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The EP-16 is intended for use in the operating room and critical care areas for neurological monitoring and assessment. The instrument assess a patient's neurological status during surgery of long term monitoring in the ICU.

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I am sorry, but based on the provided document, there is no study described that proves the XLTEK EP-16 Evoked Potential Headbox meets specific acceptance criteria. The document is an FDA 510(k) substantial equivalence letter, which confirms that the device is substantially equivalent to a legally marketed predicate device for its stated indications for use.

Here's why the requested information about acceptance criteria and a study proving their fulfillment cannot be extracted from this document:

• Nature of the Document: This letter is a regulatory approval, not a scientific study report. It states that the device is "substantially equivalent" to existing devices, meaning it has similar technological characteristics and is intended for the same use as legally marketed devices. It does not detail specific performance acceptance criteria or the studies conducted to meet them.
• Absence of Study Details: There is no mention of a clinical trial, performance study, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment.
• Focus on Indications for Use: The main "study" or evidence provided is the "Statement of Indications for Use" (Attachment #1), which defines what the device is intended for (neurological monitoring and assessment in operating rooms and critical care). This is about intended use, not performance metrics.

Therefore, I cannot provide the requested table and study details because they are not present in the provided text.

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