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WLX & Bio Human Lubricant is a water based 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 not compatible with natural rubber latex, polyurethane, and polyisoprene condoms.

WLX & Bio Human Lubricant is a non-sterile, water-based, clear gel personal lubricant. It is a Class II medical device classified under 21 CFR 884.5300 (condom) and product code NUC (lubricant, personal). It contains Water, Glycerin, Propylene Glycol, Carbomer, Hydroxyethylcellulose, Triethanolamine, and Phenoxyethanol. The lubricant is not compatible with natural rubber latex, polyurethane, and polyisoprene condoms. The lubricant is packaged in polyethylene (PE) bottles of 100 mL capacity (Model -WLX100).

This document is a 510(k) Premarket Notification from the FDA regarding a personal lubricant, not a medical device that relies on an algorithm or AI for its primary function. Therefore, the questions related to AI/algorithm performance, such as acceptance criteria based on performance metrics like sensitivity/specificity, sample sizes for test sets, establishment of ground truth by experts, MRMC studies, and training set details, are not applicable to this submission.

The document focuses on the physical and chemical properties, biocompatibility, and intended use of the lubricant to establish its substantial equivalence to a predicate device.

However, I can interpret the request in the context of the provided document by identifying the "acceptance criteria" as the device specifications and the "study that proves the device meets the acceptance criteria" as the non-clinical performance testing.

Here's an adaptation of the requested information based on the provided FDA 510(k) summary for the WLX & Bio Human Lubricant:

Acceptance Criteria and Device Performance for WLX & Bio Human Lubricant

This device, WLX & Bio Human Lubricant, is a personal lubricant. Its acceptance criteria are based on physical, chemical, and biological specifications, and its performance is demonstrated through standard non-clinical tests. This is not an AI-driven device, so metrics like sensitivity, specificity, or expert adjudication for image analysis are not relevant.

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

The acceptance criteria are the "Specification" column in Table 1 (page 6), and the "Reported Device Performance" is implied by the statement "the subject device met the specifications at all time points" from the shelf-life study (page 8).

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

The document does not specify exact sample sizes for each non-clinical test (e.g., number of units tested for pH, viscosity, or biological assays). It states that the device was tested per relevant USP and ISO standards, which typically include specific sample size requirements.

The "data provenance" is derived from testing conducted by the manufacturer, Jiangxi Wulinxiang Biological Technology Co., Ltd. (CHN), as part of their 510(k) submission. These tests are inherently "prospective" for the purpose of demonstrating compliance.

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

Not applicable. This is not an AI/algorithm-driven device requiring expert human interpretation for "ground truth." The ground truth for the physical, chemical, and biological properties is established through standardized laboratory testing methods (e.g., USP and ISO standards).

4. Adjudication method for the test set

Not applicable. There is no human interpretation or subjective assessment that would require adjudication for this type of device testing.

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 not an AI software.

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

Not applicable. This device is not an AI algorithm.

7. The type of ground truth used

The ground truth used for performance assessment consists of:

• Standardized Test Methods: Adherence to established pharmacopoeial standards (USP , , , , , ) for chemical and microbial properties.
• International Standards: Compliance with ISO 10993 series for biocompatibility testing (ISO 10993-5, 10, 11, 23).
• Industry Standards: Compliance with ASTM F1980-16 for shelf-life testing.

These standards define the acceptable ranges and methodologies that serve as the "ground truth" for the device's performance.

8. The sample size for the training set

Not applicable. This device does not involve machine learning or a "training set."

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

Not applicable.

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