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Astroglide Warming is a personal lubricant for penile, vaginal, and/or anal 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. This product is not compatible with polyurethane condoms.

Astroglide Warming is non-sterile, clear and water based personal lubricant. This product is not a spermicide or contraceptive. It is compatible with natural rubber latex and polyisoprene condoms only. It is not compatible with polyurethane condoms. The device is composed of water, glycerin, propylene glycol, polyquaternium-7 and citric acid.

The provided document describes the K221036 submission for Astroglide Warming, a personal lubricant. It does not describe a study involving an AI/ML device and human readers. Therefore, I cannot fulfill all aspects of your request as it pertains to AI/ML device performance, ground truth, expert opinions, or MRMC studies.

However, I can extract the acceptance criteria and the summary of non-clinical performance testing for the Astroglide Warming device itself.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

The document describes non-clinical performance testing for a personal lubricant, not an AI/ML device. Therefore, the concept of "test set" in the context of AI/ML is not applicable here. The testing involved samples of the product itself.

• Biocompatibility testing: Not specified number of samples, but refers to ISO and ASTM standards.
• Shelf Life Accelerated Aging Study: Not specified number of samples. The study duration was 3 months at 40°C.
• Condom Compatibility: Not specified number of samples, but refers to ASTM D7661-18.
• Data provenance: Not explicitly stated, but assumed to be from internal lab testing conducted by or for BioFilm, Inc. It is retrospective in the sense that the tests were completed before submission.

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

Not applicable. This is a physical product, not an AI/ML device requiring expert ground truth for image or data interpretation.

4. Adjudication method for the test set:

Not applicable. This is a physical product, not an AI/ML device requiring adjudication for ambiguous cases.

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 is a physical product, not an AI/ML device.

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

Not applicable. This is a physical product, not an AI/ML algorithm. The "standalone" performance here refers to the device's inherent physical and chemical properties.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for this product is based on established industry standards and validated test methods as defined by organizations like ISO, ASTM, and USP. For example:

• Physical and Chemical Properties: The specifications (e.g., viscosity, pH, osmolality, color, odor, clarity, absence of particulate matter) are based on direct measurements against defined ranges.
• Microbial Limits: Determined by specific USP and methods.
• Antimicrobial Effectiveness: Determined by USP methods.
• Biocompatibility: Determined by ISO 10993-5, ISO 10993-11, and ASTM D6355 standards.
• Condom Compatibility: Determined by ASTM D7661-18.

8. The sample size for the training set:

Not applicable. This is a physical product, not an AI/ML device that requires a training set.

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

Not applicable.

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