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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

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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.

K Y Banksy Aloe is a personal lubricant that is non-sterile, water-based, and provides lubrication during intimate sexual activity. This device is compatible with natural rubber latex and polyisoprene condoms, and is not compatible with polyurethane condoms. Its formulation consists of Water, Propanediol, Xanthan Gum, Benzoic Acid, Aloe Barbadensis Leaf Juice, Potassium Lactate and Lactic Acid. KY Banksy Aloe is packaged in 100 mL tubes composed of High Density Polyethylene (HDPE) and Low-Density Polyethylene (LDPE), covered with a 50 micron aluminium/linear low-density polyethylene seal and fitted with the Polypropylene (PP) cap. The tube is packaged in an outer cardboard carton. KY Banksy Aloe is a personal lubricant for over-the-counter (OTC) use.

The provided text is a 510(k) premarket notification for a personal lubricant, KY Banksy Aloe. It describes various performance tests conducted on the device, primarily focusing on its physical properties, sterility, biocompatibility, and condom compatibility.

However, the questions you've asked (related to AI/algorithm performance, multi-reader multi-case studies, ground truth establishment for training and test sets, and expert involvement for image-based diagnostics) are not applicable to this document.

This document pertains to a physical medical device (a personal lubricant), not a software or AI-driven diagnostic device. Therefore, the concepts of image-based ground truth, AI performance metrics, expert adjudication of images, or training/test sets for AI models are entirely irrelevant to this submission.

The document discusses acceptance criteria and proof of substantial equivalence to a predicate device, which is a regulatory pathway for low-to-moderate risk medical devices. The "performance" described is about the lubricant's physical and chemical properties and biological interactions, not diagnostic accuracy.

Therefore, I cannot provide answers to your specific questions based on the provided text because the context of the document is entirely different from what your questions assume.

Ask a specific question about this device