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Poise Personal Lubricant is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is not compatible with natural rubber latex condoms but is compatible with polyisoprene and polyurethane condoms.

Poise Personal Lubricant is a water soluble, clear, colorless, viscous liquid composed of purified water, hydroxyethyl cellulose (Natrosol 250), propylene glycol, benzoic acid and sodium hydroxide. Poise Personal Lubricant is presented as a non-sterile product. It is neither a contraceptive nor a spermicide and is sold over-the-counter. The product is packaged in a seventy-four ml plastic, cylindrical pump bottle placed inside a display carton. The outside of the display carton contains a tamper evident seal. Poise Personal Lubricant is a non-greasy and fragrance-free formulation which contains only United States Pharmacopeia (USP) or National Formulary (NF) ingredients.

The Kimberly-Clark Poise® Personal Lubricant is not an AI/ML device, and therefore, the requested information regarding AI/ML acceptance criteria and studies is not applicable.

The provided documentation describes the traditional 510(k) submission process for a medical device (personal lubricant) and focuses on demonstrating substantial equivalence to a predicate device (Durex® Play™ Lubricant). The "acceptance criteria" discussed in this context are related to the safety and effectiveness of the lubricant itself, as proven by various non-clinical laboratory tests.

Here's an overview of the "acceptance criteria" and how the device met them, based on the provided text, adapted to the closest relevant information:

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

Note: The cytotoxicity result shows "Non-cytotoxic ≤ 3.13%". The document clarifies that while propylene glycol has moderate cytotoxic potential in vitro, cytotoxicity is not demonstrated in vivo for the lubricant.

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

The document does not specify human "test sets" or "data provenance" in the context of clinical trials as it pertains to AI/ML devices. The studies conducted are non-clinical (laboratory and animal studies).

• For Cytotoxicity (In Vitro): Not specified (cell culture).
• For Sensitization (In Vivo): Guinea Pig Maximization Assay. Sample size not specified.
• For Vaginal Irritation (Rabbit): Rabbit Vaginal Irritation study. Sample size not specified.
• For Subacute Toxicity (Rabbit): Two-week Rabbit Vaginal Exposure. Sample size not specified.
• For Genotoxicity (In Vitro): Bacterial Reverse Mutation, Chromosome Aberration. Sample sizes not specified (cell culture).
• For Genotoxicity (In Vivo): Mouse Micronucleus. Sample size not specified.
• For Ocular Irritation (In Vitro): 3D Cell Culture (EpiOcular). Sample size not specified (cell culture).
• For Microbial Limits Test: Three process validation lots were used.
• For Oral Toxicity Assessment: Based on individual component assessment, not a direct animal or human study for the final product in this context.

All these studies represent preclinical data. The "country of origin" is not specified, but these are standard international laboratory tests.

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

This information is not applicable as there is no "test set" requiring expert ground truth in the context of an AI/ML device. The "ground truth" for the non-clinical studies is established by the results of the specific biological or chemical assays performed in a laboratory setting, following recognized standards (e.g., ISO, OECD, USP).

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

Not applicable. There is no "test set" and no human expert adjudication as would be relevant for an AI/ML device.

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.

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

Not applicable. This is not an AI device.

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

The "ground truth" for the performance of the personal lubricant is based on:

• Biological/Chemical Assay Results: For biocompatibility endpoints (e.g., cytotoxicity, sensitization, irritation, genotoxicity, oral toxicity). These are determined by the specific methodologies of the laboratory tests referenced (e.g., ISO 10993 series, OECD guidelines, MatTek EpiOcular MTT Viability Assay).
• Microbial Testing Standards: For microbial limits, ground truth is established by meeting predefined USP and criteria (≤ 100 cfu/ml and no objectionable organisms).
• Physical/Chemical Property Measurements: For characteristics like pH, viscosity, specific gravity, osmolality, and long-lasting lubricity (coefficient of friction). These are measured and compared to the predicate device and established specifications.
• Condom Compatibility Testing Standards: ASTM-D7661-10 was used to determine compatibility with different condom materials.

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

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