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For DA-100 series: This acid concentrate product is formulated for use in acute and chronic hemodialysis and to be used in conjunction with MedicaLyteTM bicarbonate, or an equivalent bicarbonate labeled for use in acute and chronic hemodialysis and having the same composition as MedicaLyteTM bicarbonate, in a 36.83X three-stream artificial kidney (hemodialysis) machine. -Or- For DA-200 series: This acid concentrate product is formulated for use in acute and to be used in conjunction with Medical yteTM bicarbonate, or an equivalent bicarbonate labeled for use in acute and chronic hemodialysis and having the same composition as MedicalyteTM bicarbonate, in a 45X three-stream artificial kidney (hemodialysis) machine. -Or- For DA-300 series: This acid concentrate product is formulated for use in acute and to be used in conjunction with MedicaLyteTM bicarbonate, or an equivalent bicarbonate labeled for use in acute and chronic hemodialysis and having the same composition as MedicaLyteTM bicarbonate, in a 35X three-stream artificial kidney (hemodialysis) machine.

The Nipro Dry Complete™ dry acid concentrate devices for hemodialysis are comprised of USP grade sodium chloride, USP grade magnesium chloride, USP grade calcium chloride, USP grade potassium chloride, USP grade dextrose, and USP grade acetic acid. These products may be used in conventional, commercially available hemodialysis machines or monitors as one of the necessary components of three-component hemodialysis solution, and are formulated for 36.83X (DA-100 series), 45X (DA-200 series), and 35X (DA-300 series) proportioning dialysis machines. The hemodialysis concentrate solutions presented in this 510(k) premarket notification are intended to be used in an appropriately proportioned three-stream hemodialysis machines (36.83X, 45X, or 35X as specified on the device label) in which bicarbonate concentrate is proportioned into one stream, an acid solution prepared from the Nipro Dry Complete™ dry acid concentrate device is proportioned into a second stream, and water is proportioned into the third stream of the hemodialysis machine proportioning system. These three streams are then mixed by the hemodialysis machine to prepare the final proportioned hemodialysis solution. The final hemodialysis solution is separated from the patient's blood by semi-permeable membranes which permit the passage of waste products and toxins contained in the patient's blood circulating through the hemodialyzer, and such waste products and toxins pass through the semi-permeable membranes into the hemodialysis solution and exit the hemodialyzer with the hemodialysis solution. By such treatment, waste products and toxins are removed from the patient's blood during acute and end-stage renal failure.

The provided text is a 510(k) summary for a medical device called "Nipro Dry Complete™ Dry Acid Concentrate for Hemodialysis." It describes the device, its intended use, and the studies conducted to demonstrate its substantial equivalence to predicate devices. However, it does not contain information related to an AI/ML-driven device or human-in-the-loop performance studies.

Therefore, I cannot extract the specific information requested in your prompt regarding acceptance criteria, study details for AI/ML performance, sample sizes for test/training sets, expert qualifications, or adjudication methods for ground truth, as these concepts are not applicable to the traditional medical device described in this document.

The document primarily focuses on:

• Device Description: The chemical composition and intended use of the dry acid concentrate for hemodialysis.
• Substantial Equivalence: Comparing the device to existing predicate devices based on chemical composition, manufacturing materials (bottles, bags), and intended use.
• Performance Testing: Chemical analysis to ensure the final solution meets specifications after mixing according to label instructions, transportation testing, biocompatibility, and endotoxin analysis. This is not a performance study of a diagnostic or AI-driven tool, but rather a quality control and safety assessment of a consumable medical product.
• Shelf Life and Sterilization: Stability testing and package integrity.

Here's an attempt to answer the prompt based on the available information, with the understanding that many requested points cannot be answered as they pertain to AI/ML or diagnostic device studies not covered here:

This document describes the Nipro Dry Complete™ Dry Acid Concentrate for Hemodialysis. This is a chemical concentrate used in hemodialysis machines, not an AI/ML diagnostic or image analysis device. Therefore, many of the requested criteria related to AI/ML performance, human-in-the-loop studies, multi-reader multi-case studies, and expert ground truth establishment are not applicable to this device and its 510(k) submission.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" for this product are related to its chemical composition, safety, and functionality as a hemodialysis concentrate.

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance

• Sample Size for Performance Testing: "Performance testing was conducted on three batches each of [specific DA-100 series, DA-200 series, and DA-300 series formulations – 15 total formulations listed]."
• Data Provenance: Not explicitly stated, but it's understood to be from internal laboratory testing conducted by or for Nipro Renal Solutions Corporation USA as part of their 510(k) submission for the US market. The document implies these were prospective tests of manufactured product.

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

• Not applicable. This device is a chemical concentrate. "Ground truth" in the context of device performance refers to whether the chemical composition and purity meet defined standards (e.g., ANSI/AAMI/ISO 13958:2014), which are established by scientific consensus and regulatory bodies, not by expert interpretation of data points.

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

• Not applicable. No human interpretation or adjudication of outputs is described or necessary for this type of chemical product testing.

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 is not an AI/ML diagnostic or image analysis device, nor does it involve human readers.

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

• Not applicable. This is not an algorithm.

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

• The "ground truth" for this device's performance is established by validated analytical chemistry methods confirming the concentrations of components and purity levels (e.g., endotoxin, bioburden) against predefined specifications from relevant consensus standards (e.g., ANSI/AAMI/ISO 13958:2014).

8. The sample size for the training set

• Not applicable. This device does not involve a training set as it is not an AI/ML model.

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

• Not applicable. As above, no training set information is relevant or provided.

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