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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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