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HemoSplit® and HemoStar™ long-term hemodialysis catheters with BioBloc™ coating are indicated for use in attaining short-term or long-term vascular access for hemodialysis, hemoperfusion or apheresis therapy. Access is attained via the internal jugular vein, external jugular vein, subclavian vein, or femoral vein.

Catheters greater than 40 cm are intended for femoral vein insertion.

The performance of the BioBloc™ coating on the HemoStar™ catheters in reducing bacterial adhesion for 21 days was supported by in vitro testing.

The HemoSplit and HemoStar" catheters with BioBloc" coating are dual lumen long-term hemodialysis catheters. Both catheters have a dual lumen, double-D cross-sectional design. The HemoSplit® catheters are designed with a split distal tip whereas the HemoStar™ catheters incorporate a staggered distal lumen tip. The catheter shaft is the same for both designs. BioBloc" coating is present on the tunnel portion of the catheter shaft tubing. BioBloc" coating reduces bacterial adhesion to the catheter by 99.9% in the catheter tunnel for a period of 21 days as tested in an in-vitro model against Staphylococcus epidermidis. Staphylococcus aureus, Pseudomonas aeruginosa, Candida albicans, Enterococcus faecalis, and Escherichia coli. Catheters with BioBloc coating are not intended to be used as a treatment for existing infections.

Here's a breakdown of the acceptance criteria and study information for the Long-Term Hemodialysis Catheters with BioBloc™ Coating, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document explicitly states that the testing was performed using an in-vitro model. Therefore, there isn't a "test set" in the traditional sense of human or pathological samples. The "sample" refers to the tested catheters and bacterial strains.

• Sample Size: Not specified in terms of number of catheters or replicates, but the testing was done against six specific bacterial and fungal strains (Staphylococcus epidermidis, Staphylococcus aureus, Pseudomonas aeruginosa, Candida albicans, Enterococcus faecalis, and Escherichia coli).
• Data Provenance: In-vitro testing (laboratory setting). The country of origin for the data is not specified, but the submitter is Bard Access Systems, Inc., located in Salt Lake City, UT, USA.

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

Not applicable for this type of in-vitro study. Ground truth was established through direct measurement of bacterial adhesion in a laboratory setting, not through expert consensus on medical images or clinical outcomes.

4. Adjudication Method for the Test Set

Not applicable for an in-vitro study measuring bacterial adhesion. The results are quantitative measurements, not subjective interpretations requiring adjudication.

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 device is a medical catheter with a coating to reduce bacterial adhesion, not an AI-powered diagnostic or assistive technology for human readers.

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

Not applicable. This is a medical device (catheter), not an algorithm. The "standalone performance" refers to the coating's effectiveness on the catheter itself, which was evaluated in the in-vitro study.

7. The Type of Ground Truth Used

The ground truth was established through direct quantitative measurement of bacterial adhesion in a controlled in-vitro environment.

8. The Sample Size for the Training Set

Not applicable. This is a medical device, not a machine learning algorithm requiring a training set.

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

Not applicable. As above, there is no training set for this device.

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