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Warming Liquid Personal Lubricant is primarily intended as a personal lubricant to warming bigule I crocion, and to enhance the ease and comfort of intimate sexual activity. This lubricant may be safely applied to vaginal or penile tissue for purposes of lubrication, and moisturization. It is also compatible with latex condoms.

PharmaPac Warming Liquid is a non-sterile, clear, non-staining, non-greasy, liquid I harmal as a personal lubricant. This product is highly lubricous and may be used with or without a latex condom during intimate sexual activity. Warming Liquid with or without a later of a contraceptive or spermicide. It is compatible with latex condoms.

The acceptance criteria and the study proving the device meets them are described below:

Acceptance Criteria and Device Performance

The "PharmaPac Warming Liquid Personal Lubricant" is a personal lubricant, and its performance criteria primarily revolve around safety and compatibility for its intended use. The provided studies validate these aspects.

Study Details:

1. Sample sizes used for the test set and the data provenance:

   • Dermal Sensitization Study: Albino guinea pigs (specific number not provided).
   • Intracutaneous Irritation Study: Rabbits (specific number not provided).
   • Vaginal Irritation Study: Rabbits (specific number not provided).
   • Systemic Injection Study: Mice (specific number not provided).
   • Condom Compatibility Studies: Several brands and varieties of latex condoms. Tested in-vitro.
   • Accelerated Stability Study: Samples of the Warming Liquid Personal Lubricant.

   The studies were conducted "by an outside In VIVO Standard Laboratory." The country of origin for the data is not explicitly stated, but the submission is to the U.S. FDA. The biocompatibility studies appear to be prospective, laboratory animal studies, and the condom compatibility studies are prospective in-vitro tests.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   The preclinical studies (biocompatibility and condom compatibility) described do not typically involve human experts establishing a "ground truth" in the way clinical studies do. The "ground truth" is established by direct observation and measurement in animal models or in-vitro settings based on established scientific protocols (e.g., microscopic tissue examination, burst pressure measurements).

3. Adjudication method for the test set:
   Not applicable to these types of preclinical and in-vitro studies. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers assess data or images.

4. 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:
   Not applicable. This device is a personal lubricant, not an AI-powered diagnostic or assistive technology that would involve human readers or MRMC studies.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable. The device is a physical product (personal lubricant), not an algorithm or AI.

6. The type of ground truth used:
   For the biocompatibility studies, the "ground truth" was established through direct histopathological examination (e.g., "microscopic tissue examination showed no significant irritation") and observable biological responses (e.g., "no evidence of being a contact sensitizing agent," "no mortality"). For condom compatibility, the "ground truth" was derived from quantifiable physical measurements (burst pressure/volume, tensile strength/elongation) performed in-vitro.

7. The sample size for the training set:
   Not applicable. This device is not an AI/ML algorithm that requires a training set. The descriptions pertain to pre-market testing of a physical product.

8. How the ground truth for the training set was established:
   Not applicable (as above).

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