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The Rockwell Medical Supply LLC. Concentrate Solutions for Acetate Dialysate are indicated for use in acute and chronic hemodialysis and to be used with the appropriate hemodialysis machine/ monitor.

The Rockwell Medical Supply, LLC. Hemodialysis concentrate solutions and for acetate dialysate contain salt (acetate, sodium, calcium, potassium and chloride), sugar (dextrose), and water containing solutions formulated and intended for use in hemodialysis when mixed or proportioned with the appropriate volume of purified water. These solutions 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 presented in this 510K Notification are intended to be used in two stream hemodialysis machines in which an acetate concentrate is proportioned into one stream, and a specified volume of water is proportioned into the second stream of the hemodialysis machine proportioning system. These two streams are then mixed to prepare a final proportioned hemodialysis solution. These types of a final hemodialysis solutions are commonly referred to as "Acetate Hemodialysis Solutions." These proportioned hemodialysis solutions are then heated to body temperature and then perfused through the dialysis fluid compartment of artificial kidneys or hemodialyzers. These acetate hemodialysis solutions are separated from the patient's blood by means of a semipermeable cellulosic or non-cellulosic membrane which serves as a molecular weight selective barrier to the passage of molecules beyond a certain molecular weight. The molecular weigh cut-off of each type of membrane may vary depending on the membrane type, manufacturing process, etc. The semi-permeable membrane in a hemodialyzer permits the passage of smaller molecular weight (less than 5,000 daltons for conventional cellulosic membranes), ionized and non-ionized molecules, waste products and toxins (i.e. blood urea nitrogen, creatinine, potassium, etc.) contained in the patient's blood circulating through the cialyzer, to pass through the semi-permeable membrane into the acetate containing hemodialysis solutions, exit the hemodialyzer, enter the hemodialysis monitor and exit the monitor and are ultimately discarded. The ionic and molecular composition of the hemodialysis solution establishes the concentration gradient between the blood and the hemodialysis solution passing through the hemodialyzer which permits the effective removal of waste products and toxins found in excess in the patient's blood during acute and end-stage renal failure.

The provided text is a 510(K) summary for a medical device: "Concentrate Solutions for Acetate Dialysate" by Rockwell Medical, LLC. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance criteria through a detailed study.

Therefore, many of the requested details about acceptance criteria, study design, and ground truth are not applicable or not provided in this type of regulatory submission. The document explicitly states: "Clinical testing was not performed."

Here's a breakdown of the information that can be extracted or inferred based on the supplied text:

Acceptance Criteria and Device Performance

Since this is a substantial equivalence submission, the "acceptance criteria" are implicitly met if the proposed device is found to be substantially equivalent to the predicate device. The primary "performance" demonstrated is that the device has the same chemical composition and intended use as the legally marketed predicate device.

Study Details Based on the Provided 510(K) Summary:

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not applicable. There was no specific "test set" in the context of clinical performance evaluation. The "testing" referred to appears to be analytical/bench testing to confirm chemical composition.
   • Data Provenance: The "in vitro testing" was performed by the submitter (Rockwell Medical, LLC). Specific details about the data's origin (e.g., country) are not provided, but it would have been conducted internally by Rockwell Medical. The study is akin to retrospective analytical comparison to the predicate device's established characteristics.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. There was no clinical test set requiring expert ground truth. Ground truth for the chemical composition would be established through laboratory analysis following recognized standards/methods, not expert consensus in the clinical sense.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable. As no clinical test set requiring human adjudication was involved.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • Not applicable. This device is a solution for hemodialysis, not an AI-assisted diagnostic or therapeutic device that would involve human "readers" or an MRMC study.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This is not an algorithm or AI device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for this submission is the established chemical composition and operational characteristics of the predicate device. The proposed device's chemical parameters were compared against these established ranges via in vitro chemical analysis.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI device that would require a "training set."

8. How the ground truth for the training set was established:

   • Not applicable. No training set was used.

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