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Intended to relieve or mitigate overhydration in patients undergoing cardiopulmonary procedures and to increase the concentration of cells and proteins in the blood.

The Low Volume Hemoconcentrator is similar to the F Series F400 Hemoconcentrator. Both hemoconcentrators are hollow fiber-type filters and will be provided with and without a tubing set. The Low Volume Hemoconcentrator has an active membrane surface area of 0.35M2 and a priming volume of 27 ml.

The provided text describes a 510(k) submission for a device modification, specifically the Fresenius F Series Low Volume Hemoconcentrator. This document is a regulatory submission for a medical device whose performance is characterized by physical specifications and in-vitro performance rather than clinical outcomes or diagnostic accuracy. Therefore, many standard AI/ML evaluation metrics like sensitivity, specificity, or AUC, and ground truth establishment methods typically associated with clinical studies, are not applicable here.

The "acceptance criteria" and "device performance" are presented as a comparison table between the modified device and its predicate device, demonstrating that the new device meets the necessary physical and performance characteristics to be considered substantially equivalent.

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

The acceptance criteria for this device are implicitly defined by its substantial equivalence to the predicate device (F400 Hemoconcentrator, K974584), meaning its specifications and performance characteristics must be comparable or within acceptable ranges relative to the predicate. The reported device performance for the new "Low Volume Hemoconcentrator" is shown in the table below, alongside the predicate device's data for comparison.

Note: For parameters like Active Membrane Surface, Priming Volume, Number of Fibers, Max. Blood Flow, Pressure Drop, and Ultrafiltration Rate, changes are expected due to the "Low Volume" nature of the device modification. The "Met?" column indicates whether the new device's characteristic is identical to the predicate (Yes) or if it's a designed difference due to the modification (N/A – meaning it's not expected to be identical but aligns with the intended modification and is presumed acceptable by the FDA for substantial equivalence).

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

The document does not detail specific "test set" sample sizes in the context of clinical or performance data collection on multiple units. The data presented is for the design specifications and nominal performance characteristics of the device itself.

• Sample Size: Not explicitly stated as this is a device modification submission based on technical specifications and in-vitro performance, not a clinical trial. The performance characteristics (e.g., pressure drop, ultrafiltration rate) are likely derived from bench testing or engineering calculations based on the design, rather than a "test set" of many devices.
• Data Provenance: Not specified, but generally, such technical specifications and in-vitro test data would be generated within the manufacturing and R&D facilities of Fresenius Hemotechnology Inc. (location: Concord, CA). The data is not derived from human subjects, thus "retrospective or prospective" is not applicable in the typical clinical sense.

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 to this type of device submission. There is no "ground truth" established by experts in the sense of clinical diagnoses or interpretations for this mechanical device. The "truth" lies in the engineering specifications and in-vitro performance data, which are verified through standard engineering and laboratory testing protocols.

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

Not applicable. This is not a study involving human interpretation or clinical adjudication.

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

Not applicable. This device is a hemoconcentrator, not an AI/ML-enabled diagnostic or therapeutic device that would involve human readers or AI assistance.

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

Not applicable. This device is a physical medical device, not an algorithm or software.

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

The "ground truth" for this device modification is the verified engineering specifications, material properties, and in-vitro performance measurements (e.g., pressure drop, ultrafiltration rates) obtained through standardized laboratory testing and quality control processes. This is analogous to "bench testing" or "design verification" rather than clinical "ground truth."

8. The sample size for the training set

Not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set."

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

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

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