Search Results

The ARTLINE Device is intended to permit access to the peripheral arterial circulation system for short term access (less than 30 days).

The ARTLINE is a single lumen peripherally inserted catheter device designed to perform short term access to the peripheral arterial circulatory system for less than 30 days. The catheter, made of radiopaque polyurethane tubing, echogenic needle, guidewire with slide advancer. Each ARTLINE has a kink resistant catheter design. The catheter is inserted over the needle into the peripheral arterial vessel, the guide wire is advanced and the catheter is threaded over the guide wire. The catheter is supplied sterile and non-pyrogenic. The ARTLINE is indicated for dwell times shorter than 30 days. The ARTLINE is a 20ga single lumen catheter. The catheter is approximately 4.45 cm long. The catheters are attached to an injectionmolded polyurethane hub with Luer lock fittings for access attachment.

The provided document is a 510(k) premarket notification for a medical device called ARTLINE, a percutaneous catheter. It describes the device, its intended use, and a comparison to a predicate device. The document also lists performance tests conducted.

Here's the breakdown of the information requested, based on the provided text:

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

The document states, "The ARTLINE met all established acceptance criteria for performance testing and design verification testing." However, the specific numerical acceptance criteria for each test are not provided in this document. Only the types of tests performed are listed. Therefore, a complete table with criteria and performance cannot be generated from the given text.

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

The document does not specify the sample size used for the performance tests, nor does it provide information about the data provenance (country of origin, retrospective or prospective nature).

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 provided in the document. The performance tests described are engineering/material tests, not clinical studies requiring expert ground truth establishment in the medical sense.

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

This information is not provided in the document. As these are physical performance tests, an adjudication method for "ground truth" in a clinical context is not applicable.

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

The document does not mention an MRMC comparative effectiveness study, nor does it refer to any AI assistance. The ARTLINE is a physical medical device (catheter), not an AI-powered diagnostic tool.

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

This is not applicable as the ARTLINE is a physical medical device, not an algorithm.

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

For the performance tests listed, the "ground truth" would be established by engineering and industry standards for medical device components and materials (e.g., ISO standards for conical fittings, established methods for tensile strength or flow rate measurement). The document implies adherence to these standards by stating "met all established acceptance criteria." However, it does not detail which specific standards were used as the "ground truth."

8. The sample size for the training set

This is not applicable. The ARTLINE is a physical medical device, not a machine learning algorithm that requires a training set.

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

This is not applicable for the same reason as point 8.

Ask a specific question about this device