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The Di-Chem Inc. Hemo-Lyte C cartridge is indicated for use in bicarbonate hemodialysis for acute and chronic renal failure, or intoxication with dialyzable substances.

The Di-Chem Hemo-Lyte C sodium bicarbonate cartridge for hemodialysis is a dry powder concentrate used to prepare sodium bicarbonate concentrate solution for use in conventional hemodialysis. The Hemo-Lyte C cartridge is a single use/non-refillable polypropylene cartridge containing a measured amount of sodium bicarbonate (USP Hemodialysis grade) which enables the online preparation of bicarbonate hemodialysis solution on commercially available hemodialysis machines/monitors equipped for use with bicarbonate cartridges.

The provided text describes a 510(k) premarket notification for the Di-Chem Hemo-Lyte C Cartridge, a dry powder sodium bicarbonate concentrate for hemodialysis. The submission demonstrates substantial equivalence to predicate devices through non-clinical testing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

It appears there are multiple test sets for different aspects of the device.

• In vitro Chemical Composition: The sample size for this specific test is not explicitly stated. The text mentions "Testing was performed in accordance with our standard operating procedures utilizing validated equipment and analytical methods." The data provenance is internal testing by Di-Chem, Inc. (retrospective).
• Transportation Testing: The sample size is not explicitly stated, but it was performed on "the proposed Hemo-Lyte C cartridge." Data provenance is internal testing by Di-Chem, Inc. (retrospective).
• Biocompatibility Testing: The sample size for each specific ISO 10993 test is not detailed. Data provenance is internal testing by Di-Chem, Inc. (retrospective).
• Shelf-Life Verification: The sample size is not explicitly stated, but it involved "aged product." Data provenance is internal testing by Di-Chem, Inc. (retrospective).
• Bench Testing (Nipro SURDIAL DX compatibility): "12 total cartridges consisting of 3 samples from each of the proposed weight sizes were tested." This would be (3 samples/weight size * 5 weight sizes) = 15 cartridges, not 12, or 12 cartridges distributed among the weight sizes. The text says "3 samples from each of the proposed weight sizes were tested" and later "12 total cartridges". It is unclear if these are referring to the same thing, or if 12 are a subset of the 15. Assuming it refers to the 12 total, the provenance is internal testing by Di-Chem, Inc. (retrospective).
• Endotoxin Analysis: "60 total test samples comprised of three different lots of sodium bicarbonate. 30 samples from the pre-stability performance testing and 30 samples from the conclusion of the shelf-life study were tested." Data provenance is internal testing by Di-Chem, Inc. (retrospective).

The data provenance for all tests is from internal testing conducted by Di-Chem, Inc. and is retrospective in nature, as it refers to performance testing completed before the 510(k) submission. No specific country of origin for the data is mentioned beyond the manufacturing company's location in the US.

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

The concept of "experts" and "ground truth" in the traditional sense (e.g., medical diagnoses for AI algorithms) does not directly apply here. This is a medical device for preparing a dialysate solution, and the "ground truth" is defined by established engineering and chemical standards (ANSI/AAMI 13958:2014, ASTM D4169-16, ISO 10993). The "experts" would be the engineers, chemists, and quality control personnel within Di-Chem, Inc. responsible for conducting and interpreting the tests according to these standards, but their specific number and qualifications (e.g., "radiologist with 10 years of experience") are not detailed.

4. Adjudication Method for the Test Set

Not applicable for this type of device and testing. Adjudication (e.g., 2+1, 3+1) is typically used in clinical studies involving multiple human readers to establish a reconciled ground truth for diagnostic accuracy, which is not the nature of these non-clinical, bench, and chemical tests. The results are compared against defined numerical specifications from recognized standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study would be relevant for diagnostic imaging devices where human readers interpret results, and it is not applicable to a hemodialysis cartridge that involves chemical and physical performance verification.

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

This question is not applicable. The Hemo-Lyte C Cartridge is a physical medical device, not an AI algorithm. Its performance is inherent to its physical and chemical properties and interaction with a hemodialysis machine.

7. The Type of Ground Truth Used

The ground truth for all performance tests is based on established regulatory and industry standards, specifically:

• ANSI/AAMI 13958:2014 (Concentrates for Hemodialysis and Related Therapies) for chemical composition, shelf-life, and endotoxin limits.
• ASTM D4169-16 (Standard Practice for Performance Testing of Shipping Containers and Systems) for transportation durability.
• ISO 10993 (Biological evaluation of medical devices) for biocompatibility.

These standards define the acceptable range and performance characteristics of such devices.

8. The Sample Size for the Training Set

This question is not applicable. Training sets are relevant for machine learning algorithms. The Hemo-Lyte C Cartridge is a physical device, and its development and verification rely on traditional engineering and chemical testing, not machine learning or AI models that require training data.

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

This question is not applicable, as there is no training set for this type of device.

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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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The Di-Chem Liquid Sodium Bicarbonate solutions are indicated for use in the treatment of acute and chronic hemodialysis and to be used with an appropriate hemodialysis machine/monitor.

Not Found

I apologize, but this document is a 510(k) clearance letter from the FDA for a medical device (Di-Chem Hemo-Lyte Bicarbonate Solution). It primarily focuses on the regulatory aspects of device marketing and substantial equivalence to a predicate device.

The document does not contain information about:

1. Acceptance criteria and reported device performance
2. Sample sizes, data provenance, number of experts, adjudication methods for a test set
3. MRMC comparative effectiveness studies
4. Standalone (algorithm-only) performance studies
5. Type of ground truth used
6. Training set sample size or ground truth establishment for a training set

Therefore, I cannot extract the requested information as it is not present in the provided text. This letter confirms that the device is substantially equivalent to a legally marketed predicate and can be marketed, but it doesn't detail the performance studies and criteria that would be found in a design document, test report, or clinical study summary.

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The DI-CHEM Sodium Bicarbonate powders are indicated for use in the treatment of acute and chronic hemodialysis and to be used with an appropriate hemodialysis machine/monitor.

Not Found

I'm sorry, but your prompt asks for details about acceptance criteria, study design, and ground truth for a medical device's performance, as if it were a software or AI/ML-based device. However, the provided document is a 510(k) clearance letter from the FDA for a product named "Di-Chem Hemo-Lyte Hemodialysis Grade Sodium Bicarbonate Powder."

This document is for a chemical product used in hemodialysis, not an AI/ML or software-based medical device. Therefore, the concepts of "acceptance criteria" and "study design" for device performance (like accuracy, sensitivity, specificity, etc.), "sample size for test set," "data provenance," "number of experts for ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," and "training set size" as they relate to AI/ML or diagnostic device performance are not applicable to this type of product or document.

The 510(k) clearance for this product primarily focuses on its substantial equivalence to a legally marketed predicate device, ensuring its safety and effectiveness for its intended use (treatment of acute and chronic hemodialysis with an appropriate machine). The "acceptance criteria" here would relate to the chemical composition, purity, and manufacturing standards, not to an algorithmic performance evaluation.

Therefore, I cannot extract the information requested in your numbered list from the provided text because it describes a different type of medical device's regulatory review.

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