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United Urologics Intermittent Catheter is intended to be used as a urinary incontinence device designed to drain urine from the bladder.

The United Urologics Intermittent Catheter is a sterile, single use, disposable, urinary incontinence device designed to drain urine from the bladder. The device is manufactured of a flexible tube with a smooth radius, atraumatic tip to facilitate introduction into the urethra. The catheter is manufactured with drainage holes in the side of the tubing closest to the tipped end of the catheter in order to allow drainage of urine from the bladder through the central lumen of the catheter tube. The catheter may be provided with a funnel bonded to the end of the catheter tube opposite the tipped end. During use, the funnel or flared end of the catheter may be attached to a universal adapter to facilitate drainage of the urine into a standard urinary collection bag (the collection bag and universal adapter are not part of this device).

The device may be used by the patient or caregiver in a healthcare facility, hospital, and home or public restroom facilitate drainage of urine from the bladder.

This document is a 510(k) summary for the United Urologics Intermittent Catheter, establishing its substantial equivalence to a predicate device. It does not contain information about a specific study testing the device against acceptance criteria in the context of AI/machine learning performance. The information provided relates to the regulatory submission for a medical device.

Therefore, many of the requested categories are not applicable to the content provided.

However, I can extract information related to the device's performance characteristics and testing as described for its regulatory approval.

Here's the breakdown based on the provided text, indicating where information is not applicable (N/A) for an AI/ML context:

1. Table of acceptance criteria and reported device performance:

The document describes the device's technical characteristics and how it was tested according to relevant international standards. It doesn't present a table of specific acceptance criteria in the format of "metric X value must be > Y" with a corresponding "device achieved Z." Instead, it states that the device was designed and tested in accordance with specified standards.

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 in the document. The text refers to "testing" that was "completed" but does not provide details on sample sizes for biocompatibility, sterilization, or functional tests.
• Data Provenance: Not specified. This document is a regulatory submission, not a research paper detailing study methodology origins.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• N/A. This is a medical device approval document, not an AI/ML study involving expert ground truth establishment for a test set. The "ground truth" for this device's performance relies on its physical and functional characteristics meeting engineering and safety standards.

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

• N/A. Not relevant for this type of device and regulatory submission.

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 pertains to a physical medical device (intermittent catheter) and does not involve AI or human readers.

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

• N/A. This document pertains to a physical medical device and does not involve an algorithm.

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

• The "ground truth" for this device is based on compliance with established international engineering and safety standards for medical devices (e.g., BS EN 1616, BS EN 1618, ISO 10993, ANSI/AAMI/ISO 11135). For biocompatibility, this would involve laboratory test results (e.g., cytotoxicity assays, irritation tests). For sterilization, it would involve sterility assurance level (SAL) validation.

8. The sample size for the training set:

• N/A. This document does not concern an AI/ML device that requires a training set.

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

• N/A. This document does not concern an AI/ML device.

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