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The proposed device is intended for use in the drainage and/or collection and/or measurement of urine. Generally drainage is accomplished by inserting the catheter through the urethra and into the bladder. However, drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as a nephrostomy tract.

The Kendall DOVER Silver Hydrogel Coated Silicone Foley Catheter is a sterile, single patient use, urinary drainage catheter extruded from 100% vulcanized silicone material. It is coated with a lubricious hydrophilic topcoat containing an inorganic silver releasing polymer.

This document is a 510(k) summary for the Kendall DOVER Silver Hydrogel Coated Silicone Foley Catheter, submitted to the FDA. It does not describe an AI device or specific performance criteria for such a device. Instead, it outlines the substantial equivalence of this catheter to a predicate device and details nonclinical testing related to biocompatibility.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving a device meets them in the context of AI device performance. The document does not contain any of the following:

1. A table of acceptance criteria and the reported device performance: There are no performance metrics or acceptance criteria for an AI device in this document.
2. Sample size used for the test set and the data provenance: Not applicable as no AI device performance study is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
6. Standalone (i.e. algorithm only without human-in-the-loop performance) study: Not applicable.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document primarily focuses on:

• Device Description: A sterile, single-patient use, urinary drainage catheter made from 100% vulcanized silicone material, coated with a lubricious hydrophilic topcoat containing an inorganic silver releasing polymer.
• Intended Use: Drainage, collection, and/or measurement of urine, typically via urethral insertion, but also suprapubic or nephrostomy tract placement.
• Substantial Equivalence: Claimed to be substantially equivalent to the Kendall DOVER Foley Catheter predicate device.
• Nonclinical Testing: Biocompatibility testing demonstrated compliance with ISO 10993-1 and FDA modified matrix (memorandum G95-1).
• FDA's Determination: The FDA determined substantial equivalence, but specifically stated that no claims regarding the effectiveness of the inorganic silver ion releasing polymer to reduce microbial adherence or urinary tract infections could be made due to a lack of microbial adherence data.

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