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To be used as a urological catheter inserted through the urinary tract by individuals that are > 30 kg and over 12 years of age. SilverCoat™ Silicone Foley Catheters should not be used on patients with known hypersensitivity or allergy to silver or silver-containing organics or inorganics.

SilverCoat™ Silicone Foley Catheters are 100% silicone Foley catheters that have a lubricious coating impregnated with silver ions. The silver is retained in the hydrophilic coating through ionic bonding and is covalently bonded to the silicone surface. The coating will not peel, flake or crack. The coating hydrates rapidly becoming slippery (lubricious) and maintains its lubricity for at least seven days. The SilverCoat™ catheter complies with the FDA recognized consensus standard, ASTM F623-99 Standard Performance Specification for Foley Catheter. The catheters are comprised of a twolumen shaft with proximal funnel, inflation valve, and distal retaining balloon. Balloon fill volumes are in millimeters and the shaft size is in French (Fr.) which is indicated on the funnel of each individual catheters are supplied in individually packaged, sealed single use pouches and they are sterilized by ethylene oxide. The SilverCoat™ Foley Catheter is a prescription-only device and it is intended to be used in healthcare facility/hospital, home, and ambulatory settings.

This document is a 510(k) summary for the Covalon SilverCoat™ Silicone Foley Catheter, comparing it to the predicate device, Medline SilverTouch™ Silicone Foley Catheter. This is a premarket notification for a medical device and therefore does not contain information about studies of AI performance or clinical studies. The document focuses on demonstrating substantial equivalence to a legally marketed predicate device through non-clinical testing.

Here's a breakdown of the requested information based on the provided text, with clarifications where the information is not applicable or not present in a 510(k) summary:

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

The document does not provide a formal table of acceptance criteria with specific numerical thresholds and corresponding device performance values for each test. Instead, it lists the types of performance tests conducted to demonstrate substantial equivalence to the predicate device and compliance with recognized standards.

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

The document does not specify the sample sizes used for the "test set" for each type of performance testing. This is common for 510(k) submissions, which typically focus on demonstrating compliance with recognized standards and substantial equivalence rather than detailed statistical analysis of clinical studies.

The data provenance is not explicitly stated as "country of origin." However, the sponsor, Covalon Technologies, Inc., is based in Mississauga, Ontario, Canada, and the testing would have been conducted by or for them, likely in Canada or a facility compliant with international standards for medical device testing. The testing described is generally prospective in nature, as it involves newly manufactured devices undergoing specific tests.

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 section is not applicable. The provided document describes non-clinical performance testing for a urological catheter. "Ground truth" and "experts" in the context of diagnostic performance (e.g., radiologists interpreting images) are concepts relevant to AI/diagnostic device studies, which are not described here. The "ground truth" for these tests would be the established scientific methods, physical properties, and safety standards against which the device is evaluated.

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

This section is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation or clinical endpoints where agreement among reviewers is required to establish a gold standard. The tests described are laboratory-based performance tests (e.g., physical properties, biocompatibility, microbial resistance) that do not involve human adjudication in this manner.

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 section is not applicable. The document is a 510(k) summary for a physical medical device (Foley catheter) and does not involve AI, human readers, or image interpretation. Therefore, no MRMC comparative effectiveness study or AI assistance evaluation was conducted.

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

This section is not applicable. The device is a physical medical device and does not involve an algorithm.

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

As mentioned in point 3, the concept of "ground truth" as it applies to diagnostic performance is not relevant here. For the performance tests listed (e.g., physical properties, biocompatibility, microbial resistance, silver elution), the "ground truth" is based on:

• Recognized consensus standards: ASTM F623-99 and EN 1616, Annex A/D.
• Established scientific methodologies: For tests like Kirby-Bauer, AMES assay, cytotoxicity, etc.
• Predetermined specifications: Derived from the predicate device and design requirements.

8. The sample size for the training set

This section is not applicable. There is no "training set" as this device does not involve machine learning or AI.

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

This section is not applicable for the same reasons as point 8.

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