Search Results

Trojan™ Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant) 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. This product is not compatible with polyurethane condoms.

The Trojan™ Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant) is a hydrous, clear water-based personal lubricant with aloe and vitamin E that is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms. It is a clear, colorless viscous gel. The lubricant formula is thickened using sodium hyaluronate and hydroxyethylcellulose. It contains a pH buffer system to maintain a slightly acidic pH of 5.9 to 6.9, and is preserved using Symocide pH (Phenoxyethanol, Hydroxyacetophenone, Caprylyl Glycol, and Water).

The Trojan™ Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant) may be packaged in two (2) types of polyethylene terephthalate (PET) bottles. One bottle (PET), 5.5 fl. oz. with a screw on, flip-top polypropylene (PP) closure. An induction seal will be placed over the bottle. The second bottle (PET), 4.5 fl. oz., will be the same bottle material with a pump in the bottle. The pump and nozzle will be made of the same material as the flip-top cap (PP). The pump bottle will have a shrink band over the pump.

This document, K180764, is a 510(k) Premarket Notification for a personal lubricant, Trojan™ Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant). It is not a medical imaging AI device, and therefore does not contain information related to AI model training, testing, or human reader studies.

The acceptance criteria and performance data provided in this document pertain to the physical, chemical, and biological properties of the personal lubricant, and its compatibility with condoms, as well as its shelf life.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving an AI device meets those criteria, as this document is for a non-AI medical device.

However, I can extract the acceptance criteria and performance data relevant to this specific device (personal lubricant) as presented in the document.

Acceptance Criteria and Reported Device Performance (for Trojan™ Azul Personal Lubricant):

Ask a specific question about this device

Azul Personal Lubricant 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. This product is not compatible with polyurethane condoms.

The Azul Personal Lubricant is a hydrous, clear water-based personal lubricant with aloe and vitamin E that is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms. The lubricant formula is thickened using sodium hyaluronate and hydroxyethylcellulose. It contains a pH buffer system to maintain a slightly acidic pH of 5.9 to 6.9, and is preserved using methylparaben. This medical device is designed to meet product specifications which include: Color/appearance, Odor, pH, Viscosity, Methylparaben assay, Osmolality, Total aerobic microbial count, Total yeast and mold count, Absence of pathogenic organisms, Antimicrobial effectiveness. The Azul Personal Lubricant is packaged in a polyethylene terephthalate (PET) bottle with a screw on, flip top polypropylene (PP) closure. An induction seal will be placed over the bottle for tamper resistance and preservation.

The document describes the Azul Personal Lubricant and its supporting studies for 510(k) premarket notification. However, it does not provide specific acceptance criteria or a study with a table of reported device performance values compared to those criteria. The provided information focuses on the device's characteristics, intended use, and a summary of various studies conducted to demonstrate its safety and compatibility.

Here's an analysis of the requested information based on the provided text, noting where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in the document. The document lists "product specifications" (Color/appearance, Odor, pH, Viscosity, Methylparaben assay, Osmolality, Total aerobic microbial count, Total yeast and mold count, Absence of pathogenic organisms, Antimicrobial effectiveness) for which the device is "designed to meet." However, the specific acceptance criteria (e.g., pH range, maximum microbial count) and the actual reported performance values are not detailed in a table format.

The document also mentions "Condom compatibility" results but does not quantify them against acceptance criteria.

2. Sample Size for the Test Set and Data Provenance

The document does not specify a single "test set" in the context of validating a device's performance against detailed acceptance criteria using a specific sample size. Instead, it describes several types of studies performed:

• Biocompatibility studies:

  • In vitro cytotoxicity study
  • Rabbit vaginal irritation study
  • Rabbit penile irritation study
  • Acute systemic toxicity study
  • Guinea pig maximization sensitization study
  • Primary rabbit skin irritation study
  • Sample Size: Not specified for any of these individual studies.
  • Data Provenance: Not explicitly stated, but these are typically conducted in a laboratory setting. The country of origin is not mentioned. These would be considered prospective studies for the purpose of this submission.

• Shelf life - Stability and shelf life testing:

  • Sample Size: Not specified.
  • Data Provenance: In vitro study, typically laboratory-based. The country of origin is not mentioned. This would be a prospective study.

• Condom compatibility testing:

  • Sample Size: Not specified (e.g., number of condoms tested, number of lubricant applications).
  • Data Provenance: Laboratory testing using a modification of ASTM D7661. The country of origin is not mentioned. This would be a prospective study.

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

Not applicable or not specified. The studies described are primarily
laboratory-based chemical, physical, and biological (animal) tests, not human-reader-based assessments requiring expert ground truth establishment in the way, for example, a diagnostic imaging AI would. Therefore, the concept of "experts establishing ground truth for a test set" with specific qualifications is not relevant to the types of studies reported for this personal lubricant.

4. Adjudication Method for the Test Set

Not applicable. Given the nature of the studies (laboratory tests, animal studies), there is no mention of an adjudication method involving multiple human assessors or an "adjudication method" in the context of clinical or diagnostic review.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No. An MRMC comparative effectiveness study, which typically evaluates the performance of human readers with and without AI assistance, was not conducted as this device is a personal lubricant and not an AI-powered diagnostic or assistive tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study

No. This device is a personal lubricant, not an algorithm or AI system. Therefore, a standalone performance study in that context was not performed. The performance studies described (biocompatibility, stability, condom compatibility) assess the device's inherent properties.

7. Type of Ground Truth Used

The "ground truth" for the studies described is based on established scientific methodologies for assessing chemical properties, physical properties, biocompatibility (animal models), and material compatibility (e.g., ASTM standards).

• Biocompatibility: In vitro assay results (cytotoxicity) and observed biological responses in animal models (irritation, systemic toxicity, sensitization).
• Shelf life: Measured physical, chemical, and microbiological parameters over time under specified conditions (e.g., accelerated aging).
• Condom compatibility: Physical property changes or damage to condoms measured according to a modified ASTM standard.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a "training set." The studies described are traditional device testing.

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

Not applicable. As there is no AI/ML algorithm or training set, this question is not relevant.

Ask a specific question about this device