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The Di-Chem, Inc. Citryte Acid Concentrate for bicarbonate dialysis is indicated for use in the treatment of acute and chronic hemodialysis. It is to be used with the appropriate hemodialysis machine and sodium bicarbonate.

The Di-Chem, Inc. proposed Citryte hemodialysis acid concentrate is provided in dry form and is for use in sodium bicarbonate dialysis. Citryte is comprised of sodium chloride (100.0mEq/L), potassium chloride (1.0-3.0mEq/L), calcium chloride (2.0-3.0mEq/L), magnesium chloride ( 1.0 mEq/L), dextrose ( 100 mg%), and citric acid (2.4mEq/L). All of the chemical constituents meet USP grade or equivalent. The proposed device will be manufactured, tested and labeled in accordance to ANSI/AAMI 13958:2014 guidelines. Each of the proposed formulations will be offered in three different mix volumes, 16.5 gallon, 20 gallon and 25 gallon to meet the three mix volume sizes of the current commercially available hemodialysis mixing machines. Each case of product contains the measured amount of each chemical component corresponding to the labeled product formula and listed final solution volume. The product packaging consists of two equal weight bags of sodium chloride, one bag of dextrose and one bag containing the citric acid, potassium chloride, calcium chloride and magnesium chloride. Each product bag is labeled indicating its contents, lot number, use by date, and product formula. The product bags are comprised of polyethylene and are 18"x24"x0.004". The four bags are then packaged into one corrugate box. Each box will contain all of the chemical components to make one of the three available volumes of the labeled formulation. The product is intended to be mixed into solution using water meeting or exceeding ANSI/AAMI Hemodialysis Water Quality Standards utilizing commercially available hemodialysis concentrate mixers in accordance with the mixer manufacturer's directions. These chemicals when in solution are intended to be used as the acid portion of a three part hemodialysis treatment in conventional commercially available hemodialysis machines or monitors in providing a hemodialysis treatment. The hemodialysis formulations presented in this 510(k) notification are intended to be used in a three-stream hemodialysis machine in which an acid concentrate (Citryte) is proportioned into one stream, a sodium bicarbonate concentrate solution is proportioned into another stream and a specified volume of water is proportioned into the remaining stream of the hemodialysis machines proportioning system. These three streams are then mixed by the hemodialysis machine to prepare a final proportioned hemodialysis solution. These proportioned hemodialysis solutions are then heated to body temperature and pumped through the hemodialysis compartment of a hemodialyzer (artificial kidney). These hemodialysis solutions are separated from the patient's blood by a semi-permeable cellulosic or non-cellulosic membrane which functions as a molecular weight selective barrier to the passage of molecules above a certain molecular weight. The semi-permeable membrane in the hemodialyzer permits the passage of both ionized and non-ionized molecules, waste products and toxins including blood urea, nitrogen, creatinine and potassium contained in the patient's blood circulating through the hemodialyzer to pass through the semi-permeable membrane into the hemodialysis solution then circulating back to the hemodialysis machine where the solution is ultimately discarded. The ionic and molecular composition of the hemodialysis solution establishes the concentration gradient between the patient's 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. Since different patients have different requirements for the removal rates and quantities of the various molecules and toxins in acute and end-stage renal failure it is necessary to have a variety of different hemodialysis solution formulations to satisfy the needs of all renal failure patients. For this reason the Citryte is offered in multiple formulations containing varying amounts of potassium chloride and calcium chloride.

The document provided is a 510(k) premarket notification for a medical device called Citryte™ Acid Concentrate. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device rather than proving safety and effectiveness through clinical trials. Therefore, the information requested, particularly regarding clinical study design, ground truth establishment, expert adjudication, and sample sizes for training/test sets in the context of an AI/ML device, is not applicable to this submission.

However, I can extract the acceptance criteria and the (non-clinical) study details that demonstrate the device meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The study that proves the device meets the acceptance criteria is an in vitro non-clinical test.

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

• Test Set Sample Size: Not explicitly stated as a number of distinct "samples" in the traditional sense of a clinical or imaging study. The testing was done on the chemical composition of the manufactured device.
• Data Provenance: The testing was "in vitro" and performed by Di-Chem, Inc. ("utilizing our standard operating procedures"). This is a manufacturer's internal testing. Not specified if retrospective or prospective, but typically such verification testing would be prospective for new product batches or formulations.

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

This is Not Applicable (N/A). The ground truth for the chemical composition is based on the ANSI/AAMI 13958:2014 standard specifications for concentrates for hemodialysis and analytical chemistry methods. It does not involve expert readers or interpretations in the medical sense.

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

N/A. Adjudication methods are relevant for subjective interpretations (e.g., image reading). Here, the assessment is objective chemical analysis against a standard.

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:

N/A. This is a chemical concentrate for hemodialysis, not an AI/ML-driven diagnostic or assistive device that would involve human readers.

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

N/A. Not an AI/ML device.

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

The ground truth used for evaluating the chemical composition of the Citryte™ Acid Concentrate is based on established chemical analytical methods and adherence to the ANSI/AAMI 13958:2014 standard. The standard specifies the acceptable ranges for electrolytes and glucose in hemodialysis concentrates.

8. The sample size for the training set:

N/A. This is not an AI/ML device; therefore, there is no "training set."

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

N/A.

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