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KayBath acid concentrate dialysate is administered with bicarbonate dialysate and AAMI quality water in a 3 stream proportioning artificial kidney equipment to perform hemodialysis in the ES ID population

KayBath hemodialysis concentrate solutions contain various salts (sodium, magnesium, calcium and potassium), along with dextrose and glacial acetic acid. Pharmaceutical grade water, produced by a reverse osmosis pump under AAMI Standards, is used to mix the salts, dextrose and acetic acid. The solution is formulated and intended for the express purpose of performing hemodialysis. The acidified dialysate is proportioned inside commercially available hemodialysis machines with water and bicarbonate dialysate. The three streams of liquid unite to become the dialysate that runs countercurrent to the blood through the dialyzer at 500cc/min. The hemodialysis device provides the means to maintain the temperature, conductivity, electrolyte balance, flow rate and pressure of the dialysate. The dialyzer consists of hundreds of hollow strands of a cellulosic or synthetic membrane inside a cylinder. The membrane serves as a selective barrier to the passage of molecules beyond a certain molecular weight. While the blood travels through the hollow strands, undesirable substances in the blood, such as urea, nitrogen, potassium, etc., pass through the semipermeable membrane into the dialysate and are flushed down the drains.

The provided document (K982813) is a 510(k) premarket notification for a medical device: Dialysate Concentrate for Hemodialysis (Liquid or Powder).

Based on the document, here's an analysis of the acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

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

• No test set was used. The device received 510(k) clearance based on substantial equivalence to a predicate device, not on direct clinical or in-vitro testing of the proposed device.

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

• Not applicable. There was no test set or ground truth established for the proposed device through expert review. The submission relies on the established safety and effectiveness of the predicate device.

4. Adjudication Method for the Test Set

• Not applicable. No test set was used.

5. 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 concentrate solution for hemodialysis, not an AI-powered diagnostic device. Therefore, no MRMC study was performed or is relevant.

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

• Not applicable. This device is a concentrate solution for hemodialysis, not an algorithm.

7. The Type of Ground Truth Used

• "Predicate Device Equivalence Ground Truth": The ground truth for this submission is the established safety and effectiveness profile of the legally marketed predicate device (Fresenius USA, Acid Concentrate for Bicarbonate Dialysis, K810925). The fundamental assertion is that the proposed device, being chemically and functionally identical within expected ranges, thereby shares the same safety and effectiveness characteristics.

8. The Sample Size for the Training Set

• Not applicable. The device is a chemical concentrate, not a machine learning model. There was no "training set."

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

• Not applicable. There was no training set. The "ground truth" for granting clearance was the existing regulatory approval and market performance of the predicate device, which would have had its own rigorous testing and validation historically.

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