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The Kendall Curity Ureteral Catheter is intended to be used to inject contrast medium for fluoroscopic ureteral visualization, to direct a guidewire into the ureter and for urinary drainage.

The proposed Kendall Curity Ureteral Catheter is a sterile, single use device which facilitates preliminary procedural components of ureteroscopy. The catheter is a single lumen extrusion fabricated from nylon resin. Graduated placement markers on the catheter shaft will allow the urologist to determine the extent of catheter advancement. The proximal end of the catheter has a friction fitted luer lock adapter. The distal catheter tip will be manufactured in a cone tip, open tip or whistle tip configuration. The catheter will be sold in a standard 70 cm working length in French sizes ranging from 4.0 Fr. to 7.0 Fr.

The provided text describes a 510(k) summary for a medical device, the Kendall Curity® Ureteral Catheter. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not typically for reporting on a study with acceptance criteria in the manner requested (e.g., diagnostic accuracy, sensitivity, specificity).

Therefore, many of the requested sections about acceptance criteria and study design are not applicable (N/A) because the provided document details a non-clinical testing approach focused on material biocompatibility and functional/mechanical equivalence to predicate devices, rather than a clinical study evaluating diagnostic or therapeutic efficacy against specific performance metrics for human perception.

Here's an attempt to answer the questions based on the available information, noting when information is N/A:

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

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: Not specified for nonclinical testing. This typically refers to the number of catheters or material samples tested.
• Data Provenance: Not applicable. The testing is described as nonclinical/laboratory-based.

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)

• N/A. Ground truth in this context refers to the expected physical/chemical properties or performance of the device itself, not a diagnostic interpretation by experts. Standard laboratory methods and predicate device performance serve as the "ground truth" for these tests.

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

• N/A. This refers to clinical expert adjudication of ambiguous cases, which is not relevant for nonclinical device performance testing.

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

• N/A. This document describes a medical device (catheter), not an AI algorithm or a diagnostic tool that involves human readers for interpretation.

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

• N/A. This describes a physical medical device, not an algorithm.

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

• For biocompatibility: Adherence to ISO-10993 standards and absence of toxic diffusible substances.
• For functional/mechanical testing: Performance comparable to or equivalent to legally marketed predicate devices, established using standard material and mechanical testing methodologies.

8. The sample size for the training set

• N/A. This is a physical device, not an algorithm that requires a "training set."

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

• N/A. Not applicable, as there is no "training set" for this type of device.

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