Search Results

The PowerLine™ catheter is indicated for short or long term access to the central venous system. PowerLine™ catheters are designed for the administration of I.V. fluids, blood products, drugs, parenteral nutrition solutions, as well as blood withdrawal. In addition, PowerLine™ catheters allow for power injection of contrast media and central venous pressure monitoring. The maximum recommended infusion rate is 5ml/sec. For central venous pressure monitoring, it is recommended that a catheter lumen of 20 gauge or larger be used.

The PowerLine™ catheters are open-ended polyurethane catheters with a reverse taper design. Catheters are available in 5 F Dual-Lumen and the 6 F Triple-Lumen configurations. The usable length of the catheter is 50 cm. Catheter shaft tubing is marked with depth indicators, with "0" indicated to serve as a reference for the catheter insertion point. The catheters have a tissue ingrowth cuff bonded to the catheter shaft. Purple colorants added to the catheter extension legs and shaft aid in distinguishing the catheter as power-injectable. The molded hub is labeled to identify the catheter as PowerLine™. The catheter extension leg and clamp are labeled with information to facilitate proper use of the device. The PowerLine™ catheters are provided in sterile tray configurations.

The provided text is a 510(k) Pre-market Notification for the Bard Access Systems PowerLine Central Venous Catheters. It describes the device, its intended use, and substantial equivalence to predicate devices, along with verification and validation activities. However, it does not contain information related to software or AI device performance, ground truth establishment, sample sizes for training/test sets, expert qualifications, or MRMC studies.

Therefore, I cannot fulfill most of your request directly from the provided text.

Based on the information available:

1. A table of acceptance criteria and the reported device performance:

The document states: "The subject PowerLine™ catheters met all predetermined acceptance criteria derived from the above mentioned references. Design validation was conducted on the subject PowerLine™ configuration and yielded acceptable results."

The "above mentioned references" refer to:

• Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, March 16, 1995
• ISO 10555-1:1997, Sterile, single-use intravascular catheters, Part 1. General requirements, Amendment 2
• BS/EN/ISO 10555-3:1997, Sterile, single-use intravascular catheters, Part 3. Central venous catheters
• AAMI/ANSI/ISO 10993-1:2003, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, and the FDA Modified ISO 10993 Test Profile
• AAMI/ANSI/ISO 10993-7:1995, Biological Evaluation of Medical Devices Part 7: Ethylene Oxide Sterilization Results

Actual specific acceptance criteria and detailed quantitative performance results are not provided in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

This information is not provided in the given text. The document mentions "Tests were performed on sterilized, finished devices," but does not specify the number of devices tested or any data provenance details.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not applicable as the document describes a physical medical device (catheter) and its performance based on engineering and biocompatibility standards, not an AI or diagnostic device that requires expert ground truth for image interpretation or diagnosis.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not applicable for a physical medical device performance study as described here.

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:

This information is not applicable as the document is about a physical medical device (catheter), not an AI-assisted diagnostic or interpretative system.

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

This information is not applicable as this is not an AI device.

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

The "ground truth" for this physical device's performance would be established by physical measurements, material science testing, biocompatibility assays, and sterilization effectiveness indicators, all against established industry standards (ISO, AAMI/ANSI). It does not involve expert consensus, pathology, or outcomes data in the context of diagnostic accuracy.

8. The sample size for the training set:

This information is not applicable as this is not an AI device.

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

This information is not applicable as this is not an AI device.

Ask a specific question about this device