(123 days)
Warming Jelly 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 not compatible with natural rubber latex, polyisoprene, or polyurethane condoms.
Warming Jelly Personal Lubricant is a clear, odorless, non-sterile, water-soluble jelly for use as a personal lubricant. The product imparts a mild warming sensation when applied to the genitalia. Warming Jelly Personal Lubricant can reduce friction during sexual intercourse thereby enhancing sexual intimacy. It is not compatible with natural rubber latex, polyisoprene, or polyurethane condoms as defined by ASTM D7661 - 10 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. Warming Jelly Personal Lubricant is not a contraceptive or spermicide.
The provided documentation describes the non-clinical performance testing of the "Warming Jelly Personal Lubricant" device, primarily to demonstrate its safety and substantial equivalence to a predicate device. It does not detail a study focused on establishing specific performance criteria that would typically be associated with diagnostic or AI-assisted devices (e.g., sensitivity, specificity, AUC).
Instead, the acceptance criteria relate to standard safety and quality control assessments for personal lubricants.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Test/Evaluation | Reported Device Performance |
|---|---|---|
| Biocompatibility | Cytotoxicity evaluation (ISO 10993-5:2009) | Confirmed safe for proposed indication |
| Maximization Test for Delayed Type Hypersensitivity (ISO 10993-10:2010) | Confirmed safe for proposed indication | |
| Vaginal Irritation Test (ISO 10993-10:2010) | Confirmed safe for proposed indication | |
| Acute System Toxicity Test (ISO 10993-11:2006) | Confirmed safe for proposed indication | |
| Condom Compatibility | ASTM D7661-10 Standard Test Method | Not compatible with natural rubber latex, polyisoprene, or polyurethane condoms. (This is a stated characteristic, not a performance target to be met, but rather an outcome that needs to be disclosed for safe use). |
| Stability | Shelf life | 12 months (currently available stability data confirms) |
| Quality Control Release | Appearance/color | Evaluated in lot release testing |
| Odor | Evaluated in lot release testing | |
| Viscosity | Evaluated in lot release testing | |
| Microbiological safety (standard plate count, absence of gram negative bacteria, absence of Pseudomonas, absence of Staphylococcus, yeast and mold count, absence of Candida albicans) | Evaluated in lot release testing | |
| pH | Evaluated in lot release testing | |
| Osmolality | Evaluated in lot release testing | |
| Water activity | Evaluated in lot release testing |
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 does not specify a "test set" in the context of clinical trials or AI/diagnostic device validation where specific patient cohorts are used. The testing described is non-clinical, involving laboratory and material compatibility assessments for a personal lubricant.
Therefore, "sample size" would refer to the number of samples of the lubricant tested for each criterion. This information is not provided in the document.
Data provenance (country of origin, retrospective/prospective) is also not applicable as these are laboratory non-clinical tests, not human studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable. The "ground truth" for these tests is established by standardized laboratory methods (e.g., ISO, ASTM) and analytical measurements, not by expert consensus on clinical cases. The document does not mention human experts establishing ground truth for these non-clinical tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or image interpretation tasks where multiple human readers assess cases and discrepancies need resolution. The described tests are laboratory-based and follow established protocols without the need for 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
This information is not applicable. The device is a personal lubricant, not an AI or diagnostic tool, so such a study would not be performed for this product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a personal lubricant, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As described in point 3, the "ground truth" for the non-clinical tests is established by adhering to standardized testing methodologies (e.g., ISO 10993 for biocompatibility, ASTM D7661-10 for condom compatibility) and quantifiable analytical measurements for quality control parameters (pH, viscosity, etc.). There isn't a "ground truth" in the clinical sense of a diagnosis or outcome.
8. The sample size for the training set
This information is not applicable. This is a non-AI/non-diagnostic device; therefore, there is no "training set."
9. How the ground truth for the training set was established
This information is not applicable. As there is no training set, there is no ground truth for it to be established.
§ 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.