(92 days)
Wet Flavored Personal Lubricants are personal lubricants 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. The product is compatible with natural rubber latex and polyisoprene condoms. The product is not compatible with polyurethane condoms.
The Wet Flavored Personal Lubricants are clear, non-sterile, over-the-counter personal lubricants, formulated to be clear, particle-free, and colorless to slight yellow. The device is designed to supplement the body's own natural lubrication fluids during intimate sexual activity. The product is compatible with natural rubber latex and polyisoprene condoms. The product is not compatible with polyurethane condoms. The device formula is neither a contraceptive nor a spermicide.
The provided document describes the FDA's 510(k) clearance for "Wet Flavored Personal Lubricants," establishing its substantial equivalence to a predicate device. The document does not contain details about a study that adheres to the format of acceptance criteria, test set, ground truth, and human reader performance typically associated with AI/ML diagnostic tools. Instead, it presents performance data for the lubricant itself, focusing on biocompatibility, shelf-life, and condom compatibility.
Here's an analysis based on the information provided, reinterpreting the "acceptance criteria" and "study" to fit the context of this device's clearance:
1. A table of acceptance criteria and the reported device performance
| Property | Acceptance Criteria (Specification) | Reported Device Performance |
|---|---|---|
| Appearance | Particle free | Particle free |
| Color | Colorless to Slight Yellow | Colorless to Slight Yellow |
| Odor | Sweet/Characteristic | Sweet/Characteristic |
| Viscosity (cps) | 200-700 cps | 200-700 cps (Meets specification) |
| Specific Gravity | 1.05 - 1.15 | 1.05 - 1.15 (Meets specification) |
| pH | 5.5-6.8 | 5.5-6.8 (Meets specification) |
| Osmolality | 400-800 mOsm/kg | 400-800 mOsm/kg (Meets specification) |
| Antimicrobial effectiveness per USP | Meets USP acceptance criteria for Category 2 products | Meets USP acceptance criteria for Category 2 products |
| Total aerobic microbial count (TAMC) per USP and | and | : |
| Pseudomonas aeruginosa | Absent | Absent |
| Staphylococcus aureus | Absent | Absent |
| Salmonella | Absent | Absent |
| Escherichia coli | Absent | Absent |
| Candida Albicans | Absent | Absent |
| Biocompatibility | Non-cytotoxic, non-irritating, non-sensitizing, not systemically toxic | Non-cytotoxic, non-irritating, non-sensitizing, not systemically toxic |
| Shelf-Life | 2 years | Shown to have a 2-year shelf-life (accelerated aging confirmed; real-time ongoing) |
| Condom Compatibility | Compatible with natural rubber latex and polyisoprene condoms; not compatible with polyurethane condoms | Compatible with natural rubber latex and polyisoprene condoms; not compatible with polyurethane condoms |
2. Sample sized used for the test set and the data provenance
The document does not specify a "sample size" in the context of a test set for an AI/ML device, nor does it provide data provenance in terms of country of origin or retrospective/prospective nature. Instead, the "test set" would be the samples of the lubricant itself that were subjected to various physical, chemical, and biological tests. The specific quantities of lubricant used for each test are not detailed in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this type of device clearance. "Ground truth" for a personal lubricant is established through objective laboratory testing against recognized standards (e.g., USP monographs, ASTM standards, ISO standards for biocompatibility), not by expert consensus in the way a diagnostic AI/ML algorithm's performance is often evaluated. The experts involved would be laboratory technicians and scientists performing the tests, but their number and specific qualifications are not detailed here.
4. Adjudication method for the test set
Not applicable. This concept is typically relevant for subjective assessments in AI/ML performance evaluation where a consensus among human experts is needed. For the lubricant, the results are objective measurements or categorical determinations (e.g., "absent," "meets criteria").
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. There are no human readers or AI assistance involved in evaluating the lubricant's performance in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an AI/ML algorithm. The performance evaluation is inherently "standalone" in the sense that the device's properties are measured directly without human interpretation influencing the measurement outcome (though humans operate the testing equipment).
7. The type of ground truth used
The ground truth for this device is based on:
- Objective laboratory measurements and chemical/physical properties: For appearance, color, odor, viscosity, specific gravity, pH, and osmolality.
- Established microbiological standards: USP , , , for antimicrobial effectiveness and microbial counts/absence of pathogens.
- International biological evaluation standards: ISO 10993 series for biocompatibility.
- ASTM standards: For condom compatibility (ASTM D7661-18, ASTM D3492-16).
These standards and measurements define the "ground truth" for whether the product meets its specifications and safety requirements.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no concept of a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of 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.