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The intended use of the device is for Volume controlled ultrafiltration and infusion of heparin through a blood pump for the treatment of renal failure or toxic Conditions. This device may be used for High. Flux Hemodialysis.

The Dialog Dialysis Machine is an artificial kidney system used for the treatment of patients with renal failure or toxic conditions. The device consists of an extracorporeal blood system for the separation of substances in solutions via a semipermeable membrane. The system allows for volume controlled ultfiltration and/or infusion of heparin through a blood pump by utilizing a standard double needle or optional single needle dialysis procedure.

The provided text is a 510(k) summary for the Dialog Dialysis Machine. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting a detailed performance study with acceptance criteria. As such, the document does not contain information on:

• Acceptance criteria in the form of specific performance metrics (e.g., sensitivity, specificity, accuracy).
• A formal study proving the device meets acceptance criteria using a test set of data.
• Sample sizes for test sets or training sets.
• Data provenance, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.
• The type of ground truth used for a study.

The primary "study" mentioned for this device is the "Safety and Effectiveness" section, which states:

"All finished products are tested and must meet all required release specifications before distribution. The array of testing required for release include, but are not limited to; physical testing, visual examination (in process and finished product). The physical testing is defined by Quality Control Test Procedure documents. These tests are established testing procedures and parameters which conform to the product design specifications. The testing instruction records for each of the individually required procedures are approved, released, distributed and revised in accordance with document control GMP's."

This describes internal quality control and manufacturing testing to ensure the device meets its own design specifications, but not a clinical performance study with specific quantitative acceptance criteria in the typical sense of AI/medical device evaluation.

Therefore, I cannot provide the requested table and information, as the input document does not contain this type of data. The document focuses on demonstrating substantial equivalence based on materials, form, and intended use to existing devices, and adherence to manufacturing quality standards.

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