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Personal Warming Gel is designed to enhance the ease and comfort of intimate activity and is compatible with latex condoms

Personal Warming Gel is a non-sterile, clear, non-staining, nongreasy, liquid gel used as a personal lubricant. This product is highly lubricous and may be used with or without a latex condom during intimate sexual activity.

The provided text describes a 510(k) premarket notification for a medical device called "Personal Warming Gel." This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving the device meets specific performance acceptance criteria through the kind of study described in the prompt. Therefore, much of the requested information is not applicable or cannot be extracted from the provided document.

Here's a breakdown of what can be derived and what cannot:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable/Not provided. This document describes non-clinical studies (stability, preservative effectiveness, comparison to predicate). These studies do not typically involve a "test set" in the context of human subject testing for diagnostic or therapeutic efficacy.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable/Not provided. No "ground truth" establishment by experts is described, as this is a non-clinical evaluation comparing a new device to a predicate based on physical and chemical properties, stability, and preservative effectiveness.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/None. Adjudication methods are typically for clinical trials or expert review panels for ground truth determination, which are not part of this 510(k) summary for a personal lubricant.

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

• Not applicable/Not done. This type of study is for diagnostic devices, particularly those involving image interpretation by human readers (e.g., radiologists, pathologists) with or without AI assistance. The Personal Warming Gel is a personal lubricant, not a diagnostic device.

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

• Not applicable/Not done. Standalone algorithm performance refers to AI/software performance without human intervention. This device is a physical product (personal lubricant), not an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable. The "ground truth" for the non-clinical studies in this 510(k) submission would be based on established laboratory testing methods and industry standards for stability, preservative effectiveness, and chemical composition analysis, rather than expert consensus, pathology, or outcomes data in a clinical sense.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not an AI/machine learning device. The studies described are non-clinical evaluations of material properties and performance.

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

• Not applicable. As there is no training set, there is no ground truth establishment for one.

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