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The capillary dialyzer is intended for use in hemodialysis and associated modalities for the treatment of chronic and acute renal failure.

The Gambro Polyflux 14L, 17L, and 21L Capillary Dialyzers/Filters, labeled for single use, have the same design, materials, intended use and function as other hemodialyzers / filters currently marketed in the United States. These devices are intended for use in hemodialysis for the treatment of acute and chronic renal failure. They may also be used in cases of acute fluid overload for the removal of plasma water. The membrane used in this device is a blend of polyarylethersulfone (PAES), PVP, and Polyamide, which is identical to the membrane used in the Gambro Polyflux H single use hemodialyzers cleared under 510K Notification (K030592) and the Polyflux L dialyzers cleared under 510(k) Notification (K010985). Blood enters a blood inlet port where it is distributed to the hollow fibers. The patient's blood traverses the inside of the hollow fibers and exits the device via a blood exit port. By means of a hydrostatic pressure or transmembrane pressure which is created by a combination of positive and negative pressures across the membrane, plasma water along with certain lower and middle molecular weight solutes pass through the membrane and into the dialysate or filtrate compartment of the device. Uremic toxins and waste products are removed from the patient's blood in this device by means of both diffusion and convection through the membrane and into the countercurrent flowing dialysis solution during hemodialysis. The dialysate exits the devices via a dialysate outlet port.

The provided text describes a 510(k) submission for the Gambro Polyflux 14L, 17L, and 21L Capillary Dialyzers/Filters. The submission argues for substantial equivalence to predicate devices (Polyflux 6L, 8L, 10L, and Polyflux 140K, 170H, 210H).

Here's an analysis of the acceptance criteria and study data based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific numerical acceptance criteria for performance metrics (e.g., clearance rates, ultrafiltration rates). Instead, it relies on demonstrating substantial equivalence to predicate devices. The primary acceptance criterion appears to be that the proposed devices "meet the same acceptance criteria as the predicate devices".

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

• Sample Size for Test Set: The document does not specify the sample size for either the in vitro or clinical tests.
• Data Provenance: The document does not explicitly state the country of origin or whether the studies were retrospective or prospective. Given the nature of a 510(k) submission involving clinical studies, it is likely that for the clinical data, it would have been prospective, but this is an assumption.

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

This information is not provided in the document. The studies conducted are related to device performance in hemodialysis, not diagnostic accuracy where expert ground truth establishment is typical.

4. Adjudication Method for the Test Set

This information is not applicable/provided. The evaluation methodology described focuses on comparing device performance parameters, not on interpretation or consensus among experts.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study investigates human reader performance, often with and without AI assistance, which is not relevant to the evaluation of a hemodialyzer device. The studies described are focused on the device's functional performance.

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

This concept is not applicable to this device. A hemodialyzer is a physical medical device, not an algorithm, and its performance is inherently "standalone" in mechanical function, albeit used by human operators. The in vitro and clinical tests described would assess the device's performance in isolation (in vitro) and in a clinical setting (with human operators, but not evaluating human interpretation).

7. The Type of Ground Truth Used

For the clinical studies, the "ground truth" would likely be patient physiological parameters and outcomes related to dialysis effectiveness (e.g., solute clearance, ultrafiltration success, patient well-being, absence of device-related adverse events). For the in vitro testing, the ground truth would be measured physical and chemical properties (e.g., membrane integrity, fluid flow rates, solute removal efficiency) against established engineering and biological standards for dialysis. The document states "clinical studies demonstrated that the proposed Polyflux 14L, 17L and 21L meet the same acceptance criteria as the predicate devices," implying objective, measurable clinical outcomes were the basis.

8. The Sample Size for the Training Set

This information is not applicable and not provided. A "training set" is relevant to machine learning algorithms. This submission is for a physical medical device.

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

This information is not applicable and not provided as a "training set" is not relevant for this device.

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