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K-Y® Brand Vaginal Moisturizer is a personal lubricant, for 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 not compatible with natural rubber latex or synthetic condoms.

K-Y® Brand Vaginal Moisturizer is a non-sterile personal moisturizer formulated to supplement the body's own natural lubricating fluids to provide personal moisturization when vaginal dryness causes discomfort. K-Y® Brand Vaginal Moisturizer, is a stable, non-sterile, translucent, aqueous based, preserved, formulated product composed of a combination of emollients, gelling agents, preservatives, vehicles, and an antioxidant. It is non-fragranced, pH balanced, and contains Vitamin E. The proposed device is packaged in pre-filled applicators to facilitate insertion directly into the vagina.

Here's a breakdown of the acceptance criteria and the study information based on the provided text, focusing on the K-Y® Brand Vaginal Moisturizer:

1. Table of Acceptance Criteria and Reported Device Performance

Study Details:

This document is a 510(k) summary for a medical device (K-Y® Brand Vaginal Moisturizer) seeking substantial equivalence to a predicate device. It describes the performed tests to demonstrate the device's safety and effectiveness. It's crucial to understand that this document primarily focuses on demonstrating substantial equivalence, not conducting a multi-reader, multi-case (MRMC) comparative effectiveness study or a standalone algorithm performance study, as these are not relevant for this type of product and regulatory filing.

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

The document does not explicitly state the specific sample sizes for each test listed (e.g., Agar Overlay Cytotoxicity, Rabbit Vaginal Irritation, Human Repeat Insult Patch Test, In-Home Consumer Use Study). It only mentions that these tests were "performed."

• Data Provenance: The studies were conducted by the applicant, Johnson & Johnson Healthcare Products. The location of the studies (e.g., country of origin) is not specified, but the applicant's address is in Morris Plains, NJ, USA. The studies would be considered prospective as they were conducted specifically for this regulatory submission.

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

Not applicable. This device is a personal lubricant, not an diagnostic imaging or AI-driven decision support system that requires expert interpretation for ground truth establishment. The "ground truth" here is determined by direct laboratory tests and human safety assessments.

4. Adjudication method for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., radiologists reviewing images) to resolve discrepancies and establish a consensus "ground truth." This is not relevant for the types of tests described for a vaginal moisturizer.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic tools or imaging systems where human readers interpret data with and without AI assistance. K-Y® Brand Vaginal Moisturizer is a physical product (lubricant), not an AI system.

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

No, a standalone (algorithm only) performance study was not done. This concept applies to AI algorithms. K-Y® Brand Vaginal Moisturizer is a physical product.

7. The type of ground truth used

The "ground truth" for this product is established through:

• Laboratory Testing: For factors like lubricity, stability, and condom compatibility.
• Biocompatibility Testing:
  • Agar Overlay Cytotoxicity (in vitro lab test).
  • Rabbit Vaginal Irritation (in vivo animal model).
• Human Safety Studies:
  • Exaggerated Human Use (Human Repeat Insult Patch Test) – direct observation of human skin reactions.
  • In-Home Consumer Use Study – direct user feedback on safety and performance.

8. The sample size for the training set

Not applicable. This device is a physical product, not an AI algorithm requiring a training set.

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

Not applicable, as there is no "training set" for this type of product.

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