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JO Actively Trying Personal Lubricant is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of sexual activity and supplement the body's natural lubrication. This product is compatible with sperm, oocytes and can be used by couples trying to conceive. This product is compatible with natural rubber latex, polyurethane and polyisoprene condoms.

JO Actively Trying Personal Lubricant is a clear, semi-viscous personal lubricant that is compatible with condoms made of natural rubber latex, polyurethane and polyisoprene. This device is a non-sterile personal lubricant for penile and/or vaginal application, to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with sperm, oocytes and embryos and can be used by couples trying to conceive. This product is provided in clear, Polyethylene Terephthalate (PET) cylinder bottles are capped with silver disc top caps. The individual bottles are hermetically sealed during the production process. This device is composed of Water (Aqua), Propylene Glycol, Hydroxyethylcellose, Fructose, Arabinogalactan, Sodium Phosphate, Salt, Potassium Phosphate, Methylparaben.

Here's a breakdown of the acceptance criteria and study information for the JO Actively Trying Personal Lubricant, based on the provided FDA 510(k) summary:

This device is a personal lubricant, and the studies performed are primarily non-clinical laboratory tests to demonstrate its safety, effectiveness, and compatibility for its intended use, rather than clinical studies in humans. Therefore, many of the typical categories for AI/medical device clinical studies (like sample size for test sets, expert ground truth, adjudication methods, MRMC studies) are not applicable here.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not applicable in the context of a typical AI/ML clinical test set. The studies performed are non-clinical laboratory tests on the product itself.
• For tests like HSSA, LAL, antimicrobial, and pathogen tests, the "sample size" would refer to the number of lubricant product samples tested, biological reagents used, or microbial cultures, which are not specified in this summary. The data provenance is from laboratory tests conducted presumably by or for the manufacturer.

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

• Not applicable. This summary does not describe a study involving human experts establishing ground truth for a test set in the way it would for an AI diagnostic device. The "ground truth" for the lubricant's properties (e.g., pH, viscosity, sperm survival, microbial counts) is established by adherence to recognized laboratory standards and methods.

4. Adjudication method for the test set

• Not applicable. No adjudication method is described as this is not a study requiring human interpretation or consensus.

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 a physical product (personal lubricant), not an AI-based diagnostic or assistive device that would involve human readers or cases.

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

• Not applicable. This is a physical product, not an algorithm.

7. The type of ground truth used

• The "ground truth" for this product is based on objective measurements, quantitative laboratory assays, and adherence to established industry and regulatory standards as defined by:
  • Device specifications (e.g., pH, viscosity, osmolality).
  • Standardized microbiological tests (e.g., USP , , , ).
  • Biocompatibility standards (e.g., ISO 10993 series).
  • Specific performance assays (Human Sperm Survival Assay, Limulus Amebocyte Lysate Gel-Clot Method, Lubricant Barrier Assay, Condom Compatibility per ASTM D7661-10).

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not an AI/ML device.

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

• Not applicable. There is no "training set" for this type of product.

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