Search Results

The Gambro Polyflux 14, 17, and 21 hemodialyzers can be used whenever hemodialysis is indicated. This dialyzer can be used for long term chronic hemodialysis as well as for acute hemodialysis. In hemodialysis therapy, monitoring of patient vital signs, the dialysate delivery system, heparin administration, and clotting times should be performed under the direction of a physician.

The membrane used in these devices is Polyamide which is identical to the polyamide membrane utilized in the Gambro Polyflux 11 dialyzers which have been previously approved for marketing in the United States under a 510K Notification (K933818). This membranes is manufactured by Gambro Dialysatoren of Germany.

Blood enters a blood inlet port where it is distributed to polyamide hollow fibers. Each hollow fiber has an inner diameter of approximately 220 microns and a wall thickness of 50 microns. The effective length of the fibers is 210 mm for the Polyflux 14 and 250 mm for the Polyflux 17 and 21. The fibers used in this device are substantially equivalent in design to the previously approved Gambro Polyflux 11 hemodialyzers. 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 Polyamide membrane, plasma water along with certain lower molecular weight solutes of plasma water pass through the membrane and into the dialysate compartment of the devices. Removal of uremic toxins and waste products are removed from the patient's blood in this device by means of both diffusion and convection through the Polyamide membrane into the counter current flowing dialysis solution. The dialysate exits the devices via a dialysate outlet port.

This 510(k) notification describes a medical device, not an AI/ML powered device, therefore, the requested information about acceptance criteria and study details for an AI/ML device is not applicable.

The document discusses the substantial equivalence of the Gambro Polyflux 14, 17, and 21 Hemodialyzers to a predicate device (Gambro Polyflux 11 Hemodialyzer) based on technological characteristics and non-clinical in vitro testing.

Here's a breakdown of the relevant information provided:

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

The document doesn't explicitly state "acceptance criteria" in a quantitative table format as one might find for an AI/ML performance study. Instead, it relies on demonstrating substantial equivalence to a predicate device. The performance is assessed through in vitro testing to ensure that certain parameters are comparable or within acceptable ranges relative to the predicate device.

The "acceptance criteria" here is implicitly that the in vitro test results for the proposed devices demonstrate performance that is "substantially equivalent" to the previously approved predicate device (Gambro Polyflux 11).

Regarding the other requested points (2-9), these are not applicable to the provided document as it describes a traditional medical device, not an AI/ML system.

Here's why each point is not applicable:

• 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set in the context of AI/ML data is used. The "testing" refers to non-clinical in vitro performance evaluations of the physical device.
• 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): No ground truth established by experts in this context. The "ground truth" is based on the measurable physical and chemical performance of the device in a lab setting, compared to a known predicate device.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for non-clinical in vitro device testing.
• 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 for AI/ML diagnostic or assistive devices, not hemodialyzers.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an algorithm.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" is the established performance characteristics of the predicate device and the physical measurements from the in vitro tests of the new devices.
• 8. The sample size for the training set: Not applicable; there is no AI/ML model to train.
• 9. How the ground truth for the training set was established: Not applicable; there is no AI/ML model to train.

In summary, the document demonstrates substantial equivalence through a comparison of technological characteristics and non-clinical in vitro performance data, rather than through AI/ML specific validation studies. The key "study" here is the series of in vitro tests performed on the proposed devices, comparing their performance against the established predicate device.

Ask a specific question about this device