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K-Y® Brand Liquibeads® Vaginal Moisturizer is a personal lubricant for over-the-counter use, 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 compatible with natural rubber latex, polyisoprene, and polyurethane condoms. The product is delivered by an applicator.

K-Y® Brand Liquibeads® Vaginal Moisturizer is a non-sterile, anhydrous silicone fill mass, encapsulated with a gelatin shell (ovule). The fill mass is composed of a proprietary blend of silicones. The gelatin shell is composed of gelatin NF, glycerin USP, and water USP. The K-Y® Brand Liquibeads® Vaginal Moisturizer is a transparent ovule with a yellowish fill mass. The product is packaged into single use blister packs with single use disposable applicators, which are then packed into a printed carton.

The provided text describes a 510(k) premarket notification for a medical device called K-Y® Brand Liquibeads® Vaginal Moisturizer. This submission focuses on establishing substantial equivalence to a predicate device, rather than proving the device meets specific performance acceptance criteria for an AI algorithm.

Therefore, many of the requested points related to AI algorithm performance, sample sizes for test/training sets, expert ground truth adjudication, MRMC studies, and standalone algorithm performance are not applicable to this document. This document details the biocompatibility and safety testing of a physical product.

However, I can extract information related to the safety and performance studies that were conducted to support the device's substantial equivalence to the predicate device.

Here's the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance (as inferred from the safety and performance studies):

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

• Vaginal and Penile Irritation (Rabbits): Specific sample size not provided, but rabbits were used. Data provenance is likely laboratory animal studies.
• In Vitro Cytotoxicity, Systemic Toxicity (Mice), Contact Sensitization (Guinea Pigs), Vaginal Irritation (Rabbits): Specific sample sizes for each study not provided, but mice, guinea pigs, and rabbits were used for these "four additional biocompatibility studies." Data provenance is likely laboratory animal studies.
• Human Repeat Insult Patch Test: This implies human subjects were used, but the specific sample size is not provided. Data provenance is a human clinical study.
• In-Home Consumer Use Test: This implies human subjects were used for consumer feedback. The specific sample size is not provided. Data provenance is a human consumer study.
• Condom Compatibility Testing: Does not involve human or animal subjects, but rather testing with condom materials. Specific number of condoms/tests not provided.
• Stability Testing: Does not involve biological subjects. Specific number of samples/tests not provided.

All studies appear to be prospective, laboratory or consumer studies conducted to specifically evaluate the device. The country of origin of the data is not explicitly stated but is implied to be within the regulatory framework for FDA submission (likely US-based or internationally recognized labs).

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 as the studies are primarily about the physical and biological effects of the device, not about algorithmic performance or diagnostic accuracy that would require expert-established ground truth. The 'ground truth' in these studies is the direct measurement of irritation, toxicity, sensitization, moisturization, compatibility, or stability.

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

This information is not applicable for the same reasons as point 3. The studies involve direct measurements and observations, not interpretations 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:

This is not applicable as this is not an AI device.

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

This is not applicable as this is not an AI device.

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

The "ground truth" for the various tests was based on:

• Direct observation of biological responses: For irritation, systemic toxicity, and contact sensitization in animal models and human patch tests.
• In vitro assay results: For cytotoxicity.
• User feedback/reported experience: For vaginal moisturization in the in-home consumer test.
• Material compatibility tests: For condom compatibility.
• Analytical testing: For stability.

8. The sample size for the training set:

This information is not applicable as this is not a learning (AI) device.

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

This information is not applicable as this is not a learning (AI) device.

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