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K-Y® Silicone is indicated for penile, vaginal and/or anal 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, polyisoprene, and polyurethane condoms.

K-Y® Silicone is a non-sterile, odorless, and anhydrous personal lubricant that provides personal lubrication during intimate sexual activity and is compatible with condoms made of natural rubber latex, polyurethane and polyisoprene. This product is composed of 100% Dimethicone. The product is packaged in a 50mL (1.69 FL oz.) HDPE bottle with a polypropylene pump. K-Y @ Silicone is identical in formulation and specifications to the predicate device (Durex Silicone, K143532).

The provided text describes the K-Y® Silicone personal lubricant, which claims to be substantially equivalent to the Durex Silicone (K143532) predicate device. The submission does not present a study proving the device meets acceptance criteria distinct from the predicate device; instead, it relies on the performance data of the predicate device due to their identical formulation and specifications.

Here's a breakdown of the requested information based on the provided text, recognizing that it primarily refers to the predicate device's data:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are essentially the specifications for the K-Y® Silicone, which are stated to be identical to the predicate device.

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

The document does not explicitly state the sample sizes for the testing described for the predicate device. The data provenance is described as "performance testing provided in the predicate submission for the Durex Silicone personal lubricant (K143532)." This implies the data is retrospective for the K-Y® Silicone application, as it's leveraging previously generated data. The country of origin for the data is not specified in this document.

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

Not applicable. This device is a personal lubricant, and its performance (biocompatibility, condom compatibility, sterility, shelf-life) is evaluated through laboratory and material testing, not through expert review of diagnostic images or clinical assessments requiring expert consensus for ground truth.

4. Adjudication Method for the Test Set

Not applicable. The testing described (biocompatibility, condom compatibility, analytical chemistry, microbiology, stability) are objective laboratory tests that do not involve subjective expert adjudication.

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 product is a physical device (personal lubricant), not an AI-powered diagnostic or assistive technology for human readers.

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

Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

For the predicate device's testing, the ground truth was established through:

• Laboratory test results: For biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity), viscosity, color, odor, and microbiological assays (TAMC, TYMC, absence of pathogens).
• Standardized test methods: For condom compatibility (ASTM method D7661-10).
• Stability studies: For shelf-life (accelerated and real-time stability studies against device specifications).

8. The Sample Size for the Training Set

Not applicable. This is a physical product, not a machine learning model that requires a training set. The term "training set" doesn't apply in this context.

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

Not applicable, as there is no training set for a personal lubricant device.

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Intended 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. This product is not compatible with polyurethane condoms.

KY Marilyn is personal lubricant that is a non-sterile, water-based formulation that provides personal lubrication and stimulation during intimate sexual activity. It is made up of Water, Glycerin, Propylene Glycol, Hydroxyethylcellulose, PEG-40 Hydrogenated Castor Oil, Flavor, Benzoic Acid and Sodium Hydroxide. The subject device is clear in appearance. The specifications for KY Marilyn include appearance, odor, pH, viscosity, benzoic acid, total aerobic microbial count, total yeast and mold count, and absence of pathogenic organisms (Pseudomonas aeruginosa. Staphylococcus aureus, and Candida albicans) and Antimicrobial Effectiveness.

The subject device will be packaged as follows:

• 12 mL Polyethylene terephthalate (PET) bottle
• Polypropylene (PP) pump
• Polypropylene (PP) snap-on cap
• Outer carton

The device, KY Marilyn, will be marketed as a non-prescription medical device for over-the- counter (OTC) use.

The provided document describes the K-Y® Marilyn Pleasure Gel (K151884), a personal lubricant. It presents performance data to demonstrate its substantial equivalence to predicate devices, particularly concerning biocompatibility and condom compatibility.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

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

The document does not explicitly state the exact sample sizes (e.g., number of rabbits, guinea pigs, or specific condom batches) for each test. However, it indicates standard animal models were used:

• Biocompatibility (Irritation): Rabbit vaginal tissue.
• Biocompatibility (Sensitization/Systemic Toxicity): Guinea pig maximization test.
• Cytotoxicity: In vitro cell culture.
• Condom Compatibility: 3NRL (Natural Rubber Latex) and PI (Polyisoprene) condoms.

