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Dryasol Acid Concentrate mix is indicated for use in acute and chronic hemodialysis. It is an accessory to be used with the appropriate hemodialysis machine in the exact prescribed proportion with RO water and Sodium Bicarbonate Mix.

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This is a PMA for a device called "Dryasol Acid Concentrate Mix". This document is a 510(k) clearance letter, not a PMA. A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. The information provided in the prompt is a 510(k) clearance letter and an Indications for Use statement. These documents do not contain the detailed study information required to answer your request.

Therefore, I cannot provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method for the test set.
5. Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Whether a standalone performance study was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

The provided documents only state that the Dryasol Acid Concentrate Mix is indicated for use in acute and chronic hemodialysis and is substantially equivalent to a legally marketed predicate device. This substantial equivalence is typically based on comparing technological characteristics and, in some cases, performance data, but the details of such comparisons are not in these specific FDA letters.

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