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The Centrysystem 600 HG 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 this device is Hemophane which is substantially equivalent to the Hemophane membrane utilized in the Gambro GFS Plus 20 dialyzers which have been previously approved for marketing in the United States under a 510K Notification (K902481). Both of these membranes are manufactured by Akzo (Enka) of Germany.

Blood enters a blood inlet port where it is distributed to Hemophane hollow fibers. Each hollow fiber has an inner diameter of approximately 200 microns and a wall thickness of 6.5 microns. The effective length of the fibers is 267 mm. The fibers used in this device are substantially equivalent in design to the previously approved Gambro GFS Plus 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 Hemophane 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 Hemophane membrane into the counter current flowing dialysis solution. The dialysate exits the devices via a dialysate outlet port.

The provided 510K K960474 notification describes a hemodialyzer, the Cobe Centrysystem 600 HG. This submission is for a medical device that performs a physical function (blood filtration) rather than a diagnostic function (e.g., image analysis or disease detection). Therefore, many of the requested categories in the prompt (e.g., 'number of experts', 'adjudication method', 'MRMC study', 'standalone performance', 'training set sample size') are not applicable to this type of device and its regulatory submission.

Here's an analysis based on the provided text, focusing on applicable points and noting where the information is not relevant to this specific device:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state "acceptance criteria" in a tabular format as might be seen for a diagnostic algorithm. Instead, it relies on demonstrating substantial equivalence to a predicate device through non-clinical in vitro testing. The performance is "accepted" if it is shown to be substantially equivalent.

2. Sample size used for the test set and the data provenance

The document refers to "in vitro testing" to determine various parameters. It does not specify the sample size (e.g., number of devices tested) for these in vitro tests. Data provenance (country of origin, retrospective/prospective) is not applicable or specified for in vitro device performance tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable as this is a physical medical device and its performance is evaluated through measurable physical characteristics in an in vitro setting, not by human expert assessment of a "ground truth" like in diagnostic imaging.

4. Adjudication method for the test set

Not applicable for in vitro physical 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 not a diagnostic AI device requiring human reader interaction.

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

Not applicable. This is a physical medical device, not an algorithm. The in vitro testing represents the "standalone" performance of the device without patient involvement.

7. The type of ground truth used

The "ground truth" in this context is the established, measurable physical and chemical properties of the device and its performance in a controlled in vitro environment. For example, "urea clearance" is measured directly, rather than being an expert consensus or pathology finding. The established performance of the predicate device serves as the benchmark for "substantial equivalence."

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning.

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

Not applicable. There is no training set for this type of device.

Study Proving Acceptance Criteria are Met:

The study proving the acceptance criteria are met is the "Summary of Non-Clinical Tests".

• Study Design: This was an in vitro test series.
• Purpose: To determine the blood side priming volume, dialysate side priming volume, dialysate and blood flow resistance, ultrafiltration coefficient, and clearances for urea, creatinine, phosphate, and vitamin B12 at varying blood flows, as well as residual blood volume.
• Methodology: The specific tests performed were standard in vitro measurements for hemodialyzers. The document mentions "varying blood flows" for clearance measurements, indicating different operational conditions were tested.
• Results/Conclusion: "The results of these tests confirmed that the proposed device is substantially equivalent to the proposed device for these parameters." This statement indicates that for all the measured parameters, the Cobe Centrysystem 600 HG performed comparably to the predicate device, the Gambro GFS Plus 20 Hemodialyzer.

Key Takeaway: The entire submission for the Cobe Centrysystem 600 HG relies on demonstrating substantial equivalence to an already approved predicate device (Gambro GFS Plus 20). This is a common pathway for physical medical devices, where the "acceptance criteria" are implicitly met if the new device performs within acceptable bounds of the predicate device's established performance for critical functional parameters. Clinical testing was explicitly not performed, further solidifying the reliance on in vitro evidence of equivalence.

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