The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin of the data. However, given it's a 510(k) submission, the studies would generally be conducted by the manufacturer or contracted labs under Good Laboratory Practice (GLP) standards.

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

This information is not applicable to the studies presented. These are performance tests against established scientific standards (ISO, USP, ASTM), not diagnostic accuracy studies requiring expert judgment for ground truth. The "ground truth" is defined by the technical criteria of the standards themselves (e.g., a certain percentage difference for condom compatibility, histological findings for irritation).

4. Adjudication method for the test set

Not applicable. The tests are objective measurements and interpretations against predefined criteria in the standards, not subjective assessments requiring adjudication.

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 medical device (personal lubricant), not an AI-powered diagnostic tool, so MRMC studies involving human readers and AI are irrelevant.

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 (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the test results is based on:

• Standardized test methods and protocols: Defined by ISO, USP, and ASTM.
• Objective measurements: Such as percentage difference in condom properties (ASTM D7661-10).
• Biological observations: Such as absence/presence of irritation or sensitization in animal models, or cytotoxic effects in cell cultures.
• Analytical chemistry: For stability and compositional analysis.

8. The sample size for the training set

Not applicable. This document describes the testing of a physical product and its formulation, not a machine learning model that requires a training set.

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

Not applicable, as there is no machine learning training set involved.

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Durex Silicone is indicated for perile 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, polyisoprene, and polyurethane condoms.

Durex Silicone is a Personal Lubricant Device that is a non-sterile, odorless, anhydrous, silicone formulation that provides personal lubrication during intimate sexual activity. It is made up of 100% Dimethicone. The ingredient is clear (same as water) in appearance. The Viscosity at 25°C is 80-110 cps. The device will be made available in a 1.69 FL oz. (50mL) HDPE pump sealed bottle with an outer carton. The final dimensions of the carton are 138mmx74mmx28mm.

This document is a 510(k) Premarket Notification for Durex Silicone, a personal lubricant. It does not describe a study involving an AI medical device or other complex diagnostic or therapeutic device. Therefore, many of the requested categories for acceptance criteria and study details are not applicable.

However, I can extract the relevant information regarding the performance data and the comparison to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Biocompatibility (Cytotoxicity, Irritation, Systemic Toxicity, Sensitization): The document does not specify the sample sizes (e.g., number of cell cultures, animals) used for these tests. The provenance of the data is implicit as part of a regulatory submission to the FDA by the manufacturer, Reckitt Benckiser LLC. These are likely prospective laboratory and in-vivo animal studies conducted according to the cited ISO standards.
• Condom Compatibility: The testing was done using ASTM method D7661-10 with "three marketed brands of Natural Rubber Latex condoms, one brand of polyisoprene condom, and one brand of polyurethane condoms." The specific number of condoms and lubricants tested per brand is not specified.

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, and the 'ground truth' is established through standardized laboratory and animal testing for biocompatibility and material compatibility, not through expert clinical interpretation of medical images or patient data.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not applicable. The tests performed are laboratory-based and follow standardized protocols, not human-read expert adjudication.

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 not an AI-enabled device.

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

• Not applicable. This is not an algorithm or software device.

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

• The "ground truth" used for this device's performance evaluation is based on standardized testing protocols and methodologies defined by international (ISO) and national (ASTM) standards.
  • For biocompatibility: Cellular response to extract, physiological reactions in animal models.
  • For condom compatibility: Physical and chemical interaction with condom materials as measured by ASTM D7661-10.
  • For shelf life: Stability of physical/chemical properties over time.

8. The sample size for the training set

• Not applicable. There is no "training set" in the context of an AI/ML model for this type of device.

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

• Not applicable. There is no "training set" for this device.

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