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The device is indicated for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted percutaneously or by cut down. Catheters with greater than 40 cm implant length are indicated for femoral placement.

The Tal Palindrome™ Symmetric Tip Dual Lumen Catheter has a radiopaque shaft with two large inner lumens designed in an opposing "double D" configuration. The proximal end of the catheter features two color-coded luer adapters. The luer adapters are connected to clear extension tubes. Each extension tube contains a clamp and is connected to the catheter hub which contains suture wings. The distal end of the catheter hub is connected to the double lumen catheter shaft contains a cuff and extends to a symmetrical distal tip configuration.

The Mahurkar® Maxid™ Dual Lumen Catheter has a 14.5 Fr. radiopaque shaft with two large inner lumens designed in an opposing "double D" configuration. The proximal end of the catheter features two color-coded luer adapters. The luer adapters are connected to clear extension tubes. Each extension tube contains a clamp and is connected to the catheter hub which contains suture wings. The distal end of the catheter hub is connected to the double lumen catheter shaft. The shaft contains a cuff and extends to a staggered distal tip configuration which is available with or without side holes. Configurations with side holes contain five side holes on the arterial lumen and two side holes on the venous lumen.

The Palindrome™ RT Reverse-Tunneled Catheter will be supplied with a detached "proximal end" allowing for the catheter tip to be positioned in the vein first before the catheter shaft is pulled through the patient's subcutaneous tunnel tract in a retrograde fashion. The fully assembled Palindrome™ RT Reverse-Tunneled Catheter has a 15.0 Fr. radiopaque shaft with two large inner lumens designed in an opposing "double D" configuration. The proximal end of the catherer features two color-coded luer adapters. The luer adapters are connected to clear extension tubes. Each extension tube contains a clamp and is connected to the hub assembly which contains suture wings. The distal end of the catheter hub is connected to the double lumen catheter shaft. The shaft contains a cuff and extends to a symmetrical distal tip configuration.

The provided text is a 510(k) summary for several hemodialysis catheters, submitted to the FDA. It does not describe an AI or software as a medical device (SaMD), but rather physical medical devices. Therefore, the questions related to AI/SaMD performance, such as acceptance criteria for algorithms, sample sizes for test/training sets, expert adjudication, MRMC studies, or standalone algorithm performance, are not applicable to this document.

The document focuses on demonstrating substantial equivalence of modified catheter designs to previously cleared predicate devices through non-clinical benchtop functional testing and biocompatibility testing.

Here's an analysis of the provided text in the context of the questions asked, highlighting why most are not applicable:

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

   • Not Applicable in the requested format for SaMD.
   • The document states: "Bench top functional testing was completed to support substantial equivalence between the modified device and the current device. The test regimen evaluated the devices' resistance to kink, leak, burst, catheter collapse, fatigue, and the tensile strength at various points of the results of the performance testing show that the modified devices continue to meet the relevant product specifications."
   • It also states: "Biocompatibility testing per ISO 10993: Biological Evaluation of Medical Devices was completed... The results... show that the modified devices continue to be biocompatible for its intended use."
   • While acceptance criteria for these physical properties (e.g., maximum kink resistance, minimum tensile strength, pass/fail for biocompatibility) would have been used internally by the manufacturer, they are not explicitly detailed in this 510(k) summary. The summary only reports that the devices "continue to meet the relevant product specifications" and "continue to be biocompatible."

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

   • Not Applicable. This document describes testing for physical medical devices (catheters), not an AI/SaMD. There isn't a "test set" in the context of data used for algorithm evaluation. The testing involved physical samples of the catheters. The document does not specify the number of catheters tested for each characteristic.

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)

   • Not Applicable. Ground truth in the context of expert consensus for data labeling is irrelevant here, as this is not an AI/SaMD.

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

   • Not Applicable. Adjudication methods are relevant for resolving discrepancies in expert labeling or diagnoses of imaging/data, which is not what this document is about.

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

   • Not Applicable. MRMC studies are for evaluating the performance of diagnostic devices, often medical imaging AI, with human readers. This is a physical catheter.

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

   • Not Applicable. This is not an algorithm or software.

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

   • Not Applicable in the requested context for SaMD ground truth. For the physical devices, the "ground truth" would be the physically measured performance against established engineering or biocompatibility standards.

8. The sample size for the training set

   • Not Applicable. There is no training set as this is not an AI/SaMD.

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

   • Not Applicable. There is no training set and therefore no ground truth to establish for it in the context of AI/SaMD.

In summary, the provided 510(k) summary for hemodialysis catheters describes the process of demonstrating substantial equivalence for physical medical devices through benchtop functional testing and biocompatibility testing, not through the evaluation of an AI or software algorithm. Therefore, the specific questions posed regarding acceptance criteria and study details for AI/SaMD are not answered by this document.

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