Search Results

The ProGuide Chronic Dialysis Catheter is indicated for use in attaining long-term vascular access for hemodialysis and apheresis. It may be implanted percutaneously and is primarily placed in the internal jugular or subclavian vein of an adult patient. Catheters greater than 40 cm are intended for femoral vein insertion.

The 55cm ProGuide Chronic Dialysis catheter is a 14.5 French dual lumen catheter that provides two dedicated (arterial/venous) lumens. The arterial and venous lumen extension legs have female connectors and atraumatic occlusion clamps which close the access to the lumen. The catheter comes with a stiffening stylet to help facilitate catheter insertion over-the-wire placement.

The provided FDA 510(k) summary for the K090148 device (55cm ProGuide Chronic Dialysis Catheter) describes its intended use and claims substantial equivalence to predicate devices. However, it does not contain the specific details about acceptance criteria, a study proving those criteria were met, or most of the requested information about test sets, ground truth, or MRMC studies.

Based solely on the provided text, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states:
"No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for these devices. However, a battery of tests was performed according to protocols based on the requirements of industry standards and guidances and were shown to meet the acceptance criteria that were determined to be applicable to the safety and efficacy of the device."

This indicates that internal acceptance criteria were established and met, but the specific criteria and their corresponding performance metrics are not detailed in the provided text. The document only broadly refers to "industry standards and guidances" as the basis for the test protocols.

Therefore, a table of specific acceptance criteria and reported performance cannot be generated from this document.

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

• Sample size: Not specified. The document refers to "a battery of tests" but does not give sample sizes for any of these tests.
• Data Provenance: Not specified. There is no mention of country of origin, nor is it specified if the data was retrospective or prospective.

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 study described is likely a series of in-vitro bench tests and possibly animal studies, not a clinical study involving expert interpretation for ground truth.

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

Not applicable and not provided. The nature of the tests (bench/performance testing) does not typically involve expert adjudication in this manner.

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:

• MRMC study: No. This device is a chronic dialysis catheter, not an AI-powered diagnostic tool, so an MRMC study is not relevant or described.
• Effect size: Not applicable.

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

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

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

The document refers to "a battery of tests... according to protocols based on the requirements of industry standards and guidances." This strongly suggests the ground truth was established through objective, standardized measurements and observations during mechanical, chemical, and potentially biocompatibility testing, rather than expert consensus on images or pathology. The specific type of ground truth used for each test is not detailed.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

Not applicable. As noted above, there is no AI model or training set mentioned.

Ask a specific question about this device