(133 days)
Wet Essential95 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 and polyisoprene condoms. This product is not compatible with polyurethane condoms.
The Wet Essential95 Personal Lubricant is a non-sterile, water-based personal lubricant for penile and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This device is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms. Its formulation consists primarily of 95% aloe barbadensis leaf juice. Wet Essential95 Personal Lubricant is sold as an over-the-counter (OTC) product and is provided in 4 oz and 6 oz HDPE bottles.
The provided document is a 510(k) summary for a medical device (Wet Essential95 Personal Lubricant). It does not describe an AI/ML-driven device or study. Therefore, most of the requested information regarding acceptance criteria for an AI model, data sets, expert involvement, and statistical studies like MRMC, is not applicable to this document.
However, I can extract information related to the device's performance testing and criteria for its intended use as a personal lubricant.
Here's the information that can be extracted or derived from the document:
1. A table of acceptance criteria and the reported device performance:
The document provides specifications that essentially serve as acceptance criteria for the physical and chemical properties of the lubricant, as well as biological and compatibility performance.
| Property | Specification (Acceptance Criteria) | Reported Device Performance (Implied "Meets Specification") |
|---|---|---|
| Appearance | Semi-opaque, particle-free, liquid gel | Met |
| Color | Light tan to brown | Met |
| Odor | Vanilla | Met |
| Viscosity@25°C Spindle LV#3 @20rpm (cps) | 400 cps - 3,200 cps | Met |
| Specific Gravity@25°C per USP | 0.99 – 1.04 | Met |
| pH per USP | 4.5 - 5.5 | Met |
| Osmolality per USP | 150-300 mOsm/kg, 1:10 dilution | Met |
| Antimicrobial effectiveness per USP | Meets USP acceptance criteria for Category 2 products | Demonstrated to meet USP acceptance criteria (implies effective against microbial growth) |
| Total aerobic microbial count (TAMC) per USP and | and | |
| Biocompatibility | Non-cytotoxic, non-irritating, non-sensitizing, non-systemically toxic | Confirmed non-cytotoxic, non-irritating, non-sensitizing, and non-systemically toxic |
| Condom Compatibility (Natural Rubber Latex) | Compatible | Compatible (per ASTM D7661-10(R) 2017) |
| Condom Compatibility (Polyisoprene) | Compatible | Compatible (per ASTM D7661-10(R) 2017) |
| Condom Compatibility (Polyurethane) | Not compatible | Not compatible (per ASTM D7661-10(R) 2017) |
| Shelf-Life | 8.5 months (maintains specifications) | Demonstrated to maintain specifications over 8.5 months (accelerated testing results) |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify exact sample sizes for each test conducted. It states that "testing was conducted" and "results from accelerated testing demonstrated," implying that sufficient samples were used to meet the requirements of the listed standards (e.g., ISO 10993-11, ISO 10993-5, ISO 10993-10, ASTM D7661-10(R) 2017, USP , , , , , ). These standards typically have their own minimum sample size requirements for valid results.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the testing was conducted in accordance with international standards (ISO, ASTM, USP) and FDA guidance, suggesting a robust and controlled testing environment. The data would be considered prospective, as it was generated specifically for this premarket notification.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This concept is not applicable to this type of device and testing. Ground truth in this context refers to the defined specifications and performance standards established by recognized testing methods (e.g., USP monographs, ISO standards, ASTM standards). The "experts" would be the scientists and technicians performing the lab tests according to these established protocols, and their qualifications would be adherence to Good Laboratory Practices (GLP) and expertise in the specific analytical or biological testing methods. No human interpretation of images or clinical data for "ground truth" establishment in the AI/ML sense is mentioned or relevant here.
4. Adjudication method for the test set:
Not applicable. Adjudication methods (e.g., 2+1, 3+1) are common in clinical studies where human readers interpret data, and discrepancies need to be resolved. This document reports on laboratory and bench testing against defined physical, chemical, and biological specifications, which do not involve such adjudication.
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 device is a personal lubricant, not an AI-assisted diagnostic or therapeutic tool. No MRMC study was conducted or relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm-based device.
7. The type of ground truth used:
The "ground truth" for this device's performance validation is the adherence to established physical, chemical, and biological standards and specifications. For instance:
- USP (United States Pharmacopeia) Monographs: for pH, viscosity, osmolality, microbial counts, and antimicrobial effectiveness.
- ISO (International Organization for Standardization) Standards: for biocompatibility (cytotoxicity, irritation, sensitization, systemic toxicity).
- ASTM (American Society for Testing and Materials) Standards: for condom compatibility.
- Developer-defined specifications: for appearance, color, odor, specific gravity, which are then verified through standard analytical methods.
8. The sample size for the training set:
Not applicable. This is a physical product, not an AI/ML model that requires a training set. The "formulation" or "design" process leads to the product, which is then validated. There isn't a "training set" in the computational sense.
9. How the ground truth for the training set was established:
Not applicable. See point 8.
§ 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.