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The device is intended for use in obtaining biopsies from soft tissues such as liver, breast, kidney, prostate, spleen, lymph nodes and various soft tissue tumors.

The Revolution™ Full Core Blopsy Device is a sterile, disposable device which features a stainless steel cutting cannula with spoon, rotating coring cannula and stylet. The device is comprised of a plastic housing that contains the mechanically actuated components. The key performance attribute of the Revolution™ Full Core Biopsy Device is the capability of obtaining a full core specimen. A variable throw feature allows the user to choose a throw setting ranging from 10 to 25 mm.

The provided text describes a medical device, the Revolution™ Full Core Biopsy Device, and its 510(k) summary for FDA clearance. However, it does not contain specific acceptance criteria, detailed study designs, or performance metrics beyond a general statement of equivalency.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor can I provide information on sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details as this information is not present in the provided document.

The document states:

• "Performance testing confirms that the quality of samples obtained with the Revolution™ Full Core Biopsy Device is equivalent to that of the predicate device." This is a high-level statement indicating a study occurred, but without details on how "quality" was measured or the specific criteria for "equivalency."

To answer your questions, the following information would be needed:

• A section detailing the specific performance tests conducted.
• The acceptance criteria for each test (e.g., in terms of specimen length, integrity, diagnostic yield, etc.).
• The results of those tests compared to the predicate device or a defined threshold.
• Details about the methodology of sample quality assessment (e.g., histological review, pathological assessment).

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