Search Results

The Palindrome Emerald 14.5 fr Cuffed catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. The performance of the heparin coating on this catheter in reducing platelet adhesion on the catheter surface for up to 720 hours of dialysis treatment is supported by bench and animal testing. It may be inserted either percutaneously or by cutdown.

The Palindrome™ Emerald™ 14.5 Fr Chronic Hemodialysis Catheter with Heparin Coating has a radiopaque polyurethane shaft with two large inner lumens designed in a "double D" configuration. The distal end of the catheter extends to a symmetrical tip. The proximal end of the catheter shaft contains a polyurethane hub assembly and silicone extension sets. The catheter contains a heparin coating on its surface, from the tip of the catheter to the cuff on the external surface, and throughout the entire length on the internal surface (tip to luer adapters), for the purpose of reduction of platelet adhesion. Results of in-vitro studies using bovine blood against an uncoated catheter demonstrate a 60% reduction in platelet adhesion along the catheter surface of the proposed device.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:

Device: Palindrome™ Emerald™ 14.5 Fr Chronic Hemodialysis Catheter with Heparin Coating

Acceptance Criteria and Reported Device Performance:

Detailed Study Information:

1. Sample size used for the test set and the data provenance:

   • In-vitro circulating blood loop test: Not explicitly stated, but the test involved comparing a coated catheter to an uncoated control.
   • Coating durability test: Involved one catheter subjected to simulated dialysis conditions for 720 hours, with measurements taken periodically.
   • In-vivo ovine model: 6 sheep were used. Each sheep had both a coated and non-coated catheter implanted.
   • Data Provenance: The studies were conducted as bench (in-vitro) and animal (in-vivo) testing. The animals used were sheep (ovine model). The origin of the in-vitro blood (bovine blood) is mentioned.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" here is objective measurement data from experiments (e.g., platelet count, thrombus weight, heparin activity), not expert interpretation of images or observations requiring multiple human readers.

3. Adjudication method for the test set: Not applicable, as there was no subjective assessment requiring adjudication. Outcomes were determined by quantitative measurements. In the in-vitro test, retrieved catheters were visually inspected and then placed in a gamma counter for quantification. In the in-vivo test, gravimetric analysis was performed.

4. 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 is a medical device for direct patient contact/treatment, not an AI diagnostic or interpretive tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical catheter, not a standalone algorithm.

6. The type of ground truth used: Experimental measurement data:

   • Quantification of radiolabeled platelet adhesion via gamma counter.
   • Gravimetric analysis of thrombus weight.
   • Measurement of heparin activity levels.

7. The sample size for the training set: Not applicable. This is not a machine learning model, so there is no training set. The term "training set" is usually reserved for AI/ML contexts.

8. How the ground truth for the training set was established: Not applicable. See point 7.

Ask a specific question about this device