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For the percutaneous punture of the abdomen or pelvis for the purpose of removing tissue of the soft tissue organs for microscopic examination, for the purpose of diagnosis of disease. The needle is to be used with the automatic biopsy devices marketed by C.R. Bard and Manan Medical Products.

Automatic Cutting Needle

I apologize, but the provided text from the FDA 510(k) clearance letter for the "Automatic Cutting Biopsy Needle" does not contain specific acceptance criteria, device performance data, details of a study (sample sizes, data provenance, expert qualifications, adjudication methods), or information about ground truth establishment.

This document is a regulatory clearance letter, primarily stating that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed. It does not typically include the detailed technical and scientific data from performance studies.

To answer your request, I would need a document specifically detailing the performance study, often found in an appendix to the 510(k) submission or a separate technical report.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details based solely on the provided text.

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