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Woo More Play Coconut Love Oil is a personal lubricant for penile and/or vaginal application, intended to lubricate, moisturize, and 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, polyurethane, and polyisoprene condoms.

Woo More Play Coconut Love Oil is a non-sterile, flavored, oil-based personal lubricant that provides lubrication during intimate sexual activity. The subject device is not compatible with natural rubber latex, polyisoprene, or polyurethane condoms. Its formulation consists of Cocos Nucifera (Coconut) Oil, Caprylic/Capric Triglyceride, Beeswax, Deionized Water, Stevia Rebaudiana Leaf Extract, Jojoba Esters, Helianthus Annuus (Sunflower) Seed Wax, Acacia Decurrens Flower Wax, Polyglycerin-3, and Natural Flavor. Woo More Play Coconut Love Oil is for over-the-counter (OTC) use and is packaged in 3.3 oz. non-sterile bottles.

The provided document is a 510(k) Premarket Notification from the FDA for a personal lubricant, "Woo More Play Coconut Love Oil." This document primarily focuses on demonstrating substantial equivalence to a predicate device based on bench testing of physical and chemical properties and biocompatibility, not on clinical performance or AI/software-based evaluations.

Therefore, many of the requested details, such as those pertaining to AI/algorithm performance, MRMC studies, human reader improvement, multi-expert ground truth establishment, and training/test set sample sizes for AI models, are not applicable to this type of medical device submission.

As such, I will answer the questions that are relevant to the provided text:

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

The document provides a "Device Specifications" table (Table 1) which serves as the acceptance criteria for various parameters of the Woo More Play Coconut Love Oil. The "reported device performance" is implicitly stated by confirming that the device met these specifications, specifically noted under the "Shelf Life" section.

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

The document does not specify a "test set" in the context of an AI/ML model for performance evaluation. Instead, it refers to non-clinical performance testing for various physical, chemical, and biological properties.

• Sample Size: The document does not explicitly state the number of samples or batches used for each specific test (e.g., pH, viscosity, microbial limits). It implies that testing was conducted on samples to demonstrate adherence to specifications and across the 3-month shelf-life.
• Data Provenance: The data provenance is internal testing performed by the manufacturer (Woo Essentials, Inc.) to support their 510(k) submission. This is not retrospective or prospective in the sense of clinical study data collection from particular countries/populations.

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

This question is not applicable. "Ground truth" established by experts in the context of medical image analysis or similar AI applications is not relevant here. The "ground truth" for this device's performance is determined by established laboratory test methods (e.g., USP standards) and the resulting measurements against predefined specifications.

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

This question is not applicable. Adjudication methods are typically used in clinical studies or expert reviews to resolve disagreements in interpretations, which is not relevant to laboratory testing of physical and chemical properties.

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 question is not applicable. The device is a personal lubricant, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study was performed.

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

This question is not applicable. The device is a personal lubricant, not an algorithm.

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

The "ground truth" for the device's performance is based on objective measurements obtained through validated laboratory test methods (e.g., USP standards) against predefined acceptance criteria (specifications). For biological compatibility, the ground truth is established through standardized biocompatibility assays (e.g., Cytotoxicity, Sensitization, Vaginal Irritation, Acute Systemic Toxicity) according to ISO standards, demonstrating non-toxic, non-irritating, and non-sensitizing properties.

8. The sample size for the training set

This question is not applicable. There is no "training set" as this is not an AI/ML device.

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

This question is not applicable. There is no "training set" for which ground truth would be established.

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