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The Wiygul Catheter is intended for use in the neonate and infant subpopulations of pediatric patients to sample urine. This device is removed after a urine sample is collected. This is not an indwelling catheter.

The Wiygul Catheter intended for use in neonatal and pediatric patients to sample urine. This device is removed after a urine sample is collected. This is not an indwelling catheter. The Wiygul Catheter is comprised of a two-layer design, including an inner sampling catheter and protective outer sheath to minimize contamination of the eyelets. The tip will be atraumatic. The handle of the device will utilize a slider to facilitate the retraction of the outer sheath once inserted into the bladder to expose eyelets for sampling. This catheter is a6Fr catheter with a working length of 300mm +/- 5mm. Material composition of the catheter is provided in in Table 5-1 below.

The Wiygul Catheter is provided in a box containing the main device (sampling catheter), a cleared syringe and Instructions for Use.

The mechanism of action will be mechanical for pulling back the outer sheathe and negative pressure from the attached syringe to withdraw a urine sample.

This FDA 510(k) summary describes the Wiygul Catheter but does not provide the detailed acceptance criteria or results of a study in the format requested. The document states "All tests met the pre-determined acceptance criteria" for various performance tests, but it does not specify what those criteria were or provide quantitative results beyond this general statement.

Therefore, many of the requested fields cannot be extracted directly from this document.

Here's an attempt to answer based on the provided text, highlighting where information is not available:

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

The document mentions several performance tests were conducted and states: "All tests met the pre-determined acceptance criteria." However, the specific acceptance criteria and the detailed reported device performance for each test are not provided in this summary.

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

This information is not provided in the document. The document primarily focuses on non-clinical performance testing of the device itself (e.g., mechanical properties, packaging) rather than clinical study data from a patient test set.

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 information is not applicable as the provided document details non-clinical laboratory testing, not a study involving expert assessment of medical images or patient data.

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

This information is not applicable as the provided document details non-clinical laboratory 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

This information is not applicable. The document describes a medical device (catheter), not an AI-powered diagnostic tool, and it does not include any MRMC study.

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

This information is not applicable as the document describes a medical device (catheter), not an algorithm.

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

For the non-clinical performance tests, the "ground truth" would be established by the specific engineering and material science standards and methodologies used for each test (e.g., ISO, ASTM standards, internal specifications). For example, for "Dimensional Inspection," the ground truth would be the design specifications for the catheter's dimensions. However, the document does not elaborate on these specific ground truth definitions for each test.

8. The sample size for the training set

This information is not applicable as the document describes a medical device (catheter) and its non-clinical performance testing. It does not refer to a "training set" in the context of an algorithm.

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

This information is not applicable as there is no "training set" mentioned in the context of this device's documentation.

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