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The AURORA™ System 1000® Series Single Patient Dialysis Delivery System is part of a high permeability hemodialysis system which consists of a controlled dialysate delivery system that incorporates an ultrafiltration controller to prevent excessive loss of water from the patient's blood, an extracorporeal blood set, and a high permeability dialyzer. The standard features of the AURORA™ System 1000® Series Single Patient Dialysis Delivery System includes a high blood flow rate capacity, automatic ultrafiltration control, standard and variable bicarbonate and sodium capabilities and automated chemical disingection. The AURORA™ System 1000® Series Single Patient Dialysis Delivery System will operate in either the bicarbonate or acetate mode for concentrates. The AURORA™ System 1000® Series Single Patient Dialysis Delivery System is designed to operate in the chronic and acute dialysis environment. It is not for home use.

The AURORA™ System 1000 Series Single Patient Dialysis Delivery System is a dialysate proportioning system for hemodialysis. The system fulfills the following functions: 1. Mixes concentrate with water in the appropriate proportions to produce dialysate. 2. Delivers dialysate at the appropriate temperature and ionic concentration to the dialyzer. 3. Removes the appropriate amount of liquid from the patient's blood. 4. Along with the dialyzer and blood pump acts as a total artificial kidney.

This 510(k) summary does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the format typically used for AI/ML device submissions. Instead, it describes a medical device called the Baxter AURORA™ System 1000® Series Single Patient Dialysis Delivery System, which is a hemodialysis machine.

The document focuses on:

• Description of the device: How it mixes concentrates, delivers dialysate, removes liquid from the patient's blood, and acts as an artificial kidney.
• Intended Use: For high permeability hemodialysis in chronic and acute settings, not for home use. It highlights features like ultrafiltration control, high blood flow, and various bicarbonate and sodium capabilities.
• Substantial Equivalence: It compares the device to several predicate devices (other System 1000® Series Dialysis Delivery Systems) and states that the AURORA™ System 1000® Series is built with the "same fluid path and hardware components."

This type of submission primarily establishes substantial equivalence to already marketed devices, meaning it demonstrates that the new device is as safe and effective as a legally marketed predicate device. It typically relies on design comparisons, performance specifications, and possibly bench testing rather than clinical trials with extensive performance metrics like sensitivity, specificity, or reader studies common in AI/ML device evaluations.

Therefore, I cannot extract the requested information (such as acceptance criteria table, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment) because this 510(k) document is for a traditional medical device (a hemodialysis machine) and not an AI/ML-driven diagnostic or treatment device, which would typically involve such performance characterizations.

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