Search Results

Minntech Corporation's RenaClear™ Dialyzer Cleaning System is used to facilitate the cleaning of blood and other debris from multiple-use hollow fiber dialyzers prior to being reprocessed in an approved dialyzer reprocessing program.

The RenaClear™ Dialyzer Cleaning System facilitates the cleaning and removal of blood and other debris from multiple-use hollow fiber dialyzers prior to an institutions approved dialyzer reprocessing program. The stand-alone countertop system is equipped with two header cleaners that attach to the blood ports of a dialyzer. The header cleaners have a retractable, rotating, directional needle jet that will inject a water/air mixture into the dialyzer header and blood pathway. Simultaneously the dialyzer dialysate compartment and the exterior of the dialyzer fibers will be pressurized water to achieve reverse ultrafiltration.

The operator, through the use of a membrane switch front panel, controls the RenaClear™ Dialyzer Cleaning System. Operators have the following cycle choices: Dialyzer clean, system clean, system sanatize and system rinse.

Here's a breakdown of the acceptance criteria and study information for the RENACLEAR™ DIALYZER CLEANING SYSTEM based on the provided text:

1. Acceptance Criteria and Reported Device Performance

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

The provided text does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It only states that "Minntech Corporation has performed functional testing."

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

The provided information does not mention using experts to establish ground truth or their qualifications. The evaluation appears to be based on functional testing and material compatibility.

4. Adjudication Method for the Test Set

The provided text does not describe any adjudication method for a test set. This type of detail is typically relevant for studies involving human interpretation or subjective assessment, which doesn't seem to be the primary focus here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The provided text does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, nor does it mention any effect size for human reader improvement with or without AI assistance. This type of study is not relevant for a device focused on mechanical cleaning.

6. Standalone (Algorithm Only) Performance Study

The provided text does not describe a standalone (algorithm only) performance study. The device is a physical cleaning system, not a software algorithm.

7. Type of Ground Truth Used

The ground truth for this device's evaluation appears to be based on:

• Functional performance criteria: Showing the system performs its intended cleaning function.
• Material compatibility testing: Verifying that the materials used are suitable for the chemicals involved.
• Comparison to a predicate device: Demonstrating that its performance is equivalent to an already approved device.

There is no mention of expert consensus, pathology, or outcomes data as a ground truth for cleaning efficacy in the provided summary.

8. Sample Size for the Training Set

The provided text does not mention a training set sample size. This concept is typically relevant for machine learning or AI models, which is not the nature of this device.

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

Since there is no mention of a training set, the establishment of its ground truth is not applicable to this device description.

Ask a specific question about this device