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The Art of Intimacy Response" ™ Liquid Personal lubricant is principally intended as personal lubricant to supplement the body's natural lubricating fluids, and to enhance the ease and comfort of intimate sexual activity with or without a latex condom.

The Art of Intimacy Response ™ is a homogenous blend of fluids. It is specifically formulated to be a clear, non-irritating, non-staining, non-greasy, medium viscosity liquid gel and is compatible for use with or without a latex condom during intimate sexual activity as evidenced by condom compatibility testing. The Art of Intimacy Response ™ is not a contraceptive or spermicide, nor does it contain any such component.

The provided text is a 510(k) summary for a personal lubricant, "The Art of Intimacy Response™ Personal Lubricant." It is a regulatory submission to the FDA and primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive study details in the way requested for a medical AI device.

Therefore, many of the requested categories for a rigorous AI device study analysis cannot be fulfilled from the provided document. The document primarily relies on conformity to industry standards and material safety, not a clinical trial comparing device performance against human experts or a gold standard using specific metrics.

Here's an attempt to extract and interpret information based on the provided text, highlighting what is available and what is missing:

Acceptance Criteria and Device Performance Study for "The Art of Intimacy Response™ Personal Lubricant"

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified in the document. The testing was conducted by "independent laboratories" using "identified industry standards." These standards likely define sample sizes for physical and chemical tests (e.g., condom integrity, cytotoxicity if applicable for biocompatibility).
• Data Provenance: The standard tests typically involve laboratory-controlled evaluations of the product itself, not human subjects or real-world usage data in the sense of a clinical trial for AI. No information on country of origin for specific test data is provided. The tests described are retrospective for the device's formulation, meaning they evaluate the final product's characteristics.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This concept is not applicable to the evaluation of this personal lubricant as described. "Ground truth" in this context refers to established industry standards (e.g., ISO or ASTM standards for condom compatibility, USP/NF for ingredient purity). The "experts" would be the chemists, toxicologists, and engineers who developed and interpret these standards, as well as the laboratory personnel performing the tests according to these validated methods. No specific number or qualifications of individual experts are detailed.

4. Adjudication method for the test set

• Not applicable as described for AI studies. Performance is determined by whether the product meets the established scientific/engineering criteria outlined in the industry standards (e.g., tensile strength of condoms after lubricant exposure, growth inhibition in preservative effectiveness tests). There isn't an "adjudication" of expert opinions because the "truth" is defined by objective physical/chemical measurements against predefined thresholds.

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. This is not an AI device, and therefore no MRMC study was conducted.

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

• Not applicable. This is not an AI device. The described tests are evaluations of the product's physical and chemical properties in a standalone manner (the lubricant itself), not an algorithm.

7. The type of ground truth used

• The "ground truth" for this device's safety and effectiveness relies on adherence to established industry standards and pharmacopeial monographs. This includes:
  • Standards for condom compatibility (e.g., ISO, ASTM standards for lubricants claiming condom compatibility).
  • Standards for biocompatibility (e.g., ISO 10993 series relevant for topical applications, though not explicitly cited).
  • Standards for preservative effectiveness (e.g., USP Antimicrobial Effectiveness Testing).
  • Chemical and purity specifications from United State Pharmacopoeia (USP) or National Formulary (NF) for ingredients.

8. The sample size for the training set

• Not applicable. This is not an AI device. There is no concept of a "training set."

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

• Not applicable. This is not an AI device. No ground truth for a training set was established.

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