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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 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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