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The 90XL Dialysis Meter is intended for use by hemodialysis professionals to measure the conductivity, temperature, pH, and pressure of the dialysate solution associated with hemodialysis delivery systems. Water purification specialists may also use the 90XL instrumentation system to verify proper characteristics of the water used in hemodialysis. These parameters are key indicators of system performance that require periodic monitoring and documentation for effective hemodialysis systems.

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I apologize, but the provided text only contains a 510(k) clearance letter for the "90XL Instrumentation System" and its "Indications for Use Statement."

It does NOT contain any information about acceptance criteria, device performance results, study details (sample sizes, ground truth establishment, expert qualifications, adjudication methods), or multi-reader multi-case studies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

To answer your request, I would need a document that specifically details:

• The performance metrics used (e.g., accuracy, sensitivity, specificity for diagnostic devices, or specific measurement tolerances for instrumentation like the 90XL).
• The predefined acceptance thresholds for those metrics.
• The methodology and results of a study designed to demonstrate the device meets those thresholds.

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