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The DBB-05 Hemodialysis Delivery System is indicated for hemodialysis prescribed by physicians for adult and pediatric patients with acute or chronic renal failure. The DBB-05 is intended for hemodialysis performed in hospitals and dialysis clinics by a qualified operator.

The DBB-05 Hemodialysis Delivery System is composed of a hydraulic unit for the delivery of dialysate and extracorporeal blood circuitry. The permeate is heated and deaerated in the hydraulic section, which is then mixed with concentrate and fed into the dialyser through the dialysate fluid feeder. The closed balancing system assures the amount of dialysate infused corresponds to the amount of dialysate extracted. The interior pressure of the dialyser is controlled automatically by adjustment of the Ultra Filtration (UF) amount and UF rate by the dialyser. Heparinization of the external circulating blood is performed with the heparin pump either by continuous or one-shot injection before it is passed on to the dialyser. The DBB-05 Hemodialysis Delivery System uses both acetate dialysis and bicarbonate dialysis. Using the various functions of the device, the conductivity and UF profile can be programmed. In addition, DBB-05 Hemodialysis Delivery System incorporates all functions necessary for double-needle dialysis as well as single-needle dialysis treatment. The hydraulic unit is cleaned and disinfected using selectable cleaning programs and is equipped with the necessary protective systems for patient safety and correct operation.

The provided text is a 510(k) summary for the DBB-05 Hemodialysis Delivery System. It describes the device, its intended use, and claims substantial equivalence to a predicate device (the original Nikkiso DBB-05 Hemodialysis Delivery System cleared under K023509).

However, the summary does not contain the detailed information required to fill out the table and answer the specific questions about acceptance criteria and a study proving the device meets those criteria.

Here's why and what information is missing:

• No Acceptance Criteria or Performance Data: The document explicitly states that the device received a 510(k) clearance based on "substantial equivalence" to a predicate device. This means the manufacturer argued the new device is as safe and effective as the previously cleared device, not necessarily that it met new, quantitative acceptance criteria through a specific performance study outlined in the summary.
• No Standalone Study Described: The core argument for clearance is equivalence, not a standalone performance study. While it mentions "verification and validation activities," these are described generally as proving the modified device is substantially equivalent, not as a specific clinical or technical study with defined acceptance criteria and performance results.
• No Information on Test Sets, Ground Truth, Experts, MRMC, or Training: Since a specific performance study proving new acceptance criteria is not described, all related questions about sample sizes, data provenance, number of experts, ground truth, MRMC studies, and training sets are unanswered by the provided text.

In summary, the document states that the device is substantially equivalent to a predicate device, and the modifications do not raise new safety or effectiveness questions. It does not provide data from a study designed to demonstrate performance against specific, quantifiable acceptance criteria.

Therefore, I cannot populate the table or answer the questions as requested based only on the provided text. The missing information would typically be found in a more detailed Device Description, Performance Data, or Clinical Data section of a 510(k) submission, which is not fully included here.

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