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Intended Use: The Remote Introducer is intended to provide stereotactic delivery of newrosurgical instruments or devices during planning and operation of neurological nrocedures within the MRI environment and in conjunction with MR imaging and guidance using the Navigus Trajectory Guide. These procedures include catheter placement and electrode implant.

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This is not an AI/ML device, and therefore the traditional acceptance criteria and study design elements you've listed (such as multi-reader multi-case studies, training sets, ground truth establishment by experts, etc.) are not applicable.

This document is a 510(k) clearance letter for a medical device called the "Remote Introducer, Model P-1000." The FDA's 510(k) process is about demonstrating substantial equivalence to a predicate device already on the market, not about proving clinical efficacy or diagnostic accuracy through AI/ML performance metrics.

The letter states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976... You may, therefore, market the device, subject to the general controls provisions of the Act."

In summary, for this specific document, the device does not employ AI, and thus the requested information regarding AI device acceptance criteria and study details cannot be extracted. The "acceptance criteria" here would be the demonstration of substantial equivalence to a predicate device as defined by the FDA's 510(k) regulations.

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