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Personal lubrication and lubrication of a body orifice to facilitate entry of a diagnostic or therapeutic device, as a moisturizer for vaginal dryness, to enhance condom use and the ease of intimate activity.

The FDS Intimate Lubricant formula is non-sticky, non-staining, non-greasy and is compatible with latex condoms in laboratory testing. It is a water soluble, clear, high viscosity, gel-like liquid. Because it is water soluble, FDS Intimate Lubricant is easily rinsed off with water. The product can reduce friction during sexual intercourse thereby enhancing sexual intimacy. It is compatible with latex condoms as demonstrated in Condom Compatibility Testing conducted according to the standards as defined by ASTM D 3492. FDS Intimate Warming Lubricant is neither a contraceptive nor a spermicide. The product is packaged in a convenient to use pump bottle.

The FDS Intimate Warming Lubricant is a non-sticky, non-staining, non-greasy gel for use as a personal lubricant. This product imparts a gentle warming sensation when applied to the skin. The product can reduce friction during sexual intercourse thereby enhancing sexual intimacy. It is compatible with latex condoms as demonstrated in Condom Compatibility Testing conducted according to the standards as defined by ASTM D 3492. FDS Intimate Warming Lubricant is neither a contraceptive nor spermicide.

It contains only United States Pharmacopeia (USP) or National Formulary (NF) ingredients, all of which are listed as "generally recognized as safe".

This is a 510(k) premarket notification for a medical device, which seeks to demonstrate substantial equivalence to a predicate device rather than fulfilling specific acceptance criteria through a clinical study with detailed performance metrics. Therefore, many of the requested elements (like sample sizes for test/training sets, number/qualifications of experts, adjudication methods, MRMC studies, or specific quantitative performance metrics against acceptance criteria) are not typically included or required in this type of submission.

However, based on the provided text, I can extract and infer the following:

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

• FDS Intimate Warming Lubricant induced a decrease of cell viability after 24 hours of contact and showed histological alterations after 10 minutes of contact in the same assay. (This indicates some irritation, but the submission still declares substantial equivalence, implying it was within acceptable limits compared to predicates or deemed clinically insignificant for the intended use given predicate equivalence for similar warming lubricants). |
  | - No acute eye irritation | - FDS Intimate Lubricant was found to be a non-irritant in the Acute Eye Irritation Assay.
• FDS Intimate Warming Lubricant was found to be very slightly irritant and induced histological alterations after 10 minutes of contact. (Similar to vaginal irritation, some irritation was noted, but was likely considered acceptable given predicate equivalence and "very slightly irritant" finding). |
  | Condom Compatibility (Latex): | |
  | - Compatible with latex condoms (per ASTM D 3492) | - FDS Intimate Lubricant and FDS Intimate Warming Lubricant compatible with latex condoms as demonstrated in Condom Compatibility Testing conducted according to ASTM D 3492. (Results are compared against water-treated controls and KY Jelly predicate). |
  | Consumer Perceptions/Performance Claims: | |
  | - Non-Messy. Convenient Pump! | - Evaluated in an In-Home Consumer Use Study against this claim. Results not explicitly detailed beyond stating statistical analysis was performed. |
  | - Warming Intimate Lubricant | - Evaluated in an In-Home Consumer Use Study against this claim. Results not explicitly detailed beyond stating statistical analysis was performed. |
  | - Warms on Contact | - Evaluated in an In-Home Consumer Use Study against this claim. Results not explicitly detailed beyond stating statistical analysis was performed. |
  | - For Enhanced Intimacy and Pleasure | - Evaluated in an In-Home Consumer Use Study against this claim. Results not explicitly detailed beyond stating statistical analysis was performed. |
  | - Fragrance Free | - Evaluated in an In-Home Consumer Use Study against this claim. Results not explicitly detailed beyond stating statistical analysis was performed. |
  | - Gentle, Long-Lasting Formula | - Evaluated in an In-Home Consumer Use Study against this claim. Results not explicitly detailed beyond stating statistical analysis was performed. |

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

• Preclinical Testing: The preclinical tests (Biocompatibility, Condom Compatibility, Vaginal Mucosal Irritation, Eye Irritation) were conducted in a laboratory setting. No specific sample sizes for these in-vitro tests are provided beyond "duplicate cultures" for some cell viability assays. The provenance is "an outside laboratory, in compliance with Good Laboratory Practices (GLPs)." This implies a controlled, prospective study environment for the tests.
• Human Repeated Insult Patch Test: Not specified.
• In-Home Consumer Use Study: Not specified. The provenance is "an independent market research firm." This would be a prospective study.

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

Not applicable. This submission relies on laboratory test results (e.g., cell viability, physical integrity of condoms), and consumer survey responses, not expert human interpretation of medical images or data requiring ground truth establishment by experts in that sense.

4. Adjudication method for the test set

Not applicable. The tests are primarily objective measurements (e.g., cell viability, strength tests for condoms) or consumer feedback.

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. This device is a personal lubricant, not an AI-assisted diagnostic or therapeutic device. Such a study would not be relevant.

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

This question is not applicable as the device is not an algorithm or AI. The performance studies are for a physical product (lubricant).

7. The type of ground truth used

• Biocompatibility: Laboratory assay results (e.g., MTT assay for cell viability, histological analysis for tissue alteration).
• Condom Compatibility: ASTM D 3492 standard measurements for strength and leakage, compared against a water-treated control and a predicate substance (KY Jelly).
• Human Repeated Insult Patch Test: Clinical observations by dermatologists/study personnel for contact sensitization.
• In-Home Consumer Use Study: Consumer feedback and perceptions relative to marketing claims.

8. The sample size for the training set

Not applicable. This device is not an AI/machine learning model, so there is no "training set."

9. How the ground truth for the training set was established
Not applicable. See response to #8.

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