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The Rockwell Medical Technologies, Inc. CitraPure® Acid Concentrate powders/liquidsfor Bicarbonate Dialysate are indicated for use in acute and chronic hemodialysis and to be used with the appropriate hemodialysis machine/monitor and bicarbonate concentrate.

The Rockwell Medical Technologies, Inc. CitraPure® Acid Concentrate for Bicarbonate Dialysis powders and liguits contain salt, sugar, and non-sugar and powders formulated and intended for use in hemodialysis when mixed or proportioned with the appropriate volume of purified water and bicarbonate concentrate/powder. These solutions and powders when proportioned/mixed with pre-treated or purified water meeting or exceeding AAMI Standards, may be used in conventional and commercially available hemodialysis machines or monitors as a hemodialysis solution. The hemodialysis concentrate solutions and powders presented in this 510K Notification are intended to be used in three stream hemodialysis machines in which an acidified concentrate is proportioned into one stream, a bicarbonate, chloride and sodium concentrate solution which has been prepared by mixing the powder with a specified volume of water and citric acid is proportioned into the second stream of the hemodialysis machine, and water is proportioned into the third stream. These three streams are then mixed to prepare a final proportioned hemodialysis solution.

The provided 510(k) notification for the CitraPure® Dry Acid Concentrate for Bicarbonate Dialysis does not present acceptance criteria in the typical format of performance metrics with thresholds. Instead, the entire submission is focused on demonstrating substantial equivalence to predicate devices based on chemical composition and intended use.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated. The "in vitro testing" likely involved laboratory analysis of the chemical composition of the CitraPure® concentrate. The number of batches or samples tested is not provided.
• Data Provenance: The testing was "in vitro," implying laboratory-based testing on the manufactured product. There is no mention of country of origin for the data or whether it was retrospective or prospective in the context of clinical data, as no clinical data was collected.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Experts: Not applicable. The "ground truth" for chemical composition would be established through analytical chemistry techniques and comparison to product specifications or predicate device data, not by expert interpretation in the way, for example, a radiologist interprets images.
• Qualifications: Not applicable for establishing chemical ground truth. The analyses would be performed by qualified laboratory technicians and chemists.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Given that the testing involved chemical composition analysis, there would not be an adjudication process involving multiple human reviewers like in a clinical study. The determination of "substantial equivalence" based on chemical parameters would be a direct comparison against established specifications or predicate device data.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No. The device is a medical concentrate, not an imaging or diagnostic device that would typically involve human readers. Clinical testing was explicitly stated as "not performed."

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

• Standalone Performance: Not applicable. This concept pertains to AI/ML devices where the algorithm performs a task independently. The CitraPure® concentrate is a chemical product, not an algorithm. The "performance" refers to its chemical properties and intended function as a component in dialysis.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the "non-clinical tests" (in vitro testing) was based on chemical composition analysis and comparison to predicate device specifications/data. This is akin to a "laboratory standard" or "established chemical profile."

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. Chemical concentrates do not have "training sets" in the context of AI/ML algorithms. The manufacturing process itself (which determines the composition) implicitly involves quality control and formulation development, but this is distinct from training a machine learning model.

9. How the Ground Truth for the Training Set Was Established

• How Ground Truth for Training Set Was Established: Not applicable. As there is no training set in the AI/ML sense, there is no ground truth to be established for it. The formulation of the CitraPure® concentrate would have been developed and refined through standard chemical engineering and manufacturing processes to achieve the desired composition, which then aligns with the predicate devices.

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