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The Swiss Navy Premium Lubricants are personal lubricants 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. These products are compatible with natural rubber latex and polyisoprene condoms. These products are not compatible with polyurethane condoms.

Swiss Navy® Premium Silicone Lubricant is a non-sterile, silicone-based personal lubricant for use with or without a condom. It is specifically formulated to be a clear, non-irritating, non-greasy and odorless liquid. This device is not a contraceptive, not does it contain any spermicidal components. Swiss Navy Premium Silicone Lubricant comes packaged in the following configurations: 20 ml square PET mini bottle with an aluminized Mylar seal, 2ounce, 4-ounce, 16-ounce, and 32-ounce PET bottles with a pump. All have the cap or pump shrink-wrapped. The 32-ounce PET size contains a travel cap with an aluminized Mylar induction seal. A pump is included with this size. This product also is packaged in 5-ml foil sachets.

The specifications for this device include color, odor, viscosity, water activity level, total aerobic microbial count, total yeast and mold count, absence of pathogenic organisms, and specific gravity.

Swiss Navy® Premium Water-Based Lubricant is a non-sterile water-based personal lubricant for use with or without a condom. It is clear, non-irritating and non-greasy. It is not a contraceptive, nor does it contain any spermicidal components. Swiss Navy® Premium Water Based into the following configurations: 20 ml square PET mini bottle with ascrew-on cap fitted with an aluminized Mylar seal, 2-ounce, 8-ounce, 16-ounce, and 32-ounce PET bottles with a pump. All have the cap or pump shrink-wrapped. The 32-ounce PET size contains a travel cap with an aluminized Mylar induction seal. A pump is included with this size. This product also is packaged in 5-ml foil sachets.

The specifications for this device include pH, osmolality, color, viscosity, water activity level, total aerobic microbial count, total yeast and mold count, absence of pathogenic organisms, and specific gravity.

The provided document is a 510(k) premarket notification for "Swiss Navy Premium Silicone Lubricant" and "Swiss Navy Premium Water-Based Lubricant." It details the FDA's determination of substantial equivalence to previously marketed predicate devices.

Here's an analysis of the acceptance criteria and supporting studies as presented in this document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a tabulated format, but rather presents the results of various tests demonstrating the safety and performance of the lubricants. We can infer the acceptance criteria from the reported "Results" for each test.

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

• Biocompatibility: The document refers to ISO standards (10993-5, 10993-10, 10993-11) for testing methods. These standards typically specify sample sizes for in-vitro and animal tests. However, the exact number of samples used in these specific tests (e.g., number of cell cultures, guinea pigs, mice, New Zealand White Rabbits) is not provided in this document.
• Condom Compatibility: The test was performed on "three marketed brands of Natural Rubber Latex Condoms and one brand of Polyisoprene condoms." The specific number of condoms tested per brand or the total sample size is not provided.
• Data Provenance: The document states that biocompatibility testing was performed by "independent third-party laboratories." The country of origin for the data is not explicitly stated. The studies appear to be prospective as they were conducted as part of the device's evaluation for market clearance.

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

For the testing described (biocompatibility and condom compatibility), the "ground truth" is established by the results of the standardized scientific tests themselves (e.g., observing cell viability, animal reactions, or condom integrity post-exposure).

• No explicit mention of "experts" in the context of establishing ground truth for these specific tests as you would for clinical image interpretation. The interpretation of these laboratory and animal test results would be conducted by qualified laboratory personnel following established protocols. Their qualifications are not specified beyond being "independent third-party laboratories."

4. Adjudication Method for the Test Set

This type of information (e.g., 2+1, 3+1) is typically relevant for studies involving subjective interpretation, like image reading by multiple experts. For the objective, standardized tests reported here (biocompatibility, condom compatibility), an adjudication method in this sense is not applicable and therefore not mentioned. The results are quantitative or clearly observable outcomes.

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

• No MRMC study was conducted or mentioned. The device is a personal lubricant, not an AI-powered diagnostic tool. This type of study is entirely irrelevant to the submission for this device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• No standalone algorithm performance study was conducted or mentioned. The device is a personal lubricant, not an algorithm. This question is irrelevant to this device.

7. The Type of Ground Truth Used

• Biocompatibility: The ground truth is based on standardized in-vitro and in-vivo (animal) test results (e.g., cell viability, observed sensitization, systemic toxicity, or irritation in animal models) according to internationally recognized ISO 10993 series standards.
• Condom Compatibility: The ground truth is based on standardized physical integrity testing of condoms (e.g., burst strength, freedom from holes) after exposure to the lubricant, as per ATM D7661-10.
• Shelf Life: The ground truth is based on accelerated aging study results with ongoing real-time aging study for confirmation, implying stability parameters (e.g., viscosity, pH, microbial counts) remain within acceptable limits over time.

8. The Sample Size for the Training Set

• This device is not an AI/ML algorithm that requires a "training set." Therefore, this information is not applicable and not provided.

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

• As there is no training set for this device, this information is not applicable and not provided.

In summary, this 510(k) submission focuses on demonstrating the safety and performance of the lubricants through standardized physical, chemical, and biological (biocompatibility) tests, and not on AI or diagnostic capabilities. Therefore, many of the requested details related to AI evaluation are not found in this document.

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