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Nirvana D is a personal lubricant for penile and/or vaginal application, intended to lubricate and moisturize, 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. Not compatible with polyurethane or other condoms.

The Nirvana D Personal Lubricant is an anhydrous, non-sterile, clear silicone-based personal lubricant composed of dimethicone, dimethiconol, vanillyl butyl ether ("VBE") and hexyl nicotinate. Nirvana D Personal Lubricant is compatible with natural rubber latex and polyisoprene condoms. This product is not a spermicide or a contraceptive. The product is packaged in a polyethylene terephthalate (PET) bottle with a screw-on, flip top polypropylene (PP) closure constituting the device's primary packaging. One bottle is packaged into a cardboard carton, which constitutes the device outer packaging

The provided document describes the 510(k) submission for the Nirvana D Personal Lubricant. The information requested pertains to studies typically performed for AI/ML-driven medical devices, which involve performance metrics like sensitivity, specificity, and reader studies. However, the Nirvana D Personal Lubricant is not an AI/ML-driven device. It is a silicone-based personal lubricant, and its evaluation focuses on biocompatibility, condom compatibility, and shelf-life, rather than statistical performance metrics like those used for diagnostic algorithms.

Therefore, the requested information cannot be fully provided in the context of this device. I will extract the relevant information that is present in the document.

Here's a breakdown of the relevant information from the document:

1. Table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

• Biocompatibility Testing: The specific sample sizes for the in vivo animal tests (Rabbit Vaginal/Penile Irritation, Acute Systemic Toxicity, Guinea Pig Maximization, Primary Rabbit Skin Irritation) are not explicitly stated in the provided text. Cell cultures would be used for cytotoxicity. The data provenance is not specified beyond "testing was performed in accordance with ISO 10993."
• Condom Compatibility Testing: "Three marketed brands of pre-lubricated and un-lubricated dry natural rubber latex condoms and one brand of polyisoprene condoms were tested." This refers to the types of condoms, not necessarily the number of individual condoms tested. The provenance is not specified.
• Shelf-life Testing: The sample size for the accelerated aging study is not specified.

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

This is not applicable as the device is not an AI/ML diagnostic tool. Performance is based on standardized biological and physical testing, not expert consensus or interpretation of images/data. The "ground truth" would be established by the results of the scientific tests themselves, according to established protocols like ISO 10993 and ASTM D7761-10.

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

Not applicable. This device is not an AI/ML diagnostic tool requiring adjudication of expert interpretations.

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 device is a personal lubricant, not an AI/ML system, so no MRMC study was performed.

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

Not applicable. This 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 this device's evaluation is primarily based on:

• Biological responses: Observed reactions in established in vitro (cytotoxicity) and in vivo (irritation, sensitization, systemic toxicity) models, conforming to recognized standards (ISO 10993).
• Physical performance standards: Compatibility with condoms assessed against an ASTM standard (ASTM D7761-10, modified).
• Physicochemical stability: Evaluation of viscosity, odor, color, appearance, and microbial counts over time.

8. The sample size for the training set:

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:

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

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