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The urinary catheter is for use with patients requiring urine drainage, with chronic urine retention and with post-void residual volume (PVR). The catheter is inserted into the urethra to reach the bladder allowing urine to drain.

The silicone pediatric urinary catheter is a small diameter tube of various diameters, 3.5, 5.0, 6.5, and 8.0 French and a length of 16". It has an integral female luer fitting. There are 2 eyelets near the tip of the tube. It has marking along the shaft of the tubing and an integral radiopaque line. It is provided sterile.

This document is a 510(k) premarket notification for a Pediatric Urinary Catheter. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific performance acceptance criteria. Therefore, much of the requested information cannot be directly extracted or is not applicable in the context of this type of regulatory submission.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative "acceptance criteria" in the format of a clinical study endpoint. Instead, the comparison to the predicate device serves as the primary means of demonstrating safety and effectiveness. The "Proposed device" column acts as the "reported device performance" in this context, showing that its attributes match or are equivalent to the predicate.

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

This document does not describe a clinical study with a "test set" in the traditional sense of evaluating performance. The submission relies on a comparison of device characteristics and intended use to a legally marketed predicate device. Therefore, information about sample size, data provenance, or study design for performance evaluation is not present.

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):

Not applicable. As there is no clinical study with a "test set" requiring ground truth establishment, this information is not provided. The "ground truth" for this submission is the characteristics and regulatory status of the predicate device.

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

Not applicable. No clinical study with a test set.

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 urinary 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 is a physical medical device, not an algorithm.

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

The "ground truth" in this context is the regulatory approval and established characteristics of the identified predicate device (ProMedic, Inc. Urinary Catheter – K031409). The equivalence is established by demonstrating that the proposed device has the same intended use, technological characteristics (materials, design features, sterility), and performs similarly to this predicate device.

8. The sample size for the training set:

Not applicable. There is no "training set" as this is not a machine learning or AI-based device. The submission relies on demonstrating similarity to a predicate device, not on data-driven model training.

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

Not applicable.

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