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Lubricating Liquid is a personal lubricant, for penile 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, polyisoprene, and polyurethane condoms.

PharmaPac Personal Lubricant is a water-based personal lubricant formulated to be a non-greasy, non-sticky, non-staining clear gel-like liquid. The water-soluble formula allows this product to be rinsed off with water.

The provided text is a 510(k) summary for the PharmaPac Personal Lubricant. It documents the submission for FDA clearance of a medical device, in this case, a personal lubricant. The content of this document does not contain the specific type of performance data and study details requested in the prompt, as it is a summary for a device that is substantially equivalent to a predicate device, and thus relies on the predicate's established performance rather than extensive new clinical studies.

Therefore, I cannot extract the information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details from the provided text.

The "Performance Data" section specifically states:
"Stability of the PharmaPac Lubricating Jelly was confirmed throughout its labeled shelf life (24 Months) by an accelerated stability study for 90 days at 40°C / 75% R.H. and parallel microbial study in accordance with USP standards."

This indicates a stability study was performed, which is a chemical/physical performance test, not a study involving human subjects or expert review for diagnostic accuracy. This type of device (personal lubricant) does not typically require the kinds of studies (e.g., MRMC, standalone algorithm performance, expert consensus on images) that would involve the criteria you've outlined, as it's not an AI/imaging diagnostic device.

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Lubricating Jelly Personal Lubricant is primarily intended for personal lubrication, and eases insertion of rectal thermometers, enemas, and tampons and similar type nozzles. It is also compatible with latex condoms.

PharmaPac Lubricating Jelly is a water-based personal lubricant containing chlorhexidine gluconate and methylparaben as preservatives in a vehicle for glucono delta lactone, glycerin, hydroxyethylcellulose, sodium hydroxide, and purified water.

The provided text describes a 510(k) submission for a personal lubricant device and does not contain information about acceptance criteria, device performance metrics, or a study that typically involves ground truth, experts, or comparative effectiveness for an AI/ML device. The "Performance Data" section solely refers to stability and microbial studies for the lubricant.

Therefore, most of the requested information cannot be extracted from the given text.

However, I can extract what little "performance data" is mentioned:

1. Table of acceptance criteria and the reported device performance

Regarding the other requested information:

• Sample sized used for the test set and the data provenance: Not applicable. The "performance data" concerns product stability and microbial testing, not a test set for an AI/ML device.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no ground truth, as this is not an AI/ML device.
• Adjudication method for the test set: Not applicable.
• 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 is not an AI/ML device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
• The sample size for the training set: Not applicable. This is not an AI/ML device.
• How the ground truth for the training set was established: Not applicable.

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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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