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The 10 Fr Tandem-Cath Chronic Hemodialysis Catheter is intended for hemodialysis, The 1011 Tandem Outh Online Homeans on each either percutaneously or by cutdown.

The Kendall TANDEM-CATH 10 Fr. Catheter System consists of two 10 Fr. Single lumen catheters. Each catheter is 50 cm long, however, the implant length measured from the cuff to the distal tip differs in arterial and venous catheters. The arterial catheter has an implant length 3 cm shorter than its paired venous catheter. The catheter lumens are distinguished by color-coded printing on the catheter shaft (redarterial / blue-venous). The catheters are offered with and without side holes. One configuration has 6 side holes oriented in a spiral pattern at the tip of both the arterial and venous catheters. The second configuration has no side holes on ether the arterial or venous catheter. The TANDEM-CATH is available in three different implant lengths. These variations are 19 cm / 22 cm (arterial / venous), 23 cm / 26 cm, and 28 cm / 31 cm. The Kendall TANDEM-CATH 10 Fr. Catheter System is supplied in kits that include other accessory devices to be used during the catheter implant process.

A Kendall TANDEM-CATH 10 Fr. Catheter repair kit to replace damaged extensions and / or extension adapters is currently marketed, however as there are no changes made to the repair kit, it is not intended to be within the scope of this special 510k.

The provided text describes a Special 510(k) Summary for a modified medical device, the Kendall Tandem-Cath 10Fr Catheter System, seeking substantial equivalence to a previously cleared device. Due to the nature of a 510(k) submission, especially a "Special 510(k)", the focus is on demonstrating that the modified device's performance is equivalent to an existing, legally marketed predicate device rather than establishing entirely new performance criteria or conducting a comprehensive study to prove novel "acceptance criteria" as one might find for a de novo device or a Class III device requiring PMA.

Therefore, the requested information elements related to a "study proving the device meets acceptance criteria" in the context of AI/software performance metrics (like sample size for test/training sets, ground truth establishment, expert adjudication, MRMC studies, standalone performance) are not applicable to this specific submission. This document pertains to physical device modifications and their performance characteristics against a predicate device.

Here's how the available information relates to your request:

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

The document states: "Performance data for the modified 10Fr Tandem-Cath is compared to that of the predicate device identified in this 510(k) summary. Results of verification / validation demonstrate that the modified device is substantially equivalent to the legally marketed device."

This implies that the "acceptance criteria" are the performance characteristics of the predicate device. The "reported device performance" is that the modified device meets or is substantially equivalent to these predicate device characteristics. However, specific numerical acceptance criteria or performance metrics are not explicitly detailed in this summary. The assessment is qualitative, focusing on substantial equivalence.

Table (reconstructed based on the document's intent):

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 a physical medical device modification (catheter), not an AI/software product requiring a "test set" of data in the sense of AI model evaluation. The "performance data" refers to engineering verification and validation tests, not clinical data sets for AI.

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 establishment by experts is relevant for AI models, not a physical device modification as described.

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

• Not applicable. No adjudication method for a "test set" is mentioned as it's not relevant to this type of submission.

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. This submission is about a physical catheter, not an AI system. MRMC studies are for evaluating diagnostic AI.

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

• Not applicable. This is not an AI algorithm.

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

• Not applicable. The "ground truth" in this context would be the established performance and safety profile of the predicate device, against which the modified device's performance (e.g., tensile strength, flow rates, biocompatibility, etc. – although not detailed in this summary) would be compared through engineering tests.

8. The sample size for the training set:

• Not applicable. No AI training set is involved.

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

• Not applicable. No AI training set is involved.

In summary: The provided document is a regulatory submission for a physical medical device (catheter) modification, demonstrating substantial equivalence to a predicate device. The information requested, particularly points 2-9, is pertinent to AI/software device evaluation, which is not the subject of this 510(k) summary. The "study" mentioned is the internal "verification / validation" that ensured the modified device performed equivalently to the predicate, but specific details of these engineering tests (like exact benchmarks or test protocols) are not included in this high-level summary.

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