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For DB-203; DB-204; DB-205;

This product is formulated to be used in conjunction with MedicaPure® liquid acid concentrate on equivalent in a 36.83x three-stream artificial kidney (hemodialysis) machine for use in treating a patient in need of hemodialysis.

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For DB-206; DB-207; DB-208:

This product is formulated to be used in conjunction with MedicaPure® liquid acid concentrate or equivalent in a 45x three-stream artificial kidney (hemodialysis) machine for use in treating a patient in need of hemodialysis.

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For DB-209; DB-210; DB-211:

This product is formulated to be used in conjunction with MedicaPure® liquid acid concentrate or equivalent in a 35x three-stream artificial kidney (hemodialysis) machine for use in treating a patient in need of hemodialysis.

The MedicaLyte® Bicarbonate Powder devices for bicarbonate dialysis are comprised of USP grade sodium bicarbonate for 35X (DB-209, DB-210 and DB-211) and 45X (DB-206, DB-207 and DB-208) proportioning dialysis machines and USP grade sodium bicarbonate and USP grade sodium chloride for 36.83X proportioning dialysis machines (DB-203, DB-204 and DB-These products may be used in conventional, commercially available hemodialysis 205). machines or monitors as one of the necessary components of three-component hemodialysis solution. The hemodialysis concentrate solutions presented in this 510(k) premarket notification are intended to be used in three-stream hemodialysis machines in which an acid concentrate is proportioned into one stream, a bicarbonate solution is prepared from the bicarbonate powder 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 hemodializer, and such waste products and toxins pass through the semi-permeable membranes into the hemodialysis solution and exit the hemodializer 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 describes a 510(k) premarket notification for a medical device, MedicaLyte® Bicarbonate Powder. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria in the context of diagnostic performance.

Therefore, many of the requested elements for a study proving a device meets acceptance criteria (e.g., sample size for test sets, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set details) are not applicable to this type of regulatory submission for this specific product.

The acceptance criteria for a 510(k) submission like this are generally met by demonstrating that the new device has the same intended use and similar technological characteristics as legally marketed predicate devices, without raising new questions of safety or effectiveness.

Here's an analysis based on the provided document:

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

For a 510(k) submission based on substantial equivalence for a chemical concentrate, the "acceptance criteria" are typically defined by demonstrating that the new device's chemical composition and yield, when prepared according to label directions, are equivalent to those of established predicate devices. The "reported device performance" is the chemical output of the new device when prepared as directed.

Note: The tables in the original document (Table 1, 2, and 3) explicitly state that "The Volume, Component and Yield columns apply equally to the Device and Predicate Device." This is a direct statement of equivalence, which serves as the "acceptance criteria" being met.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. For chemical concentrates, testing typically involves laboratory analysis of the chemical properties of the prepared solutions, not a "test set" of patient data or clinical images. The data provenance would likely be from the manufacturer's internal quality control and analytical chemistry labs, but these specifics are not stated.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable. "Ground truth" in the context of chemical composition is established through analytical chemistry methods and adherence to pharmacopeial standards (USP grade), not through expert consensus in the same way it would be for a diagnostic image.

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

This is not applicable for this type of device and submission. Adjudication methods are relevant for clinical assessments, especially in cases of subjective interpretation or when establishing a clinical diagnosis.

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

This is not applicable. MRMC studies and AI assistance are relevant for diagnostic devices that involve human interpretation of medical images or data. This device is a chemical concentrate.

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

This is not applicable. This device is a chemical concentrate, not an algorithm or an AI-based system.

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

The "ground truth" for this device is based on analytical chemistry verification against established specifications for pharmaceutical-grade ingredients (USP grade sodium bicarbonate and sodium chloride) and the expected mEq/L yield when reconstituted according to label directions. This is implicitly compared to the known specifications and performance of the predicate devices.

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of an AI/ML algorithm or a complex diagnostic device for this chemical concentrate.

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

This is not applicable for the same reasons as point 8.

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