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This product is intended for penile, vaginal and/or anal application to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

KY Banksy Moisture will be marketed as a non-sterile, non-prescription medical device for over-thecounter (OTC) use. This device is a water-based personal lubricant that contains: Water, Glycerin, Propanediol, Xanthan Gum, Benzoic Acid, Sodium Hyaluronate, Potassium Lactate and Lactic Acid. The tube material is composed of High-Density Polyethylene (HDPE) and Low-Density Polyethylene (LDPE), covered with a 50-micron aluminum/inear low-density polyethylene seal and fitted with the Polypropylene (PP) cap. The tube will be packaged in an outer cardboard carton.

The provided document is a 510(k) premarket notification for a medical device called "KY Banksy Moisture," a personal lubricant. It doesn't contain information about AI/ML models, human-in-the-loop performance, or a comparative effectiveness study. Therefore, I cannot provide details on those aspects.

However, I can extract the acceptance criteria and the studies performed to demonstrate substantial equivalence to a predicate device.

Here's the information based on the provided text:

1. Table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

• Sample Size: Not explicitly stated for each test, but studies were conducted.
• Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective.

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

• This information is not applicable as the studies are for physical/chemical properties and biological compatibility, not for expert interpretation of medical images or data. No "ground truth" in the clinical imaging sense is established by experts here.

4. Adjudication method for the test set

• Not applicable for these types of laboratory and physical property tests.

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

• No, an MRMC comparative effectiveness study was not done. This device is a personal lubricant, not an AI-assisted diagnostic tool.

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

• Not applicable as this is not an algorithm-based device. The performance tests are for the physical, chemical, and biological properties of the lubricant itself.

7. The type of ground truth used

• The "ground truth" for demonstrating the device meets acceptance criteria is based on:
  • Scientific Standards: Conformance to specified physical, chemical, and microbiological parameters (e.g., viscosity, pH, osmolality, microbial counts).
  • Biological Standards: Results from established biocompatibility tests (cytotoxicity, irritation, sensitization, acute systemic toxicity) according to ISO 10993 standards.
  • Performance Standards: Compatibility testing with condoms according to ASTM D7661-10.
  • Stability Studies: Accelerated shelf-life testing.

8. The sample size for the training set

• Not applicable as this is not an AI/ML device that requires a training set.

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

• Not applicable as this is not an AI/ML device that requires a training set or its associated ground truth establishment.

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