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The Manan™ Co-Axial Introducer Needle is intended for a range of biopsy applications of soft tissue.

The Manan Co-Axial Introducer Needle is a general purpose introducer-type needle assembly intended for a range of biopsy applications of soft tissue. The device is composed of a cannula, available in various lengths in the range of 2 ins. to 8 in. and gauges of between 8 and 22, constructed of 304 stainless steel into which a stainless steel stylet fits. The molded hub holding the cannula is comprised of medical grade plastic. The combination of the stylet and needle terminates in a trocar-type needle point.

This 510(k) summary does not contain any information regarding acceptance criteria or a study proving the device meets those criteria.

The document is a standard 510(k) premarket notification for a medical device (Manan™ Co-Axial Introducer Needles). It focuses on establishing substantial equivalence to previously marketed devices based on device description and intended use, rather than presenting performance study data.

Therefore, I cannot provide the requested information in the table or answer the specific questions about studies, sample sizes, experts, adjudication, or ground truth, as none of that data is present in the provided text.

Based on the provided text, here is what can be inferred:

• Device: Manan™ Co-Axial Introducer Needles
• Intended Use: "A range of biopsy applications of soft tissue."
• Regulatory Decision: The FDA determined the device is substantially equivalent to predicate devices, allowing it to be marketed. This decision is based on comparing the new device's characteristics and intended use to those of legally marketed predicate devices, not on specific performance data against acceptance criteria.

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