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Gambro PrismaSate™ solutions are indicated for use as a dialysate in Continuous Renal Replacement Therapy.

Gambro PrismaSate solutions are sterile dialysate solutions for use in Continuous Renal Replacement Therapy (CRRT) for the treatment of acute renal failure and in other cases necessitating fluid or solute removal, such as in the case of drug poisoning with dialysable or filterable substances. The solutions are intended to be used in commercially available continuous renal replacement therapy machines as dialysate. A physician prescribes the chemical composition of the solution to be used. The solutions are sterile, and packaged in flexible bags.

This document is a 510(k) summary for a medical device called PrismaSate, which are dialysis solutions. It states that the device is substantially equivalent to predicate devices and describes its intended use. However, it does not contain any information about acceptance criteria, device performance results, sample sizes, ground truth establishment, or clinical study methodologies typically associated with proving a device meets acceptance criteria.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance
2. Sample sizes used for the test set and data provenance
3. Number and qualifications of experts for ground truth
4. Adjudication method
5. Comparative effectiveness study results (MRMC)
6. Standalone performance results
7. Type of ground truth used
8. Sample size for the training set
9. How ground truth for the training set was established

This document is primarily for regulatory submission and approval based on substantial equivalence, not a detailed report of a performance study with specific acceptance criteria.

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