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The DIASAFE®plusUS is intended for the preparation of ultrapure dialysis fluid (for the 2008-series machines and 5008X machines) and sterile, non-pyrogenic substitution fluid (for the 5008X machines) from pretreated water and is not intended to provide primary purification. Attention must still be given to the chemical and microbiological quality of water and concentrates and the maintenance of supply systems (e.g. RO system, central delivery system). The microbiological quality (microbial count [CFU/mL] and endotoxin measurement [EU/mL]) of the incoming water should be < 200 CFU/mL and < 2 EU/mL, respectively.

The DIASAFE®plusUS can only be used with Fresenius Medical Care hemodialysis machines fitted for use with the DIASAFE®plusUS.

The DIASAFE®plusUS is a non-sterile dialysis fluid filter that produces ultrapure dialysis fluid (for the 2008-series machines and 5008X machines) and sterile, non-pyrogenic substitution fluid (for the 5008X machines) for use in chronic and acute hemodialysis and hemodiafiltration. The DIASAFE®plusUS reduces microbial contaminants including endotoxin in the dialysate during treatments. The DIASAFE®plusUS is available in one (1) configuration and is compatible for use with 2008 series and 5008X hemodialysis machines. It is installed on the hemodialysis machines using the DIAFIX™ Lock System. The DIAFIX™ Lock System is a standard feature on the hemodialysis machines and is installed during machine production.

The 2008 series hemodialysis machines use 1 DIASAFE®plusUS. Mixed dialysis fluid is forced through an open filter port across the fibers of the DIASAFE®plusUS. A closed bypass valve at the other end forces the dialysis fluid across the fiber membrane. Dialysis fluid passes through the porous membrane and into the filtrate compartment where it is allowed to flow through the uncapped side ports and into the hemodialyzer. Microorganisms and molecules too large to pass through the membrane are trapped in the fibers until they are flushed out, and/or disinfected during a routine cleaning cycle.

The 5008X hemodialysis system uses two (2) DIASAFE®plusUS for preparation of the dialysis and substitution fluid which can be used for up to 100 on-line HDF treatments. The dialysis fluid is filtered by the first DIASAFE®plusUS. A second DIASAFE®plusUS is used to filter the ultrafiltered dialysis fluid a second time to prepare the substitution fluid. The substitution fluid can be infused in the post-dilution mode (i.e., after the blood has passed through the dialyzer), in the pre-dilution mode (i.e., before the blood enters the dialyzer), or combined.

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The DIASAFE®plusUS is intended for the preparation of ultrapure dialysate from pre-treated water and is not intended to provide primary purification. Attention must still be given to the chemical and microbiological quality of water and concentrates and the maintenance of supply systems (e.g., RO system, central delivery system).

The microbiological quality (microbial count [CFU/mL] and endotoxin measurement [EU/mL]) of the incoming water should be < 200 CFU/mL and < 2 EU/mL, respectively.

The DIASAFE®plusUS can only be used with Fresenius Medical Care dialysis machines fitted for use with DIASAFE® plusus.

The DIASAFE®plusus (P/N F00007039) is a non-sterile dialysis fluid filter that produces ultrapure dialysate as defined in ANSI/AAMI/ISO 11663. The filter reduces microbial contaminants including endotoxins in the dialysate during hemodialysis treatment. The DIASAFE® plusus is installed and exchanged on 2008 Series hemodialysis machines using the DIAFIX™ Lock System. The DIAFIX™ Lock System is a standard feature on 2008 Series hemodialysis machines and is installed during machine production.

Mixed dialysate is forced through an open filter port across the fibers of DIASAFE® plusus. A bypass valve at the other end is closed which forces the dialysate across the fiber membrane. Dialysate passes through the porous membrane and into the filtrate compartment where it is allowed to flow through the uncapped side ports and into the hemodialyzer. Microorganisms and molecules too large to pass through the membrane are trapped in the fibers until they are flushed out, and/or disinfected during a routine cleaning cycle

The provided text describes the regulatory clearance (510(k)) for the DIASAFE®plusUS, a water purification system for hemodialysis. The document outlines acceptance criteria and the results of various performance tests conducted to demonstrate the device's substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

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

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

The document does not specify the exact sample sizes (number of devices tested) for each performance test. It mentions "DIASAFE®plusUS filter samples" for the Ultrafiltration Rate test and generally indicates that tests were "conducted" or "evaluated."

The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, based on the context of a 510(k) submission for a medical device, these would be lab-based, prospective studies performed by the manufacturer to demonstrate product performance.

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

This information is not applicable to the type of device and testing described. The DIASAFE®plusUS is a physical filter for water purification. Its performance is measured through objective, quantifiable laboratory tests (e.g., microbial counts, endotoxin levels, flow rates) rather than human interpretation or expert consensus on medical images or patient conditions. Therefore, there's no "ground truth" established by experts in the context of medical image review.

4. Adjudication method for the test set

This information is not applicable. Since the tests are objective, quantifiable measurements of physical and chemical properties (e.g., bacteria count, endotoxin levels), there is no need for an adjudication method among human readers or experts to determine a ground truth.

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

There was no MRMC comparative effectiveness study done. This is not an AI/software-based device that would assist human readers in, for example, diagnosing medical conditions. It is a physical filtration device.

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

This information is not applicable. The device is a physical filter, not an algorithm. Its "standalone" performance is literally its ability to perform the filtration function, which is what the performance tests evaluate.

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

The ground truth for the performance tests relies on quantitative laboratory measurements against established standards and specifications. For example:

• Bacteria and Endotoxin Retention: The ground truth is the measured microbial count and endotoxin level in the filtered dialysate falling below the specified threshold (<0.1 CFU/mL and <0.03 EU/mL respectively, as per ANSI/AAMI/ISO 11663).
• Ultrafiltration Rate: The ground truth is the measured flow rate exceeding the specified minimum (>300 mL/hr mmHg).
• Integrity/Composition: The ground truth is the observation that the device components remain intact and the dialysate composition is not adversely affected, matching the engineering specifications.

These are not based on expert consensus, pathology, or outcomes data in the medical diagnostic sense, but rather on direct physical and chemical measurements.

8. The sample size for the training set

This information is not applicable. The DIASAFE®plusUS is a physical device, not an AI or machine learning model that requires a training set.

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

This information is not applicable, as there is no training set for this type of device.

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