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Water Solubility Human Body Lubricant is a personal lubricant for penile, anal and/or vaginal application, intended 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.

Water Solubility Human Body Lubricant is a clear, colorless, odorless and semi-viscous personal lubricant that is compatible with condoms made of natural rubber latex and polyisoprene, and is not compatible with polyurethane condoms. This device is a non-sterile personal lubricant for penile, anal, and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is sold as an over-the-counter (OTC) product in 120 mL size provided in clear polyethylene terephthalate (PET) bottle. The bottles are capped with silver disc tops. The individual bottles are hermetically sealed during the production process. The device is composed of Hyaluronic acid, Lubrajel CG, Lubrajel oil, Panthenol, Trimethyl glycine, Pentanediol, Hydroxyacetophenone, Ethylene glycol, Glycerol, Purified water.

This FDA clearance letter is for a Water Solubility Human Body Lubricant, which is regulated as a condom accessory (personal lubricant). The information provided is standard for a 510(k) submission for such a device and focuses on biocompatibility, shelf-life, and condom compatibility.

Therefore, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/algorithm-based medical device (like those requiring MRMC studies, ground truth establishment by experts, training/test sets) does not apply to this product.

The document discusses performance testing, but these tests are for physical, chemical, and biological properties of the lubricant itself, not for an AI algorithm's diagnostic or assistive performance.

Here's why the AI-related questions cannot be answered based on the provided text:

• No AI/Algorithm: The device is a "Water Solubility Human Body Lubricant," a physical product, not an AI software or algorithm.
• No Diagnostic/Clinical Performance: The device's function is lubrication, not diagnosis, image analysis, or any task typically performed by an AI in healthcare.
• No Human Readers/Experts for AI Ground Truth: Since there's no AI, there's no need for human readers to establish ground truth or conduct MRMC studies.

Instead, I can summarize the performance criteria and the studies conducted for this specific medical device (the lubricant):

Device Category: Personal Lubricant (regulated under Condom, Product Code NUC)

The acceptance criteria and studies for the Water Solubility Human Body Lubricant are focused on its physical, chemical, microbiological properties, biocompatibility, shelf-life, and compatibility with condoms, as is standard for this type of device.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify the exact sample sizes used for each physical, chemical, or microbiological test (e.g., how many units were tested for viscosity or pH, or how many animals for biocompatibility). These are typically standard laboratory sample sizes for quality control and testing.
• Data Provenance: The tests were conducted according to recognized international and US standards (USP, ISO, ASTM). The manufacturer is "Dongguan Yanxuan Biotechnology Co., Ltd." in China, and the studies were performed as part of their 510(k) submission to the US FDA. The studies are prospective tests performed on the manufactured product to demonstrate compliance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

N/A - This device is a physical product (lubricant), not an AI/algorithmic device that requires expert-established ground truth for performance evaluation. The "ground truth" here is the result of the standardized laboratory tests meeting predefined physical, chemical, and biological specifications.

4. Adjudication Method for the Test Set

N/A - Not applicable for this type of product testing. Results are quantitative measurements or qualitative observations based on direct testing according to established standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

N/A - MRMC studies are for evaluating the performance of diagnostic devices, especially those involving human interpretation (e.g., radiologists reading images) sometimes with AI assistance. This device is a lubricant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

N/A - There is no algorithm for this device.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by objective laboratory measurements and tests against pre-defined specifications from recognized standards (e.g., USP monographs, ISO biocompatibility standards, ASTM condom compatibility standards).

8. The Sample Size for the Training Set

N/A - Not applicable. There is no AI model to train.

9. How the Ground Truth for the Training Set Was Established

N/A - Not applicable. There is no AI model to train.

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