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The Fresenius Ultraflux dialyzer is designed for single use acute and chronic hemodialysis.

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The presented document is a 510(k) Premarket Notification for the Fresenius Ultraflux Single Use Hemodialyzer. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving a new device's efficacy through a clinical study with detailed acceptance criteria as one might find in a PMA application or for novel software devices.

Here's a breakdown based on the provided text, addressing your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of acceptance criteria with specific thresholds for performance metrics. Instead, it states that "In vitro testing was performed to determine the following: priming volume, bloodside and dialysate-side pressure drops, ultrafiltration coefficient, urea clearance, creatinine clearance, Vitamin B12 clearance, phosphate and lysozyme clearance." The acceptance criteria for these tests are implicitly that the Ultraflux dialyzer performs "substantially equivalent" to the predicate devices (Fresenius Optiflux 200NR and Gambro Polyflux 17S) for its intended use.

Therefore, for this device, a direct table of numerical "acceptance criteria" and "reported device performance" in the way you might expect for a diagnostic or AI device is not available in the provided text. The "acceptance criteria" here is met by demonstrating performance equivalent to legally marketed predicate devices through in vitro testing.

2. Sample Size for the Test Set and Data Provenance

• Sample Size for the Test Set: Not explicitly stated in the document. The testing described is "in vitro testing," which generally refers to laboratory bench tests.
• Data Provenance: The data is generated from in vitro testing of the Fresenius Ultraflux hemodialyzers. The document does not specify the country of origin for these specific tests, but it's for a device from "Fresenius Medical Care North America." The testing is analogous to prospective data collection in a lab setting, as the tests are performed on the device itself to assess its characteristics.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable to this 510(k) submission. The ground truth for this medical device is established by its physical and functional characteristics measured through standardized in vitro tests, not by expert consensus on interpretations of data (like medical images).

4. Adjudication Method for the Test Set

Not applicable. There is no "adjudication method" in the context of expert consensus as described for an AI/diagnostic device, since the testing is in vitro and objective.

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

No. An MRMC comparative effectiveness study is not relevant for this type of medical device (a hemodialyzer). This type of study investigates the performance of human readers, sometimes with AI assistance, in interpreting medical data. The hemodialyzer is a therapeutic device, not a diagnostic one involving human interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This is not a software algorithm or AI device; it is a physical medical device (hemodialyzer). Its performance is assessed directly through in vitro measurements.

7. Type of Ground Truth Used

The ground truth is based on objective measurements from in vitro testing of the device's physical and functional properties (e.g., priming volume, pressure drops, clearance rates, ultrafiltration coefficient). These measurements are then compared to the known performance characteristics of the predicate devices to demonstrate substantial equivalence.

8. Sample Size for the Training Set

Not applicable. There is no "training set" as this is not a machine learning or AI device that requires training data.

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

Not applicable, as there is no training set for this type of device.

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