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Exalis is an integrated product able to acquire; process and supply data required when running a dialysis treatment. This software application makes it possible to insert, modify, acquire, display in textual and graphical form data about dialysis prescription, ongoing and performed dialysis treatments and patient personal data. Exalis is an accessory intended to be used with Gambro Phoenix Haemodialysis system (starting from software version 3.35) in a Chronic Dialysis Facility and at Limited Care Centers.

Exalis is an integrated product able to acquire; process and supply data required when running a dialysis treatment. This software application makes it possible to insert, modify, acquire, display in textual and graphical form data about dialysis prescription, ongoing and performed dialysis treatments and patient personal data. Exalis is an accessory intended to be used with Gambro Phoenix Haemodialysis system (starting from software version 3.35) in a Chronic Dialysis Facility and at Limited Care Centers.

The provided text describes a 510(k) summary for Gambro Renal Products, Inc.'s Exalis Software 1.15, classified as an accessory to a hemodialysis delivery system. However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert evaluations.

Based on the provided text, I cannot answer the questions regarding acceptance criteria and the study proving the device meets those criteria. The document primarily focuses on regulatory information, indications for use, and substantial equivalence to a predicate device, rather than detailed performance evaluation studies.

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