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The Rockwell Medical CitraPure® Acid Concentrates powders and liguids 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 CitraPure® Acid Concentrates for Bicarbonate Dialysis are available in liquid and dry forms and contain salt, sugar, and non-sugar 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 and 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 hemodialysis solution. The hemodialysis concentrate solutions and powders presented in this 510(k) Notification are intended to be used in three stream hemodialysis machines in which an acidified concentrate is proportioned into one stream, a bicarbonate concentrate solution prepared by mixing bicarbonate, chloride, and sodium concentrate with a specified volume of water is proportioned into the second stream, and purified water is proportioned into the third stream. These three streams are then mixed to prepare a final proportioned hemodialysis solution.

The CitraPure® series formulas are manufactured using the same validated processes, same packaging, and same USP grade ingredients. The only difference is that the raw material ingredient amounts are varied to create different formulas. This 510(k) notification establishes ranges for each concentrate ingredient, with the intent of creating different formulas by varying ingredient quantities within these established ranges using design control. Use of an approved dialysis concentrate formula range is necessary to permit the physicians flexibility to prescribe appropriate treatment meeting specific patient needs.

The provided text is a 510(k) summary for a medical device called "Rockwell Medical CitraPure® Acid Concentrates." This document is a regulatory submission to the FDA for demonstrating substantial equivalence to a predicate device, rather than a clinical study report describing product performance against specific acceptance criteria in a human-in-the-loop setting. Therefore, some of the requested information (like MRMC studies, human reader improvement, and expert ground truth establishment for a test set) is not applicable to this type of document.

However, I can extract information related to the device's technical specifications and how its performance was evaluated non-clinically.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the chemical composition are based on the ANSI/AAMI 13958 standard.

Study Details

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

   • Test Set Sample Size: Not explicitly stated as a "test set" in the context of clinical or AI performance evaluation. The testing performed was "in vitro testing... to determine the chemical composition and range of composition." The document does not specify the number of batches or samples tested, but rather refers to "validated analytical methods."
   • Data Provenance: The testing was "in vitro testing" performed by the manufacturer, Rockwell Medical. The country of origin of the data is not explicitly stated but implied to be within the company's manufacturing and testing facilities (likely USA, given the FDA submission). This is a prospective evaluation of the product's chemical properties against an engineering standard, not retrospective data.

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

   • Not Applicable. For this type of chemical concentrate device, "ground truth" is established by validated analytical chemistry methods and adherence to a recognized standard (ANSI/AAMI 13958). There are no human "experts" establishing ground truth in the way clinical diagnostic devices might have radiologists or pathologists.

3. Adjudication method for the test set:

   • Not Applicable. As no expert consensus or human interpretation was involved, no adjudication method was necessary. The evaluation was based on analytical measurement against predefined chemical specifications.

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 is a chemical concentrate for hemodialysis, not an AI or diagnostic imaging device. No MRMC study or evaluation of human reader performance was conducted or is relevant.

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

   • Not Applicable. This is not an algorithmic or software-only device. The "standalone" performance here refers to the chemical and physical properties of the concentrate itself, which was evaluated through in-vitro analytical testing.

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

   • The "ground truth" for the device's performance in this context is adherence to chemical specifications as defined by the ANSI/AAMI 13958 standard for concentrates used in hemodialysis. This is a technical/analytical standard, not clinical ground truth derived from expert consensus, pathology, or patient outcomes.

7. The sample size for the training set:

   • Not Applicable. This device is a chemical product, not an AI or machine learning algorithm. Therefore, there is no "training set." The various formulas listed in Table 2 (pages 5-6) represent the intended formulations to be marketed within the approved ranges, not a training set for an algorithm.

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

   • Not Applicable. Since there is no training set for an algorithm, the concept of establishing ground truth for it does not apply. The chemical formulations are designed and verified against established chemical standards.

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