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The Biopsy Sciences, LLC., Maxi-Cell Biopsy Needles are intended to be used for fine needle biopsies of various soft organs and tissues, including, but not limited to, biopsies for breast, lung, thyroid, liver, pancreas, spleen, kidneys, and prostate

The biopsy needle is a single lumen needle, identical in design to the predicate, from Sherwood Medical. The shaft of the needle has been modified to provide additional sampling sites approximately 0.40inches proximal to the needle tip. Once the needle is positioned at the site of interest, the stylet is removed and the needle is manually advanced to obtain a freehand needle biopsy of tissue, or aspirate, while suction is applied with a syringe. Then as the needle is withdrawn, the side-sampling site will also remove tissue, allowing the physician to collect at least twice the amount of tissue sample typically removed by a biopsy needle. The needle is made of ASTM type 304 stainless steel, as is the stylet.

The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) premarket notification summary for the Maxi-Cell Biopsy Needle, indicating that it was found substantially equivalent to predicate devices. It outlines the device description, intended use, and technological characteristics, but it does not include performance data, clinical study results, or specific acceptance criteria for performance metrics.

Therefore, I cannot populate the requested table or answer the specific questions related to acceptance criteria and study details.

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