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The Baxter Arena™ Hemodialysis Delivery System is indicated for use when a hollow fiber dialyzer is chosen for use in chronic or acute hemodialysis treatments, including high flux hemodialysis. All therapies using the Arena Hemodialysis Delivery System must be prescribed and performed under the responsibility of a physician who is familiar and well informed about renal replacement therapies and the treatment is performed in an in-clinic environment and supervised by trained healthcare professionals.

The Arena Hemodialysis Delivery System is not designed, sold or intended for any use except as indicated above. Furthermore, it is not intended to be used outside the device specifications or limitations.

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This document is a 510(k) clearance letter from the FDA for the Baxter Arena™ Hemodialysis Delivery System. It primarily focuses on regulatory approval and does not contain the detailed acceptance criteria and study data requested in the prompt.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, study details (sample size, data provenance, expert roles, adjudication, MRMC or standalone studies), or ground truth establishment based on the provided text.

The document only states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its market clearance, but it does not elaborate on the specific performance metrics or studies used to demonstrate this equivalence.

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