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ClearGuard HD Antimicrobial Barrier Cap is indicated for use with hemodialysis catheter hubs.

Using in vitro methods, the antimicrobial treatment on the ClearGuard HD Antimicrobial Barrier Cap has been shown to be effective at reducing microbial colonization in hemodialysis catheter hubs against the following microorganisms: Enterococcus faecium (VRE), Enterococus faecalis (VRE), Acinetobacter baumannii, Escherichia coli, Staphylococcus aureus (MRSA), Staphylococcus aureus, Staphylococcus epidermidis (MRSE), Pseudomonas aeruginosa, Candida albicans and Candida parapsilosis and has not been shown to be effective against Candida paratropicalis and Klebsiella pneumoniae.

Using post-market clinical surveillance data, use of the ClearGuard HD Antimicrobial Barrier Cap has been shown to reduce the incidence of central-line associated bloodstream infections (CLABSI) in hemodialysis patients. Note: CLABSI was defined as a positive blood culture (PBC) not related to an alternative source of infection per the National Healthcare Safety Network (NHSN) surveillance definition. Alternative sources were excluded if dialysis sites attributed the PBC to vascular access on the dialysis event form. The actual reduction in CLABSI rates may be less substantial as the evaluation for alternative PBC sources was not pre-specified, nor standardized between pafients and clinical sites, and supplemental data evaluating for alternative sources were not available for review.

The subject device is not intended to be used for the treatment of existing infections. The antimicrobial is only present within the hub of the catheter and does not migrate to distal portions of the catheter.

The ClearGuard HD Antimicrobial Barrier Cap (hereinafter also referred to as the ClearGuard HD cap) is a single-use male luer lock cap that incorporates an antimicrobial treatment on its surfaces.

The ClearGuard HD cap consists of 1) a polypropylene polymer plug, which has a rod extending from the luer region that is coated with the antimicrobial agent chlorhexidine acetate (CHA) and 2) a nylon lock ring with threads that are also coated with CHA. When a ClearGuard HD cap is inserted into a liquid-filled catheter, CHA elutes from the rod into the catheter lock solution. This CHA solution is designed to kill microorganisms in the hemodialysis catheter hub, which results in a reduction in Central Line-Associated Bloodstream Infection (CLABSI) rates.

The catheter extension line pinch clamps are used to maintain the lock solution within the catheter lumens to minimize the risk of air embolism and maintain catheter patency. These clamps, which are closed when the catheter is not in use, mechanically confine the CHA and prevent diffusion of CHA toward the catheter tip and the patient's bloodstream.

The ClearGuard HD Antimicrobial Barrier Cap is designed to reduce microbial colonization in hemodialysis catheter hubs and, based on clinical surveillance data, to reduce the incidence of Central-Line Associated Bloodstream Infections (CLABSI) in hemodialysis patients.

Here's an analysis of the provided information:

1. Table of acceptance criteria and the reported device performance

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

• Test Set Sample Size: For the clinical study, 1,671 subjects participated in the primary and exploratory analyses, accruing approximately 183,000 CVC-days in the primary analysis.
  • ClearGuard HD Arm: 826 subjects
  • Control Arm (Tego® Connector with Curos™ Disinfecting Cap): 845 subjects
• Data Provenance: The clinical study was a prospective, cluster-randomized, multi-arm, unblinded clinical study conducted at 40 dialysis facilities throughout the United States only.

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

The document does not explicitly state the number or qualifications of experts used to establish the ground truth for the clinical study's test set. However, it notes that:

• "As is standard policy at the participating facilities, blood culture results were reported into the electronic health record in automated fashion and to the National Healthcare Safety Network (NHSN) Dialysis Event (DE) Form, from which they were abstracted for analysis."
• CLABSI was defined per the National Healthcare Safety Network (NHSN) surveillance definition.
• "All cultures were processed by a single clinical laboratory."

This suggests that the ground truth for PBCs and CLABSIs was established through standard clinical laboratory procedures and adherence to NHSN surveillance definitions, rather than through a panel of independent experts reviewing cases.

4. Adjudication method for the test set

The document does not describe a formal adjudication method (e.g., 2+1, 3+1) for the clinical study's test set. The determination of Positive Blood Cultures (PBCs) and CLABSIs appears to be based on laboratory results and the NHSN surveillance definition, with physicians at the dialysis sites making preliminary attributions of the PBC source on the Dialysis Event form.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is an antimicrobial barrier cap, not an AI software intended for human interpretation improvement. The clinical study directly compared the effectiveness of two devices (ClearGuard HD vs. Tego+Curos) in reducing infection rates.

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

This question is not applicable as the ClearGuard HD Antimicrobial Barrier Cap is a physical medical device, not an algorithm or AI system.

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

• For antimicrobial effectiveness (in vitro tests): The ground truth was based on microbiological assays, specifically measuring reduction in microbial colonization.
• For biocompatibility: Ground truth was established through standardized biological evaluation tests (e.g., cytotoxicity, irritation, sensitization, toxicity, pyrogenicity).
• For clinical efficacy (PBC and CLABSI rates): The ground truth was based on outcomes data (positive blood cultures and CLABSI events) derived from patient medical records, laboratory results, and reported according to the National Healthcare Safety Network (NHSN) surveillance definition. Physicians at varying clinical sites attributed the PBC to a vascular access on the dialysis event form if no alternative source was identified. It is important to note the caveat regarding CLABSI: "The actual reduction in CLABSI rates may be less substantial as the evaluation for alternative PBC sources was not pre-specified, nor standardized between patients and clinical sites, and supplemental data evaluating for alternative sources were not available for review."

8. The sample size for the training set

This question is not applicable. The ClearGuard HD Antimicrobial Barrier Cap is a physical medical device and does not involve a "training set" in the context of machine learning or AI.

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

This question is not applicable for the reasons stated above.

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