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For LC+100 Series: This acid concentrate is formulated for use in acute and chronic hemodialysis, and is to be used in conjunction with Nipro MedicaLyte™ bicarbonate concentrate, or an equivalent bicarbonate concentrate of the same composition, in a 36.83X proportioning three-stream hemodialysis machine.

For LC+200 Series: This acid concentrate is formulated for use in acute and chronic hemodialysis, and is to be used in conjunction with Nipro MedicaLyte™ bicarbonate concentrate, or an equivalent bicarbonate concentrate of the same composition, in a 45X proportioning three-stream hemodialysis machine.

The Citric Complete™ Liquid Citric Acid Concentrate products are single-use, non-sterile devices intended for use in hemodialysis therapy for acute and chronic renal failure. These products are designed to be used as one (1) component in the preparation of dialysate in a three (3)-stream proportioning hemodialysis machine according to a physician's prescription.

The subject devices are formulated to be compatible with 36.83X proportioning (proposed LC+100 series devices), as well as 45X proportioning (proposed LC+200 series devices) hemodialysis machines, in which bicarbonate concentrate is proportioned into one stream, this Citric Complete™ Liquid Acid Concentrate is proportioned into a second stream, and RO water is proportioned into third stream. These three streams are then mixed by the hemodialysis machine in distinctly specific ratios to prepared hemodialysis solution, or final dialysate.

The Citric Complete™ Liquid Citric Acid Concentrate products 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 citric acid.

The final dialysate solution is pumped to the dialysis system, known as the dialyzer or hemodialyzer, through which the patient's blood also flows in the opposite direction. The dialysate is separated from the patient's blood by semi-permeable membranes in the hemodialyzer, which passage of waste and toxins from the circulating blood into the hemodialysis solution. The used dialysate is disposed, while the patient blood is recirculated back into the patient with acute and end-stage renal failure can effectively have their blood filtered of wastes and toxins without the proper functioning of his or her kidneys.

The provided text describes a medical device called "Citric Complete™ Liquid Citric Acid Concentrate" and its FDA 510(k) clearance (K223431). However, the document is a 510(k) summary and does not contain detailed information about specific acceptance criteria and a study proving those criteria are met for AI/ML devices.

The document states:
"Internal verification and validation testing confirms that the Citric Acid Concentrate meets specifications equivalent in design and technological characteristics to the predicate devices. The subject device complies with all applicable voluntary consensus standards for performance, package integrity and biocompatibility. There are no significant differences with respect to any of the above presented predicate devices, and therefore a finding of substantial equivalence is deemed appropriate for the proposed Citric Complete™ Liquid Citric Acid Concentrate."

And:
"Testing was accomplished by formulating the dialysis liquid concentrate pursuant to the instructions on the device labels and measuring the concentrations of all components to ensure that by following the label instructions, end users can generate a final dialysate consistent with the values as specified on the Citric Acid Concentrate label. All testing was conducted pursuant to ANSI/AAMI/ISO 23500-4:2019. All requirements were met. All samples from all batches of each device tested were within acceptable limits for that product, as set by ANSI/AAMI/ISO 23500-4:2019."

This indicates that the device is a liquid concentrate, not an AI/ML powered device. The "acceptance criteria" and "study" described are chemical and performance specifications for the concentrate itself, and the study involves chemical analysis to ensure the concentrate produces a final dialysate consistent with specifications.

Therefore, most of the information requested in your prompt (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth types, training set size) is not applicable to this type of device and is not present in the provided text.

Based on the available information from the text, here's what can be inferred:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated, but implied to be "All samples from all batches of each device tested". This suggests multiple batches and multiple samples per batch were tested. The exact number of samples is not provided.
• Data Provenance: The testing was "internal verification and validation testing" conducted by the manufacturer, Nipro Renal Solutions USA, Corp. The country of origin of the data is not specified beyond being generated internally by this US-based company. The study is prospective, as it involves testing newly manufactured product batches.

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

• Not applicable. The ground truth is based on chemical specifications (target concentrations of components in the final dialysate) and compliance with international standards (ANSI/AAMI/ISO 23500-4:2019), not expert interpretation of data.

4. Adjudication method for the test set:

• Not applicable. The "ground truth" is determined by established chemical specifications and compliance with standards, not discretionary human judgment requiring adjudication.

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 device, nor does it involve human readers or image interpretation.

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

• Not applicable. This is not an AI/ML device.

7. The type of ground truth used:

• Chemical specifications (target concentrations of active ingredients in the final dialysate) and compliance with established international standards (ANSI/AAMI/ISO 23500-4:2019).

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable.

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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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