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A non-sterile personal lubricant for OTC consumer use, as a moisturizer for vaginal dryness and personal lubrication of the vaginal area to enhance condom use and to facilitate ease and comfort during intimate sexual activity. CVS Personal Lubricant & Moisturizer is compatible with latex condoms. This device is not a contraceptive or spermicide nor does it contain any such component.

The CVS Personal Lubricant & Moisturizer formula is non-sterile. clear, non- staining, non-greasy, aqueous gel intended for use as a moisturizer for vaginal dryness and personal lubrication of the vaginal area to enhance condom use and to facilitate ease and comfort during intimate sexual activity. CVS Personal Lubricant & Moisturizer is compatible with latex condoms as demonstrated in condom compatibility testing. This device is not a contraceptive or spermicide, nor does it contain any such component. CVS Personal Lubricant & Moisturizer is packaged in PETE bottles with a foil seal and polypropylene cap.

This document describes the premarket notification for the CVS Personal Lubricant & Moisturizer, a device that is not an AI/ML product. Therefore, it does not include information on acceptance criteria or studies involving AI/ML performance.

The provided text details the device description, intended use, comparison of technological characteristics with a predicate device (Astroglide), and non-clinical studies conducted to demonstrate substantial equivalence. These non-clinical studies serve as the "performance data" for this type of medical device, ensuring its safety and effectiveness for its stated intended use.

Here's an analysis of the information provided, tailored to what is available:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is not an AI/ML device, the concept of "acceptance criteria" is related to demonstrating substantial equivalence to a predicate device through physical, chemical, and functional characteristics, rather than diagnostic performance metrics.

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

• Non-Clinical Studies: The document does not specify exact sample sizes for the Stability, Preservative Effectiveness, or Condom Compatibility tests in terms of number of product units or condoms. These tests would typically follow established test protocols with defined sample sizes by relevant standards (e.g., ISO, ASTM, USP).
  • Data Provenance: The studies were conducted by Lake Consumer Products, Inc., as part of their submission to the FDA. The data provenance is internal to the manufacturer. It is retrospective in the sense that the data was generated specifically for this 510(k) submission, not as part of a post-market surveillance.

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

• This question is not applicable as the device is a personal lubricant, not a diagnostic AI/ML device requiring expert interpretation of medical images or data. Ground truth here refers to objective measurements against established physical, chemical, or biological standards.

4. Adjudication method for the test set:

• Not applicable for this type of device. Performance is determined by objective laboratory testing against established standards and comparison to a predicate device, not by expert adjudication of diagnostic 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:

• Not applicable. This is not an AI/ML device and therefore no MRMC study was conducted.

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

• Not applicable. This is not an AI/ML device.

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

The "ground truth" for this device's performance evaluation comes from:

• Predicate Device Comparison: The chemical composition and intended use are compared directly to an existing legally marketed device (Astroglide, K935299).
• Established Standards:
  • Preservative Effectiveness: USP Antimicrobial Effectiveness Test.
  • Condom Compatibility: Industry-standard tests for tensile strength, elongation, and burst pressure of latex condoms (implied by the statement "does not adversely affect tensile strength, elongation or burst pressure"). These tests have predefined acceptance limits.
• Internal Laboratory Testing: Stability, perceptual qualities, physical, and chemical properties were assessed through internal testing, likely against predetermined specifications or direct comparison to the predicate.

8. The sample size for the training set:

• Not applicable as this is not an AI/ML device. There is no "training set."

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

• Not applicable as this is not an AI/ML device.

Ask a specific question about this device

Personal lubrication and lubrication of a body orifice to facilitate entry of a diagnostic or therapeutic device, as a moisturizer for vaginal dryness, and to enhance condom use and the ease of intimate activity.

"CVS Personal Lubricant" is a clear , colorless and odorless personal lubricant, which is composed of the following ingredients; Purified Water, Glycerin, Propylene Glycol, Polyquaternium #5, Methyparaben and Propylparaben. The "CVS Personal Lubricant" bottle is composed of high density polyethylene plastic.

The provided text is a 510(k) summary for the "CVS Personal Lubricant" and does not contain information about acceptance criteria or a study proving device performance against such criteria. This document is focused on demonstrating substantial equivalence to a predicate device based on ingredients and intended use, rather than presenting performance data from a clinical or technical study.

Therefore, I cannot provide the requested information from the given text. The text does not describe:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number or qualifications of experts for ground truth.
4. Adjudication method for a test set.
5. A multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
6. A standalone (algorithm only) performance study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. Sample size for a training set.
9. How ground truth for a training set was established.

Ask a specific question about this device