(21 days)
Lubriglide is a non-sterile personal lubricant for over-the-counter use. Its primary use is to apply the product to the genital area to reduce the discomfort associated with sexual activity. Lubriglide can also be used to lubricate rectal thermometers, tampons, douches, and enemas.
Lubriglide is a water-based, water-soluble personal lubricant designed to imitate the body's own lubricating fluids. It is nonirritating, non-staining, and won't dry out or leave behind any solid residues. Lubriglide is non-toxic and is easily removed with water.
This document is a 510(k) summary for Lubriglide, a personal lubricant, and does not describe a study involving device performance metrics like sensitivity, specificity, or AUC, nor does it involve a ground truth established by experts or a training set for an AI/algorithm. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Astroglide) based on non-clinical studies and comparisons of characteristics.
Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth cannot be extracted from this document as it pertains to medical device performance studies, typically for diagnostic or therapeutic devices, rather than a personal lubricant.
However, I can extract the information that is present:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Non-Clinical) | Reported Device Performance |
|---|---|
| Stability: Must meet Qualis, Inc., accelerated stability protocol. | Successfully passed the requirements, assigned a two-year expiration period. |
| Preservative Effectiveness: Must meet Qualis, Inc., antimicrobial preservative challenge. | Successfully passed the requirements. |
| Comparison with Predicate Device (Astroglide): Based on perceptual qualities, physical and chemical properties, ingredients list review, label claims, and packaging. | Resulted in a "Satisfactory" comparison. |
| Safety (General): Non-irritating, non-staining, non-toxic, easily removed with water. | Device description states it meets these properties. |
2. Sample size used for the test set and the data provenance:
- Not applicable. This document describes non-clinical studies (stability, preservative effectiveness, and comparative analysis with a predicate device), not a clinical trial or performance study with a test set of human data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no ground truth established by experts for a test set in this document.
4. Adjudication method for the test set:
- Not applicable. No test set or expert adjudication is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. An MRMC study was not done.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a personal lubricant, not an algorithm or AI system.
7. The type of ground truth used:
- Not applicable. The concept of "ground truth" as typically used in medical device performance studies (e.g., pathology, clinical outcomes) is not relevant to the non-clinical tests performed for this lubricant. The "ground truth" for the non-clinical tests would be the established protocol specifications for stability and preservative effectiveness and the characteristics of the predicate device for comparison.
8. The sample size for the training set:
- Not applicable. This document does not describe the development or testing of an AI/algorithm, so there is no training set.
9. How the ground truth for the training set was established:
- Not applicable. There is no training set mentioned.
§ 880.6375 Patient lubricant.
(a)
Identification. A patient lubricant is a device intended for medical purposes that is used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.(b)
Classification. Class I (general controls). Except when the device is a vaginal patient lubricant or an oral lubricant, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.