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The Niagara™ Dual Lumen Catheter is indicated for use in attaining short term vascular access for hemodialysis, hemoperfusion, or apheresis therapy via the jugular, subclavian or femoral vein.

The Vas-Cath Niagara™ catheter is a polyurethane catheter which allows for dialysis, hemoperfusion or apheresis. The Niagara™ catheter contains two clear polyurethane clamping extensions with luer connectors at the ends and atraumatic nylon clamps. The arterial and venous extensions are identified with red and blue luer connectors. The two extensions merge into a tapered bifurcation joint or hub molded to the catheter body tubing. Both a fixed and a removable suture wing are provided for securing the catheter after initial placement.

The cross-section of the oval shaft contains two round arterial and venous lumens. The arterial lumen exit is bevelled and is perforated with two holes. The venous lumen extends beyond the arterial lumen and ends with a soft atraumatic black tip. The Niagara™ catheters are available in a straight configuration with 15cm, 20cm, and 24cm insertion lengths; as well as in a pre-curved configuration with 12.5 cm, 15 cm and 20 cm insertion lengths.

This document describes a 510(k) submission for the Niagara™ Dual Lumen Catheter, seeking to demonstrate its substantial equivalence to a predicate device, the Vas-Cath Soft-Cell™ Catheter (K871488). Therefore, the study presented focuses on justifying this equivalence rather than establishing acceptance criteria against a clinical benchmark.

Here's an analysis of the provided text in relation to your request:

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

The document does not explicitly define "acceptance criteria" in a quantitative, pass/fail sense as one might find for a new device claiming superiority or meeting a specific performance threshold. Instead, it aims to demonstrate substantial equivalence by comparing the Niagara™ catheter to the predicate device across various characteristics and in vitro performance data.

The table implicitly defines the performance characteristics being compared, and the "reported device performance" are the values listed for the Niagara™ Catheter. The "acceptance criteria" can be inferred as "being comparable to or better than the predicate device."

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

• Sample Size: The document does not specify exact sample sizes for the "in vitro performance data." It refers to "bench testing" but doesn't provide the number of units tested for elongation, tensile strength, leakage, recirculation, maximum pressure, vacuum, or flow rate.
• Data Provenance: The studies were in vitro (bench testing). The submitter, Vas-Cath Incorporated, is located in Mississauga, Ontario, Canada. Therefore, the testing likely occurred in Canada or a facility contracted by them. The data is prospective as it was generated specifically for this submission.

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 is not applicable to the presented data. The studies are in vitro performance tests of a medical device, not a diagnostic or AI-driven system requiring expert ground truth for interpretation. The "ground truth" for these tests would be the measurement results obtained from validated testing methodologies.

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

Not applicable. As noted above, these are objective in vitro measurements, not subjective evaluations requiring adjudication by experts.

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 concerns a physical medical device (catheter), not an AI-based system or diagnostic imaging. Therefore, no MRMC study was performed, nor is there any AI involvement.

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 an algorithm.

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

The "ground truth" for the in vitro performance tests would be the measured physical and mechanical properties of the catheters, derived from standard engineering and materials testing methods. For example, a flow meter would provide the ground truth for flow rate, and a pressure gauge for maximum pressure. These are objective measurements rather than expert consensus or pathology.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. No training set or ground truth for a training set was used.

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