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The Expressway Intermittent Catheter is intended to provide an intermittent pathway for draining fluids from and instilling fluids into the bladder. The device is indicated for providing lubricity during the catheter's advancement.

The Expressway intermittent catheter consists of a film membrane preloaded within the lumen of a catheter.

This document, K061766, is a 510(k) premarket notification for a medical device called the "Expressway Intermittent Catheter." The submission states that performance data is "Not required." This is because the device is being marketed as substantially equivalent to a legally marketed predicate device (SLIP Urology Catheter, Percutaneous Systems, Inc.) based on having the same intended use, indications for use, principles of operation, and technological characteristics.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment is not provided in this submission, as no new performance studies were deemed necessary for this type of submission.

Here's a breakdown of why each section cannot be addressed from the provided text:

1. A table of acceptance criteria and the reported device performance: Not provided. The submission states "Performance Data: Not required."
2. Sample sized used for the test set and the data provenance: Not applicable, as no performance testing was required.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no performance testing was required.
4. Adjudication method for the test set: Not applicable, as no performance testing was required.
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 device is a urological catheter, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a urological catheter, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no performance testing was required.
8. The sample size for the training set: Not applicable, as no 'training set' in the context of performance data would be relevant for this type of device submission.
9. How the ground truth for the training set was established: Not applicable.

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