, this letter is a regulatory approval, stating that the devices are substantially equivalent to previously marketed devices and can be legally marketed. It confirms compliance with general controls and notes that the devices may be subject to additional controls if classified as Class II or III.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and the study proving the device meets them, as that data is not present in the provided text.

Ask a specific question about this device

The disposable hypodermic monopolar needles are FOR SINGLE USE ONLY in electromyography (EMG) in situations wherein it is desired to insert an electrode, in the form of a probe, into a patient to locate a particular muscle and then inject a medication into that musche. The hypodermic needle with an open lumen is designed for muscle stimulation, motor unit action potential recording and drug, delivery. Once the physician is satisfied with the location, he/she injects a very. therein via the lumen of the needle.

Disposable Hypodermic Needle Electrode

The provided text is a 510(k) premarket notification letter from the FDA to TECA Corporation regarding their disposable monopolar needle electrodes and MyoJect disposable needle electrodes. This type of document is a regulatory approval, not a description of a scientific study that proves a device meets acceptance criteria.

Therefore, the document does not contain the information requested regarding acceptance criteria and the study that proves the device meets those criteria. It does not include:

• A table of acceptance criteria and reported device performance.
• Sample size used for a test set or data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for a test set.
• Information on a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
• Standalone (algorithm only) performance.
• Type of ground truth used.
• Sample size for a training set.
• How ground truth for the training set was established.

The letter simply states that the FDA has reviewed the 510(k) and found the devices to be substantially equivalent to devices marketed prior to May 28, 1976. This is a regulatory determination, not a scientific study report.

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