Search Results

BioNude is a personal lubricant 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. It is not compatible with polyurethane condoms.

BioNude is a 100% isotonic water-based formula with ingredients including lactic acid, hydroxyethylcellulose, carrageenan, sodium chloride, potassium sorbate, sodium benzoate, carob gum, xanthan gum, sodium hydroxide, and calcium chloride. The product is provided in a tube container and has a gel consistency. Its specifications include appearance, color, pH, specific gravity, viscosity, antimicrobial effectiveness, total aerobic microbial count, total yeast and mold count, and absence of pathogenic organisms. The lubricant is not a spermicide or contraceptive. It is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms.

The document describes the regulatory approval of the BioNude Lubricant (K180136), not a medical device in the context of an AI/ML study. Therefore, the requested information regarding acceptance criteria, study details, human reader performance, ground truth establishment, and sample sizes for an AI/ML device is not available in the provided text.

The document discusses the substantial equivalence of the BioNude Lubricant to a predicate device based on its formulation, intended use, and performance tests (biocompatibility, condom compatibility, and shelf life).

Here's what can be extracted based on the provided text, modified to indicate absence where the requested information is not applicable or not provided for this type of device:

1. Table of Acceptance Criteria and Reported Device Performance

This product is a personal lubricant, not an AI/ML medical device. Therefore, the concept of "acceptance criteria" and "device performance" relating to diagnostic accuracy, sensitivity, or specificity as would be relevant for an AI/ML device does not apply in the same way. The performance data presented are for the physical and chemical properties of the lubricant:

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

This is not applicable to the BioNude Lubricant as it is not an AI/ML device undergoing diagnostic performance testing. The "test sets" would refer to samples tested for biocompatibility, condom compatibility, and shelf-life, but specific sample sizes and data provenance (country of origin, retrospective/prospective) for these tests are not detailed in this summary.

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

Not applicable. This device is not an AI/ML diagnostic tool requiring expert consensus for ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical image interpretation studies, which is not relevant here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

Not applicable. MRMC studies are used to evaluate the impact of AI on human reader performance for diagnostic tasks. This is a personal lubricant, not a diagnostic device.

6. If a Standalone Performance Study Was Done

The performance studies conducted (biocompatibility, condom compatibility, shelf life) can be considered "standalone" in the sense that they evaluated the device's intrinsic properties. However, this is not analogous to a "standalone algorithm performance" study for an AI/ML device.

7. The Type of Ground Truth Used

For the BioNude Lubricant, the "ground truth" for its performance claims is based on:

• Established scientific methods and standards: Biocompatibility standards (e.g., ISO 10993), condom compatibility standards (e.g., ASTM D7661-10), and internal quality control specifications for formulation and shelf life.
• Laboratory testing results: The outcomes of these tests directly demonstrated the product's compliance with the relevant properties.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no training set in the AI context.

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

Not applicable. There is no training set for this device in the AI context.

Ask a specific question about this device