Search Results

The Polyflux 6H is intended for chronic and acute applications in hemodialysis, hemodiafiltration and hemofiltration on small patients including pediatric indications, considering blood flow, body weight and extracorporeal blood volume.

The Gambro Polyllex 6H 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 device is intended for use in hemodialysis, hemolitiration for the treatment of acute and chronic renal failure. Considering blood flow, body weight and extracorporeal blood volume, the Polyflux 6H is intended for pediatric indication. The membrane used in this device is a blend of polyarylethersulfone (PAES), PVP, and Pobvanide, which is identical to the membranc used in the Gambro Polyflux H single use hemodialyzers cleared under 510(k) 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 is a 510(k) summary for the Gambro Polyflux 6H Capillary Dialyzer. It does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics in the way you've outlined for an AI/software device.

This document describes a medical device (a dialyzer) and substantiates its safety and effectiveness through substantial equivalence to previously cleared predicate devices, rather than through a standalone performance study with defined acceptance criteria for classification purposes as you've presented in your query steps.

Therefore, most of the requested fields cannot be filled from the provided document.

Here's a breakdown of what can be extracted and why other fields are N/A:

1. Table of acceptance criteria and the reported device performance:

   • Acceptance Criteria: Not explicitly stated as pass/fail thresholds for performance metrics. The implicit acceptance criterion is "perform as well as the predicate devices," meaning the new device's performance should be comparable.
   • Reported Device Performance: The document states, "Testing performed on the Gambro Polyflux Dialyzers / Filters indicates that they are safe, effective and perform as well as the predicate devices, when used in accordance with the instructions for use." This is a general statement of equivalency based on presumably conducted tests (though not detailed here), rather than specific quantified performance data.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This summary refers to "testing performed" but does not detail the nature of these tests, sample sizes, or data provenance. It's likely that the "tests" refer to bench testing or performance characteristic comparisons, not clinical trials with human participant data.

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): Not applicable. Ground truth establishment by experts is not relevant for this type of device submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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 is a physical medical device, not an AI software.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical medical device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device likely refers to established performance characteristics of the predicate devices against which the new device was compared.

8. The sample size for the training set: Not applicable. This is a physical medical device.

9. How the ground truth for the training set was established: Not applicable. This is a physical medical device.

In summary, the provided document is a regulatory submission for a physical medical device (a dialyzer) demonstrating substantial equivalence to predicate devices, not an AI/software performance study with explicit acceptance criteria and detailed clinical validation data.

Ask a specific question about this device