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This concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates

The Fresenius Naturalyte® Sodium Bicarbonate Liquid Concentrate is a modified version of the Fresenius Biosol Powder Bicarbonate Concentrate. The Fresenius modified Naturalyte® Sodium Bicarbonate Liquid Concentrate is substantially equivalent in chemical formulation, chemical composition, and intended use to the commercially available Biosol Powder Bicarbonate Concentrates currently distributed as Fresenius Naturalyte® Dry Pack Bicarbonate Concentrates.

This document is a 510(k) Premarket Notification for a medical device called "Fresenius Naturalyte® Sodium Bicarbonate Liquid Concentrate "Special"". It is a submission to the FDA to demonstrate substantial equivalence to a predicate device.

Based on the provided text, a conventional acceptance criteria and study report of device performance in the typical sense (e.g., sensitivity, specificity, accuracy, etc., for a diagnostic device, or clinical outcome data for a therapeutic device) are not applicable because:

1. Device Type: This is a submission for a dialysate concentrate, which is a medical fluid used in hemodialysis. It is not a diagnostic imaging device, a treatment device with a measurable "performance" in terms of clinical outcomes presented in this document, or an AI-powered system.
2. Nature of the Submission: This is a 510(k) Premarket Notification, which aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. This equivalence is typically proven by showing similar intended use, technological characteristics, and safety/effectiveness profiles, rather than through a detailed clinical efficacy trial with specific performance metrics and acceptance criteria in the way envisioned by the prompt's questions.
3. Content of the Document: The document focuses on comparing the modified device to its predicate in terms of chemical formulation, composition, and intended use. It explicitly states: "The Fresenius modified Naturalyte® Sodium Bicarbonate Liquid Concentrates is a modified versions of the Biosol Powder Bicarbonate Concentrates. The technological characteristics of the modified devices are equivalent to those of the unmodified devices and raise no new types of safety or effectiveness questions."

Therefore, the prompt's questions regarding acceptance criteria, device performance, sample sizes for test/training sets, experts, adjudication methods, MRMC studies, standalone performance, and ground truth are not directly addressed or applicable to this type of regulatory submission for this specific device.

Instead, the "acceptance criteria" can be broadly interpreted as the FDA's criteria for determining "substantial equivalence," and "device performance" as successful demonstration of that equivalence.

Here's how to interpret the provided information given the context of a 510(k) submission for a dialysate concentrate:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (for Substantial Equivalence via 510(k)):

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

• Not Applicable in the traditional sense. This submission does not report results from a clinical "test set" for performance metrics like sensitivity or specificity. Equivalence is primarily based on the chemical and functional characteristics compared to the predicate, and a statement about "testing of the modified device" which likely refers to bench testing or analytical chemistry, not human subject data in the way implied by the question.
• Data Provenance: Not explicitly stated as human subject data. Chemical characteristic data would be from laboratory analysis.

3. Number of Experts and Qualifications for Ground Truth

• Not Applicable. The "ground truth" here is the regulatory determination of substantial equivalence, based on the provided documentation and comparison to the predicate device, reviewed by FDA staff. It does not involve expert consensus on clinical findings in a dataset.

4. Adjudication Method for the Test Set

• Not Applicable. No test set or adjudication process for human-interpreted data is described. The FDA performs regulatory review.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. This is not an imaging device or an AI system that would typically involve an MRMC study to compare human readers with and without AI assistance.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

• Not Applicable. This is a chemical concentrate, not an algorithm or AI system.

7. Type of Ground Truth Used

• The "ground truth" for this 510(k) submission is the chemical formulation, composition, and intended use of the predicate device (Fresenius Biosol Powder Bicarbonate Concentrate K981043). The modified device is compared against these known characteristics to establish substantial equivalence. Implicitly, safety and effectiveness knowledge about the predicate device forms part of this "ground truth."

8. Sample Size for the Training Set

• Not Applicable. There is no "training set" in the context of an AI/ML algorithm for this device.

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

• Not Applicable. As there is no training set, this question is not relevant. The "ground truth" (predicate device's characteristics) was established through its prior regulatory clearance (K981043) and its documented chemical and functional properties.

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