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The Premere™ Delivery Sheath is indicated for use in intravascular introduction of therapeutic devices into the left atrium of the heart through the septal wall.

The Premere™ Delivery Sheath consists of a non-tapered catheter introducer and an obturator. The distal portion is tapered to facilitate positioning and crossing the atrial septum. The Premere™ Delivery Sheath is intended to provide a pathway for introduction of therapeutic devices into the right and left atrium.

The delivery sheath is fitted with a hemostasis valve at the proximal end to allow insertion of devices while minimizing blood loss and a side port with a three-way stopcock for infusion, blood sampling and pressure monitoring. The sheath is provided with a stainless steel braid and a radiopaque material on outer jacket with a high-contrast radiopaque marker at the tip.

The obturator is radiopaque with a tapered tip and is compatible with a 0.038" guiding wire.

The provided text does not contain information about acceptance criteria and a study proving a device meets them. The document is a 510(k) summary for the Premere™ Delivery Sheath, which describes the device, its indication for use, and claims substantial equivalence to predicate devices. It also lists performance data that was provided in the 510(k) submission, including various ISO standards and specific tests (dimensional verification, tensile strength, leak/burst), and in-vivo testing in a swine model. The FDA's letter states that the device is substantially equivalent based on the provided information.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor details about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set information. This type of detailed study information is typically found in the full performance data sections of a 510(k) submission, which are often not publicly available in this summarized format.

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