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The Fresenius Naturalyte® Granuflo® Dry Acid Concentrate is indicated in the treatment of acute and chronic renal failure during the hemodialysis procedure. This concentrate is formulated to be used with a three-stream hemodialysis machine which is calibrated for acid and bicarbonate concentrates.

The Fresenius Naturalyte® Granuflo® Dry Acid Concentrate is designed to be used as direct product replacement for the current Granuflo@ Concentrate (Series 1000, 2400, and 3000). The new product will be available in a non-granulated formula. It is used only during hemodialysis. It is manufactured using the same raw materials. The new Fresenius Naturalyte® Granuflo® Dry Acid Concentrate has the same chemical composition as the predicate devices. It is for single use only. It is supplied non-sterile and is non-pyrogenic.

The provided document is a 510(k) Premarket Notification for a medical device: Fresenius Naturalyte® Granuflo® Dry Acid Concentrate.

This document describes a submission for demonstrating substantial equivalence to a predicate device, rather than a study proving the device meets specific acceptance criteria for performance in the way clinical studies often do for novel devices.

Therefore, many of the requested categories for a clinical study on device performance are not applicable or cannot be extracted from this type of regulatory submission. The document explicitly states: "The safety and effectiveness of the Fresenius Naturalyte® Granuflo® Dry Acid Concentrate is supported by the substantial equivalence information, materials data, device description, and performance testing."

Here's a breakdown of what can be inferred or directly stated from the provided text, and where gaps exist:

1. Table of Acceptance Criteria and Reported Device Performance

This information is typically found in detailed test reports or clinical trial summaries. For a 510(k) submission based on substantial equivalence, the "acceptance criteria" revolve around demonstrating that the new device is as safe and effective as a legally marketed predicate device. The "performance" is generally demonstrated by showing identical or highly similar characteristics to the predicate.

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

• Sample Size: Not applicable in the context of a "test set" for a clinical study assessing performance in humans. The submission relies on "performance testing" of the product itself, "materials data," and "device description" to demonstrate substantial equivalence to existing predicate devices. Specific sample sizes for such engineering or chemical testing are not provided in this summary.
• Data Provenance: The document does not specify the country of origin for any "performance testing" data, nor whether it was retrospective or prospective. Given the nature of a chemical concentrate, direct patient data might not be the primary evidentiary support for substantial equivalence, but rather chemical and functional validation.

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

This information is not applicable. The basis for clearance is substantial equivalence to existing, legally marketed devices (predicates: Granulyte Powder Dialysate Concentrates and Mixer; K911459, and Granulyte Dialysate Concentrate; K922005). The "ground truth" for this type of submission is the established safety and effectiveness of the predicate devices and the demonstration that the new device is essentially the same. Expert consensus would apply to the FDA reviewers comparing the device.

4. Adjudication Method for the Test Set

Not applicable. There's no "test set" in the sense of a set of cases requiring adjudication by multiple experts. The FDA's review process determines substantial equivalence based on the submitted documentation compared to the predicate.

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

No. An MRMC study is typically performed for diagnostic imaging devices or software where human readers interpret results, often with and without AI assistance, to assess the impact of the AI. This device is a chemical concentrate for hemodialysis, and therefore, an MRMC study is not relevant or performed.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

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

7. The Type of Ground Truth Used

The "ground truth" for this 510(k) submission is the established safety and effectiveness of the predicate devices. The new device's characteristics (chemical composition, raw materials, intended use, technological characteristics, design features) are compared against these known predicates to demonstrate equivalence.

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. This is not an AI/ML device.

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