Search Results

The Acute Dual Lumen Hemodialysis Catheter is indicated for short-term central venous access for hemodialysis, apheresis, and infusion.

The Acute Dual Lumen Hemodialysis Catheter is manufactured from thermal reactive polyurethane material known for its rigidity at room temperature which allows bedside insertion, and softness at body temperature minimizing the risk of vein perforation and improving patient comfort after insertion. The catheter shaft is made of radiopaque polyurethane with two independent, non-communicating inner lumens, where the distal end of the catheter, with arranged outflow eyelets, extends to a symmetrical tip configuration. The proximal end of the catheter shaft joins to a polyurethane hub assembly having each inner lumen connected to individual extension tubes. The extension tubes are made of silicone material and are identified by color coded occlusion clamps. The red clamp identifies the lumen which provides "arterial" outflow from the patient, the blue clamp identifies the lumen which provides "venous" inflow return when used for hemodialysis, apheresis and infusion. Lumen priming volume is printed on each ID tag clamp insert, and catheter size and length are printed in the hub. Centimeter markings are placed along the length of the indwelling portion of the catheter body to facilitate proper positioning.

Here's a breakdown of the acceptance criteria and study information for the Acute Dual Lumen Hemodialysis Catheter, based on the provided document:

1. Table of Acceptance Criteria and the Reported Device Performance:

The document lists various performance characteristics that were tested. While specific numerical acceptance criteria (e.g., "flow rate must be > X mL/min") are not explicitly detailed in the summary, the general statement indicates the device "met the minimum requirements that are considered adequate for its intended use." This implies that for each test, there was an established benchmark or range that the device successfully achieved.

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

The document does not specify the exact sample sizes used for each individual performance test (e.g., how many catheters were tested for flow rate or tensile strength). It only states that "Bench testing was conducted."

Regarding data provenance:

• Country of Origin: Not specified.
• Retrospective or Prospective: The testing described is prospective, as it involves the evaluation of the subject device's performance before market approval.

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

This information is not provided in the document. The document describes bench testing and biocompatibility testing against established standards (FDA recognized standards, ISO standards), rather than studies involving human experts establishing "ground truth" on clinical cases. The "ground truth" here is the adherence to these engineering and biocompatibility standards.

4. Adjudication Method for the Test Set:

This is not applicable as the described testing does not involve human expert adjudication of clinical cases. The "adjudication" is essentially the determination by a testing facility or qualified personnel that the device either passed or failed the specified test criteria based on the relevant standard.

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:

No MRMC comparative effectiveness study was mentioned. The device is a physical medical device (catheter), not an AI algorithm or a diagnostic tool that would typically involve human readers.

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

Not applicable. This device is a physical medical catheter, not an algorithm.

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

The "ground truth" for the performance evaluation of this medical device is based on established engineering standards, international standards (ISO), and regulatory requirements for the safety and performance of such devices. For example:

• Bench Testing: Engineering specifications and performance limits for properties like flow rate, tensile strength, leakage, etc.
• Biocompatibility Testing: Standards outlined in ISO 10993-1, which define acceptable levels of biological response to medical devices.
• Sterilization and Shelf Life: Standards like ISO 11135 and ISO 11607-1.

8. The Sample Size for the Training Set:

Not applicable. This document describes the evaluation of a physical medical device, not a machine learning algorithm that would have a "training set."

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

Not applicable. As above, no training set is relevant for this type of device submission.

Ask a specific question about this device