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Diapact is an extracorpeal blood purification septem intended to be used for acute renal failure. The septem provides high flow continuous rinal replacement therapies, emergency intermittent dialipis and plasmapheresis.

In accordance with section 510(k) for the Federal Food, Drug, and Cosmetic Act, B. Braun Medical, Inc. intends to introduce into interstate commerce the DIAPACT CRRT - ( Continuous Renal Replacement Therapies). It is an extracorpeal blood purification system intended to be used for acute renal failure. The system provides high flow continuous renal replacement therapies, emergency intermittent dialysis treatment and plasmapheresis.

The provided text describes a 510(k) submission for the Diapact CRRT device, which is an extracorporeal blood purification system. The submission focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance studies with acceptance criteria in the manner typically seen for novel AI/machine learning devices.

Due to the nature of this submission (a 510(k) for a medical device that predates the common use of AI and machine learning in such applications), the document does not contain the information requested in your prompt regarding acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert consensus, or MRMC studies.

Instead, the submission states:

• Substantial Equivalence: The DIAPACT CRRT is "identical in materials, form, and intended use" to two predicate devices: SPECTRA - Blood Component Separator Therapeutic (K900105) and PRISMA - CFM - Continuous Fluid Management System (K946279). This is the primary "acceptance criterion" from a regulatory perspective for this type of submission.
• Safety and Effectiveness: It states, "There are no new issues of safety and effectiveness raised by Diapact CRRT."
• Product Testing: "All finished products are tested and must meet all required release specifications before distribution." This includes "physical testing, visual examination (in process and finished product)." These physical tests are defined by Quality Control Test Procedure documents, conforming to product design specifications and GMPs.

Therefore, I cannot populate the table or answer the specific questions as the information is not present in the provided text. The "study" proving acceptance criteria, in this context, is the demonstration of substantial equivalence through comparison to legally marketed predicate devices and internal quality control testing procedures, rather than a clinical performance study with defined metrics against a ground truth.

If this were a submission for a modern AI/ML medical device, the expectations for performance criteria and study details would be much more aligned with your questions.

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