Search Results

To aid in the cleaning of the headers, header spaces, and header caps of multiple-use hemodialyzers prior to an approved reprocessing procedure for reusable hemodialyzers.

The ASSIST Header Cleaner™ is a one-piece device used to assist with the manual cleaning of headers in reusable hemodialyzers. One end of the ASSIST unit is inserted and attached to the arterial blood port on the header cap. The other end of the ASSIST unit is connected to a supply of reverse osmosis water. Jets of RO water are sprayed inside of the header to break up and clear away any debris, including clotted blood, in the header space. The dialyzer is manually turned along its longitudinal axis during this process to allow the water jets to contact all side surfaces of the header. This operation is repeated on the venous end where, besides cleaning, the water is used to flush the blood/debris/water mixture from the arterial end of the dialyzer. The dialyzer is flipped again and the process is repeated for a second time at the arterial end to flush away any blood/debris/water mixture from the venous end of the dialyzer.

This submission does not contain information typically found in a study for an AI/ML device. The "ASSIST Header Cleaner™" is a non-AI manual device designed to assist in cleaning hemodialyzer headers. Therefore, the questions related to AI/ML device performance, ground truth, expert adjudication, and comparative effectiveness studies are not applicable.

Here's an analysis based on the provided text, addressing the relevant sections:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not specify quantitative acceptance criteria. Instead, it makes a general statement about the device's performance relative to existing technology.

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

The document states that "Tests have been performed," but does not provide any details regarding sample size, type of test set (e.g., dialyzers tested), or data provenance (e.g., country of origin, retrospective or prospective). Given the nature of the device (manual cleaning tool), the "test set" would likely refer to the number of hemodialyzers on which the cleaning performance was evaluated and the impact on the dialyzer's integrity.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided. For a non-AI device like this, "ground truth" would likely refer to objective measurements of cleanliness or dialyzer integrity, rather than expert interpretation of medical images.

4. Adjudication Method for the Test Set

No adjudication method is mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This is a manual medical device, not an AI/ML algorithm. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant. The comparison mentioned is between the new device and existing "dialyzer cleaning systems currently in use in the United States."

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

Not Applicable. This is not an AI algorithm; it's a manual device. It can be considered a standalone device, as its function doesn't rely on human interpretation of its internal "decisions" or AI output, but its effectiveness is still predicated on human operation.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The document does not specify the type of ground truth used for testing. For a device cleaning hemodialyzers, the ground truth would likely involve:

• Visual inspection: To confirm removal of visible debris/blood.
• Quantitative measurements: Such as residual blood protein assays, or testing of dialyzer performance parameters (e.g., clearance, ultrafiltration coefficient) after cleaning and reprocessing to ensure no damage.
• Material compatibility tests: To ensure the device does not leach harmful substances or damage the dialyzer materials.

8. The Sample Size for the Training Set

Not Applicable. This is a manual device, not an AI/ML model, so there is no "training set."

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

Not Applicable. As there is no training set for an AI/ML model, this question is not relevant.

Ask a specific question about this device