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For vaginal/penile and condom application during sexual intimacy

Description of Delly is a non-sterile, clear, non-staining, non-greasy, water soluble ielly for use as a personal lubricant. This product imparts a gentle warming sensation when Jen' for use as a personal nas designed to meet a customer need for a lubricant that does not feel cold when applied. K-Y® Brand Warming Jelly reduce can reduce friction that does not feel cold which upplives and intimacy. It is compatible with latex during sexual mercounse theres your Compatibility Testing conducted according the condonis as defined by ASTM D 3492. K-Y® Brand WARMING Jelly is not a contraceptive nor spermicide.

The provided text describes the 510(k) summary for the K-Y® Brand WARMING Jelly Personal Lubricant. It outlines preclinical and clinical testing to demonstrate safety and substantial equivalence to a predicate device. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state "acceptance criteria" with numerical thresholds for each test. Instead, it describes the tests and then reports the positive (or negative, where appropriate) outcomes as evidence of safety and performance. I've inferred the acceptance criteria based on the reported results.

2. Sample Sizes Used for the Test Set and Data Provenance

• Human Repeated Insult Patch Test: The sample size is not explicitly stated, but the test compared the product to the currently marketed K-Y® Brand Warming LIQUID.
• Consumer Perception Study (Warming): The total number of participants is not explicitly stated. It mentions "75.50% of the participants felt the product warmed well."
• In Home Consumer Use Study:
  • Female subjects: Consented female subjects received speculum examinations at baseline and following the last coital episode. The exact number of subjects is not explicitly stated but is implied to be at least 245 based on the reported responses.
  • Reported Responses: 245 reported responses for various criteria.
  • Data Provenance: The studies are described as "Human Clinical Testing" and "Preclinical Testing of Formulation," implying prospective human studies conducted by an "outside laboratory." The country of origin is not explicitly stated, but the submission is to the FDA in the US.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

• In Home Consumer Use Study (Gynecological Examinations): The study involved "gynecological examinations at baseline and following the last coital episode." It then states, "It was concluded that the product did not cause irritation as determined by final gynecological examination." This implies a medical professional (likely a gynecologist) performed these examinations. The number of such experts and their specific qualifications (e.g., years of experience) are not specified in this document.
• Other studies (Human Repeated Insult Patch Test, Biocompatibility): The "ground truth" here would be laboratory analysis and expert interpretation of those results. The number and qualifications of experts involved in these analyses are not specified.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for any of its human studies. The results appear to be reported based on the observations and findings of the individuals conducting the tests and assessments. For the In Home Consumer Use Study, the "conclusion" about irritation was "determined by final gynecological examination," suggesting a single expert's assessment or the consensus of a study team.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging or interpretative tasks where multiple human readers assess cases with and without AI assistance. The K-Y® Brand Warming Jelly is a personal lubricant, and the studies focused on safety, biocompatibility, and consumer perception, not diagnostic effectiveness.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

N/A (Not Applicable). This device is a personal lubricant, not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm without human-in-the-loop is not relevant to this product. The testing performed evaluates the product's direct interaction with the human body and user perception.

7. The Type of Ground Truth Used

• Biocompatibility: Laboratory test results (e.g., contact sensitization, systemic toxicity measurements) interpreted against established scientific standards (ISO 10993 and G93-1).
• Human Repeated Insult Patch Test: Clinical observation by trained professionals for skin reactions, comparing the test product to a predicate.
• Consumer Perception Studies: Self-reported subjective experience of participants (e.g., rating warming, feedback on intimacy enhancement, discomfort).
• In Home Consumer Use Study (Irritation): Objective medical assessment via "gynecological examinations" by a qualified professional.
• Condom Compatibility: Laboratory testing results based on ASTM D 3492.

8. The Sample Size for the Training Set

N/A (Not Applicable). This device is a personal lubricant, not an AI or machine learning model. Therefore, there is no "training set" in the context of data science. The "formulation" of the product is proprietary and developed through chemical and material science processes, not through a data-driven training set.

9. How the Ground Truth for the Training Set Was Established

N/A (Not Applicable). As explained above, there is no "training set" for this product. The ground truth for its development and testing is established through standard preclinical and clinical methodologies for medical devices, focusing on safety, biocompatibility, and intended use performance.

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