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The NMT Medical Transseptal Sheath Set is indicated for percutaneous introduction of various cardiovascular devices into the left side of the hear through the atrial septum.

The NMT Medical Transseptal Sheath Set consists of a long and short introducer sheath set. The long sheath set is comprised of a curved 75cm length introducer sheath and curved 81 cm length dilator. The short sheath set is comprised of a straight 12cm length introducer sheath and straight 19cm length dilator.

The provided text describes a medical device, the NMT Medical Transseptal Sheath Set, and its 510(k) summary for FDA clearance. However, it does not contain the specific information requested in your prompt regarding acceptance criteria, device performance tables, study details (sample sizes, expert involvement, adjudication, MRMC, standalone performance), or ground truth establishment.

The document focuses on demonstrating substantial equivalence to a predicate device (COOK Check-Flo® Transseptal Introducer Sets) based on:

• Indications for Use
• Product Design
• Materials
• Packaging
• Labeling
• Sterilization methods

It mentions that "In-vitro and biocompatibility tests were conducted to compare the NMT Transseptal Sheath Set to the predicate device. Test results demonstrate that the applicant device met performance specification requirements and is substantially equivalent to the predicate device." It also states that the device met applicable requirements of ISO-10993-1, ISO-11070, ISO-10555, and ISO 594-2.

Therefore, I cannot provide the detailed information requested in your prompt as it is not present in the given text.

If this were a real-world scenario, you would need to consult detailed test reports and study protocols submitted to the FDA, which are typically much more extensive than a 510(k) summary.

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