Search Results

For use during surgical procedures to cut hard tissue, bone and soft tissue and to hold cranial perforators that have a standard Hudson fitting.

Hudson Chuck for Mednext TRITON Handpiece

This request cannot be fulfilled. The document provided is a 510(k) clearance letter from the FDA, a statement of intended use, and the device name. It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. This type of information is typically found in the 510(k) submission itself or in published studies related to the device, neither of which are part of the provided text.

Ask a specific question about this device

To provide power to operate various accessories to cut hard tissue, bone, soft tissue.

Not Found

I am sorry, but the provided text does not contain the detailed study information required to answer your request. The document is a 510(k) clearance letter for a "Med'ext 1000 Surgical Drill," indicating it has been deemed substantially equivalent to a predicate device. However, it does not include:

• A table of acceptance criteria or reported device performance.
• Information on sample sizes, data provenance, number or qualifications of experts, or adjudication methods for a test set.
• Details about multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
• The type of ground truth used or how it was established for either test or training sets.
• The sample size for the training set.

The document primarily focuses on the regulatory clearance of the device based on substantial equivalence, rather than a detailed performance study report.

Ask a specific question about this device

Ask a specific question about this device