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The One-Step Suprapubic Introducer is used for introducing a drainage catheter suprapubically into the bladder.

The One-Step Suprapubic Introducer is comprised of a stainless steel trocar stylet needle and a dilator with a peel-away sheath. The trocar stylet needle is 20 centimeters (cm) long with a trocar beveled tip at the distal end of the device. The dilator is 14-22 French (Fr) and 18-19 cm in length. The peel-away sheath is 14-22 Fr and 17 cm in length. The three components are designed to fit together to form a single assembly.

This document describes the Cook Incorporated One-Step Suprapubic Introducer (K182709) and its claim of substantial equivalence to a predicate device. The information provided focuses on the device's technical specifications and the performance tests conducted, rather than a clinical study involving human patients or AI systems. Therefore, many of the requested categories related to clinical studies, AI performance, and human reader effect sizes cannot be populated from the provided text.

Here's the breakdown of the information available:

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

The document broadly states, "All predetermined acceptance criteria were met" for all listed tests. Specific quantitative acceptance criteria are not provided.

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

The document does not specify the sample sizes used for any of the performance tests. The data provenance is Cook Incorporated, based in Bloomington, Indiana, U.S.A. The testing described appears to be prospective lab/bench testing, not clinical data.

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 question is not applicable as the document describes technical performance testing of a physical medical device, not a diagnostic device requiring expert interpretation or ground truth establishment in a clinical context.

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

This question is not applicable for the same reasons as #3.

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

This question is not applicable. The device is a physical suprapubic introducer, not an AI system or a diagnostic tool that would be evaluated with an MRMC study comparing human readers with and without AI assistance.

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

This question is not applicable as the device is not an algorithm or an AI system.

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

This question is not applicable for the type of device and testing described. The "ground truth" for these engineering and biocompatibility tests would be the established test standards and specifications against which the device's performance is measured.

8. The sample size for the training set

This question is not applicable as the device is not an AI system that requires a training set.

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

This question is not applicable for the same reasons as #8.

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