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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):

Study Proving the Device Meets Acceptance Criteria (as described in the document):

The performance data to demonstrate substantial equivalence to the predicate device was derived from non-clinical testing.

1. Biocompatibility:

   • Tests performed:
     • Cytotoxicity with Agarose Overlay (ISO 10993-5)
     • Rabbit Vaginal Irritation Study (ISO 10993-10)
     • Acute Systemic Toxicity Study (ISO 10993-11)
     • Guinea Pig Maximization Sensitization Study (ISO 10993-10)
   • Results: Not explicitly detailed beyond stating "the following biocompatibility testing was performed... in accordance with ISO 10993." The implication is that the device met the criteria for these tests.

2. Condom Compatibility:

   • Methodology: A modification of ASTM D7661 (Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms) was used.
   • Results: "Laboratory test results demonstrated that the proposed device is compatible with leading commercial brands of natural rubber latex and polyisoprene condoms, but not compatible with polyurethane condoms." This matches the acceptance criteria.

3. Shelf Life:

   • Methodology: Validated shelf life based on results of an accelerated aging stability study.
   • Evaluation parameters: Odor, Color, Viscosity, Osmolality, and pH. Microbial evaluation was conducted via USP testing.
   • Results: "results were met for all parameters."

Addressing the specific questions asked for an AI device (which are not applicable to this document):

• Sample sized used for the test set and the data provenance: Not applicable. This is not an AI device.
• Number of experts used to establish the ground truth... and qualifications: Not applicable. Ground truth for this product is established through laboratory testing (analytical, chemical, biological).
• Adjudication method for the test set: Not applicable.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used: For this device, ground truth is based on established laboratory analytical methods, biological tests, and international standards (e.g., ISO, ASTM, USP).
• The sample size for the training set: Not applicable (no AI training set).
• How the ground truth for the training set was established: Not applicable.

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