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Ultrasmooth 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 and polyisoprene condoms.

Medline Lubricating Liquid and Vaginal Moisturizer 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 and polyisoprene condoms.

The UltraSmooth Lubricating Liquid, and Medline Lubricating Liquid and Vaginal Moisturizer are non-sterile aqueous personal lubricants. Both lubricants are clear, odorless. The ingredients for the UltraSmooth Lubricating Liquid are similar to other personal lubricants currently on the market. The specifications for UltraSmooth Lubricating Liquid, and Medline Lubricating Liquid and Vaginal Moisturizer include color, pH, viscosity, lubricity, osmolarity, antimicrobial effectiveness, total aerobic microbial count, total yeast and mold count, and absence of pathogenic organisms.

Both the UltraSmooth, and Medline Lubricating Liquid and Vaginal Moisturizer are compatible with natural rubber latex and polyisoprene condoms.

The UltraSmooth Lubricating Liquid product will be offered in two sizes, a 2 fluid ounce and a 6 fluid ounce. The primary packaging consists of a high density polyethylene (HDPE) bottle with a polypropylene closure. Each bottle of product will be packaged into a cardboard carton, which constitutes the product's outer packaging.

The Medline Lubricating Liquid and Vaginal Moisturizer will be offered in two sizes, 2.5 fluid ounces and 4 fluid ounces. The primary packaging consists of a high density polyethylene (HDPE) bottle with a polypropylene closure. Each bottle of product will be packaged into a cardboard carton, which constitutes the product's outer packaging.

The provided documents describe the regulatory submission for two personal lubricants, Ultrasmooth Lubricating Liquid and Medline Lubricating Liquid and Vaginal Moisturizer. The bulk of the information pertains to demonstrating substantial equivalence to a predicate device (K-Y UltraGel) through non-clinical and some clinical testing.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The documents do not explicitly list formal "acceptance criteria" for the device's main function as a lubricant. Instead, they demonstrate compatibility with condoms and general safety. They mention specifications for properties like pH, viscosity, lubricity, osmolarity, and microbiological characteristics, but do not provide specific numerical criteria or reported performance values for these non-clinical attributes.

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

• Clinical (in-use) study:

  • Test set sample size: 30 subjects for Medline's Lubricating Liquid and Vaginal Moisturizer; 29 subjects for UltraSmooth Lubricating Liquid.
  • Data provenance: Not specified (e.g., country of origin). The study is described as "a ten-day in use clinical study," which implies it was specifically conducted for this submission (prospective).

• Non-clinical (biocompatibility, condom compatibility, staining) studies:

  • Sample sizes are not specified for these tests. The documents state that the products "were tested" or "are biocompatible based on the results." These are likely laboratory tests on manufactured samples rather than patient data.
  • Data provenance: Not specified. Implicitly, these are laboratory tests performed for the device submission (prospective in nature towards the submission).

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

This is not applicable as the studies described are not diagnostic AI studies requiring expert ground truth for interpretation.

For the in-use clinical study, "safety when used as intended" was assessed, but the method of assessment (e.g., self-report, clinician evaluation) and the number/qualifications of any evaluating experts are not provided.

4. Adjudication method for the test set

Not applicable, as this refers to a multi-reader consensus process often used in diagnostic image interpretation studies. The studies described are not of this nature.

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

No such study was conducted or described. This type of study is relevant for diagnostic AI tools, which is not the nature of these personal lubricants.

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

Not applicable. The device is a personal lubricant, not an algorithm.

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

• Clinical (in-use) study: The "ground truth" was likely inferred from the reported experience or observations of the subjects regarding safety during use. Specific "outcomes data" that would serve as ground truth are not detailed (e.g., no adverse events reported, satisfactory comfort, etc.). The conclusion is simply that the devices are "safe when used as intended."

• Non-clinical studies: The "ground truth" for these tests (biocompatibility, condom compatibility, staining) would be established by the standardized methods themselves (e.g., ISO, ASTM, AATCC standards). Passing the test according to the defined parameters of these standards constitutes the "ground truth" of performance.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device.

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

Not applicable. This is not an AI/machine learning device.

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