(170 days)
LifeStyles® Warm Lovin'™ Personal Lubricant is a personal lubricant, 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. This product is compatible with natural rubber latex, polyurethane, and polyisoprene condoms.
LifeStyles® Warm Lovin'™ Personal Lubricant is a non-sterile, personal lubricant designed to moisturize and Jubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. The formula is a clear, nonstaining, long-lasting, warming and biocompatible gel-like liquid that is compatible with natural rubber latex, polyurethane, and polyisoprene condoms. The product is provided in a plastic pump dispenser.
The provided text describes the 510(k) summary for the LifeStyles® Warm Lovin'™ Personal Lubricant, detailing its non-clinical testing to demonstrate substantial equivalence to a predicate device. It does not describe a study involving a device that uses a machine learning algorithm or AI.
Therefore, many of the requested categories related to AI/ML device studies are not applicable to this document.
Here's the information that can be extracted from the provided text, primarily focusing on the non-clinical testing performed:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria / Test | Reported Device Performance (LifeStyles® Warm Lovin'™) |
|---|---|
| Condom Compatibility (ASTM D 7661) | Compatible with condoms (natural rubber latex, polyurethane, polyisoprene) |
| Biocompatibility (ISO 10993) | Biocompatible (tested for cytotoxicity, vaginal irritation, sensitization, and systemic toxicity) |
| Non-staining | Non-staining |
| Viscosity | Appropriate viscosity (for substantial equivalence to predicate) |
| pH | Appropriate pH (for substantial equivalence to predicate) |
| Specific Gravity | Appropriate specific gravity (for substantial equivalence to predicate) |
| Appearance | Appropriate appearance (clear, gel-like liquid) |
| Color | Appropriate color (for substantial equivalence to predicate) |
| Odor | Appropriate odor (for substantial equivalence to predicate) |
| Microbial Quality (USP) | Microbial quality (tested for Total Aerobic Microbial Counts, Total Yeast and Mold Counts, absence of microbial pathogens, and antimicrobial effectiveness) |
| Shelf-life | 3-year shelf-life (indicated by real-time and accelerated aging tests) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes non-clinical bench testing and biocompatibility studies. Specific sample sizes for these tests are not provided in the summary. The studies are described as "non-clinical testing" and are likely performed in a laboratory setting, not on human subjects where data provenance (country, retrospective/prospective) would typically apply.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable. The tests performed are laboratory-based and follow established standards (e.g., ASTM, ISO, USP). "Ground truth" in the context of expert consensus is not relevant for this type of device and testing.
4. Adjudication method for the test set
This is not applicable. Adjudication methods like 2+1 or 3+1 typically refer to human expert review processes for medical image interpretation or similar tasks, which is not relevant to the described non-clinical testing.
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
This is not applicable. This document describes a personal lubricant and its non-clinical performance; it does not involve AI or human readers for diagnostic tasks.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a personal lubricant, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the non-clinical testing:
- Condom compatibility: Established by adherence to ASTM D 7661 standards.
- Biocompatibility: Established by adherence to ISO 10993 standards.
- Physical/Chemical properties (viscosity, pH, specific gravity, appearance, color, odor, non-staining): Established through bench testing against internal specifications and comparison to the predicate device.
- Microbial Quality: Established by adherence to USP testing standards.
- Shelf-life: Established by real-time and accelerated aging tests against pre-defined stability criteria.
These are objective, quantifiable measures against established scientific and regulatory standards, rather than subjective "ground truth" derived from expert consensus, pathology, or outcomes data in a clinical sense.
8. The sample size for the training set
This is not applicable. There is no training set mentioned as this is not an AI/ML device.
9. How the ground truth for the training set was established
This is not applicable. There is no ground truth for a training set as this is not an AI/ML device.
§ 884.5300 Condom.
(a)
Identification. A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility.(b)
Classification. (1) Class II (special controls) for condoms made of materials other than natural rubber latex, including natural membrane (skin) or synthetic.(2) Class II (special controls) for natural rubber latex condoms. The guidance document entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300” will serve as the special control. See § 884.1(e) for the availability of this guidance document.