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Sheffield's Warming LubriGel Personal Lubricant (formula number 3120) is an over-the-counter personal lubricant intended to be used with or without a condom. Sheffield's Warming LubriGel is specially formulated to help supplement the body's natural lubricating fluids and to reduce friction during sexual intimacy. This lubricant may be safely applied to vaginal, anal or penile tissues for the purpose of lubrication and provides a mild warming sensation when applied to the genital area. This product is compatible with latex condoms.

Warming LubriGel Personal Lubricant is a non-sterile, clear, colorless, odorless, non-greasy, non-staining, non-irritating personal lubricant. It is a water soluble, high viscosity gel-like liquid for use as a personal lubricant. This product provides a gentle warming sensation upon application, according to consumer's need for a lubricant that does not dry out. It is water-soluble and easily rinsed off with water. It is compatible with latex condoms as demonstrated in the Condom Compatibility Study conducted according to the standards as defined by ASTM D 3492-03. The product is packaged in a convenient laminate tube with a flip top cap and peel seal.

Here's a breakdown of the acceptance criteria and study information for Sheffield's Warming LubriGel, based on the provided document:

This 510(k) submission primarily relies on demonstrating substantial equivalence to predicate devices rather than proving novel clinical effectiveness through new performance criteria. Therefore, the "acceptance criteria" are largely framed around matching the characteristics and performance of existing, legally marketed products. The "study" referenced is a comparative evaluation.

Acceptance Criteria and Device Performance

The core acceptance criterion for Sheffield's Warming LubriGel appears to be its demonstration of being substantially equivalent to established predicate devices (K-Y Brand Warming Jelly and K-Y Liquid Personal Lubricant Jelly), particularly in terms of technological characteristics and sensory attributes.

Study Details

1. Sample sized used for the test set and the data provenance:

   • Test Set Sample Size: Not explicitly stated for the sensory evaluation.
   • Data Provenance: The study was a "comparative evaluation" performed by Shuster Laboratories. The location or specific country of origin for the data is not mentioned, nor is whether the data was retrospective or prospective. It is implied to be prospective data collected for the purpose of this comparison.

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

   • Not applicable/Not specified. The "ground truth" for the sensory evaluation appears to be the collective "sensory ratings" determined by the laboratory, not expert consensus on a complex medical condition.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable/Not specified. The methodology for how the sensory ratings were derived is not detailed beyond stating that "sensory ratings were scored as identical."

4. 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, an MRMC comparative effectiveness study was not done. This device is a personal lubricant, not an AI-assisted diagnostic tool for human readers.

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

   • No, a standalone algorithm performance study was not done. This device is a physical product, not an algorithm.

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

   • The "ground truth" for the comparative study was based on sensory ratings and laboratory tests (e.g., ingredient analysis, condom compatibility testing according to ASTM D 3492-03) comparing Sheffield's Warming LubriGel to the predicate devices. It is a direct comparison of physical and chemical properties and user experience attributes.

7. The sample size for the training set:

   • Not applicable. There is no AI model or algorithm being "trained" in this context. The product development would involve formulations and testing.

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

   • Not applicable, as there is no training set for an AI model. For product development, the "ground truth" would be established by R&D, chemical analysis, and potentially user trials to optimize the formulation to meet desired characteristics and safety profiles.

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