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The U9000 Plus Ultrafilter is indication of incoming water for dialysis fluid as well as purification of dialysis fluid to obtain standard dialysis fluid in accordance with international standards requirements and local regulations. The risk of exposure to bacteria and endotoxins can thereby be minimized. The U9000 Plus Ultrafilter is intended to be used in conjunction with a water treatment system.

WARNING! The U9000 Plus Ultrafilter can only be used with AK98 dialysis machines equipped with holder for an ultrafilter.

The Ultrafilter product family (U9000 Plus, and its predicate device U9000) are ultrafilters intended for water filtration (removal of pyrogens and microorganisms), and filtration of dialysis fluid. The risk of exposure to bacteria and endotoxins can thereby be minimized.

The U9000 Plus is intended to be used in conjunction with an upstream water treatment system. The Ultrafilter U9000 Plus can only be used with AK98 machines equipped with a dedicated holder. This places the U9000 Plus ultrafilter in the pre-dialyzer flow-path to filter the fluid before it reaches the dialyzer.

U9000 Plus Ultrafilter is intended to be used as a required component of the AK 98 Hemodialysis System, to minimize the risk of exposure to bacteria and endotoxins.

After installation, U9000 Plus Ultrafilter becomes an integral part of the dialysis fluid flow path of the dialysis machine; all machine processes that involve the Ultrafilter (e.g., dialysis fluid preparation, disinfection, rinsing) are controlled by the dialysis machine.

The provided document is a 510(k) premarket notification for a medical device (U9000 Plus Ultrafilter) and does not contain the specific information typically found in a study proving a device meets acceptance criteria for an AI/ML or diagnostic imaging device.

This document describes a water purification system for hemodialysis and its substantial equivalence to a predicate device. The "performance testing" mentioned refers to engineering and chemical tests for water filtration, not diagnostic performance with human readers or AI.

Therefore, I cannot extract the requested information (Acceptance Criteria Table, Sample Size, Expert Ground Truth, MRMC, Standalone Performance, Training Set details) as it is not present in the provided text.

The "discussion of nonclinical tests" section lists typical engineering and material compatibility tests for a water filter:

• Biocompatibility
• Pressure drop
• Retention capacity for Bacteria and Endotoxin
• Ultrafiltration rate
• Dialysis fluid composition
• Filter and membrane integrity
• Chemical evaluation

These tests are to confirm the device's physical and functional performance for water purification, not diagnostic accuracy or AI performance.

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