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The Rockwell Medical Supply LLC. Dri-Sate Acid Concentrate Solutions and powders for 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 Supply, LLC. Dri-Sate Acid Concentrate Mixes / hemodialysis concentrate solutions and powders contain salt, sugar, and non-sugar and water containing solutions and powders are formulated and intended for use in hemodialysis when mixed or proportioned with the appropriate volume of purified water and bicarbonate solution/powder. These solutions and powders when proportioned/ mixed with pretreated 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 glacial acetic 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. These types of a final hemodialysis solutions are commonly referred to as "Bicarbonate 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 bicarbonate hemodialysis solutions are separated from the patient's blood by means of a semi-permeable 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 dialyzer, to pass through the semi-permeable membrane into the bicarbonate 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.

Here's an analysis of the provided text regarding acceptance criteria and the study conducted for the Rockwell Medical Supply, LLC. Dri-Sate Acid Concentrate Mixes:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state defined acceptance criteria with numerical targets. Instead, the basis for approval is "substantial equivalence" to a predicate device. The performance is reported in terms of chemical composition and functionality.

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

• Sample Size for Test Set: The document does not specify a quantitative sample size for the "in vitro testing." It only generally mentions "testing was performed."
• Data Provenance: The testing was "in vitro testing." The country of origin is not explicitly stated, but given the submission to the FDA, it is presumed to be relevant to the US market or conducted according to US regulatory standards. The testing appears to be retrospective in the sense that it's comparing a new product to an existing predicate.

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

This information is not applicable as the study described is a non-clinical, in vitro chemical comparison study, not one requiring expert human interpretation of medical data. There is no "ground truth" established by experts in the context of diagnostic or interventional performance.

4. Adjudication Method for the Test Set

This is not applicable for an in vitro chemical comparison. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human interpretation or subjective assessments.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not performed."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable as the device is a medical concentrate solution, not an algorithm or AI-driven system. The "standalone" performance here would refer to the chemical properties of the concentrate itself, which was assessed through in vitro testing.

7. The Type of Ground Truth Used

For this specific device, the "ground truth" used for comparison was the chemical composition and performance characteristics of the predicate device (Renal Systems Hemodialysis Concentrate Solutions / Renal Systems Sta-Pak Bicarbonate Hemodialysis Bath Concentrate Solutions & Powders), as determined by testing. There was no pathology, expert consensus on clinical findings, or outcomes data used as the ground truth.

8. The Sample Size for the Training Set

This information is not applicable. The device is a chemical concentrate, not a machine learning model. Therefore, there is no "training set" in the context of an AI algorithm.

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

This information is not applicable for the reasons stated in point 8.

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